[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2005 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          
          
          21


          Part 1300 to End

                         Revised as of April 1, 2005


          Food and Drugs
          
          


________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2005
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

[[Page ii]]

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 21:
          Chapter II--Drug Enforcement Administration, 
          Department of Justice                                      3
          Chapter III--Office of National Drug Control Policy      191
  Finding Aids:
      Material Approved for Incorporation by Reference........     263
      Table of CFR Titles and Chapters........................     265
      Alphabetical List of Agencies Appearing in the CFR......     283
      List of CFR Sections Affected...........................     293

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                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 1300.01 
                       refers to title 21, part 
                       1300, section 01.

                     ----------------------------

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                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 2005), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate 
volumes. For the period beginning January 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call 202-741-6010.

CFR INDEXES AND TABULAR GUIDES

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separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

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appearing in the Code of Federal Regulations.

INQUIRIES

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                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

April 1, 2005.

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                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The 
first eight volumes, containing parts 1-1299, comprise Chapter I--Food 
and Drug Administration, Department of Health and Human Services. The 
ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2005.

    For this volume, Elmer Barksdale was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Frances D. McDonald, assisted by Alomha S. Morris.

[[Page 1]]



                         TITLE 21-FOOD AND DRUGS




                  (This book contains part 1300 to End)

  --------------------------------------------------------------------
                                                                    Part

chapter ii--Drug Enforcement Administration, Department of 
  Justice...................................................        1301

chapter iii--Office of National Drug Control Policy.........        1401

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   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE




  --------------------------------------------------------------------
Part                                                                Page
1300            Definitions.................................           5
1301            Registration of manufacturers, distributors, 
                    and dispensers of controlled substances.          13
1302            Labeling and packaging requirements for 
                    controlled substances...................          43
1303            Quotas......................................          44
1304            Records and reports of registrants..........          52
1305            Order forms (Eff. until May 31, 2005).......          66
1305            Orders for schedule I and II controlled 
                    substances (Eff. May 31, 2005)..........          72
1306            Prescriptions...............................          78
1307            Miscellaneous...............................          88
1308            Schedules of controlled substances..........          91
1309            Registration of manufacturers, distributors, 
                    importers and exporters of list I 
                    chemicals...............................         110
1310            Records and reports of listed chemicals and 
                    certain machines........................         121
1311            Digital Certificates........................         141
1312            Importation and exportation of controlled 
                    substances..............................         147
1313            Importation and exportation of precursors 
                    and essential chemicals.................         160
1314-1315       [Reserved]
1316            Administrative functions, practices, and 
                    procedures..............................         167

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PART 1300_DEFINITIONS--Table of Contents

Sec.
1300.01 Definitions relating to controlled substances.
1300.02 Definitions relating to listed chemicals.

    Authority: 21 U.S.C. 802, 871(b), 951, 958(f)

    Source: 62 FR 13941, Mar. 24, 1997, unless otherwise noted.



Sec. 1300.01  Definitions relating to controlled substances.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802), except that certain 
terms used in part 1316 of this chapter are defined at the beginning of 
each subpart of that part.
    (b) As used in parts 1301 through 1308 and part 1312 of this 
chapter, the following terms shall have the meanings specified:
    (1) The term Act means the Controlled Substances Act, as amended (84 
Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and 
Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).
    (2) The term Administration means the Drug Enforcement 
Administration.
    (3) The term Administrator means the Administrator of the Drug 
Enforcement Administration. The Administrator has been delegated 
authority under the Act by the Attorney General (28 CFR 0.100).
    (4) The term anabolic steroid means any drug or hormonal substance, 
chemically and pharmacologically related to testosterone (other than 
estrogens, progestins, and corticosteroids) that promotes muscle growth, 
and includes:
    (i) Boldenone;
    (ii) Chlorotestosterone (4-chlortestosterone);
    (iii) Clostebol;
    (iv) Dehydrochlormethyltestosterone;
    (v) Dihydrotestosterone (4-dihydrotestosterone);
    (vi) Drostanolone;
    (vii) Ethylestrenol;
    (viii) Fluoxymesterone;
    (ix) Formebulone (formebolone);
    (x) Mesterolone;
    (xi) Methandienone;
    (xii) Methandranone;
    (xiii) Methandriol;
    (xiv) Methandrostenolone;
    (xv) Methenolone;
    (xvi) Methyltestosterone;
    (xvii) Mibolerone;
    (xviii) Nandrolone;
    (xix) Norethandrolone;
    (xx) Oxandrolone;
    (xxi) Oxymesterone;
    (xxii) Oxymetholone;
    (xxiii) Stanolone;
    (xxiv) Stanozolol;
    (xxv) Testolactone;
    (xxvi) Testosterone;
    (xxvii) Trenbolone; and
    (xxviii) Any salt, ester, or isomer of a drug or substance described 
or listed in this paragraph, if that salt, ester, or isomer promotes 
muscle growth. Except such term does not include an anabolic steroid 
which is expressly intended for administration through implants to 
cattle or other nonhuman species and which has been approved by the 
Secretary of Health and Human Services for such administration. If any 
person prescribes, dispenses, or distributes such steroid for human use, 
such person shall be considered to have prescribed, dispensed, or 
distributed an anabolic steroid within the meaning of this paragraph.
    (5) The term basic class means, as to controlled substances listed 
in Schedules I and II:
    (i) Each of the opiates, including its isomers, esters, ethers, 
salts, and salts of isomers, esters, and ethers whenever the existence 
of such isomers, esters, ethers, and salts is possible within the 
specific chemical designation, listed in Sec. 1308.11(b) of this 
chapter;
    (ii) Each of the opium derivatives, including its salts, isomers, 
and salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation, 
listed in Sec. 1308.11(c) of this chapter;
    (iii) Each of the hallucinogenic substances, including its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation, listed in Sec. 1308.11(d) of this chapter;
    (iv) Each of the following substances, whether produced directly or 
indirectly

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by extraction from substances of vegetable origin, or independently by 
means of chemical synthesis, or by a combination of extraction and 
chemical synthesis:
    (A) Opium, including raw opium, opium extracts, opium fluid 
extracts, powdered opium, granulated opium, deodorized opium and 
tincture of opium;
    (B) Apomorphine;
    (C) Codeine;
    (D) Etorphine hydrochloride;
    (E) Ethylmorphine;
    (F) Hydrocodone;
    (G) Hydromorphone;
    (H) Metopon;
    (I) Morphine;
    (J) Oxycodone;
    (K) Oxymorphone;
    (L) Thebaine;
    (M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of this 
chapter;
    (N) Cocaine; and
    (O) Ecgonine;
    (v) Each of the opiates, including its isomers, esters, ethers, 
salts, and salts of isomers, esters, and ethers whenever the existence 
of such isomers, esters, ethers, and salts is possible within the 
specific chemical designation, listed in Sec. 1308.12(c) of this 
chapter; and
    (vi) Methamphetamine, its salts, isomers, and salts of its isomers;
    (vii) Amphetamine, its salts, optical isomers, and salts of its 
optical isomers;
    (viii) Phenmetrazine and its salts;
    (ix) Methylphenidate;
    (x) Each of the substances having a depressant effect on the central 
nervous system, including its salts, isomers, and salts of isomers 
whenever the existence of such salts, isomers, and salts of isomers is 
possible within the specific chemical designation, listed in Sec. 
1308.12(e) of this chapter.
    (6) The term commercial container means any bottle, jar, tube, 
ampule, or other receptacle in which a substance is held for 
distribution or dispensing to an ultimate user, and in addition, any box 
or package in which the receptacle is held for distribution or 
dispensing to an ultimate user. The term commercial container does not 
include any package liner, package insert or other material kept with or 
within a commercial container, nor any carton, crate, drum, or other 
package in which commercial containers are stored or are used for 
shipment of controlled substances.
    (7) The term compounder means any person engaging in maintenance or 
detoxification treatment who also mixes, prepares, packages or changes 
the dosage form of a narcotic drug listed in Schedules II, III, IV or V 
for use in maintenance or detoxification treatment by another narcotic 
treatment program.
    (8) The term controlled substance has the meaning given in section 
802(6) of Title 21, United States Code (U.S.C.).
    (9) The term customs territory of the United States means the 
several States, the District of Columbia, and Puerto Rico.
    (10) The term detoxification treatment means the dispensing, for a 
period of time as specified below, of a narcotic drug or narcotic drugs 
in decreasing doses to an individual to alleviate adverse physiological 
or psychological effects incident to withdrawal from the continuous or 
sustained use of a narcotic drug and as a method of bringing the 
individual to a narcotic drug-free state within such period of time. 
There are two types of detoxification treatment: Short-term 
detoxification treatment and long-term detoxification treatment.
    (i) Short-term detoxification treatment is for a period not in 
excess of 30 days.
    (ii) Long-term detoxification treatment is for a period more than 30 
days but not in excess of 180 days.
    (11) The term dispenser means an individual practitioner, 
institutional practitioner, pharmacy or pharmacist who dispenses a 
controlled substance.
    (12) The term export means, with respect to any article, any taking 
out or removal of such article from the jurisdiction of the United 
States (whether or not such taking out or removal constitutes an 
exportation within the meaning of the customs and related laws of the 
United States).
    (13) The term exporter includes every person who exports, or who 
acts as an export broker for exportation of, controlled substances 
listed in any schedule.
    (14) The term hearing means:
    (i) In part 1301 of this chapter, any hearing held for the granting, 
denial,

[[Page 7]]

revocation, or suspension of a registration pursuant to sections 303, 
304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
    (ii) In part 1303 of this chapter, any hearing held regarding the 
determination of aggregate production quota or the issuance, adjustment, 
suspension, or denial of a procurement quota or an individual 
manufacturing quota.
    (iii) In part 1308 of this chapter, any hearing held for the 
issuance, amendment, or repeal of any rule issuable pursuant to section 
201 of the Act (21 U.S.C. 811).
    (15) The term import means, with respect to any article, any 
bringing in or introduction of such article into either the jurisdiction 
of the United States or the customs territory of the United States, and 
from the jurisdiction of the United States into the customs territory of 
the United States (whether or not such bringing in or introduction 
constitutes an importation within the meaning of the tariff laws of the 
United States).
    (16) The term importer includes every person who imports, or who 
acts as an import broker for importation of, controlled substances 
listed in any schedule.
    (17) The term individual practitioner means a physician, dentist, 
veterinarian, or other individual licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which he/she 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacist, a pharmacy, or 
an institutional practitioner.
    (18) The term institutional practitioner means a hospital or other 
person (other than an individual) licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which it 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacy.
    (19) The term interested person means any person adversely affected 
or aggrieved by any rule or proposed rule issuable pursuant to section 
201 of the Act (21 U.S.C. 811).
    (20) The term inventory means all factory and branch stocks in 
finished form of a basic class of controlled substance manufactured or 
otherwise acquired by a registrant, whether in bulk, commercial 
containers, or contained in pharmaceutical preparations in the 
possession of the registrant (including stocks held by the registrant 
under separate registration as a manufacturer, importer, exporter, or 
distributor).
    (21) The term isomer means the optical isomer, except as used in 
Sec. 1308.11(d) and Sec. 1308.12(b)(4) of this chapter. As used in 
Sec. 1308.11(d) of this chapter, the term isomer means the optical, 
positional, or geometric isomer. As used in Sec. 1308.12(b)(4) of this 
chapter, the term isomer means the optical or geometric isomer.
    (22) The term jurisdiction of the United States means the customs 
territory of the United States, the Virgin Islands, the Canal Zone, 
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
    (23) The term label means any display of written, printed, or 
graphic matter placed upon the commercial container of any controlled 
substance by any manufacturer of such substance.
    (24) The term labeling means all labels and other written, printed, 
or graphic matter:
    (i) Upon any controlled substance or any of its commercial 
containers or wrappers, or
    (ii) Accompanying such controlled substance.
    (25) The term Long Term Care Facility (LTCF) means a nursing home, 
retirement care, mental care or other facility or institution which 
provides extended health care to resident patients.
    (26) The term maintenance treatment means the dispensing for a 
period in excess of twenty-one days, of a narcotic drug or narcotic 
drugs in the treatment of an individual for dependence upon heroin or 
other morphine-like drug.
    (27) The term manufacture means the producing, preparation, 
propagation, compounding, or processing of a drug or other substance or 
the packaging or repackaging of such substance, or the labeling or 
relabeling of the commercial container of such substance, but does not 
include the activities of a practitioner who, as an incident to his/her 
administration or dispensing such

[[Page 8]]

substance in the course of his/her professional practice, prepares, 
compounds, packages or labels such substance. The term manufacturer 
means a person who manufactures a drug or other substance, whether under 
a registration as a manufacturer or under authority of registration as a 
researcher or chemical analyst.
    (28) The term mid-level practitioner means an individual 
practitioner, other than a physician, dentist, veterinarian, or 
podiatrist, who is licensed, registered, or otherwise permitted by the 
United States or the jurisdiction in which he/she practices, to dispense 
a controlled substance in the course of professional practice. Examples 
of mid-level practitioners include, but are not limited to, health care 
providers such as nurse practitioners, nurse midwives, nurse 
anesthetists, clinical nurse specialists and physician assistants who 
are authorized to dispense controlled substances by the state in which 
they practice.
    (29) The term name means the official name, common or usual name, 
chemical name, or brand name of a substance.
    (30) The term narcotic drug means any of the following whether 
produced directly or indirectly by extraction from substances of 
vegetable origin or independently by means of chemical synthesis or by a 
combination of extraction and chemical synthesis:
    (i) Opium, opiates, derivatives of opium and opiates, including 
their isomers, esters, ethers, salts, and salts of isomers, esters, and 
ethers whenever the existence of such isomers, esters, ethers and salts 
is possible within the specific chemical designation. Such term does not 
include the isoquinoline alkaloids of opium.
    (ii) Poppy straw and concentrate of poppy straw.
    (iii) Coca leaves, except coca leaves and extracts of coca leaves 
from which cocaine, ecgonine and derivatives of ecgonine or their salts 
have been removed.
    (iv) Cocaine, its salts, optical and geometric isomers, and salts of 
isomers.
    (v) Ecgonine, its derivatives, their salts, isomers and salts of 
isomers.
    (vi) Any compound, mixture, or preparation which contains any 
quantity of any of the substances referred to in paragraphs (b)(31)(i) 
through (v) of this section.
    (31) The term narcotic treatment program means a program engaged in 
maintenance and/or detoxification treatment with narcotic drugs.
    (32) The term net disposal means, for a stated period, the quantity 
of a basic class of controlled substance distributed by the registrant 
to another person, plus the quantity of that basic class used by the 
registrant in the production of (or converted by the registrant into) 
another basic class of controlled substance or a noncontrolled 
substance, plus the quantity of that basic class otherwise disposed of 
by the registrant, less the quantity of that basic class returned to the 
registrant by any purchaser, and less the quantity of that basic class 
distributed by the registrant to another registered manufacturer of that 
basic class for purposes other than use in the production of, or 
conversion into, another basic class of controlled substance or a 
noncontrolled substance or in the manufacture of dosage forms of that 
basic class.
    (33) The term pharmacist means any pharmacist licensed by a State to 
dispense controlled substances, and shall include any other person 
(e.g., pharmacist intern) authorized by a State to dispense controlled 
substances under the supervision of a pharmacist licensed by such State.
    (34) The term person includes any individual, corporation, 
government or governmental subdivision or agency, business trust, 
partnership, association, or other legal entity.
    (35) The term prescription means an order for medication which is 
dispensed to or for an ultimate user but does not include an order for 
medication which is dispensed for immediate administration to the 
ultimate user. (e.g., an order to dispense a drug to a bed patient for 
immediate administration in a hospital is not a prescription.)
    (36) The term proceeding means all actions taken for the issuance, 
amendment, or repeal of any rule issued pursuant to section 201 of the 
Act (21 U.S.C. 811), commencing with the publication by the 
Administrator of the

[[Page 9]]

proposed rule, amended rule, or repeal in the Federal Register.
    (37) The term purchaser means any registered person entitled to 
obtain and execute order forms pursuant to Sec. Sec. 1305.04 and 
1305.06.
    (38) The term readily retrievable means that certain records are 
kept by automatic data processing systems or other electronic or 
mechanized recordkeeping systems in such a manner that they can be 
separated out from all other records in a reasonable time and/or records 
are kept on which certain items are asterisked, redlined, or in some 
other manner visually identifiable apart from other items appearing on 
the records.
    (39) The terms register and registration refer only to registration 
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 
or 957).
    (40) The term registrant means any person who is registered pursuant 
to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
    (41) The term reverse distributor means a registrant who receives 
controlled substances acquired from another DEA registrant for the 
purpose of--
    (i) Returning unwanted, unusable, or outdated controlled substances 
to the manufacturer or the manufacturer's agent; or
    (ii) Where necessary, processing such substances or arranging for 
processing such substances for disposal.
    (42) The term supplier means any registered person entitled to fill 
order forms pursuant to Sec. 1305.08 of this chapter.
    (43) The term freight forwarding facility means a separate facility 
operated by a distributing registrant through which sealed, packaged 
controlled substances in unmarked shipping containers (i.e., the 
containers do not indicate that the contents include controlled 
substances) are, in the course of delivery to, or return from, 
customers, transferred in less than 24 hours. A distributing registrant 
who operates a freight forwarding facility may use the facility to 
transfer controlled substances from any location the distributing 
registrant operates that is registered with the Administration to 
manufacture, distribute, or import controlled substances, or, with 
respect to returns, registered to dispense controlled substances, 
provided that the notice required by Sec. 1301.12(b)(4) of Part 1301 of 
this chapter has been submitted and approved. For purposes of this 
definition, a distributing registrant is a person who is registered with 
the Administration as a manufacturer, distributor, and/or importer.
    (44) The term central fill pharmacy means a pharmacy which is 
permitted by the state in which it is located to prepare controlled 
substances orders for dispensing pursuant to a valid prescription 
transmitted to it by a registered retail pharmacy and to return the 
labeled and filled prescriptions to the retail pharmacy for delivery to 
the ultimate user. Such central fill pharmacy shall be deemed 
``authorized'' to fill prescriptions on behalf of a retail pharmacy only 
if the retail pharmacy and central fill pharmacy have a contractual 
relationship providing for such activities or share a common owner.

[62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 
68 FR 37409, June 24, 2003; 68 FR 41228, July 11, 2003]



Sec. 1300.02  Definitions relating to listed chemicals.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802), except that certain 
terms used in part 1316 of this chapter are defined at the beginning of 
each subpart of that part.
    (b) As used in parts 1309, 1310, and 1313 of this chapter, the 
following terms shall have the meaning specified:
    (1) The term Act means the Controlled Substances Act, as amended (84 
Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and 
Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951) as amended.
    (2) The term Administration means the Drug Enforcement 
Administration.
    (3) The term Administrator means the Administrator of the Drug 
Enforcement Administration. The Administrator has been delegated 
authority under the Act by the Attorney General (28 CFR 0.100).
    (4) The terms broker and trader mean any individual, corporation, 
corporate division, partnership, association, or

[[Page 10]]

other legal entity which assists in arranging an international 
transaction in a listed chemical by--
    (i) Negotiating contracts;
    (ii) Serving as an agent or intermediary; or
    (iii) Fulfilling a formal obligation to complete the transaction by 
bringing together a buyer and seller, a buyer and transporter, or a 
seller and transporter, or by receiving any form of compensation for so 
doing.
    (5) The term chemical export means transferring ownership or 
control, or the sending or taking of threshold quantities of listed 
chemicals out of the United States (whether or not such sending or 
taking out constitutes an exportation within the meaning of the Customs 
and related laws of the United States).
    (6) The term chemical exporter is a regulated person who, as the 
principal party in interest in the export transaction, has the power and 
responsibility for determining and controlling the sending of the listed 
chemical out of the United States.
    (7) The term chemical import means with respect to a listed 
chemical, any bringing in or introduction of such listed chemical into 
either the jurisdiction of the United States or into the Customs 
territory of the United States (whether or not such bringing in or 
introduction constitutes an importation within the meaning of the tariff 
laws of the United States).
    (8) The term chemical importer is a regulated person who, as the 
principal party in interest in the import transaction, has the power and 
responsibility for determining and controlling the bringing in or 
introduction of the listed chemical into the United States.
    (9) The term chemical mixture means a combination of two or more 
chemical substances, at least one of which is not a listed chemical, 
except that such term does not include any combination of a listed 
chemical with another chemical that is present solely as an impurity or 
which has been created to evade the requirements of the Act.
    (10) The term customs territory of the United States means the 
several States, the District of Columbia, and Puerto Rico.
    (11) The term encapsulating machine means any manual, semi-
automatic, or fully automatic equipment which may be used to fill shells 
or capsules with any powdered, granular, semi-solid, or liquid material.
    (12) The term established business relationship with a foreign 
customer means the regulated person has exported a listed chemical at 
least once within the past six months, or twice within the past twelve 
months to a foreign manufacturer, distributor, or end user of the 
chemical that has an established business in the foreign country with a 
fixed street address. A person or business which functions as a broker 
or intermediary is not a customer for purposes of this definition. The 
term also means that the regulated person has provided the 
Administration with the following information in accordance with the 
waiver of 15-day advance notice requirements of Sec. 1313.24 of this 
chapter:
    (i) The name and street address of the chemical exporter and of each 
regular customer;
    (ii) The telephone number, telex number, contact person, and where 
available, the facsimile number for the chemical exporter and for each 
regular customer;
    (iii) The nature of the regular customer's business (i.e., importer, 
exporter, distributor, manufacturer, etc.), and if known, the use to 
which the listed chemical or chemicals will be applied;
    (iv) The duration of the business relationship;
    (v) The frequency and number of transactions occurring during the 
preceding 12-month period;
    (vi) the amounts and the listed chemical or chemicals involved in 
regulated transactions between the chemical exporter and regular 
customer;
    (vii) The method of delivery (direct shipment or through a broker or 
forwarding agent); and
    (viii) Other information that the chemical exporter considers 
relevant for determining whether a customer is a regular customer.
    (13) The term established record as an importer means that the 
regulated person has imported a listed chemical at least once within the 
past six months,

[[Page 11]]

or twice within the past twelve months from a foreign supplier. The term 
also means that the regulated person has provided the Administration 
with the following information in accordance with the waiver of the 15-
day advance notice requirements of Sec. 1313.15 of this chapter:
    (i) The name, DEA registration number (where applicable), street 
address, telephone number, telex number, and, where available, the 
facsimile number of the regulated person and of each foreign supplier; 
and
    (ii) The frequency and number of transactions occurring during the 
preceding 12 month period.
    (14) The term hearing means any hearing held for the granting, 
denial, revocation, or suspension of a registration pursuant to sections 
303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
    (15) The term international transaction means a transaction 
involving the shipment of a listed chemical across an international 
border (other than a United States border) in which a broker or trader 
located in the United States participates.
    (16) The term jurisdiction of the United States means the customs 
territory of the United States, the Virgin Islands, the Canal Zone, 
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
    (17) The term listed chemical means any List I chemical or List II 
chemical.
    (18) The term List I chemical means a chemical specifically 
designated by the Administrator in Sec. 1310.02(a) of this chapter 
that, in addition to legitimate uses, is used in manufacturing a 
controlled substance in violation of the Act and is important to the 
manufacture of a controlled substance.
    (19) The term List II chemical means a chemical, other than a List I 
chemical, specifically designated by the Administrator in Sec. 
1310.02(b) of this chapter that, in addition to legitimate uses, is used 
in manufacturing a controlled substance in violation of the Act.
    (20) The term name means the official name, common or usual name, 
chemical name, or brand name of a substance.
    (21) The term person includes any individual, corporation, 
government or governmental subdivision or agency, business trust, 
partnership, association, or other legal entity.
    (22) The term readily retrievable means that certain records are 
kept by automatic data processing systems or other electronic or 
mechanized recordkeeping systems in such a manner that they can be 
separated out from all other records in a reasonable time and/or records 
are kept on which certain items are asterisked, redlined, or in some 
other manner visually identifiable apart from other items appearing on 
the records.
    (23) The terms register and registration refer only to registration 
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 
or 957).
    (24) The term registrant means any person who is registered pursuant 
to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
    (25) The term regular customer means a person with whom the 
regulated person has an established business relationship for a 
specified listed chemical or chemicals that has been reported to the 
Administration subject to the criteria established in Sec. 
1300.02(b)(12).
    (26) The term regular importer means, with respect to a listed 
chemical, a person that has an established record as an importer of that 
listed chemical that is reported to the Administrator.
    (27) The term regulated person means any individual, corporation, 
partnership, association, or other legal entity who manufactures, 
distributes, imports, or exports a listed chemical, a tableting machine, 
or an encapsulating machine, or who acts as a broker or trader for an 
international transaction involving a listed chemical, tableting 
machine, or encapsulating machine.
    (28) The term regulated transaction means:
    (i) A distribution, receipt, sale, importation, or exportation of a 
listed chemical, or an international transaction involving shipment of a 
listed chemical, or if the Administrator establishes a threshold amount 
for a specific listed chemical, a threshold amount as determined by the 
Administrator, which includes a cumulative threshold amount for multiple 
transactions, of a listed chemical, except that such term does not 
include:

[[Page 12]]

    (A) A domestic lawful distribution in the usual course of business 
between agents or employees of a single regulated person; in this 
context, agents or employees means individuals under the direct 
management and control of the regulated person;
    (B) A delivery of a listed chemical to or by a common or contract 
carrier for carriage in the lawful and usual course of the business of 
the common or contract carrier, or to or by a warehouseman for storage 
in the lawful and usual course of the business of the warehouseman, 
except that if the carriage or storage is in connection with the 
distribution, importation, or exportation of a listed chemical to a 
third person, this paragraph does not relieve a distributor, importer, 
or exporter from compliance with parts 1309, 1310, and 1313 of this 
chapter;
    (C) Any category of transaction or any category of transaction for a 
specific listed chemical or chemicals specified by regulation of the 
Administrator as excluded from this definition as unnecessary for 
enforcement of the Act;
    (D) Any transaction in a listed chemical that is contained in a drug 
that may be marketed or distributed lawfully in the United States under 
the Federal Food, Drug, and Cosmetic Act unless--
    (1)(i) the drug contains ephedrine or its salts, optical isomers, or 
salts of optical isomers, pseudoephedrine or its salts, optical isomers, 
or salts of optical isomers, or phenylpropanolamine or its salts, 
optical isomers, or salts of optical isomers unless otherwise exempted 
under Sec. 1310.11 of this chapter, except that any sale of ordinary 
over-the-counter pseudoephedrine or phenylpropanolamine products by 
retail distributors shall not be a regulated transaction; or
    (ii) The Administrator has determined pursuant to the criteria in 
Sec. 1310.10 of this chapter that the drug or group of drugs is being 
diverted to obtain the listed chemical for use in the illicit production 
of a controlled substance; and
    (2) The quantity of ephedrine, pseudoephedrine, phenylpropanolamine, 
or other listed chemical contained in the drug included in the 
transaction or multiple transactions equals or exceeds the threshold 
established for that chemical, except that the threshold for any sale of 
products containing pseudoephedrine or phenylpropanolamine by retail 
distributors or by distributors required to submit reports by Sec. 
1310.03(c) shall be 9 grams of pseudoephedrine or 9 grams of 
phenylpropanolamine in a single transaction and sold in package sizes of 
not more than 3 grams of pseudoephedrine base or 3 grams of 
phenylpropanolamine base. For combination ephedrine products the 
threshold for any sale by retail distributors or by distributors 
required to submit reports by Sec. 1310.03(c) shall be 24 grams of 
ephedrine in a single transaction.
    (E) Any transaction in a chemical mixture designated in Sec. 
1310.12 and Sec. 1310.13 that the Administrator has exempted from 
regulation.
    (ii) A distribution, importation, or exportation of a tableting 
machine or encapsulating machine except that such term does not include 
a domestic lawful distribution in the usual course of business between 
agents and employees of a single regulated person; in this context, 
agents or employees means individuals under the direct management and 
control of the regulated person.
    (29) The term retail distributor means a grocery store, general 
merchandise store, drug store, or other entity or person whose 
activities as a distributor relating to drug products containing 
pseudoephedrine, phenylpropanolamine, or ephedrine are limited almost 
exclusively to sales for personal use, both in number of sales and 
volume of sales, either directly to walk-in customers or in face-to-face 
transactions by direct sales. For the purposes of this paragraph, sale 
for personal use means the distribution of below-threshold quantities in 
a single transaction to an individual for legitimate medical use. Also 
for the purposes of this paragraph, a grocery store is an entity within 
Standard Industrial Classification (SIC) code 5411, a general 
merchandise store is an entity within SIC codes 5300 through 5399 and 
5499, and a drug store is an entity within SIC code 5912.
    (30) The term tableting machine means any manual, semi-automatic, or 
fully automatic equipment which may be

[[Page 13]]

used for the compaction or molding of powdered or granular solids, or 
semi-solid material, to produce coherent solid tablets.
    (31) The term ordinary over-the-counter pseudoephedrine or 
phenylpropanolamine product means any product containing pseudoephedrine 
or phenylpropanolamine that is--
    (i) Regulated pursuant to the Act; and
    (ii)(A) Except for liquids, sold in package sizes of not more than 
3.0 grams of pseudoephedrine base or 3.0 grams of phenylpropanolamine 
base, and that is packaged in blister packs, each blister containing not 
more than two dosage units, or where the use of blister packs is 
technically infeasible, that is packaged in unit dose packets or 
pouches, and
    (B) For liquids, sold in package sizes of not more than 3.0 grams of 
pseudoephedrine base or 3.0 grams of phenylpropanolamine base.
    (32) The term combination ephedrine product means a drug product 
containing ephedrine or its salts, optical isomers, or salts of optical 
isomers, and therapeutically significant quantities of another active 
medicinal ingredient.
    (33) The term drug product means an active ingredient in dosage form 
that has been approved or otherwise may be lawfully marketed under the 
Food, Drug, and Cosmetic Act for distribution in the United States.
    (34) The term valid prescription means a prescription that is issued 
for a legitimate medical purpose by an individual practitioner licensed 
by law to administer and prescribe the drugs concerned and acting in the 
usual course of the practitioner's professional practice.

[62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. 1, 1997; 67 FR 14859, 
Mar. 28, 2002, as amended at 68 FR 23203, May 1, 2003; 68 FR 57803, Oct. 
7, 2003]



PART 1301_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS 
OF CONTROLLED SUBSTANCES--Table of Contents

                           General Information

Sec.
1301.01 Scope of this part 1301.
1301.02 Definitions.
1301.03 Information; special instructions.

                              Registration

1301.11 Persons required to register.
1301.12 Separate registrations for separate locations.
1301.13 Application for registration; time for application; expiration 
          date; registration for independent activities; application 
          forms, fees, contents and signature; coincident activities.
1301.14 Filing of application; acceptance for filing; defective 
          applications.
1301.15 Additional information.
1301.16 Amendments to and withdrawal of applications.
1301.17 Special procedures for certain applications.
1301.18 Research protocols.

                   Exceptions to Registration and Fees

1301.21 Exception from fees.
1301.22 Exemption of agents and employees; affiliated practitioners.
1301.23 Exemption of certain military and other personnel.
1301.24 Exemption of law enforcement officials.
1301.25 Registration regarding ocean vessels, aircraft, and other 
          entities.
1301.26 Exemptions from import or export requirements for personal 
          medical use.

  Action on Application for Registration: Revocation or Suspension of 
                              Registration

1301.31 Administrative review generally.
1301.32 Action on applications for research in Schedule I substances.
1301.33 Application for bulk manufacture of Schedule I and II 
          substances.
1301.34 Application for importation of Schedule I and II substances.
1301.35 Certificate of registration; denial of registration.
1301.36 Suspension or revocation of registration; suspension of 
          registration pending final order; extension of registration 
          pending final order.
1301.37 Order to show cause.

                                Hearings

1301.41 Hearings generally.
1301.42 Purpose of hearing.
1301.43 Request for hearing or appearance; waiver.
1301.44 Burden of proof.
1301.45 Time and place of hearing.
1301.46 Final order.

         Modification, Transfer, and Termination of Registration

1301.51 Modification in registration.

[[Page 14]]

1301.52 Termination of registration; transfer of registration; 
          distribution upon discontinuance of business.

                          Security Requirements

1301.71 Security requirements generally.
1301.72 Physical security controls for nonpractitioners; narcotic 
          treatment programs and compounders for narcotic treatment 
          programs; storage areas.
1301.73 Physical security controls for nonpractitioners; compounders for 
          narcotic treatment programs; manufacturing and compounding 
          areas.
1301.74 Other security controls for nonpractitioners; narcotic treatment 
          programs and compounders for narcotic treatment programs.
1301.75 Physical security controls for practitioners.
1301.76 Other security controls for practitioners.
1301.77 Security controls for freight forwarding facilities.

                  Employee Screening--Non-Practitioners

1301.90 Employee screening procedures.
1301.91 Employee responsibility to report drug diversion.
1301.92 Illicit activities by employees.
1301.93 Sources of information for employee checks.

    Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 951, 952, 
953, 956, 957.

    Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information



Sec. 1301.01  Scope of this part 1301.

    Procedures governing the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances pursuant to sections 301-304 and 1007-1008 of the Act (21 
U.S.C. 821-824 and 957-958) are set forth generally by those sections 
and specifically by the sections of this part.

[62 FR 13945, Mar. 24, 1997]



Sec. 1301.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13945, Mar. 24, 1997]



Sec. 1301.03  Information; special instructions.

    Information regarding procedures under these rules and instructions 
supplementing these rules will be furnished upon request by writing to 
the Registration Unit, Drug Enforcement Administration, Department of 
Justice, Post Office Box 28083, Central Station, Washington, DC 20005.

[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 23, 1973, 
and amended at 51 FR 5319, Feb. 13, 1986]

                              Registration



Sec. 1301.11  Persons required to register.

    (a) Every person who manufactures, distributes, dispenses, imports, 
or exports any controlled substance or who proposes to engage in the 
manufacture, distribution, dispensing, importation or exportation of any 
controlled substance shall obtain a registration unless exempted by law 
or pursuant to Sec. Sec. 1301.22-1301.26. Only persons actually engaged 
in such activities are required to obtain a registration; related or 
affiliated persons who are not engaged in such activities are not 
required to be registered. (For example, a stockholder or parent 
corporation of a corporation manufacturing controlled substances is not 
required to obtain a registration.)
    (b) [Reserved]

[62 FR 13945, Mar. 24, 1997]



Sec. 1301.12  Separate registrations for separate locations.

    (a) A separate registration is required for each principal place of 
business or professional practice at one general physical location where 
controlled substances are manufactured, distributed, imported, exported, 
or dispensed by a person.
    (b) The following locations shall be deemed not to be places where 
controlled substances are manufactured, distributed, or dispensed:
    (1) A warehouse where controlled substances are stored by or on 
behalf of a registered person, unless such substances are distributed 
directly from such warehouse to registered locations other than the 
registered location from which the substances were delivered or to 
persons not required to register by

[[Page 15]]

virtue of subsection 302(c)(2) or subsection 1007(b)(1)(B) of the Act 
(21 U.S.C. 822(c)(2) or 957(b)(1)(B));
    (2) An office used by agents of a registrant where sales of 
controlled substances are solicited, made, or supervised but which 
neither contains such substances (other than substances for display 
purposes or lawful distribution as samples only) nor serves as a 
distribution point for filling sales orders; and
    (3) An office used by a practitioner (who is registered at another 
location) where controlled substances are prescribed but neither 
administered nor otherwise dispensed as a regular part of the 
professional practice of the practitioner at such office, and where no 
supplies of controlled substances are maintained.
    (4) A freight forwarding facility, as defined in Sec. 1300.01 of 
this part, provided that the distributing registrant operating the 
facility has submitted written notice of intent to operate the facility 
by registered mail, return receipt requested (or other suitable means of 
documented delivery) and such notice has been approved. The notice shall 
be submitted to the Special Agent in Charge of the Administration's 
offices in both the area in which the facility is located and each area 
in which the distributing registrant maintains a registered location 
that will transfer controlled substances through the facility. The 
notice shall detail the registered locations that will utilize the 
facility, the location of the facility, the hours of operation, the 
individual(s) responsible for the controlled substances, the security 
and recordkeeping procedures that will be employed, and whether 
controlled substances returns will be processed through the facility. 
The notice must also detail what state licensing requirements apply to 
the facility and the registrant's actions to comply with any such 
requirements. The Special Agent in Charge of the DEA Office in the area 
where the freight forwarding facility will be operated will provide 
written notice of approval or disapproval to the person within thirty 
days after confirmed receipt of the notice. Registrants that are 
currently operating freight forwarding facilities under a memorandum of 
understanding with the Administration must provide notice as required by 
this section no later than September 18, 2000 and receive written 
approval from the Special Agent in Charge of the DEA Office in the area 
in which the freight forwarding facility is operated in order to 
continue operation of the facility.

[62 FR 13945, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 
65 FR 45829, July 25, 2000]



Sec. 1301.13  Application for registration; time for application; expiration 

date; registration for independent activities; application forms, fees, 
contents 
          and signature; coincident activities.

    (a) Any person who is required to be registered and who is not so 
registered may apply for registration at any time. No person required to 
be registered shall engage in any activity for which registration is 
required until the application for registration is granted and a 
Certificate of Registration is issued by the Administrator to such 
person.
    (b) Any person who is registered may apply to be reregistered not 
more than 60 days before the expiration date of his/her registration, 
except that a bulk manufacturer of Schedule I or II controlled 
substances or an importer of Schedule I or II controlled substances may 
apply to be reregistered no more than 120 days before the expiration 
date of their registration.
    (c) At the time a manufacturer, distributor, reverse distributor, 
researcher, analytical lab, importer, exporter or narcotic treatment 
program is first registered, that business activity shall be assigned to 
one of twelve groups, which shall correspond to the months of the year. 
The expiration date of the registrations of all registrants within any 
group will be the last date of the month designated for that group. In 
assigning any of these business activities to a group, the 
Administration may select a group the expiration date of which is less 
than one year from the date such business activity was registered. If 
the business activity is assigned to a group which has an expiration 
date less than three months from the date of which the

[[Page 16]]

business activity is registered, the registration shall not expire until 
one year from that expiration date; in all other cases, the registration 
shall expire on the expiration date following the date on which the 
business activity is registered.
    (d) At the time a retail pharmacy, hospital/clinic, practitioner or 
teaching institution is first registered, that business activity shall 
be assigned to one of twelve groups, which shall correspond to the 
months of the year. The expiration date of the registrations of all 
registrants within any group will be the last day of the month 
designated for that group. In assigning any of the above business 
activities to a group, the Administration may select a group the 
expiration date of which is not less than 28 months nor more than 39 
months from the date such business activity was registered. After the 
initial registration period, the registration shall expire 36 months 
from the initial expiration date.
    (e) Any person who is required to be registered and who is not so 
registered, shall make application for registration for one of the 
following groups of controlled substances activities, which are deemed 
to be independent of each other. Application for each registration shall 
be made on the indicated form, and shall be accompanied by the indicated 
fee. Fee payments shall be made in the form of a personal, certified, or 
cashier's check or money order made payable to the ``Drug Enforcement 
Administration''. The application fees are not refundable. Any person, 
when registered to engage in the activities described in each 
subparagraph in this paragraph, shall be authorized to engage in the 
coincident activities described without obtaining a registration to 
engage in such coincident activities, provided that, unless specifically 
exempted, he/she complies with all requirements and duties prescribed by 
law for persons registered to engage in such coincident activities. Any 
person who engages in more than one group of independent activities 
shall obtain a separate registration for each group of activities, 
except as provided in this paragraph under coincident activities. A 
single registration to engage in any group of independent activities 
listed below may include one or more controlled substances listed in the 
schedules authorized in that group of independent activities. A person 
registered to conduct research with controlled substances listed in 
Schedule I may conduct research with any substances listed in Schedule I 
for which he/she has filed and had approved a research protocol.
    (1)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                           Registration
     Business activity                         Controlled substances                                    DEA application forms                 Application     period      Coincident activities
                                                                                                                                                fee  ($)      (years)            allowed
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(i) Manufacturing            Schedules I-V............................................  New--225............................................       1,625            1    Schedules I-V:May
                                                                                        Renewal--225a.......................................       1,625                  distribute that
                                                                                                                                                                          substance or class for
                                                                                                                                                                          which registration was
                                                                                                                                                                          issued; may not
                                                                                                                                                                          distribute or dispose
                                                                                                                                                                          any substance or class
                                                                                                                                                                          for which not
                                                                                                                                                                          registered. Schedules
                                                                                                                                                                          II-V: except a person
                                                                                                                                                                          registered to dispose
                                                                                                                                                                          of any controlled
                                                                                                                                                                          substance may conduct
                                                                                                                                                                          chemical analysis and
                                                                                                                                                                          preclinical research
                                                                                                                                                                          (including quality
                                                                                                                                                                          control analysis) with
                                                                                                                                                                          substances listed in
                                                                                                                                                                          those schedules for
                                                                                                                                                                          which authorization as
                                                                                                                                                                          a mfg. Was issued.
(ii) Distributing            Schedules I-V............................................  New--225............................................         813            1    .......................
                                                                                        Renewal--225a.......................................         813
(iii) Reverse distributing   Schedules I-V............................................  New--225............................................         813            1    .......................
                                                                                        Renewal 225a........................................         813

[[Page 17]]

 
(iv) Dispensing or           Schedules II-V...........................................  New--224............................................         390            3    May conduct research
 instructing (includes                                                                  Renewal--224a.......................................         390                  and instructional
 Practitioner, Hospital/                                                                                                                                                  activities with those
 Clinic, Retail Pharmacy,                                                                                                                                                 substances for which
 Central Fill Pharmacy,                                                                                                                                                   registration was
 Teaching Institution)                                                                                                                                                    granted, except that a
                                                                                                                                                                          mid-level practitioner
                                                                                                                                                                          may conduct such
                                                                                                                                                                          research only to the
                                                                                                                                                                          extent expressly
                                                                                                                                                                          authorized under state
                                                                                                                                                                          statute. A pharmacist
                                                                                                                                                                          may manufacture an
                                                                                                                                                                          aqueous or oleaginous
                                                                                                                                                                          solution or solid
                                                                                                                                                                          dosage form containing
                                                                                                                                                                          a narcotic controlled
                                                                                                                                                                          substance in Schedule
                                                                                                                                                                          II-V in a proportion
                                                                                                                                                                          not exceeding 20% of
                                                                                                                                                                          the complete solution,
                                                                                                                                                                          compound or mixture. A
                                                                                                                                                                          retail pharmacy may
                                                                                                                                                                          perform central fill
                                                                                                                                                                          pharmacy activities.
(v) Research                 Schedule I...............................................  New--225............................................         130            1    A researcher may
                                                                                        Renewal--225a.......................................         130                  manufacture or import
                                                                                                                                                                          the basic class of
                                                                                                                                                                          substance or
                                                                                                                                                                          substances for which
                                                                                                                                                                          registration was
                                                                                                                                                                          issued, provided that
                                                                                                                                                                          such manufacture or
                                                                                                                                                                          import is set forth in
                                                                                                                                                                          the protocol required
                                                                                                                                                                          in Section 1301.18 and
                                                                                                                                                                          to distribute such
                                                                                                                                                                          class to persons
                                                                                                                                                                          registered or
                                                                                                                                                                          authorized to conduct
                                                                                                                                                                          research with such
                                                                                                                                                                          class of substance or
                                                                                                                                                                          registered or
                                                                                                                                                                          authorized to conduct
                                                                                                                                                                          chemical analysis with
                                                                                                                                                                          controlled substances.
(vi) Research                Schedules II-V...........................................  New--225............................................         130            1    May conduct chemical
                                                                                        Renewal--225a.......................................         130                  analysis with
                                                                                                                                                                          controlled substances
                                                                                                                                                                          in those schedules for
                                                                                                                                                                          which registration was
                                                                                                                                                                          issued; manufacture
                                                                                                                                                                          such substances if and
                                                                                                                                                                          to the extent that
                                                                                                                                                                          such manufacture is
                                                                                                                                                                          set forth in a
                                                                                                                                                                          statement filed with
                                                                                                                                                                          the application for
                                                                                                                                                                          registration or
                                                                                                                                                                          reregistration and
                                                                                                                                                                          provided that the
                                                                                                                                                                          manufacture is not for
                                                                                                                                                                          the purposes of dosage
                                                                                                                                                                          form development;
                                                                                                                                                                          import such substances
                                                                                                                                                                          for research purposes;
                                                                                                                                                                          distribute such
                                                                                                                                                                          substances to persons
                                                                                                                                                                          registered or
                                                                                                                                                                          authorized to conduct
                                                                                                                                                                          chemical analysis,
                                                                                                                                                                          instructional
                                                                                                                                                                          activities or research
                                                                                                                                                                          with such substances,
                                                                                                                                                                          and to persons
                                                                                                                                                                          exempted from
                                                                                                                                                                          registration pursuant
                                                                                                                                                                          to Section 1301.24;
                                                                                                                                                                          and conduct
                                                                                                                                                                          instructional
                                                                                                                                                                          activities with
                                                                                                                                                                          controlled substances.
(vii) Narcotic Treatment     Narcotic Drugs in Schedules II-V.........................  New--363............................................         130            1    .......................
 Program (including                                                                     Renewal 363a........................................         130
 compounder)
(viii) Importing             Schedules I-V............................................  New--225............................................         813            1    May distribute that
                                                                                        Renewal--225a.......................................         813                  substance or class for
                                                                                                                                                                          which registration was
                                                                                                                                                                          issued; may not
                                                                                                                                                                          distribute any
                                                                                                                                                                          substance or class for
                                                                                                                                                                          which not registered.
(ix) Exporting               Schedules I-V............................................  New--225............................................         813            1
                                                                                        Renewal--225a.......................................         813

[[Page 18]]

 
(x) Chemical Analysis        Schedules I-V............................................  New--225............................................         130            1    May manufacture and
                                                                                        Renewal--225a.......................................         130                  import controlled
                                                                                                                                                                          substances for
                                                                                                                                                                          analytical or
                                                                                                                                                                          instructional
                                                                                                                                                                          activities; may
                                                                                                                                                                          distribute such
                                                                                                                                                                          substances to persons
                                                                                                                                                                          registered or
                                                                                                                                                                          authorized to conduct
                                                                                                                                                                          chemical analysis,
                                                                                                                                                                          instructional
                                                                                                                                                                          activities, or
                                                                                                                                                                          research with such
                                                                                                                                                                          substances and to
                                                                                                                                                                          persons exempted from
                                                                                                                                                                          registration pursuant
                                                                                                                                                                          to section 1301.24;
                                                                                                                                                                          may export such
                                                                                                                                                                          substances to persons
                                                                                                                                                                          in other countries
                                                                                                                                                                          performing chemical
                                                                                                                                                                          analysis or enforcing
                                                                                                                                                                          laws related to
                                                                                                                                                                          controlled substances
                                                                                                                                                                          or drugs in those
                                                                                                                                                                          countries; and may
                                                                                                                                                                          conduct instructional
                                                                                                                                                                          activities with
                                                                                                                                                                          controlled substances.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) DEA Forms 224, 225, and 363 may be obtained at any area office 
of the Administration or by writing to the Registration Unit, Drug 
Enforcement Administration, Department of Justice, Post Office Box 
28083, Central Station, Washington, DC 20005.
    (3) DEA Forms 224a, 225a, and 363a will be mailed, as applicable, to 
each registered person approximately 60 days before the expiration date 
of his/her registration; if any registered person does not receive such 
forms within 45 days before the expiration date of his/her registration, 
he/she must promptly give notice of such fact and request such forms by 
writing to the Registration Unit of the Administration at the foregoing 
address.
    (f) Each application for registration to handle any basic class of 
controlled substance listed in Schedule I (except to conduct chemical 
analysis with such classes), and each application for registration to 
manufacture a basic class of controlled substance listed in Schedule II 
shall include the Administration Controlled Substances Code Number, as 
set forth in part 1308 of this chapter, for each basic class to be 
covered by such registration.
    (g) Each application for registration to import or export controlled 
substances shall include the Administration Controlled Substances Code 
Number, as set forth in part 1308 of this chapter, for each controlled 
substance whose importation or exportation is to be authorized by such 
registration. Registration as an importer or exporter shall not entitle 
a registrant to import or export any controlled substance not specified 
in such registration.
    (h) Each application for registration to conduct research with any 
basic class of controlled substance listed in Schedule II shall include 
the Administration Controlled Substances Code Number, as set forth in 
part 1308 of this chapter, for each such basic class to be manufactured 
or imported as a coincident activity of that registration. A statement 
listing the quantity of each such basic class of controlled substance to 
be imported or manufactured during the registration period for which 
application is being made shall be included with each such application. 
For purposes of this paragraph only, manufacturing is defined as the 
production of a controlled substance by synthesis, extraction or by 
agricultural/horticultural means.
    (i) Each application shall include all information called for in the 
form, unless the item is not applicable, in which case this fact shall 
be indicated.
    (j) Each application, attachment, or other document filed as part of 
an application, shall be signed by the applicant, if an individual; by a 
partner of the applicant, if a partnership; or by an officer of the 
applicant, if a corporation, corporate division, association, trust or 
other entity. An applicant may authorize one or more individuals, who 
would not otherwise be authorized to

[[Page 19]]

do so, to sign applications for the applicant by filing with the 
Registration Unit of the Administration a power of attorney for each 
such individual. The power of attorney shall be signed by a person who 
is authorized to sign applications under this paragraph and shall 
contain the signature of the individual being authorized to sign 
applications. The power of attorney shall be valid until revoked by the 
applicant.

[62 FR 13946, Mar. 24, 1997, as amended at 68 FR 37409, June 24, 2003; 
68 FR 41228, July 11, 2003; 68 FR 58598, Oct. 10, 2003]



Sec. 1301.14  Filing of application; acceptance for filing; defective 
applications.

    (a) All applications for registration shall be submitted for filing 
to the Registration Unit, Drug Enforcement Administration, Department of 
Justice, Post Office Box 28083, Central Station, Washington, DC 20005. 
The appropriate registration fee and any required attachments must 
accompany the application.
    (b) Any person required to obtain more than one registration may 
submit all applications in one package. Each application must be 
complete and should not refer to any accompanying application for 
required information.
    (c) Applications submitted for filing are dated upon receipt. If 
found to be complete, the application will be accepted for filing. 
Applications failing to comply with the requirements of this part will 
not generally be accepted for filing. In the case of minor defects as to 
completeness, the Administrator may accept the application for filing 
with a request to the applicant for additional information. A defective 
application will be returned to the applicant within 10 days following 
its receipt with a statement of the reason for not accepting the 
application for filing. A defective application may be corrected and 
resubmitted for filing at any time; the Administrator shall accept for 
filing any application upon resubmission by the applicant, whether 
complete or not.
    (d) Accepting an application for filing does not preclude any 
subsequent request for additional information pursuant to Sec. 1301.15 
and has no bearing on whether the application will be granted.

[62 FR 13948, Mar. 24, 1997]



Sec. 1301.15  Additional information.

    The Administrator may require an applicant to submit such documents 
or written statements of fact relevant to the application as he/she 
deems necessary to determine whether the application should be granted. 
The failure of the applicant to provide such documents or statements 
within a reasonable time after being requested to do so shall be deemed 
to be a waiver by the applicant of an opportunity to present such 
documents or facts for consideration by the Administrator in granting or 
denying the application.

[62 FR 13948, Mar. 24, 1997]



Sec. 1301.16  Amendments to and withdrawal of applications.

    (a) An application may be amended or withdrawn without permission of 
the Administrator at any time before the date on which the applicant 
receives an order to show cause pursuant to Sec. 1301.37. An 
application may be amended or withdrawn with permission of the 
Administrator at any time where good cause is shown by the applicant or 
where the amendment or withdrawal is in the public interest.
    (b) After an application has been accepted for filing, the request 
by the applicant that it be returned or the failure of the applicant to 
respond to official correspondence regarding the application, when sent 
by registered or certified mail, return receipt requested, shall be 
deemed to be a withdrawal of the application.

[62 FR 13949, Mar. 24, 1997]



Sec. 1301.17  Special procedures for certain applications.

    (a) If, at the time of application for registration of a new 
pharmacy, the pharmacy has been issued a license from the appropriate 
State licensing agency, the applicant may include with his/her 
application an affidavit as to the existence of the State license in the 
following form:

[[Page 20]]

                       Affidavit for New Pharmacy

    I, --------------------, the -------------------- (Title of officer, 
official, partner, or other position) of -------------------- 
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) at -------------------- (Number and Street), 
-------------------- (City) ------------ (State) ------------ (Zip 
code), hereby certify that said store was issued a pharmacy permit No. 
-------- by the ---------------- (Board of Pharmacy or Licensing Agency) 
of the State of ------------ on ------------ (Date).
    This statement is submitted in order to obtain a Drug Enforcement 
Administration registration number. I understand that if any information 
is false, the Administration may immediately suspend the registration 
for this store and commence proceedings to revoke under 21 U.S.C. 824(a) 
because of the danger to public health and safety. I further understand 
that any false information contained in this affidavit may subject me 
personally and the above-named corporation/partnership/business to 
prosecution under 21 U.S.C. 843, the penalties for conviction of which 
include imprisonment for up to 4 years, a fine of not more than $30,000 
or both.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
    Subscribed to and sworn before me this -------- day of --------, 
19------.
________________________________________________________________________
Notary Public

    (b) Whenever the ownership of a pharmacy is being transferred from 
one person to another, if the transferee owns at least one other 
pharmacy licensed in the same State as the one the ownership of which is 
being transferred, the transferee may apply for registration prior to 
the date of transfer. The Administrator may register the applicant and 
authorize him to obtain controlled substances at the time of transfer. 
Such registration shall not authorize the transferee to dispense 
controlled substances until the pharmacy has been issued a valid State 
license. The transferee shall include with his/her application the 
following affidavit:

                   Affidavit for Transfer of Pharmacy

    I, --------------------, the -------------------- (Title of officer, 
official, partner or other position) of -------------------- 
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) hereby certify:
    (1) That said company was issued a pharmacy permit No.------------by 
the -------------------- (Board of Pharmacy of Licensing Agency) of the 
State of ------------ and a DEA Registration Number -------------------- 
for a pharmacy located at -------------------- (Number and Street) ----
-------- (City) ------------ (State) ------------ (Zip Code); and
    (2) That said company is acquiring the pharmacy business of --------
-------- (Name of Seller) doing business as--------------------with DEA 
Registration Number ------------ on or about ------------ (Date of 
Transfer) and that said company has applied (or will apply on ----------
-- (Date) for a pharmacy permit from the board of pharmacy (or licensing 
agency) of the State of ------------ to do business as ----------------
---- (Store name) at -------------------- (Number and Street) ----------
---------- (City) ------------ (State) ------------ (Zip Code).

    This statement is submitted in order to obtain a Drug Enforcement 
Administration registration number.

    I understand that if a DEA registration number is issued, the 
pharmacy may acquire controlled substances but may not dispense them 
until a pharmacy permit or license is issued by the State board of 
pharmacy or licensing agency.
    I understand that if any information is false, the Administration 
may immediately suspend the registration for this store and commence 
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to 
public health and safety. I further understand that any false 
information contained in this affidavit may subject me personally to 
prosecution under 21 U.S.C. 843, the penalties for conviction of which 
include imprisonment for up to 4 years, a fine of not more than $30,000 
or both.

________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
    Subscribed to and sworn before me this----day of------------, 19--
--.
________________________________________________________________________
Notary Public

    (c) The Administrator shall follow the normal procedures for 
approving an application to verify the statements in the affidavit. If 
the statements prove to be false, the Administrator may revoke the 
registration on the basis of section 304(a)(1) of the Act (21 U.S.C. 
824(a)(1)) and suspend the registration

[[Page 21]]

immediately by pending revocation on the basis of section 304(d) of the 
Act (21 U.S.C. 824(d)). At the same time, the Administrator may seize 
and place under seal all controlled substances possessed by the 
applicant under section 304(f) of the Act (21 U.S.C. 824(f)). 
Intentional misuse of the affidavit procedure may subject the applicant 
to prosecution for fraud under section 403(a)(4) of the Act (21 U.S.C. 
843(a)(4)), and obtaining controlled substances through registration by 
fraudulent means may subject the applicant to prosecution under section 
403(a)(3) of the Act (21 U.S.C. 843(a)(3)). The penalties for conviction 
of either offense include imprisonment for up to 4 years, a fine not 
exceeding $30,000 or both.

[62 FR 13949, Mar. 24, 1997]



Sec. 1301.18  Research protocols.

    (a) A protocol to conduct research with controlled substances listed 
in Schedule I shall be in the following form and contain the following 
information where applicable:
    (1) Investigator:
    (i) Name, address, and DEA registration number; if any.
    (ii) Institutional affiliation.
    (iii) Qualifications, including a curriculum vitae and an 
appropriate bibliography (list of publications).
    (2) Research project:
    (i) Title of project.
    (ii) Statement of the purpose.
    (iii) Name of the controlled substances or substances involved and 
the amount of each needed.
    (iv) Description of the research to be conducted, including the 
number and species of research subjects, the dosage to be administered, 
the route and method of administration, and the duration of the project.
    (v) Location where the research will be conducted.
    (vi) Statement of the security provisions for storing the controlled 
substances (in accordance with Sec. 1301.75) and for dispensing the 
controlled substances in order to prevent diversion.
    (vii) If the investigator desires to manufacture or import any 
controlled substance listed in paragraph (a)(2)(iii) of this section, a 
statement of the quantity to be manufactured or imported and the sources 
of the chemicals to be used or the substance to be imported.
    (3) Authority:
    (i) Institutional approval.
    (ii) Approval of a Human Research Committee for human studies.
    (iii) Indication of an approved active Notice of Claimed 
Investigational Exemption for a New Drug (number).
    (iv) Indication of an approved funded grant (number), if any.
    (b) In the case of a clinical investigation with controlled 
substances listed in Schedule I, the applicant shall submit three copies 
of a Notice of Claimed Investigational Exemption for a New Drug (IND) 
together with a statement of the security provisions (as proscribed in 
paragraph (a)(2)(vi) of this section for a research protocol) to, and 
have such submission approved by, the Food and Drug Administration as 
required in 21 U.S.C. 355(i) and Sec. 130.3 of this title. Submission 
of this Notice and statement to the Food and Drug Administration shall 
be in lieu of a research protocol to the Administration as required in 
paragraph (a) of this section. The applicant, when applying for 
registration with the Administration, shall indicate that such notice 
has been submitted to the Food and Drug Administration by submitting to 
the Administration with his/her DEA Form 225 three copies of the 
following certificate:

    I hereby certify that on -------------------- (Date), pursuant to 21 
U.S.C. 355(i) and 21 CFR 130.3, I, -------------------- (Name and 
Address of IND Sponsor) submitted a Notice of Claimed Investigational 
Exemption for a New Drug (IND) to the Food and Drug Administration for:

________________________________________________________________________
(Name of Investigational Drug).

________________________________________________________________________
(Date)

________________________________________________________________________
(Signature of Applicant).

    (c) In the event that the registrant desires to increase the 
quantity of a controlled substance used for an approved research 
project, he/she shall submit a request to the Registration Unit, Drug 
Enforcement Administration, Post Office Box 28083, Central Station, 
Washington, DC 20005, by registered mail, return receipt requested. The 
request shall contain the following

[[Page 22]]

information: DEA registration number; name of the controlled substance 
or substances and the quantity of each authorized in the approved 
protocol; and the additional quantity of each desired. Upon return of 
the receipt, the registrant shall be authorized to purchase the 
additional quantity of the controlled substance or substances specified 
in the request. The Administration shall review the letter and forward 
it to the Food and Drug Administration together with the Administration 
comments. The Food and Drug Administration shall approve or deny the 
request as an amendment to the protocol and so notify the registrant. 
Approval of the letter by the Food and Drug Administration shall 
authorize the registrant to use the additional quantity of the 
controlled substance in the research project.
    (d) In the event the registrant desires to conduct research beyond 
the variations provided in the registrant's approved protocol (excluding 
any increase in the quantity of the controlled substance requested for 
his/her research project as outlined in paragraph (c) of this section), 
he/she shall submit three copies of a supplemental protocol in 
accordance with paragraph (a) of this section describing the new 
research and omitting information in the supplemental protocol which has 
been stated in the original protocol. Supplemental protocols shall be 
processed and approved or denied in the same manner as original research 
protocols.

[62 FR 13949, Mar. 24, 1997]

                   Exceptions to Registration and Fees



Sec. 1301.21  Exemption from fees.

    (a) The Administrator shall exempt from payment of an application 
fee for registration or reregistration:
    (1) Any hospital or other institution which is operated by an agency 
of the United States (including the U.S. Army, Navy, Marine Corps., Air 
Force, and Coast Guard), of any State, or any political subdivision or 
agency thereof.
    (2) Any individual practitioner who is required to obtain an 
individual registration in order to carry out his or her duties as an 
official of an agency of the United States (including the U.S. Army, 
Navy, Marine Corps, Air Force, and Coast Guard), of any State, or any 
political subdivision or agency thereof.
    (b) In order to claim exemption from payment of a registration or 
reregistration application fee, the registrant shall have completed the 
certification on the appropriate application form, wherein the 
registrant's superior (if the registrant is an individual) or officer 
(if the registrant is an agency) certifies to the status and address of 
the registrant and to the authority of the registrant to acquire, 
possess, or handle controlled substances.
    (c) Exemption from payment of a registration or reregistration 
application fee does not relieve the registrant of any other 
requirements or duties prescribed by law.

[62 FR 13950, Mar. 24, 1997]



Sec. 1301.22  Exemption of agents and employees; affiliated practitioners.

    (a) The requirement of registration is waived for any agent or 
employee of a person who is registered to engage in any group of 
independent activities, if such agent or employee is acting in the usual 
course of his/her business or employment.
    (b) An individual practitioner who is an agent or employee of 
another practitioner (other than a mid-level practitioner) registered to 
dispense controlled substances may, when acting in the normal course of 
business or employment, administer or dispense (other than by issuance 
of prescription) controlled substances if and to the extent that such 
individual practitioner is authorized or permitted to do so by the 
jurisdiction in which he or she practices, under the registration of the 
employer or principal practitioner in lieu of being registered him/
herself.
    (c) An individual practitioner who is an agent or employee of a 
hospital or other institution may, when acting in the normal course of 
business or employment, administer, dispense, or prescribe controlled 
substances under the registration of the hospital or other institution 
which is registered in lieu of being registered him/herself, provided 
that:
    (1) Such dispensing, administering or prescribing is done in the 
usual course of his/her professional practice;

[[Page 23]]

    (2) Such individual practitioner is authorized or permitted to do so 
by the jurisdiction in which he/she is practicing;
    (3) The hospital or other institution by whom he/she is employed has 
verified that the individual practitioner is so permitted to dispense, 
administer, or prescribe drugs within the jurisdiction;
    (4) Such individual practitioner is acting only within the scope of 
his/her employment in the hospital or institution;
    (5) The hospital or other institution authorizes the individual 
practitioner to administer, dispense or prescribe under the hospital 
registration and designates a specific internal code number for each 
individual practitioner so authorized. The code number shall consist of 
numbers, letters, or a combination thereof and shall be a suffix to the 
institution's DEA registration number, preceded by a hyphen (e.g., 
APO123456-10 or APO123456-A12); and
    (6) A current list of internal codes and the corresponding 
individual practitioners is kept by the hospital or other institution 
and is made available at all times to other registrants and law 
enforcement agencies upon request for the purpose of verifying the 
authority of the prescribing individual practitioner.

[62 FR 13950, Mar. 24, 1997]



Sec. 1301.23  Exemption of certain military and other personnel.

    (a) The requirement of registration is waived for any official of 
the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health 
Service, or Bureau of Prisons who is authorized to prescribe, dispense, 
or administer, but not to procure or purchase, controlled substances in 
the course of his/her official duties. Such officials shall follow 
procedures set forth in part 1306 of this chapter regarding 
prescriptions, but shall state the branch of service or agency (e.g., 
``U.S. Army'' or ``Public Health Service'') and the service 
identification number of the issuing official in lieu of the 
registration number required on prescription forms. The service 
identification number for a Public Health Service employee is his/her 
Social Security identification number.
    (b) The requirement of registration is waived for any official or 
agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or 
Public Health Service who or which is authorized to import or export 
controlled substances in the course of his/her official duties.
    (c) If any official exempted by this section also engages as a 
private individual in any activity or group of activities for which 
registration is required, such official shall obtain a registration for 
such private activities.

[62 FR 13951, Mar. 24, 1997]



Sec. 1301.24  Exemption of law enforcement officials.

    (a) The requirement of registration is waived for the following 
persons in the circumstances described in this section:
    (1) Any officer or employee of the Administration, any officer of 
the U.S. Customs Service, any officer or employee of the United States 
Food and Drug Administration, and any other Federal officer who is 
lawfully engaged in the enforcement of any Federal law relating to 
controlled substances, drugs or customs, and is duly authorized to 
possess or to import or export controlled substances in the course of 
his/her official duties; and
    (2) Any officer or employee of any State, or any political 
subdivision or agency thereof, who is engaged in the enforcement of any 
State or local law relating to controlled substances and is duly 
authorized to possess controlled substances in the course of his/her 
official duties.
    (b) Any official exempted by this section may, when acting in the 
course of his/her official duties, procure any controlled substance in 
the course of an inspection, in accordance with Sec. 1316.03(d) of this 
chapter, or in the course of any criminal investigation involving the 
person from whom the substance was procured, and may possess any 
controlled substance and distribute any such substance to any other 
official who is also exempted by this section and acting in the course 
of his/her official duties.
    (c) In order to enable law enforcement agency laboratories, 
including

[[Page 24]]

laboratories of the Administration, to obtain and transfer controlled 
substances for use as standards in chemical analysis, such laboratories 
shall obtain annually a registration to conduct chemical analysis. Such 
laboratories shall be exempted from payment of a fee for registration. 
Laboratory personnel, when acting in the scope of their official duties, 
are deemed to be officials exempted by this section and within the 
activity described in section 515(d) of the Act (21 U.S.C. 885(d)). For 
purposes of this paragraph, laboratory activities shall not include 
field or other preliminary chemical tests by officials exempted by this 
section.
    (d) In addition to the activities authorized under a registration to 
conduct chemical analysis pursuant to Sec. 1301.13(e)(1)(ix), 
laboratories of the Administration shall be authorized to manufacture or 
import controlled substances for any lawful purpose, to distribute or 
export such substances to any person, and to import and export such 
substances in emergencies without regard to the requirements of part 
1312 of this chapter if a report concerning the importation or 
exportation is made to the Drug Operations Section of the Administration 
within 30 days of such importation or exportation.

[62 FR 13951, Mar. 24, 1997]



Sec. 1301.25  Registration regarding ocean vessels, aircraft, and other 
entities.

    (a) If acquired by and dispensed under the general supervision of a 
medical officer described in paragraph (b) of this section, or the 
master or first officer of the vessel under the circumstances described 
in paragraph (d) of this section, controlled substances may be held for 
stocking, be maintained in, and dispensed from medicine chests, first 
aid packets, or dispensaries:
    (1) On board any vessel engaged in international trade or in trade 
between ports of the United States and any merchant vessel belonging to 
the U.S. Government;
    (2) On board any aircraft operated by an air carrier under a 
certificate of permit issued pursuant to the Federal Aviation Act of 
1958 (49 U.S.C. 1301); and
    (3) In any other entity of fixed or transient location approved by 
the Administrator as appropriate for application of this section (e.g., 
emergency kits at field sites of an industrial firm).
    (b) A medical officer shall be:
    (1) Licensed in a state as a physician;
    (2) Employed by the owner or operator of the vessel, aircraft or 
other entity; and
    (3) Registered under the Act at either of the following locations:
    (i) The principal office of the owner or operator of the vessel, 
aircraft or other entity or
    (ii) At any other location provided that the name, address, 
registration number and expiration date as they appear on his/her 
Certificate of Registration (DEA Form 223) for this location are 
maintained for inspection at said principal office in a readily 
retrievable manner.
    (c) A registered medical officer may serve as medical officer for 
more than one vessel, aircraft, or other entity under a single 
registration, unless he/she serves as medical officer for more than one 
owner or operator, in which case he/she shall either maintain a separate 
registration at the location of the principal office of each such owner 
or operator or utilize one or more registrations pursuant to paragraph 
(b)(3)(ii) of this section.
    (d) If no medical officer is employed by the owner or operator of a 
vessel, or in the event such medical officer is not accessible and the 
acquisition of controlled substances is required, the master or first 
officer of the vessel, who shall not be registered under the Act, may 
purchase controlled substances from a registered manufacturer or 
distributor, or from an authorized pharmacy as described in paragraph 
(f) of this section, by following the procedure outlined below:
    (1) The master or first officer of the vessel must personally appear 
at the vendor's place of business, present proper identification (e.g., 
Seaman's photographic identification card) and a written requisition for 
the controlled substances.
    (2) The written requisition must be on the vessel's official 
stationery or purchase order form and must include the name and address 
of the vendor, the name of the controlled substance, description of the 
controlled substance

[[Page 25]]

(dosage form, strength and number or volume per container) number of 
containers ordered, the name of the vessel, the vessel's official number 
and country of registry, the owner or operator of the vessel, the port 
at which the vessel is located, signature of the vessel's officer who is 
ordering the controlled substances and the date of the requisition.
    (3) The vendor may, after verifying the identification of the 
vessel's officer requisitioning the controlled substances, deliver the 
control substances to that officer. The transaction shall be documented, 
in triplicate, on a record of sale in a format similar to that outlined 
in paragraph (d)(4) of this section. The vessel's requisition shall be 
attached to copy 1 of the record of sale and filed with the controlled 
substances records of the vendor, copy 2 of the record of sale shall be 
furnished to the officer of the vessel and retained aboard the vessel, 
copy 3 of the record of sale shall be forwarded to the nearest DEA 
Division Office within 15 days after the end of the month in which the 
sale is made.
    (4) The vendor's record of sale should be similar to, and must 
include all the information contained in, the below listed format.

                Sale of Controlled Substances to Vessels

(Name of registrant)____________________________________________________

(Address of registrant)_________________________________________________

(DEA registration number)_______________________________________________

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of                                                Packages
                          Line No.                            packages ordered   Size of packages   Name of product     distributed     Date distributed
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..........................................................  .................  .................  ................  .................  ................
2..........................................................  .................  .................  ................  .................  ................
3..........................................................  .................  .................  ................  .................  ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnote: Line numbers may be continued according to needs of the vendor.

Number of lines completed_______________________________________________
Name of vessel__________________________________________________________
Vessel's official number________________________________________________
Vessel's country of registry____________________________________________
Owner or operator of the vessel_________________________________________

Name and title of vessel's officer who presented the requisition ------
          --
Signature of vessel's officer who presented the requisition --------

    (e) Any medical officer described in paragraph (b) of this section 
shall, in addition to complying with all requirements and duties 
prescribed for registrants generally, prepare an annual report as of the 
date on which his/her registration expires, which shall give in detail 
an accounting for each vessel, aircraft, or other entity, and a summary 
accounting for all vessels, aircraft, or other entities under his/her 
supervision for all controlled substances purchased, dispensed or 
disposed of during the year. The medical officer shall maintain this 
report with other records required to be kept under the Act and, upon 
request, deliver a copy of the report to the Administration. The medical 
officer need not be present when controlled substances are dispensed, if 
the person who actually dispensed the controlled substances is 
responsible to the medical officer to justify his/her actions.
    (f) Any registered pharmacy that wishes to distribute controlled 
substances pursuant to this section shall be authorized to do so, 
provided:
    (1) The registered pharmacy notifies the nearest Division Office of 
the Administration of its intention to so distribute controlled 
substances prior to the initiation of such activity. This notification 
shall be by registered mail and shall contain the name, address, and 
registration number of the pharmacy as well as the date upon which such 
activity will commence; and
    (2) Such activity is authorized by state law; and
    (3) The total number of dosage units of all controlled substances 
distributed by the pharmacy during any calendar year in which the 
pharmacy is registered to dispense does not exceed the limitations 
imposed upon such distribution by Sec. 1307.11(a)(4) and (b) of this 
chapter.
    (g) Owners or operators of vessels, aircraft, or other entities 
described in this section shall not be deemed to possess or dispense any 
controlled substance acquired, stored and dispensed

[[Page 26]]

in accordance with this section. Additionally, owners or operators of 
vessels, aircraft, or other entities described in this section or in 
Article 32 of the Single Convention on Narcotic Drugs, 1961, or in 
Article 14 of the Convention on Psychotropic Substances, 1971, shall not 
be deemed to import or export any controlled substances purchased and 
stored in accordance with that section or applicable article.
    (h) The Master of a vessel shall prepare a report for each calendar 
year which shall give in detail an accounting for all controlled 
substances purchased, dispensed, or disposed of during the year. The 
Master shall file this report with the medical officer employed by the 
owner or operator of his/her vessel, if any, or, if not, he/she shall 
maintain this report with other records required to be kept under the 
Act and, upon request, deliver a copy of the report to the 
Administration.
    (i) Controlled substances acquired and possessed in accordance with 
this section shall not be distributed to persons not under the general 
supervision of the medical officer employed by the owner or operator of 
the vessel, aircraft, or other entity, except in accordance with Sec. 
1307.21 of this chapter.

[62 FR 13951, Mar. 24, 1997]



Sec. 1301.26  Exemptions from import or export requirements for personal 
medical use.

    Any individual who has in his/her possession a controlled substance 
listed in schedules II, III, IV, or V, which he/she has lawfully 
obtained for his/her personal medical use, or for administration to an 
animal accompanying him/her, may enter or depart the United States with 
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 
952-955), provided the following conditions are met:
    (a) The controlled substance is in the original container in which 
it was dispensed to the individual; and
    (b) The individual makes a declaration to an appropriate official of 
the Bureau of Customs and Border Protection stating:
    (1) That the controlled substance is possessed for his/her personal 
use, or for an animal accompanying him/her; and
    (2) The trade or chemical name and the symbol designating the 
schedule of the controlled substance if it appears on the container 
label, or, if such name does not appear on the label, the name and 
address of the pharmacy or practitioner who dispensed the substance and 
the prescription number.
    (c) In addition to (and not in lieu of) the foregoing requirements 
of this section, a United States resident may import into the United 
States no more than 50 dosage units combined of all such controlled 
substances in the individual's possession that were obtained abroad for 
personal medical use. (For purposes of this section, a United States 
resident is a person whose residence (i.e., place of general abode--
meaning one's principal, actual dwelling place in fact, without regard 
to intent) is in the United States.) This 50 dosage unit limitation does 
not apply to controlled substances lawfully obtained in the United 
States pursuant to a prescription issued by a DEA registrant.

[69 FR 55347, Sept. 14, 2004]

  Action on Application for Registration: Revocation or Suspension of 
                              Registration



Sec. 1301.31  Administrative review generally.

    The Administrator may inspect, or cause to be inspected, the 
establishment of an applicant or registrant, pursuant to subpart A of 
part 1316 of this chapter. The Administrator shall review the 
application for registration and other information gathered by the 
Administrator regarding an applicant in order to determine whether the 
applicable standards of section 303 (21 U.S.C. 823) or section 1008 (21 
U.S.C. 958) of the Act have been met by the applicant.

[62 FR 13953, Mar. 24, 1997]



Sec. 1301.32  Action on applications for research in Schedule I substances.

    (a) In the case of an application for registration to conduct 
research with controlled substances listed in Schedule I, the 
Administrator shall process the application and protocol and forward a 
copy of each to the Secretary of Health and Human Services (Secretary)

[[Page 27]]

within 7 days after receipt. The Secretary shall determine the 
qualifications and competency of the applicant, as well as the merits of 
the protocol (and shall notify the Administrator of his/her 
determination) within 21 days after receipt of the application and 
complete protocol, except that in the case of a clinical investigation, 
the Secretary shall have 30 days to make such determination and notify 
the Administrator. The Secretary, in determining the merits of the 
protocol, shall consult with the Administrator as to effective 
procedures to safeguard adequately against diversion of such controlled 
substances from legitimate medical or scientific use.
    (b) An applicant whose protocol is defective shall be notified by 
the Secretary within 21 days after receipt of such protocol from the 
Administrator (or in the case of a clinical investigation within 30 
days), and he/she shall be requested to correct the existing defects 
before consideration shall be given to his/her submission.
    (c) If the Secretary determines the applicant qualified and 
competent and the research protocol meritorious, he/she shall notify the 
Administrator in writing of such determination. The Administrator shall 
issue a certificate of registration within 10 days after receipt of this 
notice, unless he/she determines that the certificate of registration 
should be denied on a ground specified in section 304(a) of the Act (21 
U.S.C. 824(a)). In the case of a supplemental protocol, a replacement 
certificate of registration shall be issued by the Administrator.
    (d) If the Secretary determines that the protocol is not meritorious 
and/or the applicant is not qualified or competent, he/she shall notify 
the Administrator in writing setting forth the reasons for such 
determination. If the Administrator determines that grounds exist for 
the denial of the application, he/she shall within 10 days issue an 
order to show cause pursuant to Sec. 1301.37 and, if requested by the 
applicant, hold a hearing on the application pursuant to Sec. 1301.41. 
If the grounds for denial of the application include a determination by 
the Secretary, the Secretary or his duly authorized agent shall furnish 
testimony and documents pertaining to his determination at such hearing.
    (e) Supplemental protocols will be processed in the same manner as 
original research protocols. If the processing of an application or 
research protocol is delayed beyond the time limits imposed by this 
section, the applicant shall be so notified in writing.

[62 FR 13953, Mar. 24, 1997]



Sec. 1301.33  Application for bulk manufacture of Schedule I and II 
substances.

    (a) In the case of an application for registration or reregistration 
to manufacture in bulk a basic class of controlled substance listed in 
Schedule I or II, the Administrator shall, upon the filing of such 
application, publish in the Federal Register a notice naming the 
applicant and stating that such applicant has applied to be registered 
as a bulk manufacturer of a basic class of narcotic or nonnarcotic 
controlled substance, which class shall be identified. A copy of said 
notice shall be mailed simultaneously to each person registered as a 
bulk manufacturer of that basic class and to any other applicant 
therefor. Any such person may, within 60 days from the date of 
publication of the notice in the Federal Register, file with the 
Administrator written comments on or objections to the issuance of the 
proposed registration.
    (b) In order to provide adequate competition, the Administrator 
shall not be required to limit the number of manufacturers in any basic 
class to a number less than that consistent with maintenance of 
effective controls against diversion solely because a smaller number is 
capable of producing an adequate and uninterrupted supply.
    (c) This section shall not apply to the manufacture of basic classes 
of controlled substances listed in Schedules I or II as an incident to 
research or chemical analysis as authorized in Sec. 1301.13(e)(1).

[62 FR 13953, Mar. 24, 1997]



Sec. 1301.34  Application for importation of Schedule I and II substances.

    (a) In the case of an application for registration or reregistration 
to import

[[Page 28]]

a controlled substance listed in Schedule I or II, under the authority 
of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the 
Administrator shall, upon the filing of such application, publish in the 
Federal Register a notice naming the applicant and stating that such 
applicant has applied to be registered as an importer of a Schedule I or 
II controlled substance, which substance shall be identified. A copy of 
said notice shall be mailed simultaneously to each person registered as 
a bulk manufacturer of that controlled substance and to any other 
applicant therefor. Any such person may, within 30 days from the date of 
publication of the notice in the Federal Register, file written comments 
on or objections to the issuance of the proposed registration, and may, 
at the same time, file a written request for a hearing on the 
application pursuant to Sec. 1301.43. If a hearing is requested, the 
Administrator shall hold a hearing on the application in accordance with 
Sec. 1301.41. Notice of the hearing shall be published in the Federal 
Register, and shall be mailed simultaneously to the applicant and to all 
persons to whom notice of the application was mailed. Any such person 
may participate in the hearing by filing a notice of appearance in 
accordance with Sec. 1301.43 of this chapter. Notice of the hearing 
shall contain a summary of all comments and objections filed regarding 
the application and shall state the time and place for the hearing, 
which shall not be less than 30 days after the date of publication of 
such notice in the Federal Register. A hearing pursuant to this section 
may be consolidated with a hearing held pursuant to Sec. 1301.35 or 
Sec. 1301.36 of this part.
    (b) The Administrator shall register an applicant to import a 
controlled substance listed in Schedule I or II if he/she determines 
that such registration is consistent with the public interest and with 
U.S. obligations under international treaties, conventions, or protocols 
in effect on May 1, 1971. In determining the public interest, the 
following factors shall be considered:
    (1) Maintenance of effective controls against diversion of 
particular controlled substances and any controlled substance in 
Schedule I or II compounded therefrom into other than legitimate 
medical, scientific research, or industrial channels, by limiting the 
importation and bulk manufacture of such controlled substances to a 
number of establishments which can produce an adequate and uninterrupted 
supply of these substances under adequately competitive conditions for 
legitimate medical, scientific, research, and industrial purposes;
    (2) Compliance with applicable State and local law;
    (3) Promotion of technical advances in the art of manufacturing 
these substances and the development of new substances;
    (4) Prior conviction record of applicant under Federal and State 
laws relating to the manufacture, distribution, or dispensing of such 
substances;
    (5) Past experience in the manufacture of controlled substances, and 
the existence in the establishment of effective control against 
diversion;
    (6) That the applicant will be permitted to import only:
    (i) Such amounts of crude opium, poppy straw, concentrate of poppy 
straw, and coca leaves as the Administrator finds to be necessary to 
provide for medical, scientific, or other legitimate purposes; or
    (ii) Such amounts of any controlled substances listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for the 
medical, scientific, or other legitimate needs of the United States 
during an emergency in which domestic supplies of such substances are 
found by the Administrator to be inadequate; or
    (iii) Such amounts of any controlled substance listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for the 
medical, scientific, or other legitimate needs of the United States in 
any case in which the Administrator finds that competition among 
domestic manufacturers of the controlled substance is inadequate and 
will not be rendered adequate by the registration of additional 
manufacturers under section 303 of the Act (21 U.S.C. 823); or
    (iv) Such limited quantities of any controlled substance listed in 
Schedule I or II as the Administrator shall find

[[Page 29]]

to be necessary for scientific, analytical or research uses; and
    (7) Such other factors as may be relevant to and consistent with the 
public health and safety.
    (c) In determining whether the applicant can and will maintain 
effective controls against diversion within the meaning of paragraph (b) 
of this section, the Administrator shall consider among other factors:
    (1) Compliance with the security requirements set forth in 
Sec. Sec. 1301.71-1301.76; and
    (2) Employment of security procedures to guard against in-transit 
losses within and without the jurisdiction of the United States.
    (d) In determining whether competition among the domestic 
manufacturers of a controlled substance is adequate within the meaning 
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as section 
1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator 
shall consider:
    (1) The extent of price rigidity in the light of changes in:
    (i) raw materials and other costs and
    (ii) conditions of supply and demand;
    (2) The extent of service and quality competition among the domestic 
manufacturers for shares of the domestic market including:
    (i) Shifts in market shares and
    (ii) Shifts in individual customers among domestic manufacturers;
    (3) The existence of substantial differentials between domestic 
prices and the higher of prices generally prevailing in foreign markets 
or the prices at which the applicant for registration to import is 
committed to undertake to provide such products in the domestic market 
in conformity with the Act. In determining the existence of substantial 
differentials hereunder, appropriate consideration should be given to 
any additional costs imposed on domestic manufacturers by the 
requirements of the Act and such other cost-related and other factors as 
the Administrator may deem relevant. In no event shall an importer's 
offering prices in the United States be considered if they are lower 
than those prevailing in the foreign market or markets from which the 
importer is obtaining his/her supply;
    (4) The existence of competitive restraints imposed upon domestic 
manufacturers by governmental regulations; and
    (5) Such other factors as may be relevant to the determinations 
required under this paragraph.
    (e) In considering the scope of the domestic market, consideration 
shall be given to substitute products which are reasonably 
interchangeable in terms of price, quality and use.
    (f) The fact that the number of existing manufacturers is small 
shall not demonstrate, in and of itself, that adequate competition among 
them does not exist.

[62 FR 13953, Mar. 24, 1997]



Sec. 1301.35  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration (DEA 
Form 223) to an applicant if the issuance of registration or 
reregistration is required under the applicable provisions of sections 
303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the 
issuance of registration or reregistration is not required, the 
Administrator shall deny the application. Before denying any 
application, the Administrator shall issue an order to show cause 
pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold 
a hearing on the application pursuant to Sec. 1301.41.
    (b) If in response to a show cause order a hearing is requested by 
an applicant for registration or reregistration to manufacture in bulk a 
basic class of controlled substance listed in Schedule I or II, notice 
that a hearing has been requested shall be published in the Federal 
Register and shall be mailed simultaneously to the applicant and to all 
persons to whom notice of the application was mailed. Any person 
entitled to file comments or objections to the issuance of the proposed 
registration pursuant to Sec. 1301.33(a) may participate in the hearing 
by filing notice of appearance in accordance with Sec. 1301.43. Such 
persons shall have 30 days to file a notice of appearance after the date 
of publication of the notice of a request for a hearing in the Federal 
Register.

[[Page 30]]

    (c) The Certificate of Registration (DEA Form 223) shall contain the 
name, address, and registration number of the registrant, the activity 
authorized by the registration, the schedules and/or Administration 
Controlled Substances Code Number (as set forth in part 1308 of this 
chapter) of the controlled substances which the registrant is authorized 
to handle, the amount of fee paid (or exemption), and the expiration 
date of the registration. The registrant shall maintain the certificate 
of registration at the registered location in a readily retrievable 
manner and shall permit inspection of the certificate by any official, 
agent or employee of the Administration or of any Federal, State, or 
local agency engaged in enforcement of laws relating to controlled 
substances.

[62 FR 13954, Mar. 24, 1997]



Sec. 1301.36  Suspension or revocation of registration; suspension of 

registration pending final order; extension of registration pending 
final order.

    (a) For any registration issued under section 303 of the Act (21 
U.S.C. 823), the Administrator may:
    (1) Suspend the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)) for any period of time.
    (2) Revoke the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)).
    (b) For any registration issued under section 1008 of the Act (21 
U.S.C. 958), the Administrator may:
    (1) Suspend the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) for any period of time.
    (2) Revoke the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) if he/she determines that such registration is 
inconsistent with the public interest as defined in section 1008 or with 
the United States obligations under international treaties, conventions, 
or protocols in effect on October 12, 1984.
    (c) The Administrator may limit the revocation or suspension of a 
registration to the particular controlled substance, or substances, with 
respect to which grounds for revocation or suspension exist.
    (d) Before revoking or suspending any registration, the 
Administrator shall issue an order to show cause pursuant to Sec. 
1301.37 and, if requested by the registrant, shall hold a hearing 
pursuant to Sec. 1301.41.
    (e) The Administrator may suspend any registration simultaneously 
with or at any time subsequent to the service upon the registrant of an 
order to show cause why such registration should not be revoked or 
suspended, in any case where he/she finds that there is an imminent 
danger to the public health or safety. If the Administrator so suspends, 
he/she shall serve with the order to show cause pursuant to Sec. 
1301.37 an order of immediate suspension which shall contain a statement 
of his findings regarding the danger to public health or safety.
    (f) Upon service of the order of the Administrator suspending or 
revoking registration, the registrant shall immediately deliver his/her 
Certificate of Registration, any order forms, and any import or export 
permits in his/her possession to the nearest office of the 
Administration. The suspension or revocation of a registration shall 
suspend or revoke any individual manufacturing or procurement quota 
fixed for the registrant pursuant to part 1303 of this chapter and any 
import or export permits issued to the registrant pursuant to part 1312 
of this chapter. Also, upon service of the order of the Administrator 
revoking or suspending registration, the registrant shall, as instructed 
by the Administrator:
    (1) Deliver all controlled substances in his/her possession to the 
nearest office of the Administration or to authorized agents of the 
Administration; or
    (2) Place all controlled substances in his/her possession under seal 
as described in sections 304(f) or 1008(d)(6) of the Act (21 U.S.C. 
824(f) or 958(d)(6)).
    (g) In the event that revocation or suspension is limited to a 
particular controlled substance or substances, the registrant shall be 
given a new Certificate of Registration for all substances not affected 
by such revocation or suspension; no fee shall be required to be paid 
for the new Certificate of Registration. The registrant shall deliver 
the old Certificate of Registration and, if appropriate, any order forms 
in his/her possession to the nearest office of

[[Page 31]]

the Administration. The suspension or revocation of a registration, when 
limited to a particular basic class or classes of controlled substances, 
shall suspend or revoke any individual manufacturing or procurement 
quota fixed for the registrant for such class or classes pursuant to 
part 1303 of this chapter and any import or export permits issued to the 
registrant for such class or classes pursuant to part 1312 of this 
chapter. Also, upon service of the order of the Administrator revoking 
or suspending registration, the registrant shall, as instructed by the 
Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular controlled 
substance or substances affected by the revocation or suspension which 
are in his/her possession; or
    (2) Place all of such substances under seal as described in sections 
304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or 958(d)(6)).
    (h) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the revocation or suspension, including any 
judicial review thereof, unless sooner withdrawn by the Administrator or 
dissolved by a court of competent jurisdiction. Any registrant whose 
registration is suspended under paragraph (e) of this section may 
request a hearing on the revocation or suspension of his/her 
registration at a time earlier than specified in the order to show cause 
pursuant to Sec. 1301.37. This request shall be granted by the 
Administrator, who shall fix a date for such hearing as early as 
reasonably possible.
    (i) In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before the 
date on which the existing registration is due to expire, and the 
Administrator has issued no order on the application on the date on 
which the existing registration is due to expire, the existing 
registration of the applicant shall automatically be extended and 
continue in effect until the date on which the Administrator so issues 
his/her order. The Administrator may extend any other existing 
registration under the circumstances contemplated in this section even 
though the registrant failed to apply for reregistration at least 45 
days before expiration of the existing registration, with or without 
request by the registrant, if the Administrator finds that such 
extension is not inconsistent with the public health and safety.

[62 FR 13955, Mar. 24, 1997]



Sec. 1301.37  Order to show cause.

    (a) If, upon examination of the application for registration from 
any applicant and other information gathered by the Administration 
regarding the applicant, the Administrator is unable to make the 
determinations required by the applicable provisions of section 303 and/
or section 1008 of the Act (21 U.S.C. 823 and 958) to register the 
applicant, the Administrator shall serve upon the applicant an order to 
show cause why the registration should not be denied.
    (b) If, upon information gathered by the Administration regarding 
any registrant, the Administrator determines that the registration of 
such registrant is subject to suspension or revocation pursuant to 
section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the 
Administrator shall serve upon the registrant an order to show cause why 
the registration should not be revoked or suspended.
    (c) The order to show cause shall call upon the applicant or 
registrant to appear before the Administrator at a time and place stated 
in the order, which shall not be less than 30 days after the date of 
receipt of the order. The order to show cause shall also contain a 
statement of the legal basis for such hearing and for the denial, 
revocation, or suspension of registration and a summary of the matters 
of fact and law asserted.
    (d) Upon receipt of an order to show cause, the applicant or 
registrant must, if he/she desires a hearing, file a request for a 
hearing pursuant to Sec. 1301.43. If a hearing is requested, the 
Administrator shall hold a hearing at the time and place stated in the 
order, pursuant to Sec. 1301.41.

[[Page 32]]

    (e) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.

[62 FR 13955, Mar. 24, 1997]

                                Hearings



Sec. 1301.41  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing on any 
registration or application therefor, the procedures for such hearing 
shall be governed generally by the adjudication procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
sections 303, 304, and 1008 of the Act (21 U.S.C. 823-824 and 958), by 
Sec. Sec. 1301.42-1301.46 of this part, and by the procedures for 
administrative hearings under the Act set forth in Sec. Sec. 1316.41-
1316.67 of this chapter.
    (b) Any hearing under this part shall be independent of, and not in 
lieu of, criminal prosecutions or other proceedings under the Act or any 
other law of the United States.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.42  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall hold a hearing for the purpose of receiving factual evidence 
regarding the issues involved in the denial, revocation, or suspension 
of any registration, and the granting of any application for 
registration to import or to manufacture in bulk a basic class of 
controlled substance listed in Schedule I or II. Extensive argument 
should not be offered into evidence but rather presented in opening or 
closing statements of counsel or in memoranda or proposed findings of 
fact and conclusions of law.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.43  Request for hearing or appearance; waiver.

    (a) Any person entitled to a hearing pursuant to Sec. 1301.32 or 
Sec. Sec. 1301.34-1301.36 and desiring a hearing shall, within 30 days 
after the date of receipt of the order to show cause (or the date of 
publication of notice of the application for registration in the Federal 
Register in the case of Sec. 1301.34), file with the Administrator a 
written request for a hearing in the form prescribed in Sec. 1316.47 of 
this chapter.
    (b) Any person entitled to participate in a hearing pursuant to 
Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30 
days of the date of publication of notice of the request for a hearing 
in the Federal Register, file with the Administrator a written notice of 
intent to participate in such hearing in the form prescribed in Sec. 
1316.48 of this chapter. Any person filing a request for a hearing need 
not also file a notice of appearance.
    (c) Any person entitled to a hearing or to participate in a hearing 
pursuant to Sec. 1301.32 or Sec. Sec. 1301.34-1301.36 may, within the 
period permitted for filing a request for a hearing or a notice of 
appearance, file with the Administrator a waiver of an opportunity for a 
hearing or to participate in a hearing, together with a written 
statement regarding such person's position on the matters of fact and 
law involved in such hearing. Such statement, if admissible, shall be 
made a part of the record and shall be considered in light of the lack 
of opportunity for cross-examination in determining the weight to be 
attached to matters of fact asserted therein.
    (d) If any person entitled to a hearing or to participate in a 
hearing pursuant to Sec. 1301.32 or Sec. Sec. 1301.34-1301.36 fails to 
file a request for a hearing or a notice of appearance, or if such 
person so files and fails to appear at the hearing, such person shall be 
deemed to have waived the opportunity for a hearing or to participate in 
the hearing, unless such person shows good cause for such failure.
    (e) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his/her final order pursuant to Sec. 
1301.46 without a hearing.

[62 FR 13956, Mar. 24, 1997]

[[Page 33]]



Sec. 1301.44  Burden of proof.

    (a) At any hearing on an application to manufacture any controlled 
substance listed in Schedule I or II, the applicant shall have the 
burden of proving that the requirements for such registration pursuant 
to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any other 
person participating in the hearing pursuant to Sec. 1301.35(b) shall 
have the burden of proving any propositions of fact or law asserted by 
such person in the hearing.
    (b) At any hearing on the granting or denial of an applicant to be 
registered to conduct a narcotic treatment program or as a compounder, 
the applicant shall have the burden of proving that the requirements for 
each registration pursuant to section 303(g) of the Act (21 U.S.C. 
823(g)) are satisfied.
    (c) At any hearing on the granting or denial of an application to be 
registered to import or export any controlled substance listed in 
Schedule I or II, the applicant shall have the burden of proving that 
the requirements for such registration pursuant to sections 1008(a) and 
(d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other 
person participating in the hearing pursuant to Sec. 1301.34 shall have 
the burden of proving any propositions of fact or law asserted by him/
her in the hearings.
    (d) At any other hearing for the denial of a registration, the 
Administration shall have the burden of proving that the requirements 
for such registration pursuant to section 303 or section 1008(c) and (d) 
of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.
    (e) At any hearing for the revocation or suspension of a 
registration, the Administration shall have the burden of proving that 
the requirements for such revocation or suspension pursuant to section 
304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are 
satisfied.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.45  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
order to show cause or notice of hearing published in the Federal 
Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter 
it may be moved to a different place and may be continued from day to 
day or recessed to a later day without notice other than announcement 
thereof by the presiding officer at the hearing.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.46  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his/her order 
on the granting, denial, revocation, or suspension of registration. In 
the event that an application for registration to import or to 
manufacture in bulk a basic class of any controlled substance listed in 
Schedule I or II is granted, or any application for registration is 
denied, or any registration is revoked or suspended, the order shall 
include the findings of fact and conclusions of law upon which the order 
is based. The order shall specify the date on which it shall take 
effect. The Administrator shall serve one copy of his/her order upon 
each party in the hearing.

[62 FR 13956, Mar. 24, 1997]

         Modification, Transfer and Termination of Registration



Sec. 1301.51  Modification in registration.

    Any registrant may apply to modify his/her registration to authorize 
the handling of additional controlled substances or to change his/her 
name or address, by submitting a letter of request to the Registration 
Unit, Drug Enforcement Administration, Department of Justice, Post 
Office Box 28083, Central Station, Washington, DC 20005. The letter 
shall contain the registrant's name, address, and registration number as 
printed on the certificate of registration, and the substances and/or 
schedules to be added to his/her registration or the new name or address 
and shall be signed in accordance with Sec. 1301.13(j). If the 
registrant is seeking to handle additional controlled substances listed 
in Schedule I for the purpose of research or instructional activities, 
he/she shall attach three copies of a research protocol describing each 
research project involving the additional substances, or two copies of a

[[Page 34]]

statement describing the nature, extent, and duration of such 
instructional activities, as appropriate. No fee shall be required to be 
paid for the modification. The request for modification shall be handled 
in the same manner as an application for registration. If the 
modification in registration is approved, the Administrator shall issue 
a new certificate of registration (DEA Form 223) to the registrant, who 
shall maintain it with the old certificate of registration until 
expiration.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.52  Termination of registration; transfer of registration; 
distribution upon discontinuance of business.

    (a) Except as provided in paragraph (b) of this section, the 
registration of any person shall terminate if and when such person dies, 
ceases legal existence, or discontinues business or professional 
practice. Any registrant who ceases legal existence or discontinues 
business or professional practice shall notify the Administrator 
promptly of such fact.
    (b) No registration or any authority conferred thereby shall be 
assigned or otherwise transferred except upon such conditions as the 
Administration may specifically designate and then only pursuant to 
written consent. Any person seeking authority to transfer a registration 
shall submit a written request, providing full details regarding the 
proposed transfer of registration, to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Department of Justice, Washington, DC 20537.
    (c) Any registrant desiring to discontinue business activities 
altogether or with respect to controlled substances (without 
transferring such business activities to another person) shall return 
for cancellation his/her certificate of registration, and any unexecuted 
order forms in his/her possession, to the Registration Unit, Drug 
Enforcement Administration, Department of Justice, Post Office Box 
28083, Central Station, Washington, DC 20005. Any controlled substances 
in his/her possession may be disposed of in accordance with Sec. 
1307.21 of this chapter.
    (d) Any registrant desiring to discontinue business activities 
altogether or with respect to controlled substance (by transferring such 
business activities to another person) shall submit in person or by 
registered or certified mail, return receipt requested, to the Special 
Agent in Charge in his/her area, at least 14 days in advance of the date 
of the proposed transfer (unless the Special Agent in Charge waives this 
time limitation in individual instances), the following information:
    (1) The name, address, registration number, and authorized business 
activity of the registrant discontinuing the business (registrant-
transferor);
    (2) The name, address, registration number, and authorized business 
activity of the person acquiring the business (registrant-transferee);
    (3) Whether the business activities will be continued at the 
location registered by the person discontinuing business, or moved to 
another location (if the latter, the address of the new location should 
be listed);
    (4) Whether the registrant-transferor has a quota to manufacture or 
procure any controlled substance listed in Schedule I or II (if so, the 
basic class or class of the substance should be indicated); and
    (5) The date on which the transfer of controlled substances will 
occur.
    (e) Unless the registrant-transferor is informed by the Special 
Agent in Charge, before the date on which the transfer was stated to 
occur, that the transfer may not occur, the registrant-transferor may 
distribute (without being registered to distribute) controlled 
substances in his/her possession to the registrant-transferee in 
accordance with the following:
    (1) On the date of transfer of the controlled substances, a complete 
inventory of all controlled substances being transferred shall be taken 
in accordance with Sec. 1304.11 of this chapter. This inventory shall 
serve as the final inventory of the registrant-transferor and the 
initial inventory of the registrant-transferee, and a copy of the 
inventory shall be included in the records of each person. It shall not 
be necessary to file a copy of the inventory with the Administration 
unless requested by the Special Agent in Charge. Transfers of any 
substances listed in Schedule I or II shall require

[[Page 35]]

the use of order forms in accordance with part 1305 of this chapter.
    (2) On the date of transfer of the controlled substances, all 
records required to be kept by the registrant-transferor with reference 
to the controlled substances being transferred, under part 1304 of this 
chapter, shall be transferred to the registrant-transferee. 
Responsibility for the accuracy of records prior to the date of transfer 
remains with the transferor, but responsibility for custody and 
maintenance shall be upon the transferee.
    (3) In the case of registrants required to make reports pursuant to 
part 1304 of this chapter, a report marked ``Final'' will be prepared 
and submitted by the registrant-transferor showing the disposition of 
all the controlled substances for which a report is required; no 
additional report will be required from him, if no further transactions 
involving controlled substances are consummated by him. The initial 
report of the registrant-transferee shall account for transactions 
beginning with the day next succeeding the date of discontinuance or 
transfer of business by the transferor-registrant and the substances 
transferred to him shall be reported as receipts in his/her initial 
report.

[62 FR 13957, Mar. 24, 1997]

                          Security Requirements



Sec. 1301.71  Security requirements generally.

    (a) All applicants and registrants shall provide effective controls 
and procedures to guard against theft and diversion of controlled 
substances. In order to determine whether a registrant has provided 
effective controls against diversion, the Administrator shall use the 
security requirements set forth in Sec. Sec. 1301.72-1301.76 as 
standards for the physical security controls and operating procedures 
necessary to prevent diversion. Materials and construction which will 
provide a structural equivalent to the physical security controls set 
forth in Sec. Sec. 1301.72, 1301.73 and 1301.75 may be used in lieu of 
the materials and construction described in those sections.
    (b) Substantial compliance with the standards set forth in 
Sec. Sec. 1301.72-1301.76 may be deemed sufficient by the Administrator 
after evaluation of the overall security system and needs of the 
applicant or registrant. In evaluating the overall security system of a 
registrant or applicant, the Administrator may consider any of the 
following factors as he may deem relevant to the need for strict 
compliance with security requirements:
    (1) The type of activity conducted (e.g., processing of bulk 
chemicals, preparing dosage forms, packaging, labeling, cooperative 
buying, etc.);
    (2) The type and form of controlled substances handled (e.g., bulk 
liquids or dosage units, usable powders or nonusable powders);
    (3) The quantity of controlled substances handled;
    (4) The location of the premises and the relationship such location 
bears on security needs;
    (5) The type of building construction comprising the facility and 
the general characteristics of the building or buildings;
    (6) The type of vault, safe, and secure enclosures or other storage 
system (e.g., automatic storage and retrieval system) used;
    (7) The type of closures on vaults, safes, and secure enclosures;
    (8) The adequacy of key control systems and/or combination lock 
control systems;
    (9) The adequacy of electric detection and alarm systems, if any 
including use of supervised transmittal lines and standby power sources;
    (10) The extent of unsupervised public access to the facility, 
including the presence and characteristics of perimeter fencing, if any;
    (11) The adequacy of supervision over employees having access to 
manufacturing and storage areas;
    (12) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel;
    (13) The availability of local police protection or of the 
registrant's or applicant's security personnel;
    (14) The adequacy of the registrant's or applicant's system for 
monitoring the receipt, manufacture, distribution, and disposition of 
controlled substances in its operations; and

[[Page 36]]

    (15) The applicability of the security requirements contained in all 
Federal, State, and local laws and regulations governing the management 
of waste.
    (c) When physical security controls become inadequate as a result of 
a controlled substance being transferred to a different schedule, or as 
a result of a noncontrolled substance being listed on any schedule, or 
as a result of a significant increase in the quantity of controlled 
substances in the possession of the registrant during normal business 
operations, the physical security controls shall be expanded and 
extended accordingly. A registrant may adjust physical security controls 
within the requirements set forth in Sec. Sec. 1301.72-1301.76 when the 
need for such controls decreases as a result of a controlled substance 
being transferred to a different schedule, or a result of a controlled 
substance being removed from control, or as a result of a significant 
decrease in the quantity of controlled substances in the possession of 
the registrant during normal business operations.
    (d) Any registrant or applicant desiring to determine whether a 
proposed security system substantially complies with, or is the 
structural equivalent of, the requirements set forth in Sec. Sec. 
1301.72-1301.76 may submit any plans, blueprints, sketches or other 
materials regarding the proposed security system either to the Special 
Agent in Charge in the region in which the system will be used, or to 
the Diversion Operations Section, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537.
    (e) Physical security controls of locations registered under the 
Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on 
April 30, 1971, shall be deemed to comply substantially with the 
standards set forth in Sec. Sec. 1301.72, 1301.73 and 1301.75. Any new 
facilities or work or storage areas constructed or utilized for 
controlled substances, which facilities or work or storage areas have 
not been previously approved by the Administration, shall not 
necessarily be deemed to comply substantially with the standards set 
forth in Sec. Sec. 1301.72, 1301.73 and 1301.75, notwithstanding that 
such facilities or work or storage areas have physical security controls 
similar to those previously approved by the Administration.

[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
l973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, 
1982; 51 FR 5319, Feb. 13, 1986; 68 FR 41228, July 11, 2003]



Sec. 1301.72  Physical security controls for non-practitioners; narcotic 

treatment programs and compounders for narcotic treatment programs; storage 
areas.

    (a) Schedules I and II. Raw material, bulk materials awaiting 
further processing, and finished products which are controlled 
substances listed in Schedule I or II (except GHB that is manufactured 
or distributed in accordance with an exemption under section 505(i) of 
the FFDCA which shall be subject to the requirements of paragraph (b) of 
this section) shall be stored in one of the following secured areas:
    (1) Where small quantities permit, a safe or steel cabinet;
    (i) Which safe or steel cabinet shall have the following 
specifications or the equivalent: 30 man-minutes against surreptitious 
entry, 10 man-minutes against forced entry, 20 man-hours against lock 
manipulation, and 20 man-hours against radiological techniques;
    (ii) Which safe or steel cabinet, if it weighs less than 750 pounds, 
is bolted or cemented to the floor or wall in such a way that it cannot 
be readily removed; and
    (iii) Which safe or steel cabinet, if necessary, depending upon the 
quantities and type of controlled substances stored, is equipped with an 
alarm system which, upon attempted unauthorized entry, shall transmit a 
signal directly to a central protection company or a local or State 
police agency which has a legal duty to respond, or a 24-hour control 
station operated by the registrant, or such other protection as the 
Administrator may approve.
    (2) A vault constructed before, or under construction on, September 
1, 1971, which is of substantial construction with a steel door, 
combination or key lock, and an alarm system; or
    (3) A vault constructed after September 1, 1971:
    (i) The walls, floors, and ceilings of which vault are constructed 
of at least

[[Page 37]]

8 inches of reinforced concrete or other substantial masonry, reinforced 
vertically and horizontally with \1/2\-inch steel rods tied 6 inches on 
center, or the structural equivalent to such reinforced walls, floors, 
and ceilings;
    (ii) The door and frame unit of which vault shall conform to the 
following specifications or the equivalent: 30 man-minutes against 
surreptitious entry, 10 man-minutes against forced entry, 20 man-hours 
against lock manipulation, and 20 man-hours against radiological 
techniques;
    (iii) Which vault, if operations require it to remain open for 
frequent access, is equipped with a ``day-gate'' which is self-closing 
and self-locking, or the equivalent, for use during the hours of 
operation in which the vault door is open;
    (iv) The walls or perimeter of which vault are equipped with an 
alarm, which upon unauthorized entry shall transmit a signal directly to 
a central station protection company, or a local or State police agency 
which has a legal duty to respond, or a 24-hour control station operated 
by the registrant, or such other protection as the Administrator may 
approve, and, if necessary, holdup buttons at strategic points of entry 
to the perimeter area of the vault;
    (v) The door of which vault is equipped with contact switches; and
    (vi) Which vault has one of the following: Complete electrical 
lacing of the walls, floor and ceilings; sensitive ultrasonic equipment 
within the vault; a sensitive sound accumulator system; or such other 
device designed to detect illegal entry as may be approved by the 
Administration.
    (b) Schedules III, IV and V. Raw material, bulk materials awaiting 
further processing, and finished products which are controlled 
substances listed in Schedules III, IV, and V, and GHB when it is 
manufactured or distributed in accordance with an exemption under 
section 505(i) of the FFDCA, shall be stored in the following secure 
storage areas:
    (1) A safe or steel cabinet as described in paragraph (a)(1) of this 
section;
    (2) A vault as described in paragraph (a)(2) or (3) of this section 
equipped with an alarm system as described in paragraph (b)(4)(v) of 
this section;
    (3) A building used for storage of Schedules III through V 
controlled substances with perimeter security which limits access during 
working hours and provides security after working hours and meets the 
following specifications:
    (i) Has an electronic alarm system as described in paragraph 
(b)(4)(v) of this section,
    (ii) Is equipped with self-closing, self-locking doors constructed 
of substantial material commensurate with the type of building 
construction, provided, however, a door which is kept closed and locked 
at all times when not in use and when in use is kept under direct 
observation of a responsible employee or agent of the registrant is 
permitted in lieu of a self-closing, self-locking door. Doors may be 
sliding or hinged. Regarding hinged doors, where hinges are mounted on 
the outside, such hinges shall be sealed, welded or otherwise 
constructed to inhibit removal. Locking devices for such doors shall be 
either of the multiple-position combination or key lock type and:
    (a) In the case of key locks, shall require key control which limits 
access to a limited number of employees, or;
    (b) In the case of combination locks, the combination shall be 
limited to a minimum number of employees and can be changed upon 
termination of employment of an employee having knowledge of the 
combination;
    (4) A cage, located within a building on the premises, meeting the 
following specifications:
    (i) Having walls constructed of not less than No. 10 gauge steel 
fabric mounted on steel posts, which posts are:
    (a) At least one inch in diameter;
    (b) Set in concrete or installed with lag bolts that are pinned or 
brazed; and
    (c) Which are placed no more than ten feet apart with horizontal one 
and one-half inch reinforcements every sixty inches;
    (ii) Having a mesh construction with openings of not more than two 
and one-half inches across the square,
    (iii) Having a ceiling constructed of the same material, or in the 
alternative, a cage shall be erected which reaches and is securely 
attached to the

[[Page 38]]

structural ceiling of the building. A lighter gauge mesh may be used for 
the ceilings of large enclosed areas if walls are at least 14 feet in 
height,
    (iv) Is equipped with a door constructed of No. 10 gauge steel 
fabric on a metal door frame in a metal door flange, and in all other 
respects conforms to all the requirements of 21 CFR 1301.72(b)(3)(ii), 
and
    (v) Is equipped with an alarm system which upon unauthorized entry 
shall transmit a signal directly to a central station protection agency 
or a local or state police agency, each having a legal duty to respond, 
or to a 24-hour control station operated by the registrant, or to such 
other source of protection as the Administrator may approve;
    (5) An enclosure of masonry or other material, approved in writing 
by the Administrator as providing security comparable to a cage;
    (6) A building or enclosure within a building which has been 
inspected and approved by DEA or its predecessor agency, BND, and 
continues to provide adequate security against the diversion of Schedule 
III through V controlled substances, of which fact written 
acknowledgment has been made by the Special Agent in Charge of DEA for 
the area in which such building or enclosure is situated;
    (7) Such other secure storage areas as may be approved by the 
Administrator after considering the factors listed in Sec. 1301.71(b);
    (8)(i) Schedule III through V controlled substances may be stored 
with Schedules I and II controlled substances under security measures 
provided by 21 CFR 1301.72(a);
    (ii) Non-controlled drugs, substances and other materials may be 
stored with Schedule III through V controlled substances in any of the 
secure storage areas required by 21 CFR 1301.72(b), provided that 
permission for such storage of non-controlled items is obtained in 
advance, in writing, from the Special Agent in Charge of DEA for the 
area in which such storage area is situated. Any such permission 
tendered must be upon the Special Agent in Charge's written 
determination that such non-segregated storage does not diminish 
security effectiveness for Schedules III through V controlled 
substances.
    (c) Multiple storage areas. Where several types or classes of 
controlled substances are handled separately by the registrant or 
applicant for different purposes (e.g., returned goods, or goods in 
process), the controlled substances may be stored separately, provided 
that each storage area complies with the requirements set forth in this 
section.
    (d) Accessibility to storage areas. The controlled substances 
storage areas shall be accessible only to an absolute minimum number of 
specifically authorized employees. When it is necessary for employee 
maintenance personnel, nonemployee maintenance personnel, business 
guests, or visitors to be present in or pass through controlled 
substances storage areas, the registrant shall provide for adequate 
observation of the area by an employee specifically authorized in 
writing.

[36 FR 18730, Sept. 21, 1971, as amended at 37 FR 15919, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, l973]

    Editorial Note: For Federal Register citations affecting Sec. 
1301.72, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1301.73  Physical security controls for non-practitioners; 

compounders for narcotic treatment programs; manufacturing and compounding 
areas.

    All manufacturing activities (including processing, packaging and 
labeling) involving controlled substances listed in any schedule and all 
activities of compounders shall be conducted in accordance with the 
following:
    (a) All in-process substances shall be returned to the controlled 
substances storage area at the termination of the process. If the 
process is not terminated at the end of a workday (except where a 
continuous process or other normal manufacturing operation should not be 
interrupted), the processing area or tanks, vessels, bins or bulk 
containers containing such substances shall be securely locked, with 
adequate security for the area or building. If such security requires an 
alarm, such alarm, upon unauthorized entry, shall transmit a signal 
directly to a

[[Page 39]]

central station protection company, or local or state police agency 
which has a legal duty to respond, or a 24-hour control station operated 
by the registrant.
    (b) Manufacturing activities with controlled substances shall be 
conducted in an area or areas of clearly defined limited access which is 
under surveillance by an employee or employees designated in writing as 
responsible for the area. ``Limited access'' may be provided, in the 
absence of physical dividers such as walls or partitions, by traffic 
control lines or restricted space designation. The employee designated 
as responsible for the area may be engaged in the particular 
manufacturing operation being conducted: Provided, That he is able to 
provide continuous surveillance of the area in order that unauthorized 
persons may not enter or leave the area without his knowledge.
    (c) During the production of controlled substances, the 
manufacturing areas shall be accessible to only those employees required 
for efficient operation. When it is necessary for employee maintenance 
personnel, nonemployee maintenance personnel, business guests, or 
visitors to be present in or pass through manufacturing areas during 
production of controlled substances, the registrant shall provide for 
adequate observation of the area by an employee specifically authorized 
in writing.

[36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
l973 and amended at 39 FR 37984, Oct. 25, 1974]



Sec. 1301.74  Other security controls for non-practitioners; narcotic 
treatment programs and compounders for narcotic treatment programs.

    (a) Before distributing a controlled substance to any person who the 
registrant does not know to be registered to possess the controlled 
substance, the registrant shall make a good faith inquiry either with 
the Administration or with the appropriate State controlled substances 
registration agency, if any, to determine that the person is registered 
to possess the controlled substance.
    (b) The registrant shall design and operate a system to disclose to 
the registrant suspicious orders of controlled substances. The 
registrant shall inform the Field Division Office of the Administration 
in his area of suspicious orders when discovered by the registrant. 
Suspicious orders include orders of unusual size, orders deviating 
substantially from a normal pattern, and orders of unusual frequency.
    (c) The registrant shall notify the Field Division Office of the 
Administration in his area of any theft or significant loss of any 
controlled substances upon discovery of such theft or loss. The supplier 
shall be responsible for reporting in-transit losses of controlled 
substances by the common or contract carrier selected pursuant to Sec. 
1301.74(e), upon discovery of such theft or loss. The registrant shall 
also complete DEA Form 106 regarding such theft or loss. Thefts must be 
reported whether or not the controlled substances are subsequently 
recovered and/or the responsible parties are identified and action taken 
against them.
    (d) The registrant shall not distribute any controlled substance 
listed in Schedules II through V as a complimentary sample to any 
potential or current customer (1) without the prior written request of 
the customer, (2) to be used only for satisfying the legitimate medical 
needs of patients of the customer, and (3) only in reasonable 
quantities. Such request must contain the name, address, and 
registration number of the customer and the name and quantity of the 
specific controlled substance desired. The request shall be preserved by 
the registrant with other records of distribution of controlled 
substances. In addition, the requirements of part 1305 of the chapter 
shall be complied with for any distribution of a controlled substance 
listed in Schedule II. For purposes of this paragraph, the term 
``customer'' includes a person to whom a complimentary sample of a 
substance is given in order to encourage the prescribing or recommending 
of the substance by the person.
    (e) When shipping controlled substances, a registrant is responsible 
for selecting common or contract carriers which provide adequate 
security to guard against in-transit losses. When

[[Page 40]]

storing controlled substances in a public warehouse, a registrant is 
responsible for selecting a warehouseman which will provide adequate 
security to guard against storage losses; wherever possible, the 
registrant shall store controlled substances in a public warehouse which 
complies with the requirements set forth in Sec. 1301.72. In addition, 
the registrant shall employ precautions (e.g., assuring that shipping 
containers do not indicate that contents are controlled substances) to 
guard against storage or in-transit losses.
    (f) When distributing controlled substances through agents (e.g., 
detailmen), a registrant is responsible for providing and requiring 
adequate security to guard against theft and diversion while the 
substances are being stored or handled by the agent or agents.
    (g) Before the initial distribution of carfentanil etorphine 
hydrochloride and/or diprenorphine to any person, the registrant must 
verify that the person is authorized to handle the substances(s) by 
contacting the Drug Enforcement Administration.
    (h) The acceptance of delivery of narcotic substances by a narcotic 
treatment program shall be made only by a licensed practitioner employed 
at the facility or other authorized individuals designated in writing. 
At the time of delivery, the licensed practitioner or other authorized 
individual designated in writing (excluding persons currently or 
previously dependent on narcotic drugs), shall sign for the narcotics 
and place his specific title (if any) on any invoice. Copies of these 
signed invoices shall be kept by the distributor.
    (i) Narcotics dispensed or administered at a narcotic treatment 
program will be dispensed or administered directly to the patient by 
either (1) the licensed practitioner, (2) a registered nurse under the 
direction of the licensed practitioner, (3) a licensed practical nurse 
under the direction of the licensed practitioner, or (4) a pharmacist 
under the direction of the licensed practitioner.
    (j) Persons enrolled in a narcotic treatment program will be 
required to wait in an area physically separated from the narcotic 
storage and dispensing area. This requirement will be enforced by the 
program physician and employees.
    (k) All narcotic treatment programs must comply with standards 
established by the Secretary of Health and Human Services (after 
consultation with the Administration) respecting the quantities of 
narcotic drugs which may be provided to persons enrolled in a narcotic 
treatment program for unsupervised use.
    (l) DEA may exercise discretion regarding the degree of security 
required in narcotic treatment programs based on such factors as the 
location of a program, the number of patients enrolled in a program and 
the number of physicians, staff members and security guards. Similarly, 
such factors will be taken into consideration when evaluating existing 
security or requiring new security at a narcotic treatment program.

[36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, 1971, as amended at 36 
FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, l973]

    Editorial Note: For Federal Register citations affecting Sec. 
1301.74, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1301.75  Physical security controls for practitioners.

    (a) Controlled substances listed in Schedule I shall be stored in a 
securely locked, substantially constructed cabinet.
    (b) Controlled substances listed in Schedules II, III, IV, and V 
shall be stored in a securely locked, substantially constructed cabinet. 
However, pharmacies and institutional practitioners may disperse such 
substances throughout the stock of noncontrolled substances in such a 
manner as to obstruct the theft or diversion of the controlled 
substances.
    (c) This section shall also apply to nonpractitioners authorized to 
conduct research or chemical analysis under another registration.
    (d) Carfentanil etorphine hydrochloride and diprenorphine shall be

[[Page 41]]

stored in a safe or steel cabinet equivalent to a U.S. Government Class 
V security container.

[39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54 
FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997]



Sec. 1301.76  Other security controls for practitioners.

    (a) The registrant shall not employ, as an agent or employee who has 
access to controlled substances, any person who has been convicted of a 
felony offense relating to controlled substances or who, at any time, 
had an application for registration with the DEA denied, had a DEA 
registration revoked or has surrendered a DEA registration for cause. 
For purposes of this subsection, the term ``for cause'' means a 
surrender in lieu of, or as a consequence of, any federal or state 
administrative, civil or criminal action resulting from an investigation 
of the individual's handling of controlled substances.
    (b) The registrant shall notify the Field Division Office of the 
Administration in his area of the theft or significant loss of any 
controlled substances upon discovery of such loss or theft. The 
registrant shall also complete DEA (or BND) Form 106 regarding such loss 
or theft.
    (c) Whenever the registrant distributes a controlled substance 
(without being registered as a distributor, as permitted in Sec. 
1301.13(e)(1) and/or Sec. Sec. 1307.11-1307.12) he/she shall comply 
with the requirements imposed on nonpractitioners in Sec. 1301.74 (a), 
(b), and (e).
    (d) Central fill pharmacies must comply with Sec. 1301.74(e) when 
selecting private, common or contract carriers to transport filled 
prescriptions to a retail pharmacy for delivery to the ultimate user. 
When central fill pharmacies contract with private, common or contract 
carriers to transport filled prescriptions to a retail pharmacy, the 
central fill pharmacy is responsible for reporting in-transit losses 
upon discovery of such loss by use of a DEA Form 106. Retail pharmacies 
must comply with Sec. 1301.74(e) when selecting private, common or 
contract carriers to retrieve filled prescriptions from a central fill 
pharmacy. When retail pharmacies contract with private, common or 
contract carriers to retrieve filled prescriptions from a central fill 
pharmacy, the retail pharmacy is responsible for reporting in-transit 
losses upon discovery of such loss by use of a DEA Form 106.

[36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, l973; 
47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957, 
Mar. 24, 1997; 68 FR 37409, June 24, 2003]



Sec. 1301.77  Security controls for freight forwarding facilities.

    (a) All Schedule II-V controlled substances that will be temporarily 
stored at the freight forwarding facility must be either:
    (1) stored in a segregated area under constant observation by 
designated responsible individual(s); or
    (2) stored in a secured area that meets the requirements of Section 
1301.72(b) of this Part. For purposes of this requirement, a facility 
that may be locked down (i.e., secured against physical entry in a 
manner consistent with requirements of Section 1301.72(b)(3)(ii) of this 
part) and has a monitored alarm system or is subject to continuous 
monitoring by security personnel will be deemed to meet the requirements 
of Section 1301.72(b)(3) of this Part.
    (b) Access to controlled substances must be kept to an absolute 
minimum number of specifically authorized individuals. Non-authorized 
individuals may not be present in or pass through controlled substances 
storage areas without adequate observation provided by an individual 
authorized in writing by the registrant.
    (c) Controlled substances being transferred through a freight 
forwarding facility must be packed in sealed, unmarked shipping 
containers.

[65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000]

                  Employee Screening--Non-Practitioners



Sec. 1301.90  Employee screening procedures.

    It is the position of DEA that the obtaining of certain information 
by non-practitioners is vital to fairly assess

[[Page 42]]

the likelihood of an employee committing a drug security breach. The 
need to know this information is a matter of business necessity, 
essential to overall controlled substances security. In this regard, it 
is believed that conviction of crimes and unauthorized use of controlled 
substances are activities that are proper subjects for inquiry. It is, 
therefore, assumed that the following questions will become a part of an 
employer's comprehensive employee screening program:

    Question. Within the past five years, have you been convicted of a 
felony, or within the past two years, of any misdemeanor or are you 
presently formally charged with committing a criminal offense? (Do not 
include any traffic violations, juvenile offenses or military 
convictions, except by general court-martial.) If the answer is yes, 
furnish details of conviction, offense, location, date and sentence.

    Question. In the past three years, have you ever knowingly used any 
narcotics, amphetamines or barbiturates, other than those prescribed to 
you by a physician? If the answer is yes, furnish details.

    Advice. An authorization, in writing, that allows inquiries to be 
made of courts and law enforcement agencies for possible pending charges 
or convictions must be executed by a person who is allowed to work in an 
area where access to controlled substances clearly exists. A person must 
be advised that any false information or omission of information will 
jeopardize his or her position with respect to employment. The 
application for employment should inform a person that information 
furnished or recovered as a result of any inquiry will not necessarily 
preclude employment, but will be considered as part of an overall 
evaluation of the person's qualifications. The maintaining of fair 
employment practices, the protection of the person's right of privacy, 
and the assurance that the results of such inquiries will be treated by 
the employer in confidence will be explained to the employee.

[40 FR 17143, Apr. 17, 1975]



Sec. 1301.91  Employee responsibility to report drug diversion.

    Reports of drug diversion by fellow employees is not only a 
necessary part of an overall employee security program but also serves 
the public interest at large. It is, therefore, the position of DEA that 
an employee who has knowledge of drug diversion from his employer by a 
fellow employee has an obligation to report such information to a 
responsible security official of the employer. The employer shall treat 
such information as confidential and shall take all reasonable steps to 
protect the confidentiality of the information and the identity of the 
employee furnishing information. A failure to report information of drug 
diversion will be considered in determining the feasibility of 
continuing to allow an employee to work in a drug security area. The 
employer shall inform all employees concerning this policy.

[40 FR 17143, Apr. 17, 1975]



Sec. 1301.92  Illicit activities by employees.

    It is the position of DEA that employees who possess, sell, use or 
divert controlled substances will subject themselves not only to State 
or Federal prosecution for any illicit activity, but shall also 
immediately become the subject of independent action regarding their 
continued employment. The employer will assess the seriousness of the 
employee's violation, the position of responsibility held by the 
employee, past record of employment, etc., in determining whether to 
suspend, transfer, terminate or take other action against the employee.

[40 FR 17143, Apr. 17, 1975]



Sec. 1301.93  Sources of information for employee checks.

    DEA recommends that inquiries concerning employees' criminal records 
be made as follows:

    Local inquiries. Inquiries should be made by name, date and place of 
birth, and other identifying information, to local courts and law 
enforcement agencies for records of pending charges and convictions. 
Local practice may require such inquiries to be made in person, rather 
than by mail, and a copy of an authorization from the employee may be 
required by certain law enforcement agencies.
    DEA inquiries. Inquiries supplying identifying information should 
also be furnished to DEA Field Division Offices along with written 
consent from the concerned individual for a check of DEA files for 
records of convictions. The Regional check will result in a national 
check being made by the Field Division Office.

[40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22, 1982]

[[Page 43]]



PART 1302_LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
--Table of Contents

Sec.
1302.01 Scope of part 1302.
1302.02 Definitions.
1302.03 Symbol required; exceptions.
1302.04 Location and size of symbol on label and labeling.
1302.05 Effective dates of labeling requirements.
1302.06 Sealing of controlled substances.
1302.07 Labeling and packaging requirements for imported and exported 
          substances.

    Authority: 21 U.S.C. 821, 825, 871(b), 958(e).

    Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.



Sec. 1302.01  Scope of part 1302.

    Requirements governing the labeling and packaging of controlled 
substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 
825 and 958(d)) are set forth generally by those sections and 
specifically by the sections of this part.

[36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
l973]



Sec. 1302.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]



Sec. 1302.03  Symbol required; exceptions.

    (a) Each commercial container of a controlled substance (except for 
a controlled substance excepted by the Administrator pursuant to Sec. 
1308.31 of this chapter) shall have printed on the label the symbol 
designating the schedule in which such controlled substance is listed. 
Each such commercial container, if it otherwise has no label, must bear 
a label complying with the requirement of this part.
    (b) Each manufacturer shall print upon the labeling of each 
controlled substance distributed by him the symbol designating the 
schedule in which such controlled substance is listed.
    (c) The following symbols shall designate the schedule corresponding 
thereto:

 
                 Schedule
 
Schedule I................................  CI or C-I.
Schedule II...............................  CII or C-II.
Schedule III..............................  CIII or C-III.
Schedule IV...............................  CIV or C-IV.
Schedule V................................  CV or C-V.
 


The word ``schedule'' need not be used. No distinction need be made 
between narcotic and nonnarcotic substances.
    (d) The symbol is not required on a carton or wrapper in which a 
commercial container is held if the symbol is easily legible through 
such carton or wrapper.
    (e) The symbol is not required on a commercial container too small 
or otherwise unable to accommodate a label, if the symbol is printed on 
the box or package from which the commercial container is removed upon 
dispensing to an ultimate user.
    (f) The symbol is not required on a commercial container containing, 
or on the labeling of, a controlled substance being utilized in clinical 
research involving blind and double blind studies.

[36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1302.04  Location and size of symbol on label and labeling.

    The symbol shall be prominently located on the label or the labeling 
of the commercial container and/or the panel of the commercial container 
normally displayed to dispensers of any controlled substance. The symbol 
on labels shall be clear and large enough to afford easy identification 
of the schedule of the controlled substance upon inspection without 
removal from the dispenser's shelf. The symbol on all other labeling 
shall be clear and large enough to afford prompt identification of the 
controlled substance upon inspection of the labeling.

[62 FR 13958, Mar. 24, 1997]



Sec. 1302.05  Effective dates of labeling requirements.

    All labels on commercial containers of, and all labeling of, a 
controlled substance which either is transferred to another schedule or 
is added to any

[[Page 44]]

schedule shall comply with the requirements of Sec. 1302.03, on or 
before the effective date established in the final order for the 
transfer or addition.

[62 FR 13958, Mar. 24, 1997]



Sec. 1302.06  Sealing of controlled substances.

    On each bottle, multiple dose vial, or other commercial container of 
any controlled substance, there shall be securely affixed to the 
stopper, cap, lid, covering, or wrapper or such container a seal to 
disclose upon inspection any tampering or opening of the container.

[62 FR 13958, Mar. 24, 1997]



Sec. 1302.07  Labeling and packaging requirements for imported and 
exported substances.

    (a) The symbol requirements of Sec. Sec. 1302.03-1302.05 apply to 
every commercial container containing, and to all labeling of, 
controlled substances imported into the jurisdiction of and/or the 
customs territory of the United States.
    (b) The symbol requirements of Sec. Sec. 1302.03-1302.05 do not 
apply to any commercial containers containing, or any labeling of, a 
controlled substance intended for export from the jurisdiction of the 
United States.
    (c) The sealing requirements of Sec. 1302.06 apply to every bottle, 
multiple dose vial, or other commercial container of any controlled 
substance listed in schedule I or II, or any narcotic controlled 
substance listed in schedule III or IV, imported into, exported from, or 
intended for export from, the jurisdiction of and/or the customs 
territory of the United States.

[62 FR 13958, Mar. 24, 1997]



PART 1303_QUOTAS--Table of Contents
                           General Information

Sec.
1303.01 Scope of part 1303.
1303.02 Definitions.

               Aggregate Production and Procurement Quotas

1303.11 Aggregate production quotas.
1303.12 Procurement quotas.
1303.13 Adjustments of aggregate production quotas.

                     Individual Manufacturing Quotas

1303.21 Individual manufacturing quotas.
1303.22 Procedure for applying for individual manufacturing quotas.
1303.23 Procedure for fixing individual manufacturing quotas.
1303.24 Inventory allowance.
1303.25 Increase in individual manufacturing quotas.
1303.26 Reduction in individual manufacturing quotas.
1303.27 Abandonment of quota.

                                Hearings

1303.31 Hearings generally.
1303.32 Purpose of hearing.
1303.33 Waiver or modification of rules.
1303.34 Request for hearing or appearance; waiver.
1303.35 Burden of proof.
1303.36 Time and place of hearing.
1303.37 Final order.

    Authority: 21 U.S.C. 821, 826, 871(b).

                           General Information



Sec. 1303.01  Scope of part 1303.

    Procedures governing the establishment of production and 
manufacturing quotas on basic classes of controlled substances listed in 
schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826) 
are governed generally by that section and specifically by the sections 
of this part.

[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]

               Aggregate Production and Procurement Quotas



Sec. 1303.11  Aggregate production quotas.

    (a) The Administrator shall determine the total quantity of each 
basic class of controlled substance listed in Schedule I or II necessary 
to be manufactured during the following calendar year to provide for the 
estimated medical, scientific, research and industrial needs of the 
United States, for lawful export requirements, and for the establishment 
and maintenance of reserve stocks.

[[Page 45]]

    (b) In making his determinations, the Administrator shall consider 
the following factors:
    (1) Total net disposal of the class by all manufacturers during the 
current and 2 preceding years;
    (2) Trends in the national rate of net disposal of the class;
    (3) Total actual (or estimated) inventories of the class and of all 
substances manufactured from the class, and trends in inventory 
accumulation;
    (4) Projected demand for such class as indicated by procurement 
quotas requested pursuant to Sec. 1303.12; and
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States and lawful export requirements, as 
the Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the class or the substances which 
are manufactured from it, the economic and physical availability of raw 
materials for use in manufacturing and for inventory purposes, yield and 
stability problems, potential disruptions to production (including 
possible labor strikes), and recent unforeseen emergencies such as 
floods and fires.
    (c) The Administrator shall, on or before May 1 of each year, 
publish in the Federal Register, general notice of an aggregate 
production quota for any basic class determined by him under this 
section. A copy of said notice shall be mailed simultaneously to each 
person registered as a bulk manufacturer of the basic class. The 
Administrator shall permit any interested person to file written 
comments on or objections to the proposal and shall designate in the 
notice the time during which such filings may be made. The Administrator 
may, but shall not be required to, hold a public hearing on one or more 
issues raised by the comments and objections filed with him. In the 
event the Administrator decides to hold such a hearing, he shall publish 
notice of the hearing in the Federal Register, which notice shall 
summarize the issues to be heard and shall set the time for the hearing 
which shall nnt be less than 30 days after the date of publication of 
the notice. After consideration of any comments or objections, or after 
a hearing if one is ordered by the Administrator, the Administrator 
shall issue and publish in the Federal Register his final order 
determining the aggregate production quota for the basic class of 
controlled substance. The order shall include the findings of fact and 
conclusions of law upon which the order is based. The order shall 
specify the date on which it shall take effect. A copy of said order 
shall be mailed simultaneously to each person registered as a bulk 
manufacturer of the basic class.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.12  Procurement quotas.

    (a) In order to determine the estimated needs for, and to insure an 
adequate and uninterrupted supply of, basic classes of controlled 
substances listed in Schedules I and II (except raw opium being imported 
by the registrant pursuant to an import permit) the Administrator shall 
issue procurement quotas authorizing persons to procure and use 
quantities of each basic class of such substances for the purpose of 
manufacturing such class into dosage forms or into other substances.
    (b) Any person who is registered to manufacture controlled 
substances listed in any schedule and who desires to use during the next 
calendar year any basic class of controlled substances listed in 
Schedule I or II (except raw opium being imported by the registrant 
pursuant to an import permit) for purposes of manufacturing, shall apply 
on DEA Form 250 for a procurement quota for such basic class. A separate 
application must be made for each basic class desired to be procured or 
used. The applicant shall state whether he intends to manufacture the 
basic class himself or purchase it from another manufacturer. The 
applicant shall state separately each purpose for which the basic class 
is desired, the quantity desired for that purpose during the next 
calendar year, and the quantities used and estimated to be used, if any, 
for that purpose during the current and preceding 2 calendar years. If 
the purpose is to manufacture the basic class into dosage form, the 
applicant shall state the official name, common or usual name, chemical 
name, or brand name

[[Page 46]]

of that form. If the purpose is to manufacture another substance, the 
applicant shall state the official name, common or usual name, chemical 
name, or brand name of the substance, and, if a controlled substance 
listed in any schedule, the schedule number and Administration 
Controlled Substances Code Number, as set forth in part 1308 of this 
chapter, of the substance. If the purpose is to manufacture another 
basic class of controlled substance listed in Schedule I or II, the 
applicant shall also state the quantity of the other basic class which 
the applicant has applied to manufacture pursuant to Sec. 1303.22 and 
the quantity of the first basic class necessary to manufacture a 
specified unit of the second basic class. DEA Form 250 shall be filed on 
or before April 1 of the year preceding the calendar year for which the 
procurement quota is being applied. Copies of DEA Form 250 may be 
obtained from, and shall be filed with, the Drug & Chemical Evaluation 
Section, Drug Enforcement Administration, Department of Justice, 
Washington, DC 20537.
    (c) The Administrator shall, on or before July 1 of the year 
preceding the calendar year during which the quota shall be effective, 
issue to each qualified applicant a procurement quota authorizing him to 
procure and use:
    (1) All quantities of such class necessary to manufacture all 
quantities of other basic classes of controlled substances listed in 
Schedules I and II which the applicant is authorized to manufacture 
pursuant to Sec. 1303.23; and
    (2) Such other quantities of such class as the applicant has applied 
to procure and use and are consistent with his past use, his estimated 
needs, and the total quantity of such class that will be produced.
    (d) Any person to whom a procurement quota has been issued may at 
any time request an adjustment in the quota by applying to the 
Administrator with a statement showing the need for the adjustment. Such 
application shall be filed with the Drug & Chemical Evaluation Section, 
Drug Enforcement Administration, Department of Justice, Washington, DC 
20537. The Administrator shall increase or decrease the procurement 
quota of such person if and to the extent that he finds, after 
considering the factors enumerated in paragraph (c) of this section and 
any occurrences since the issuance of the procurement quota, that the 
need justifies an adjustment.
    (e) The following persons need not obtain a procurement quota:
    (1) Any person who is registered to manufacture a basic class of 
controlled substance listed in Schedule I or II and who uses all of the 
quantity he manufactures in the manufacture of a substance not 
controlled under the Act;
    (2) Any person who is registered or authorized to conduct chemical 
analysis with controlled substances (for controlled substances to be 
used in such analysis only); and
    (3) Any person who is registered to conduct research with a basic 
class of controlled substance listed in Schedule I or II and who is 
authorized to manufacture a quantity of such class pursuant to Sec. 
1301.13 of this chapter.
    (f) Any person to whom a procurement quota has been issued, 
authorizing that person to procure and use a quantity of a basic class 
of controlled substances listed in Schedules I or II during the current 
calendar year, shall, at or before the time of giving an order to 
another manufacturer requiring the distribution of a quantity of such 
basic class, certify in writing to such other manufacturer that the 
quantity of such basic class ordered does not exceed the person's unused 
and available procurement quota of such basic class for the current 
calendar year. The written certification shall be executed by the same 
individual who signed the DEA Form 222 transmitting the order. 
Manufacturers shall not fill an order from persons required to apply for 
a procurement quota under paragraph (b) of this section unless the order 
is accompanied by a certification as required under this section. The 
certification required by this section shall contain the following: The 
date of the certification; the name and address of the bulk manufacturer 
to whom the certification is directed; a reference to the number of the 
DEA Form 222 to which the certification applies; the name of the person 
giving the order to which the certification applies; the name of the 
basic class specified in the DEA Form 222 to

[[Page 47]]

which the certification applies; the appropriate schedule within which 
is listed the basic class specified in the DEA Form 222 to which the 
certification applies; a statement that the quantity (expressed in 
grams) of the basic class specified in the DEA Form 222 to which the 
certification applies does not exceed the unused and available 
procurement quota of such basic class, issued to the person giving the 
order, for the current calendar year; and the signature of the 
individual who signed the DEA Form 222 to which the certification 
applies.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 
FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, 1972. Redesignated at 38 
FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1303.12, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1303.13  Adjustments of aggregate production quotas.

    (a) The Administrator may at any time increase or reduce the 
aggregate production quota for a basic class of controlled substance 
listed in Schedule I or II which he has previously fixed pursuant to 
Sec. 1303.11.
    (b) In determining to adjust the aggregate production quota, the 
Administrator shall consider the following factors:
    (1) Changes in the demand for that class, changes in the national 
rate of net disposal of the class, and changes in the rate of net 
disposal of the class by registrants holding individual manufacturing 
quotas for that class;
    (2) Whether any increased demand for that class, the national and/or 
individual rates of net disposal of that class are temporary, short 
term, or long term;
    (3) Whether any increased demand for that class can be met through 
existing inventories, increased individual manufacturing quotas, or 
increased importation, without increasing the aggregate production 
quota, taking into account production delays and the probability that 
other individual manufacturing quotas may be suspended pursuant to Sec. 
1303.24(b);
    (4) Whether any decreased demand for that class will result in 
excessive inventory accumulation by all persons registered to handle 
that class (including manufacturers, distributors, practitioners, 
importers, and exporters), notwithstanding the possibility that 
individual manufacturing quotas may be suspended pursuant to Sec. 
1303.24(b) or abandoned pursuant to Sec. 1303.27;
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States and lawful export requirements, as 
the Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the class or the substances which 
are manufactured from it, the economic and physical availability of raw 
materials for use in manufacturing and for inventory purposes, yield and 
stability problems, potential disruptions to production (including 
possible labor strikes), and recent unforeseen emergencies such as 
floods and fires.
    (c) The Administrator in the event he determines to increase or 
reduce the aggregate production quota for a basic class of controlled 
substance, shall publish in the Federal Register general notice of an 
adjustment in the aggregate production quota for that class determined 
by him under this section. A copy of said notice shall be mailed 
simultaneously to each person registered as a bulk manufacturer of the 
basic class. The Administrator shall permit any interested person to 
file written comments on or objections to the proposal and shall 
designate in the notice the time during which such filings may be made. 
The Administrator may, but shall not be required to, hold a public 
hearing on one or more issues raised by the comments and objections 
filed with him. In the event the Administrator decides to hold such a 
hearing, he shall publish notice of the hearing in the Federal Register, 
which notice shall summarize the issues to be heard and shall set the 
time for the hearing, which shall not be less than 10 days after the 
date of publication of the notice. After consideration of any comments 
or objections, or after a hearing if one is ordered by the 
Administrator, the Administrator shall issue and publish in the Federal 
Register his final

[[Page 48]]

order determining the aggregate production for the basic class of 
controlled substance. The order shall include the findings of fact and 
conclusions of law upon which the order is based. The order shall 
specify the date on which it shall take effect. A copy of said order 
shall be mailed simultaneously to each person registered as a bulk 
manufacturer of the basic class.

[37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

                     Individual Manufacturing Quotas



Sec. 1303.21  Individual manufacturing quotas.

    (a) The Administrator shall, on or before July 1 of each year, fix 
for and issue to each person who is registered to manufacture a basic 
class of controlled substance listed in Schedule I or II, and who 
applies for a manufacturing quota, an individual manufacturing quota 
authorizing that person to manufacture during the next calendar year a 
quantity of that basic class. Any manufacturing quota fixed and issued 
by the Administrator shall be subject to his authority to reduce or 
limit it at a later date pursuant to Sec. 1303.26 and to his authority 
to revoke or suspend it at any time pursuant to Sec. Sec. 1301.36 of 
this chapter.
    (b) No individual manufacturing quota shall be required for 
registrants listed in Sec. 1303.12(e).

[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13958, Mar. 24, 1997]



Sec. 1303.22  Procedure for applying for individual manufacturing quotas.

    Any person who is registered to manufacture any basic class of 
controlled substance listed in Schedule I or II and who desires to 
manufacture a quantity of such class shall apply on DEA Form 189 for a 
manufacturing quota for such quantity of such class. Copies of DEA Form 
189 may be obtained from, and shall be filed (on or before May 1 of the 
year preceding the calendar year for which the manufacturing quota is 
being applied) with, the Drug & Chemical Evaluation Section, Drug 
Enforcement Administration, Department of Justice, Washington, D.C. 
20537. A separate application must be made for each basic class desired 
to be manufactured. The applicant shall state:
    (a) The name and Administration Controlled Substances Code Number, 
as set forth in part 1308 of this chapter, of the basic class.
    (b) For the basic class in each of the current and preceding 2 
calendar years,
    (1) The authorized individual manufacturing quota, if any;
    (2) The actual or estimated quantity manufactured;
    (3) The actual or estimated net disposal;
    (4) The actual or estimated inventory allowance pursuant to Sec. 
1303.24; and
    (5) The actual or estimated inventory as of December 31;
    (c) For the basic class in the next calendar year,
    (1) The desired individual manufacturing quota; and
    (2) Any additional factors which the applicant finds relevant to the 
fixing of his individual manufacturing quota, including the trend of 
(and recent changes in) his and the national rates of net disposal, his 
production cycle and current inventory position, the econolic and 
physical availability of raw materials for use in manufacturing and for 
inventory purposes, yield and stability problems, potential disruptions 
to production (including possible labor strikes) and recent unforeseen 
emergencies such as floods and fires.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 37 
FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and 
amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 
13958, Mar. 24, 1997]



Sec. 1303.23  Procedure for fixing individual manufacturing quotas.

    (a) In fixing individual manufacturing quotas for a basic class of 
controlled substance listed in Schedule I or II, the Administrator shall 
allocate to each applicant who is currently manufacturing such class a 
quota equal to 100 percent of the estimated net disposal of that 
applicant for the next calendar year, adjusted--
    (1) By the amount necessary to increase or reduce the estimated 
inventory of the applicant on December 31 of

[[Page 49]]

the current year to his estimated inventory allowance for the next 
calendar year, pursuant to Sec. 1303.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including the trend of (and recent changes in) his and the national 
rates of net disposal, his production cycle and current inventory 
position, the economic and physical availability of raw materials for 
use in manufacturing and for inventory purposes, yield and stability 
problems, potential disruptions to production (including possible labor 
strikes), and recent unforeseen emergencies such as floods and fires.
    (b) In fixing individual manufacturing quotas for a basic class of 
controlled substance listed in Schedule I or II, the Administrator shall 
allocate to each applicant who is not currently manufacturing such class 
a quota equal to 100 percent of the reasonably estimated net disposal of 
that applicant for the next calendar year, as determined by the 
Administrator, adjusted--
    (1) By the amount necessary to provide the applicant his estimated 
inventory allowance for the next calendar year, pursuant to Sec. 
1303.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including the trend of (and recent changes in) the national rate of net 
disposal, his production cycle and current inventory position, the 
economic and physical availability of raw materials for use in 
manufacturing and for inventory purposes, yield and stability problems, 
potential disruptions to production (including possible labor strikes), 
and recent unforeseen emergencies such as floods and fires.
    (c) The Administrator shall, on or before March 1 of each year, 
adjust the individual manufacturing quota allocated for that year to 
each applicant in paragraph (a) of this section by the amount necessary 
to increase or reduce the actual inventory of the applicant to December 
31 of the preceding year to his estimated inventory allowance for the 
current calendar year, pursuant to Sec. 1303.24.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.24  Inventory allowance.

    (a) For the purpose of determining individual manufacturing quotas 
pursuant to Sec. 1303.23, each registered manufacturer shall be allowed 
as a part of such quota an amount sufficient to maintain an inventory 
equal to,
    (1) For current manufacturers, 50 percent of his average estimated 
net disposal for the current calendar year and the last preceding 
calendar year; or
    (2) For new manufacturers, 50 percent of his reasonably estimated 
net disposal for the next calendar year as determined by the 
Administrator.
    (b) During each calendar year each registered manufacturer shall be 
allowed to maintain an inventory of a basic class not exceeding 65 
percent of his estimated net disposal of that class for that year, as 
determined at the time his quota for that year was determined. At any 
time the inventory of a basic class held by a manufacturer exceeds 65 
percent of his estimated net disposal, his quota for that class is 
automatically suspended and shall remain suspended until his inventory 
is less than 60 percent of his estimated net disposal. The Administrator 
may, upon application and for good cause shown, permit a manufacturer 
whose quota is, or is likely to be, suspended pursuant to this paragraph 
to continue manufacturing and to accumulate an inventory in excess of 65 
percent of his estimated net disposal, upon such conditions and within 
such limitations as the Administrator may find necessary or desirable.
    (c) If, during a calendar year, a registrant has manufactured the 
entire quantity of a basic class allocated to him under an individual 
manufacturing quota, and his inventory of that class is less than 40 
percent of his estimated net disposal of that class for that year, the 
Administrator may, upon application pursuant to Sec. 1303.25, increase 
the quota of such registrant sufficiently to allow restoration of the 
inventory to 50

[[Page 50]]

percent of the estimated net disposal for that year.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.25  Increase in individual manufacturing quotas.

    (a) Any registrant who holds an individual manufacturing quota for a 
basic class of controlled substance listed in Schedule I or II may file 
with the Administrator an application on Administration Form 189 for an 
increase in such quota in order for him to meet his estimated net 
disposal, inventory and other requirements during the remainder of such 
calendar year.
    (b) The Administrator, in passing upon a registrant's application 
for an increase in his individual manufacturing quota, shall take into 
consideration any occurrences since the filing of such registrant's 
initial quota application that may require an increased manufacturing 
rate by such registrant during the balance of the calendar year. In 
passing upon such application the Administrator may also take into 
consideration the amount, if any, by which his determination of the 
total quantity for the basic class of controlled substance to be 
manufactured under Sec. 1303.11 exceeds the aggregate of all the 
individual manufacturing quotas for the basic class of controlled 
substance, and the equitable distribution of such excess among other 
registrants.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.26  Reduction in individual manufacturing quotas.

    The Administrator may at any time reduce an individual manufacturing 
quota for a basic class of controlled substance listed in Schedule I or 
II which he has previously fixed in order to prevent the aggregate of 
the individual manufacturing quotas and import permits outstanding or to 
be granted from exceeding the aggregate production quota which has been 
established for that class pursuant of Sec. 1303.11, as adjusted 
pursuant to Sec. 1303.13. If a quota assigned to a new manufacturer 
pursuant to Sec. 1303.23(b), or if a quota assigned to any manufacturer 
is increased pursuant to Sec. 1303.24(c), or if an import permit issued 
to an importer pursuant to part 1312 of this chapter, causes the total 
quantity of a basic class to be manufactured and imported during the 
year to exceed the aggregate production quota which has been established 
for that class pursuant to Sec. 1303.11, as adjusted pursuant to Sec. 
1303.13, the Administrator may proportionately reduce the individual 
manufacturing quotas and import permits of all other registrants to keep 
the aggregate production quota within the limits originally established, 
or, alternatively, the Administrator may reduce the individual 
manufacturing quota of any registrant whose quota is suspended pursuant 
to Sec. 1303.24(b) or Sec. 1301.36 of this chapter, or is abandoned 
pursuant to Sec. 1303.27.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]



Sec. 1303.27  Abandonment of quota.

    Any manufacturer assigned an individual manufacturing quota for any 
basic class pursuant to Sec. 1303.23 may at any time abandon his right 
to manufacture all or any part of such quota by filing with the Drug & 
Chemical Evaluation Section a written notice of such abandonment, 
stating the name and Administration Controlled Substances Code Number, 
as set forth in part 1308 of this chapter, of the substance and the 
amount which he has chosen not to manufacture. The Administrator may, in 
his discretion, allocate such amount among the other manufacturers in 
proportion to their respective quotas.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, 
May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Mar. 24, 1997]

                                Hearings



Sec. 1303.31  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing 
regarding the determination of an aggregate production quota pursuant to 
Sec. 1303.11(c), or regarding the adjustment of an aggregate production 
quota pursuant to

[[Page 51]]

Sec. 1303.13(c), the procedures for such hearing shall be governed 
generally by the rule making procedures set forth in the Administrative 
Procedure Act (5 U.S.C. 551-559) and specifically by section 306 of the 
Act (21 U.S.C. 826), by Sec. Sec. 1303.32-1303.37, and by the 
procedures for administrative hearings under the Act set forth in 
Sec. Sec. 1316.41-1316.67 of this chapter.
    (b) In any case where the Administrator shall hold a hearing 
regarding the issuance, adjustment, suspension, or denial of a 
procurement quota pursuant to Sec. 1303.12, or the issuance, 
adjustment, suspension, or denial of an individual manufacturing quota 
pursuant to Sec. Sec. 1303.21-1303.27, the procedures for such hearing 
shall be governed generally by the adjudication procedures set forth in 
the Administrative Procedures Act (5 U.S.C. 551-559) and specifically by 
section 306 of the Act (21 U.S.C. 826), by Sec. Sec. 1303.32-1303.37, 
and by the procedures for administrative hearings under the Act set 
forth in Sec. Sec. 1316.41-1316.67 of this chapter.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.32  Purpose of hearing.

    (a) The Administrator may, in his sole discretion, hold a hearing 
for the purpose of receiving factual evidence regarding any one or more 
issues (to be specified by him) involved in the determination or 
adjustment of any aggregate production quota.
    (b) If requested by a person applying for or holding a procurement 
quota or an individual manufacturing quota, the Administrator shall hold 
a hearing for the purpose of receiving factual evidence regarding the 
issues involved in the issuance, adjustment, suspension, or denial of 
such quota to such person, but the Administrator need not hold a hearing 
on the suspension of a quota pursuant to Sec. 1301.36 of this chapter 
separate from a hearing on the suspension of registration pursuant to 
those sections.
    (c) Extensive argument should not be offered into evidence but 
rather presented in opening or closing statements of counsel or in 
memoranda or proposed findings of fact and conclusions of law.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]



Sec. 1303.33  Waiver or modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.

[36 FR 7786, Apr. 24,1971. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.34  Request for hearing or appearance; waiver.

    (a) Any applicant or registrant who desires a hearing on the 
issuance, adjustment, suspension, or denial of his procurement and/or 
individual manufacturing quota shall, within 30 days after the date of 
receipt of the issuance, adjustment, suspension, or denial of such 
quota, file with the Administrator a written request for a hearing in 
the form prescribed in Sec. 1316.47 of this chapter. Any interested 
person who desires a hearing on the determination of an aggregate 
production quota shall, within the time prescribed in Sec. 1303.11(c), 
file with the Administrator a written request for a hearing in the form 
prescribed in Sec. 1316.47 of this chapter, including in the request a 
statement of the grounds for a hearing.
    (b) Any interested person who desires to participate in a hearing on 
the determination or adjustment of an aggregate production quota, which 
hearing is ordered by the Administrator pursuant to Sec. 1303.11(c) or 
Sec. 1303.13(c) may do so by filing with the Administrator, within 30 
days of the date of publication of notice of the hearing in the Federal 
Register, a written notice of his intention to participate in such 
hearing in the form prescribed in Sec. 1316.48 of this chapter.
    (c) Any person entitled to a hearing or to participate in a hearing 
pursuant to paragraph (b) of this section, may,

[[Page 52]]

within the period permitted for filing a request for a hearing of notice 
of appearance, file with the Administrator a waiver of an opportunity 
for a hearing or to participate in a hearing, together with a written 
statement regarding his position on the matters of fact and law involved 
in such hearing. Such statement, if admissible, shall be made a part of 
the record and shall be considered in light of the lack of opportunity 
for cross-examination in determining the weight to be attached to 
matters of fact asserted therein.
    (d) If any person entitled to a hearing or to participate in a 
hearing pursuant to paragraph (b) of this section, fails to file a 
request for a hearing or notice of appearance, or if he so files and 
fails to appear at the hearing, he shall be deemed to have waived his 
opportunity for the hearing or to participate in the hearing, unless he 
shows good cause for such failure.
    (e) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to Sec. 
1303.37 without a hearing.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.35  Burden of proof.

    (a) At any hearing regarding the determination or adjustment of an 
aggregate production quota, each interested person participating in the 
hearing shall have the burden of proving any propositions of fact or law 
asserted by him in the hearing.
    (b) At any hearing regarding the issuance, adjustment, suspension, 
or denial of a procurement or individual manufacturing quota, the 
Administration shall have the burden of proving that the requirements of 
this part for such issuance, adjustment, suspension, or denial are 
satisfied.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]



Sec. 1303.36  Time and place of hearing.

    (a) If any applicant or registrant requests a hearing on the 
issuance, adjustment, suspension, or denial of his procurement and/or 
individual manufacturing quota pursuant to Sec. 1303.34, the 
Administrator shall hold such hearing. Notice of the hearing shall be 
given to the applicant or registrant of the time and place at least 30 
days prior to the hearing, unless the applicant or registrant waives 
such notice and requests the hearing be held at an earlier time, in 
which case the Administrator shall fix a date for such hearing as early 
as reasonably possible.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section or in the 
notice of hearing published in the Federal Register pursuant to Sec. 
1303.11(c) or Sec. 1303.13 (c), but thereafter it may be moved to a 
different place and may be continued from day to day or recessed to a 
later day without notice other than announcement thereof by the 
presiding officer at the hearing.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.37  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order on 
the determination or adjustment of the aggregate production quota or on 
the issuance, adjustment, suspension, or denial of the procurement quota 
or individual manufacturing quota, as case may be. The order shall 
include the findings of fact and conclusions of law upon which the order 
is based. The order shall specify the date on which it shall take 
effect. The Administrator shall serve one copy of his order upon each 
party in the hearing.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



PART 1304_RECORDS AND REPORTS OF REGISTRANTS--Table of Contents
                           General Information

Sec.
1304.01 Scope of part 1304.

[[Page 53]]

1304.02 Definitions.
1304.03 Persons required to keep records and file reports.
1304.04 Maintenance of records and inventories.
1304.05 Records of authorized central fill pharmacies and retail 
          pharmacies.

                         Inventory Requirements

1304.11 Inventory requirements.

                           Continuing Records

1304.21 General requirements for continuing records.
1304.22 Records for manufacturers, distributors, dispensers, 
          researchers, importers, and exporters.
1304.23 Records for chemical analysts.
1304.24 Records for maintenance treatment programs and detoxification 
          treatment programs.
1304.25 Records for treatment programs which compound narcotics for 
          treatment programs and other locations.
1304.26 Additional recordkeeping requirements applicable to drug 
          products containing gamma-hydroxybutyric acid.

                                 Reports

1304.31 Reports from manufacturers importing narcotic raw material.
1304.32 Reports of manufacturers importing coca leaves.
1304.33 Reports to ARCOS.

    Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965, unless otherwise 
noted.

                           General Information



Sec. 1304.01  Scope of part 1304.

    Inventory and other records and reports required under section 307 
or section 1008(d) of the Act (21 U.S.C. 827 and 958(d)) shall be in 
accordance with, and contain the information required by, those sections 
and by the sections of this part.

[36 FR 7789, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1304.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]



Sec. 1304.03  Persons required to keep records and file reports.

    (a) Each registrant shall maintain the records and inventories and 
shall file the reports required by this part, except as exempted by this 
section. Any registrant who is authorized to conduct other activities 
without being registered to conduct those activities, either pursuant to 
Sec. 1301.22(b) of this chapter or pursuant to Sec. Sec. 1307.11-
1307.15 of this chapter, shall maintain the records and inventories and 
shall file the reports required by this part for persons registered to 
conduct such activities. This latter requirement should not be construed 
as requiring stocks of controlled substances being used in various 
activities under one registration to be stored separately, nor that 
separate records are required for each activity. The intent of the 
Administration is to permit the registrant to keep one set of records 
which are adapted by the registrant to account for controlled substances 
used in any activity. Also, the Administration does not wish to acquire 
separate stocks of the same substance to be purchased and stored for 
separate activities. Otherwise, there is no advantage gained by 
permitting several activities under one registration. Thus, when a 
researcher manufactures a controlled item, he must keep a record of the 
quantity manufactured; when he distributes a quantity of the item, he 
must use and keep invoices or order forms to document the transfer; when 
he imports a substance, he keeps as part of his records the 
documentation required of an importer; and when substances are used in 
chemical analysis, he need not keep a record of this because such a 
record would not be required of him under a registration to do chemical 
analysis. All of these records may be maintained in one consolidated 
record system. Similarly, the researcher may store all of his controlled 
items in one place, and every two years take inventory of all items on 
hand, regardless of whether the substances were manufactured by him, 
imported by him, or purchased domestically by him, of whether the 
substances will be administered to subjects, distributed to other 
researchers, or destroyed during chemical analysis.
    (b) A registered individual practitioner is required to keep 
records, as described in Sec. 1304.04, of controlled substances in 
Schedules II, III, IV, and V

[[Page 54]]

which are dispensed, other than by prescribing or administering in the 
lawful course of professional practice.
    (c) A registered individual practitioner is not required to keep 
records of controlled substances in Schedules II, III, IV, and V which 
are prescribed in the lawful course of professional practice, unless 
such substances are prescribed in the course of maintenance or 
detoxification treatment of an individual.
    (d) A registered individual practitioner is not required to keep 
records of controlled substances listed in Schedules II, III, IV and V 
which are administered in the lawful course of professional practice 
unless the practitioner regularly engages in the dispensing or 
administering of controlled substances and charges patients, either 
separately or together with charges for other professional services, for 
substances so dispensed or administered. Records are required to be kept 
for controlled substances administered in the course of maintenance or 
detoxification treatment of an individual.
    (e) Each registered mid-level practitioner shall maintain in a 
readily retrievable manner those documents required by the state in 
which he/she practices which describe the conditions and extent of his/
her authorization to dispense controlled substances and shall make such 
documents available for inspection and copying by authorized employees 
of the Administration. Examples of such documentation include protocols, 
practice guidelines or practice agreements.
    (f) Registered persons using any controlled substances while 
conducting preclinical research, in teaching at a registered 
establishment which maintains records with respect to such substances or 
conducting research in conformity with an exemption granted under 
section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(i) or 360b(j)) at a registered establishment which maintains 
records in accordance with either of those sections, are not required to 
keep records if he/she notifies the Administration of the name, address, 
and registration number of the establishment maintaining such records. 
This notification shall be given at the time the person applies for 
registration or reregistration and shall be made in the form of an 
attachment to the application, which shall be filed with the 
application.
    (g) A distributing registrant who utilizes a freight forwarding 
facility shall maintain records to reflect transfer of controlled 
substances through the facility. These records must contain the date, 
time of transfer, number of cartons, crates, drums or other packages in 
which commercial containers of controlled substances are shipped and 
authorized signatures for each transfer. A distributing registrant may, 
as part of the initial request to operate a freight forwarding facility, 
request permission to store records at a central location. Approval of 
the request to maintain central records would be implicit in the 
approval of the request to operate the facility. Otherwise, a request to 
maintain records at a central location must be submitted in accordance 
with Sec. 1304.04 of this part. These records must be maintained for a 
period of two years.

[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 50 FR 40523, Oct. 4, 1985; 51 FR 5320, Feb. 13, 1986; 51 
FR 26154, July 21, 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, Mar. 
24, 1997; 65 FR 44679, July 19, 2000]



Sec. 1304.04  Maintenance of records and inventories.

    (a) Every inventory and other records required to be kept under this 
part shall be kept by the registrant and be available, for at least 2 
years from the date of such inventory or records, for inspection and 
copying by authorized employees of the Administration, except that 
financial and shipping records (such as invoices and packing slips but 
not executed order forms subject to Sec. 1305.13 of this chapter) may 
be kept at a central location, rather than at the registered location, 
if the registrant has notified the Administration of his intention to 
keep central records. Written notification must be submitted by 
registered or certified mail, return receipt requested, in triplicate, 
to the Special Agent in Charge of the Administration in the area in 
which the registrant is located. Unless

[[Page 55]]

the registrant is informed by the Special Agent in Charge that 
permission to keep central records is denied, the registrant may 
maintain central records commencing 14 days after receipt of his 
notification by the Special Agent in Charge.

All notifications must include:
    (1) The nature of the records to be kept centrally.
    (2) The exact location where the records will be kept.
    (3) The name, address, DEA registration number and type of DEA 
registration of the registrant whose records are being maintained 
centrally.
    (4) Whether central records will be maintained in a manual, or 
computer readable form.
    (b) All registrants that are authorized to maintain a central 
recordkeeping system shall be subject to the following conditions:
    (1) The records to be maintained at the central record location 
shall not include executed order forms, prescriptions and/or inventories 
which shall be maintained at each registered location.
    (2) If the records are kept on microfilm, computer media or in any 
form requiring special equipment to render the records easily readable, 
the registrant shall provide access to such equipment with the records. 
If any code system is used (other than pricing information), a key to 
the code shall be provided to make the records understandable.
    (3) The registrant agrees to deliver all or any part of such records 
to the registered location within two business days upon receipt of a 
written request from the Administration for such records, and if the 
Administration chooses to do so in lieu of requiring delivery of such 
records to the registered location, to allow authorized employees of the 
Administration to inspect such records at the central location upon 
request by such employees without a warrant of any kind.
    (4) In the event that a registrant fails to comply with these 
conditions, the Special Agent in Charge may cancel such central 
recordkeeping authorization, and all other central recordkeeping 
authorizations held by the registrant without a hearing or other 
procedures. In the event of a cancellation of central recordkeeping 
authorizations under this paragraph the registrant shall, within the 
time specified by the Special Agent in Charge, comply with the 
requirements of this section that all records be kept at the registered 
location.
    (c) Registrants need not notify the Special Agent in Charge or 
obtain central recordkeeping approval in order to maintain records on an 
in-house computer system.
    (d) ARCOS participants who desire authorization to report from other 
than their registered locations must obtain a separate central reporting 
identifier. Request for central reporting identifiers will be submitted 
to: ARCOS Unit, P.O. Box 28293, Central Station, Washington, DC 20005.
    (e) All central recordkeeping permits previously issued by the 
Administration expired September 30, 1980.
    (f) Each registered manufacturer, distributor, importer, exporter, 
narcotic treatment program and compounder for narcotic treatment program 
shall maintain inventories and records of controlled substances as 
follows:
    (1) Inventories and records of controlled substances listed in 
Schedules I and II shall be maintained separately from all of the 
records of the registrant; and
    (2) Inventories and records of controlled substances listed in 
Schedules III, IV, and V shall be maintained either separately from all 
other records of the registrant or in such form that the information 
required is readily retrievable from the ordinary business records of 
the registrant.
    (g) Each registered individual practitioner required to keep records 
and institutional practitioner shall maintain inventories and records of 
controlled substances in the manner prescribed in paragraph (f) of this 
section.
    (h) Each registered pharmacy shall maintain the inventories and 
records of controlled substances as follows:
    (1) Inventories and records of all controlled substances listed in 
Schedules I and II shall be maintained separately from all other records 
of the pharmacy, and prescriptions for such substances shall be 
maintained in a separate prescription file; and

[[Page 56]]

    (2) Inventories and records of controlled substances listed in 
Schedules III, IV, and V shall be maintained either separately from all 
other records of the pharmacy or in such form that the information 
required is readily retrievable from ordinary business records of the 
pharmacy, and prescriptions for such substances shall be maintained 
either in a separate prescription file for controlled substances listed 
in Schedules III, IV, and V only or in such form that they are readily 
retrievable from the other prescription records of the pharmacy. 
Prescriptions will be deemed readily retrievable if, at the time they 
are initially filed, the face of the prescription is stamped in red ink 
in the lower right corner with the letter ``C'' no less than 1 inch high 
and filed either in the prescription file for controlled substances 
listed in Schedules I and II or in the usual consecutively numbered 
prescription file for non-controlled substances. However, if a pharmacy 
employs an ADP system or other electronic recordkeeping system for 
prescriptions which permits identification by prescription number and 
retrieval of original documents by prescriber's name, patient's name, 
drug dispensed, and date filled, then the requirement to mark the hard 
copy prescription with a red ``C'' is waived.

(Authority: 21 U.S.C. 821 and 871(b); 28 CFR 0.100)

[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 39 FR 37985, 
Oct. 25, 1974; 45 FR 44266, July 1, 1980; 47 FR 41735, Sept. 22, 1982; 
51 FR 5320, Feb. 13, 1986; 62 FR 13959, Mar. 24, 1997]



Sec. 1304.05  Records of authorized central fill pharmacies and retail 
pharmacies.

    (a) Every retail pharmacy that utilizes the services of a central 
fill pharmacy must keep a record of all central fill pharmacies, 
including name, address and DEA number, that are authorized to fill 
prescriptions on its behalf. The retail pharmacy must also verify the 
registration for each central fill pharmacy authorized to fill 
prescriptions on its behalf. These records must be made available upon 
request for inspection by DEA.
    (b) Every central fill pharmacy must keep a record of all retail 
pharmacies, including name, address and DEA number, for which it is 
authorized to fill prescriptions. The central fill pharmacy must also 
verify the registration for all retail pharmacies for which it is 
authorized to fill prescriptions. These records must be made available 
upon request for inspection by DEA.

[68 FR 37410, June 24, 2003]

                         Inventory Requirements



Sec. 1304.11  Inventory requirements.

    (a) General requirements. Each inventory shall contain a complete 
and accurate record of all controlled substances on hand on the date the 
inventory is taken, and shall be maintained in written, typewritten, or 
printed form at the registered location. An inventory taken by use of an 
oral recording device must be promptly transcribed. Controlled 
substances shall be deemed to be ``on hand'' if they are in the 
possession of or under the control of the registrant, including 
substances returned by a customer, ordered by a customer but not yet 
invoiced, stored in a warehouse on behalf of the registrant, and 
substances in the possession of employees of the registrant and intended 
for distribution as complimentary samples. A separate inventory shall be 
made for each registered location and each independent activity 
registered, except as provided in paragraph (e)(4) of this section. In 
the event controlled substances in the possession or under the control 
of the registrant are stored at a location for which he/she is not 
registered, the substances shall be included in the inventory of the 
registered location to which they are subject to control or to which the 
person possessing the substance is responsible. The inventory may be 
taken either as of opening of business or as of the close of business on 
the inventory date and it shall be indicated on the inventory.
    (b) Initial inventory date. Every person required to keep records 
shall take an inventory of all stocks of controlled substances on hand 
on the date he/she first engages in the manufacture, distribution, or 
dispensing of controlled substances, in accordance with paragraph (e) of 
this section as applicable.

[[Page 57]]

In the event a person commences business with no controlled substances 
on hand, he/she shall record this fact as the initial inventory.
    (c) Biennial inventory date. After the initial inventory is taken, 
the registrant shall take a new inventory of all stocks of controlled 
substances on hand at least every two years. The biennial inventory may 
be taken on any date which is within two years of the previous biennial 
inventory date.
    (d) Inventory date for newly controlled substances. On the effective 
date of a rule by the Administrator pursuant to Sec. Sec. 1308.45, 
1308.46, or 1308.47 of this chapter adding a substance to any schedule 
of controlled substances, which substance was, immediately prior to that 
date, not listed on any such schedule, every registrant required to keep 
records who possesses that substance shall take an inventory of all 
stocks of the substance on hand. Thereafter, such substance shall be 
included in each inventory made by the registrant pursuant to paragraph 
(c) of this section.
    (e) Inventories of manufacturers, distributors, dispensers, 
researchers, importers, exporters and chemical analysts. Each person 
registered or authorized (by Sec. 1301.13 or Sec. Sec. 1307.11-1307.13 
of this chapter) to manufacture, distribute, dispense, import, export, 
conduct research or chemical analysis with controlled substances and 
required to keep records pursuant to Sec. 1304.03 shall include in the 
inventory the information listed below.
    (1) Inventories of manufacturers. Each person registered or 
authorized to manufacture controlled substances shall include the 
following information in the inventory:
    (i) For each controlled substance in bulk form to be used in (or 
capable of use in) the manufacture of the same or other controlled or 
non-controlled substances in finished form, the inventory shall include:
    (A) The name of the substance and
    (B) The total quantity of the substance to the nearest metric unit 
weight consistent with unit size.
    (ii) For each controlled substance in the process of manufacture on 
the inventory date, the inventory shall include:
    (A) The name of the substance;
    (B) The quantity of the substance in each batch and/or stage of 
manufacture, identified by the batch number or other appropriate 
identifying number; and
    (C) The physical form which the substance is to take upon completion 
of the manufacturing process (e.g., granulations, tablets, capsules, or 
solutions), identified by the batch number or other appropriate 
identifying number, and if possible the finished form of the substance 
(e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce 
or milliliter) and the number or volume thereof.
    (iii) For each controlled substance in finished form the inventory 
shall include:
    (A) The name of the substance;
    (B) Each finished form of the substance (e.g., 10-milligram tablet 
or 10-milligram concentration per fluid ounce or milliliter);
    (C) The number of units or volume of each finished form in each 
commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
    (D) The number of commercial containers of each such finished form 
(e.g. four 100-tablet bottles or six 3-milliliter vials).
    (iv) For each controlled substance not included in paragraphs (e)(1) 
(i), (ii) or (iii) of this section (e.g., damaged, defective or impure 
substances awaiting disposal, substances held for quality control 
purposes, or substances maintained for extemporaneous compoundings) the 
inventories shall include:
    (A) The name of the substance;
    (B) The total quantity of the substance to the nearest metric unit 
weight or the total number of units of finished form; and
    (C) The reason for the substance being maintained by the registrant 
and whether such substance is capable of use in the manufacture of any 
controlled substance in finished form.
    (2) Inventories of distributors. Except for reverse distributors 
covered by paragraph (e)(3) of this section, each

[[Page 58]]

person registered or authorized to distribute controlled substances 
shall include in the inventory the same information required of 
manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this 
section.
    (3) Inventories of dispensers, researchers, and reverse 
distributors. Each person registered or authorized to dispense, conduct 
research, or act as a reverse distributor with controlled substances 
shall include in the inventory the same information required of 
manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this 
section. In determining the number of units of each finished form of a 
controlled substance in a commercial container which has been opened, 
the dispenser, researcher, or reverse distributor shall do as follows:
    (i) If the substance is listed in Schedule I or II, make an exact 
count or measure of the contents, or
    (ii) If the substance is listed in Schedule III, IV or V, make an 
estimated count or measure of the contents, unless the container holds 
more than 1,000 tablets or capsules in which case he/she must make an 
exact count of the contents.
    (4) Inventories of importers and exporters. Each person registered 
or authorized to import or export controlled substances shall include in 
the inventory the same information required of manufacturers pursuant to 
paragraphs (e)(1) (iii) and (iv) of this section. Each such person who 
is also registered as a manufacturer or as a distributor shall include 
in his/her inventory as an importer or exporter only those stocks of 
controlled substances that are actually separated from his stocks as a 
manufacturer or as a distributor (e.g., in transit or in storage for 
shipment).
    (5) Inventories of chemical analysts. Each person registered or 
authorized to conduct chemical analysis with controlled substances shall 
include in his inventory the same information required of manufacturers 
pursuant to paragraphs (e)(1) (iii) and (iv) of this section as to 
substances which have been manufactured, imported, or received by such 
person. If less than 1 kilogram of any controlled substance (other than 
a hallucinogenic controlled substance listed in Schedule I), or less 
than 20 grams of a hallucinogenic substance listed in Schedule I (other 
than lysergic acid diethylamide), or less than 0.5 gram of lysergic acid 
diethylamide, is on hand at the time of inventory, that substance need 
not be included in the inventory. Laboratories of the Administration may 
possess up to 150 grams of any hallucinogenic substance in Schedule I 
without regard to a need for an inventory of those substances. No 
inventory is required of known or suspected controlled substances 
received as evidentiary materials for analysis.

[62 FR 13959, Mar. 24, 1997, as amended at 68 FR 41228, July 11, 2003]

                           Continuing Records



Sec. 1304.21  General requirements for continuing records.

    (a) Every registrant required to keep records pursuant to Sec. 
1304.03 shall maintain on a current basis a complete and accurate record 
of each such substance manufactured, imported, received, sold, 
delivered, exported, or otherwise disposed of by him/her, except that no 
registrant shall be required to maintain a perpetual inventory.
    (b) Separate records shall be maintained by a registrant for each 
registered location except as provided in Sec. 1304.04 (a). In the 
event controlled substances are in the possession or under the control 
of a registrant at a location for which he is not registered, the 
substances shall be included in the records of the registered location 
to which they are subject to control or to which the person possessing 
the substance is responsible.
    (c) Separate records shall be maintained by a registrant for each 
independent activity for which he/she is registered, except as provided 
in Sec. 1304.22(d).
    (d) In recording dates of receipt, importation, distribution, 
exportation, or other transfers, the date on which the controlled 
substances are actually received, imported, distributed, exported, or 
otherwise transferred shall be used as the date of receipt or 
distribution of

[[Page 59]]

any documents of transfer (e.g., invoices or packing slips).

[36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13960, 
Mar. 24, 1997]



Sec. 1304.22  Records for manufacturers, distributors, dispensers, 
researchers, importers and exporters.

    Each person registered or authorized (by Sec. 1301.13(e) or 
Sec. Sec. 1307.11-1307.13 of this chapter) to manufacture, distribute, 
dispense, import, export or conduct research with controlled substances 
shall maintain records with the information listed below.
    (a) Records for manufacturers. Each person registered or authorized 
to manufacture controlled substances shall maintain records with the 
following information:
    (1) For each controlled substance in bulk form to be used in, or 
capable of use in, or being used in, the manufacture of the same or 
other controlled or noncontrolled substances in finished form,
    (i) The name of the substance;
    (ii) The quantity manufactured in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch manufactured;
    (iii) The quantity received from other persons, including the date 
and quantity of each receipt and the name, address, and registration 
number of the other person from whom the substance was received;
    (iv) The quantity imported directly by the registrant (under a 
registration as an importer) for use in manufacture by him/her, 
including the date, quantity, and import permit or declaration number 
for each importation;
    (v) The quantity used to manufacture the same substance in finished 
form, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The quantity used in the manufacture;
    (C) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter);
    (D) The number of units of finished form manufactured;
    (E) The quantity used in quality control;
    (F) The quantity lost during manufacturing and the causes therefore, 
if known;
    (G) The total quantity of the substance contained in the finished 
form;
    (H) The theoretical and actual yields; and
    (I) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vi) The quantity used to manufacture other controlled and 
noncontrolled substances, including the name of each substance 
manufactured and the information required in paragraph (a)(1)(v) of this 
section;
    (vii) The quantity distributed in bulk form to other persons, 
including the date and quantity of each distribution and the name, 
address, and registration number of each person to whom a distribution 
was made;
    (viii) The quantity exported directly by the registrant (under a 
registration as an exporter), including the date, quantity, and export 
permit or declaration number of each exportation;
    (ix) The quantity distributed or disposed of in any other manner by 
the registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or disposal, 
the name, address, and registration number of the person to whom 
distributed, and the quantity distributed or disposed; and
    (x) The originals of all written certifications of available 
procurement quotas submitted by other persons (as required by Sec. 
1303.12(f) of this chapter) relating to each order requiring the 
distribution of a basic class of controlled substance listed in Schedule 
I or II.
    (2) For each controlled substance in finished form,
    (i) The name of the substance;
    (ii) Each finished form (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume of finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (iii) The number of containers of each such commercial finished form

[[Page 60]]

manufactured from bulk form by the registrant, including the information 
required pursuant to paragraph (a)(1)(v) of this section;
    (iv) The number of units of finished forms and/or commercial 
containers acquired from other persons, including the date of and number 
of units and/or commercial containers in each acquisition to inventory 
and the name, address, and registration number of the person from whom 
the units were acquired;
    (v) The number of units of finished forms and/or commercial 
containers imported directly by the person (under a registration or 
authorization to import), including the date of, the number of units 
and/or commercial containers in, and the import permit or declaration 
number for, each importation;
    (vi) The number of units and/or commercial containers manufactured 
by the registrant from units in finished form received from others or 
imported, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The operation performed (e.g., repackaging or relabeling);
    (C) The number of units of finished form used in the manufacture, 
the number manufactured and the number lost during manufacture, with the 
causes for such losses, if known; and
    (D) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vii) The number of commercial containers distributed to other 
persons, including the date of and number of containers in each 
reduction from inventory, and the name, address, and registration number 
of the person to whom the containers were distributed; (viii) The number 
of commercial containers exported directly by the registrant (under a 
registration as an exporter), including the date, number of containers 
and export permit or declaration number for each exportation; and
    (ix) The number of units of finished forms and/or commercial 
containers distributed or disposed of in any other manner by the 
registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or disposal, 
the name, address, and registration number of the person to whom 
distributed, and the quantity in finished form distributed or disposed.
    (b) Records for distributors. Except as provided in paragraph (e) of 
this section, each person registered or authorized to distribute 
controlled substances shall maintain records with the same information 
required of manufacturers pursuant to paragraphs (a)(2)(i), (ii), (iv), 
(v), (vii), (viii) and (ix) of this section.
    (c) Records for dispensers and researchers. Each person registered 
or authorized to dispense or conduct research with controlled substances 
shall maintain records with the same information required of 
manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and 
(ix) of this section. In addition, records shall be maintained of the 
number of units or volume of such finished form dispensed, including the 
name and address of the person to whom it was dispensed, the date of 
dispensing, the number of units or volume dispensed, and the written or 
typewritten name or initials of the individual who dispensed or 
administered the substance on behalf of the dispenser. In addition to 
the requirements of this paragraph, practitioners dispensing gamma-
hydroxybutyric acid under a prescription must also comply with Sec. 
1304.26.
    (d) Records for importers and exporters. Each person registered or 
authorized to import or export controlled substances shall maintain 
records with the same information required of manufacturers pursuant to 
paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In addition, 
the quantity disposed of in any other manner by the registrant (except 
quantities used in manufacturing by an importer under a registration as 
a manufacturer), which quantities are to be recorded pursuant to 
paragraphs (a)(1) (iv) and (v) of this section; and the quantity (or 
number of units or volume in finished form) exported, including the 
date, quantity (or number of units or volume), and the export permit or 
declaration number for each exportation, but excluding all quantities 
(and number of units and volumes) manufactured by an exporter under a

[[Page 61]]

registration as a manufacturer, which quantities (and numbers of units 
and volumes) are to be recorded pursuant to paragraphs (a)(1)(xiii) or 
(a)(2)(xiii) of this section.
    (e) Records for reverse distributors. Each person registered to 
distribute controlled substances as a reverse distributor shall maintain 
records with the following information for each controlled substance:
    (1) For each controlled substance in bulk form the following:
    (i) The name of the controlled substance.
    (ii) The total quantity of the controlled substance to the nearest 
metric unit weight consistent with unit size.
    (iii) The quantity received from other persons, including the date 
and quantity of each receipt and the name, address, and registration 
number of the other person from whom the controlled substance was 
received.
    (iv) The quantity returned to the original manufacturer of the 
controlled substance or the manufacturer's agent, including the date of 
and quantity of each distribution and the name, address and registration 
number of the manufacturer or manufacturer's agent to whom the 
controlled substance was distributed.
    (v) The quantity disposed of including the date and manner of 
disposal and the signatures of two responsible employees of the 
registrant who witnessed the disposal.
    (2) For each controlled substance in finished form the following:
    (i) The name of the substance.
    (ii) Each finished form (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume of finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial).
    (iii) The number of commercial containers of each such finished form 
received from other persons, including the date of and number of 
containers in each receipt and the name, address, and registration 
number of the person from whom the containers were received.
    (iv) The number of commercial containers of each such finished form 
distributed back to the original manufacturer of the substance or the 
manufacturer's agent, including the date of and number of containers in 
each distribution and the name, address, and registration number of the 
manufacturer or manufacturer's agent to whom the containers were 
distributed.
    (v) The number of units or volume of finished forms and/or 
commercial containers disposed of including the date and manner of 
disposal, the quantity of the substance in finished form disposed, and 
the signatures of two responsible employees of the registrant who 
witnessed the disposal.

[62 FR 13960, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 
70 FR 293, Jan. 4, 2005]



Sec. 1304.23  Records for chemical analysts.

    (a) Each person registered or authorized (by Sec. 1301.22(b) of 
this chapter) to conduct chemical analysis with controlled substances 
shall maintain records with the following information (to the extent 
known and reasonably ascertainable by him) for each controlled 
substance:
    (1) The name of the substance;
    (2) The form or forms in which the substance is received, imported, 
or manufactured by the registrant (e.g., powder, granulation, tablet, 
capsule, or solution) and the concentration of the substance in such 
form (e.g., C.P., U.S.P., N.F., 10-milligram tablet or 10-milligram 
concentration per milliliter);
    (3) The total number of the forms received, imported or manufactured 
(e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder), 
including the date and quantity of each receipt, importation, or 
manufacture and the name, address, and registration number, if any, of 
the person from whom the substance was received;
    (4) The quantity distributed, exported, or destroyed in any manner 
by the registrant (except quantities used in chemical analysis or other 
laboratory work), including the date and manner of distribution, 
exportation, or destruction, and the name, address, and registration 
number, if any, of each person to whom the substance was distributed or 
exported.

[[Page 62]]

    (b) Records of controlled substances used in chemical analysis or 
other laboratory work are not required.
    (c) Records relating to known or suspected controlled substances 
received as evidentiary material for analysis are not required under 
paragraph (a) of this section.

[36 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 
FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13961, Mar. 24, 1997]



Sec. 1304.24  Records for maintenance treatment programs and detoxification 
treatment programs.

    (a) Each person registered or authorized (by Sec. 1301.22 of this 
chapter) to maintain and/or detoxify controlled substance users in a 
narcotic treatment program shall maintain records with the following 
information for each narcotic controlled substance:
    (1) Name of substance;
    (2) Strength of substance;
    (3) Dosage form;
    (4) Date dispensed;
    (5) Adequate identification of patient (consumer);
    (6) Amount consumed;
    (7) Amount and dosage form taken home by patient; and
    (8) Dispenser's initials.
    (b) The records required by paragraph (a) of this section will be 
maintained in a dispensing log at the narcotic treatment program site 
and will be maintained in compliance with Sec. 1304.22 without 
reference to Sec. 1304.03.
    (c) All sites which compound a bulk narcotic solution from bulk 
narcotic powder to liquid for on-site use must keep a separate batch 
record of the compounding.
    (d) Records of identity, diagnosis, prognosis, or treatment of any 
patients which are maintained in connection with the performance of a 
narcotic treatment program shall be confidential, except that such 
records may be disclosed for purposes and under the circumstances 
authorized by part 310 and 42 CFR part 2.

[39 FR 37985, Oct. 25, 1974. Redesignated and amended at 62 FR 13961, 
Mar. 24, 1997]



Sec. 1304.25  Records for treatment programs which compound narcotics 
for treatment programs and other locations.

    Each person registered or authorized by Sec. 1301.22 of this 
chapter to compound narcotic drugs for off-site use in a narcotic 
treatment program shall maintain records which include the following 
information for each narcotic drug:
    (a) For each narcotic controlled substance in bulk form to be used 
in, or capable of use in, or being used in, the compounding of the same 
or other noncontrolled substances in finished form:
    (1) The name of the substance;
    (2) The quantity compounded in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch compounded;
    (3) The quantity received from other persons, including the date and 
quantity of each receipt and the name, address and registration number 
of the other person from whom the substance was received;
    (4) The quantity imported directly by the registrant (under a 
registration as an importer) for use in compounding by him, including 
the date, quantity and import permit or declaration number of each 
importation;
    (5) The quantity used to compound the same substance in finished 
form, including:
    (i) The date and batch or other identifying number of each 
compounding;
    (ii) The quantity used in the compound;
    (iii) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter;
    (iv) The number of units of finished form compounded;
    (v) The quantity used in quality control;
    (vi) The quantity lost during compounding and the causes therefore, 
if known;
    (vii) The total quantity of the substance contained in the finished 
form;
    (viii) The theoretical and actual yields; and
    (ix) Such other information as is necessary to account for all 
controlled substances used in the compounding process;

[[Page 63]]

    (6) The quantity used to manufacture other controlled and non-
controlled substances; including the name of each substance manufactured 
and the information required in paragraph (a)(5) of this section;
    (7) The quantity distributed in bulk form to other programs, 
including the date and quantity of each distribution and the name, 
address and registration number of each program to whom a distribution 
was made;
    (8) The quantity exported directly by the registrant (under a 
registration as an exporter), including the date, quantity, and export 
permit or declaration number of each exploration; and
    (9) The quantity disposed of by destruction, including the reason, 
date and manner of destruction. All other destruction of narcotic 
controlled substances will comply with Sec. 1307.22.
    (b) For each narcotic controlled substance in finished form:
    (1) The name of the substance;
    (2) Each finished form (e.g., 10-milligram tablet or 10 milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume or finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (3) The number of containers of each such commercial finished form 
compounded from bulk form by the registrant, including the information 
required pursuant to paragraph (a)(5) of this section;
    (4) The number of units of finished forms and/or commercial 
containers received from other persons, including the date of and number 
of units and/or commercial containers in each receipt and the name, 
address and registration number of the person from whom the units were 
received;
    (5) The number of units of finished forms and/or commercial 
containers imported directly by the person (under a registration or 
authorization to import), including the date of, the number of units 
and/or commercial containers in, and the import permit or declaration 
number for, each importation;
    (6) The number of units and/or commercial containers compounded by 
the registrant from units in finished form received from others or 
imported, including:
    (i) The date and batch or other identifying number of each 
compounding;
    (ii) The operation performed (e.g., repackaging or relabeling);
    (iii) The number of units of finished form used in the compound, the 
number compounded and the number lost during compounding, with the 
causes for such losses, if known; and
    (iv) Such other information as is necessary to account for all 
controlled substances used in the compounding process;
    (7) The number of containers distributed to other programs, 
including the date, the number of containers in each distribution, and 
the name, address and registration number of the program to whom the 
containers were distributed;
    (8) The number of commercial containers exported directly by the 
registrant (under a registration as an exporter), including the date, 
number of containers and export permit or declaration number for each 
exportation; and
    (9) The number of units of finished forms and/or commercial 
containers destroyed in any manner by the registrant, including the 
reason, the date and manner of destruction. All other destruction of 
narcotic controlled substances will comply with Sec. 1307.22.

[39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997]



Sec. 1304.26  Additional recordkeeping requirements applicable to drug 
products containing gamma-hydroxybutyric acid.

    In addition to the recordkeeping requirements for dispensers and 
researchers provided in Sec. 1304.22, practitioners dispensing gamma-
hydroxybutyric acid that is manufactured or distributed in accordance 
with an application under section 505 of the Federal Food, Drug, and 
Cosmetic Act must maintain and make available for inspection and copying 
by the Attorney General, all of the following information for each 
prescription:
    (a) Name of the prescribing practitioner.
    (b) Prescribing practitioner's Federal and State registration 
numbers, with

[[Page 64]]

the expiration dates of these registrations.
    (c) Verification that the prescribing practitioner possesses the 
appropriate registration to prescribe this controlled substance.
    (d) Patient's name and address.
    (e) Patient's insurance provider, if available.

[70 FR 293, Jan. 4, 2005]

                                 Reports



Sec. 1304.31  Reports from manufacturers importing narcotic raw material.

    (a) Every manufacturer which imports or manufactures from narcotic 
raw material (opium, poppy straw, and concentrate of poppy straw) shall 
submit information which accounts for the importation and for all 
manufacturing operations performed between importation and the 
production in bulk or finished marketable products, standardized in 
accordance with the U.S. Pharmacopeia, National Formulary or other 
recognized medical standards. Reports shall be signed by the authorized 
official and submitted quarterly on company letterhead to the Drug 
Enforcement Administration, Drug and Chemical Evaluation Section, 
Washington, D.C. 20537, on or before the 15th day of the month 
immediately following the period for which it is submitted.
    (b) The following information shall be submitted for each type of 
narcotic raw material (quantities are expressed as grams of anhydrous 
morphine alkaloid):
    (1) Beginning inventory;
    (2) Gains on reweighing;
    (3) Imports;
    (4) Other receipts;
    (5) Quantity put into process;
    (6) Losses on reweighing;
    (7) Other dispositions and
    (8) Ending inventory.
    (c) The following information shall be submitted for each narcotic 
raw material derivative including morphine, codeine, thebaine, 
oxycodone, hydrocodone, medicinal opium, manufacturing opium, crude 
alkaloids and other derivatives (quantities are expressed as grams of 
anhydrous base or anhydrous morphine alkaloid for manufacturing opium 
and medicinal opium):
    (1) Beginning inventory;
    (2) Gains on reweighing;
    (3) Quantity extracted from narcotic raw material;
    (4) Quantity produced/manufactured/synthesized;
    (5) Quantity sold;
    (6) Quantity returned to conversion processes for reworking;
    (7) Quantity used for conversion;
    (8) Quantity placed in process;
    (9) Other dispositions;
    (10) Losses on reweighing and
    (11) Ending inventory.
    (d) The following information shall be submitted for importation of 
each narcotic raw material:
    (1) Import permit number;
    (2) Date shipment arrived at the United States port of entry;
    (3) Actual quantity shipped;
    (4) Assay (percent) of morphine, codeine and thebaine and
    (5) Quantity shipped, expressed as anhydrous morphine alkaloid.
    (e) Upon importation of crude opium, samples will be selected and 
assays made by the importing manufacturer in the manner and according to 
the method specified in the U.S. Pharmacopoeia. Where final assay data 
is not determined at the time of rendering report, the report shall be 
made on the basis of the best data available, subject to adjustment, and 
the necessary adjusting entries shall be made on the next report.
    (f) Where factory procedure is such that partial withdrawals of 
opium are made from individual containers, there shall be attached to 
each container a stock record card on which shall be kept a complete 
record of all withdrawals therefrom.
    (g) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed or 
placed into process for the manufacture of a specified end-product, it 
must no longer be accounted for as precursor stocks available for 
conversion or use, but rather as end-product in-process inventories.

[62 FR 13961, Mar. 24, 1997]

[[Page 65]]



Sec. 1304.32  Reports of manufacturers importing coca leaves.

    (a) Every manufacturer importing or manufacturing from raw coca 
leaves shall submit information accounting for the importation and for 
all manufacturing operations performed between the importation and the 
manufacture of bulk or finished products standardized in accordance with 
U.S. Pharmacopoeia, National Formulary, or other recognized standards. 
The reports shall be submitted quarterly on company letterhead to the 
Drug Enforcement Administration, Drug and Chemical Evaluation Section, 
Washington, DC 20537, on or before the 15th day of the month immediately 
following the period for which it is submitted.
    (b) The following information shall be submitted for raw coca leaf, 
ecgonine, ecgonine for conversion or further manufacture, 
benzoylecgonine, manufacturing coca extracts (list for tinctures and 
extracts; and others separately), other crude alkaloids and other 
derivatives (quantities should be reported as grams of actual quantity 
involved and the cocaine alkaloid content or equivalency):
    (1) Beginning inventory;
    (2) Imports;
    (3) Gains on reweighing;
    (4) Quantity purchased;
    (5) Quantity produced;
    (6) Other receipts;
    (7) Quantity returned to processes for reworking;
    (8) Material used in purification for sale;
    (9) Material used for manufacture or production;
    (10) Losses on reweighing;
    (11) Material used for conversion;
    (12) Other dispositions and
    (13) Ending inventory.
    (c) The following information shall be submitted for importation of 
coca leaves:
    (1) Import permit number;
    (2) Date the shipment arrived at the United States port of entry;
    (3) Actual quantity shipped;
    (4) Assay (percent) of cocaine alkaloid and
    (5) Total cocaine alkaloid content.
    (d) Upon importation of coca leaves, samples will be selected and 
assays made by the importing manufacturer in accordance with recognized 
chemical procedures. These assays shall form the basis of accounting for 
such coca leaves, which shall be accounted for in terms of their cocaine 
alkaloid content or equivalency or their total anhydrous coca alkaloid 
content. Where final assay data is not determined at the time of 
submission, the report shall be made on the basis of the best data 
available, subject to adjustment, and the necessary adjusting entries 
shall be made on the next report.
    (e) Where factory procedure is such that partial withdrawals of 
medicinal coca leaves are made from individual containers, there shall 
be attached to the container a stock record card on which shall be kept 
a complete record of withdrawals therefrom.
    (f) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed or 
placed into process for the manufacture of a specified end-product, it 
must no longer be accounted for as precursor stocks available for 
conversion or use, but rather as end-product in-process inventories.

[62 FR 13962, Mar. 24, 1997]



Sec. 1304.33  Reports to ARCOS.

    (a) Reports generally. All reports required by this section shall be 
filed with the ARCOS Unit, PO 28293, Central Station, Washington, DC 
20005 on DEA Form 333, or on media which contains the data required by 
DEA Form 333 and which is acceptable to the ARCOS Unit.
    (b) Frequency of reports. Acquisition/Distribution transaction 
reports shall be filed every quarter not later than the 15th day of the 
month succeeding the quarter for which it is submitted; except that a 
registrant may be given permission to file more frequently (but not more 
frequently than monthly), depending on the number of transactions being 
reported each time by that registrant. Inventories shall provide data on 
the stocks of each reported controlled substance on hand as of the close 
of business on December 31 of each year, indicating whether the 
substance is in storage or in process of manufacturing. These reports 
shall be

[[Page 66]]

filed not later than January 15 of the following year. Manufacturing 
transaction reports shall be filed annually for each calendar year not 
later than January 15 of the following year, except that a registrant 
may be given permission to file more frequently (but not more frequently 
than quarterly).
    (c) Persons reporting. For controlled substances in Schedules I, II, 
narcotic controlled substances in Schedule III, and gamma-hydroxybutyric 
acid drug product controlled substances in Schedule III, each person who 
is registered to manufacture in bulk or dosage form, or to package, 
repackage, label or relabel, and each person who is registered to 
distribute, including each person who is registered to reverse 
distribute, shall report acquisition/distribution transactions. In 
addition to reporting acquisition/distribution transactions, each person 
who is registered to manufacture controlled substances in bulk or dosage 
form shall report manufacturing transactions on controlled substances in 
Schedules I and II, each narcotic controlled substance listed in 
Schedules III, IV, and V, gamma-hydroxybutyric acid drug product 
controlled substances in Schedule III, and on each psychotropic 
controlled substance listed in Schedules III and IV as identified in 
paragraph (d) of this section.
    (d) Substances covered. (1) Manufacturing and acquisition/
distribution transaction reports shall include data on each controlled 
substance listed in Schedules I and II, on each narcotic controlled 
substance listed in Schedule III (but not on any material, compound, 
mixture or preparation containing a quantity of a substance having a 
stimulant effect on the central nervous system, which material, 
compound, mixture or preparation is listed in Schedule III or on any 
narcotic controlled substance listed in Schedule V), and on gamma-
hydroxybutyric acid drug products listed in Schedule III. Additionally, 
reports on manufacturing transactions shall include the following 
psychotropic controlled substances listed in Schedules III and IV:
    (i) Schedule III
    (A) Benzphetamine;
    (B) Cyclobarbital;
    (C) Methyprylon; and
    (D) Phendimetrazine.
    (ii) Schedule IV
    (A) Barbital;
    (B) Diethylpropion (Amfepramone);
    (C) Ethchlorvynol;
    (D) Ethinamate;
    (E) Lefetamine (SPA);
    (F) Mazindol;
    (G) Meprobamate;
    (H) Methylphenobarbital;
    (I) Phenobarbital;
    (J) Phentermine; and
    (K) Pipradrol.
    (2) Data shall be presented in such a manner as to identify the 
particular form, strength, and trade name, if any, of the product 
containing the controlled substance for which the report is being made. 
For this purpose, persons filing reports shall utilize the National Drug 
Code Number assigned to the product under the National Drug Code System 
of the Food and Drug Administration.
    (e) Transactions reported. Acquisition/distribution transaction 
reports shall provide data on each acquisition to inventory (identifying 
whether it is, e.g., by purchase or transfer, return from a customer, or 
supply by the Federal Government) and each reduction from inventory 
(identifying whether it is, e.g., by sale or transfer, theft, 
destruction or seizure by Government agencies). Manufacturing reports 
shall provide data on material manufactured, manufacture from other 
material, use in manufacturing other material and use in producing 
dosage forms.
    (f) Exceptions. A registered institutional practitioner who 
repackages or relabels exclusively for distribution or who distributes 
exclusively to (for dispensing by) agents, employees, or affiliated 
institutional practitioners of the registrant may be exempted from 
filing reports under this section by applying to the ARCOS Unit of the 
Administration.

(Approved by the Office of Management and Budget under control number 
1117-0003)

[62 FR 13962, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 
70 FR 294, Jan. 4, 2005]



PART 1305_ORDER FORMS--Table of Contents

Sec.
1305.01 Scope of part 1305.
1305.02 Definitions.

[[Page 67]]

1305.03 Distributions requiring order forms.
1305.04 Persons entitled to obtain and execute order forms.
1305.05 Procedure for obtaining order forms.
1305.06 Procedure for executing order forms.
1305.07 Power of attorney.
1305.08 Persons entitled to fill order forms.
1305.09 Procedure for filling order forms.
1305.10 Procedure for endorsing order forms.
1305.11 Unaccepted and defective order forms.
1305.12 Lost and stolen order forms.
1305.13 Preservation of order forms.
1305.14 Return of unused order forms.
1305.15 Cancellation and voiding of order forms.
1305.16 Special procedure for filling certain order forms.

    Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.

    Source: 36 FR 7796, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

    Effective Date Note: At 70 FR 16911, Apr. 1, 2005, part 1305 was 
revised, effective May 31, 2005. For the convenience of the user, the 
new part 1305 follows the text of this part.



Sec. 1305.01  Scope of part 1305.

    Procedures governing the issuance, use, and preservation of order 
forms pursuant to section 1308 of the Act (21 U.S.C. 828) are set forth 
generally by that section and specifically by the sections of this part.



Sec. 1305.02   Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13963, Mar. 24, 1997]



Sec. 1305.03  Distributions requiring order forms.

    An order form (DEA Form 222) is required for each distribution of a 
Schedule I or II controlled substance except to persons exempted from 
registration under part 1301 of this chapter; which are exported from 
the United States in conformity with the Act; for delivery to a 
registered analytical laboratory, or its agent approved by DEA; or for 
delivery from a central fill pharmacy, as defined in Sec. 
1300.01(b)(43), to a retail pharmacy.

[68 FR 37410, June 24, 2003]



Sec. 1305.04  Persons entitled to obtain and execute order forms.

    (a) Order forms may be obtained only by persons who are registered 
under section 303 of the Act (21 U.S.C. 823) to handle controlled 
substances listed in Schedules I and II, and by persons who are 
registered under section 1008 of the Act (21 U.S.C. 958) to export such 
substances. Persons not registered to handle controlled substances 
listed in Schedule I or II and persons registered only to import 
controlled substances listed in any schedule are not entitled to obtain 
order forms.
    (b) An order form may be executed only on behalf of the registrant 
named thereon and only if his/her registration as to the substances 
being purchased has not expired or been revoked or suspended.

[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13964, Mar. 24, 1997]



Sec. 1305.05  Procedure for obtaining order forms.

    (a) Order Forms are issued in mailing envelopes containing either 
seven or fourteen forms, each form containing an original duplicate and 
triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, 
which is based on the business activity of the registrant, will be 
imposed on the number of order forms which will be furnished on any 
requisition unless additional forms are specifically requested and a 
reasonable need for such additional forms is shown.
    (b) Any person applying for a registration which would entitle him/
her to obtain order forms may requisition such forms by so indicating on 
the application form; order forms will be supplied upon the registration 
of the applicant. Any person holding a registration entitling him/her to 
obtain order forms may requisition such forms for the first time by 
contacting any Division Office or the Registration Unit of the 
Administration. Any person already holding order forms may requisition 
additional forms on DEA Form 222a which is mailed to a registrant 
approximately 30 days after each shipment of order forms to that 
registrant or by contacting any Division Office or

[[Page 68]]

the Registration Unit of the Administration. All requisition forms (DEA 
Form 222a) shall be submitted to the Registration Unit, Drug Enforcement 
Administration, Department of Justice, Post Office Box 28083, Central 
Station, Washington, DC 20005.
    (c) Each requisition shall show the name, address, and registration 
number of the registrant and the number of books of order forms desired. 
Each requisition shall be signed and dated by the same person who signed 
the most recent application for registration or for reregistration, or 
by any person authorized to obtain and execute order forms by a power of 
attorney pursuant to Sec. 1305.07.
    (d) Order forms will be serially numbered and issued with the name, 
address and registration number of the registrant, the authorized 
activity and schedules of the registrant. This information cannot be 
altered or changed by the registrant; any errors must be corrected by 
the Registration Unit of the Administration by returning the forms with 
notification of the error.

[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5319, 
Feb. 13, 1986; 53 FR 4963, Feb. 19, 1988; 62 FR 13964, Mar. 24, 1997]



Sec. 1305.06  Procedure for executing order forms.

    (a) Order forms shall be prepared and executed by the purchaser 
simultaneously in triplicate by means of interleaved carbon sheets which 
are part of the DEA Form 222. Order forms shall be prepared by use of a 
typewriter, pen, or indelible pencil.
    (b) Only one item shall be entered on each numbered line. An item 
shall consist of one or more commercial or bulk containers of the same 
finished or bulk form and quantity of the same substance. The number of 
lines completed shall be noted on that form at the bottom of the form, 
in the space provided. Order forms for carfentanil, etorphine 
hydrochloride, and diprenorphine shall contain only these substances.
    (c) The name and address of the supplier from whom the controlled 
substances are being ordered shall be entered on the form. Only one 
supplier may be listed on any form.
    (d) Each order form shall be signed and dated by a person authorized 
to sign an application for registration. The name of the purchaser, if 
different from the individual signing the order form, shall also be 
inserted in the signature space. Unexecuted order forms may be kept and 
may be executed at a location other than the registered location printed 
on the form, provided that all unexecuted forms are delivered promptly 
to the registered location upon an inspection of such location by any 
officer authorized to make inspections, or to enforce, any Federal, 
State, or local law regarding controlled substances.

[62 FR 13963, Mar. 24, 1997]



Sec. 1305.07  Power of attorney.

    Any purchaser may authorize one or more individuals, whether or not 
located at the registered location of the purchaser, to obtain and 
execute order forms on his/her behalf by executing a power of attorney 
for each such individual. The power of attorney shall be signed by the 
same person who signed the most recent application for registration or 
reregistration and by the individual being authorized to obtain and 
execute order forms. The power of attorney shall be filed with the 
executed order forms of the purchaser, and shall be retained for the 
same period as any order form bearing the signature of the attorney. The 
power of attorney shall be available for inspection together with other 
order form records. Any power of attorney may be revoked at any time by 
executing a notice of revocation, signed by the person who signed (or 
was authorized to sign) the power of attorney or by a successor, whoever 
signed the most recent application for registration or reregistration, 
and filing it with the power of attorney being revoked. The form for the 
power of attorney and notice of revocation shall be similar to the 
following:

                  Power of Attorney for DEA Order Forms

---------- (Name of registrant)
---------- (Address of registrant)
---------- (DEA registration number)

    I, ---------- (name of person granting power), the undersigned, who 
is authorized to sign the current application for registration of the 
above-named registrant under the

[[Page 69]]

Controlled Substances Act or Controlled Substances Import and Export 
Act, have made, constituted, and appointed, and by these presents, do 
make, constitute, and appoint ---------- (name of attorney-in-fact), my 
true and lawful attorney for me in my name, place, and stead, to execute 
applications for books of official order forms and to sign such order 
forms in requisition for Schedule I and II controlled substances, in 
accordance with section 308 of the Controlled Substances Act (21 U.S.C. 
828) and part 1305 of Title 21 of the Code of Federal Regulations. I 
hereby ratify and confirm all that said attorney shall lawfully do or 
cause to be done by virtue hereof.

________________________________________________________________________
(Signature of person granting power)

    I, ---------- (name of attorney-in-fact), hereby affirm that I am 
the person named herein as attorney-in-fact and that the signature 
affixed hereto is my signature.

________________________________________________________________________
(Signature of attorney-in-fact)

    Witnesses:
    1. ----------.
    2. ----------.
    Signed and dated on the ------ day of ----------, (year), at ------
----.

                          Notice of Revocation

    The foregoing power of attorney is hereby revoked by the 
undersigned, who is authorized to sign the current application for 
registration of the above-named registrant under the Controlled 
Substances Act of the Controlled Substances Import and Export Act. 
Written notice of this revocation has been given to the attorney-in-fact 
---------- this same day.

________________________________________________________________________
(Signature of person revoking power)
    Witnesses:
    1. ----------.
    2. ----------.
    Signed and dated on the ------ day of ----------, (year), at ------
----.

[62 FR 13963, Mar. 24, 1997]



Sec. 1305.08  Persons entitled to fill order forms.

    An order form may be filled only by a person registered as a 
manufacturer or distributor of controlled substances listed in Schedule 
I or II under section 303 of the Act (21 U.S.C. 823) or as an importer 
of such substances under section 1008 of the Act (21 U.S.C. 958), except 
for the following:
    (a) A person registered to dispense such substances under section 
303 of the Act, or to export such substances under section 1008 of the 
Act, if he/she is discontinuing business or if his/her registration is 
expiring without reregistration, may dispose of any controlled 
substances listed in Schedule I or II in his/her possession pursuant to 
order forms in accordance with Sec. 1307.14 of this chapter;
    (b) A person who has obtained any controlled substance in Schedule I 
or II by order form may return such substance, or portion thereof, to 
the person from whom he/she obtained the substance, to the manufacturer 
of the substance, or to a registered reverse distributor pursuant to the 
order form of the latter person;
    (c) A person registered to dispense such substances may distribute 
such substances to another dispenser pursuant to, and only in the 
circumstances described in, Sec. 1307.11 of this chapter; and
    (d) A person registered or authorized to conduct chemical analysis 
or research with controlled substances may distribute a controlled 
substance listed in Schedule I or II to another person registered or 
authorized to conduct chemical analysis, instructional activities, or 
research with such substances pursuant to the order form of the latter 
person, if such distribution is for the purpose of furthering such 
chemical analysis, instructional activities, or research.
    (e) A person registered as a compounder of narcotic substances for 
use at off-site locations in conjunction with a narcotic treatment 
program at the compounding location, who is authorized to handle 
Schedule II narcotics, is authorized to fill order forms for 
distribution of narcotic drugs to off-site narcotic treatment programs 
only.

[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 
FR 18732, Sept. 21, 1971; 37 FR 15921, Aug. 8, 1972. Redesignated at 38 
FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1305.08, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1305.09  Procedure for filling order forms.

    (a) The purchaser shall submit Copy 1 and Copy 2 of the order form 
to the

[[Page 70]]

supplier, and retain Copy 3 in his own files.
    (b) The supplier shall fill the order, if possible and if he/she 
desires to do so, and record on Copies 1 and 2 the number of commercial 
or bulk containers furnished on each item and the date on which such 
containers are shipped to the purchaser. If an order cannot be filled in 
its entirety, it may be filled in part and the balance supplied by 
additional shipments within 60 days following the date of the order 
form. No order form shall be valid more than 60 days after its execution 
by the purchaser, except as specified in paragraph (f) of this section.
    (c) The controlled substances shall only be shipped to the purchaser 
and at the location printed by the Administration on the order form, 
except as specified in paragraph (f) of this section.
    (d) The supplier shall retain Copy 1 of the order form for his/her 
own files and forward Copy 2 to the Special Agent in Charge of the Drug 
Enforcement Administration in the area in which the supplier is located. 
Copy 2 shall be forwarded at the close of the month during which the 
order is filled; if an order is filled by partial shipments, Copy 2 
shall be forwarded at the close of the month during which the final 
shipment is made or during which the 60-day validity period expires.
    (e) The purchaser shall record on Copy 3 of the order form the 
number of commercial or bulk containers furnished on each item and the 
dates on which such containers are received by the purchaser.
    (f) Order forms submitted by registered procurement officers of the 
Defense Personnel Support Center of Defense Supply Agency for delivery 
to armed services establishments within the United States may be shipped 
to locations other than the location printed on the order form, and in 
partial shipments at different times not to exceed six months from the 
date of the order, as designated by the procurement officer when 
submitting the order.

[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, 
Sept. 22, 1982; 62 FR 13964, Mar. 24, 1997]



Sec. 1305.10  Procedure for endorsing order forms.

    (a) An order form made out to any supplier who cannot fill all or a 
part of the order within the time limitation set forth in Sec. 1305.09 
may be endorsed to another supplier for filling. The endorsement shall 
be made only by the supplier to whom the order form was first made, 
shall state (in the spaces provided on the reverse sides of Copies 1 and 
2 of the order form) the name and address of the second supplier, and 
shall be signed by a person authorized to obtain and execute order forms 
on behalf of the first supplier. The first supplier may not fill any 
part of an order on an endorsed form. The second supplier shall fill the 
order, if possible and if he/she desires to do so, in accordance with 
Sec. 1305.09 (b), (c), and (d), including shipping all substances 
directly to the purchaser.
    (b) Distributions made on endorsed order forms shall be reported by 
the second supplier in the same manner as all other distributions except 
that where the name of the supplier is requested on the reporting form, 
the second supplier shall record the name, address and registration 
number of the first supplier.

[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13964, Mar. 24, 1997]



Sec. 1305.11  Unaccepted and defective order forms.

    (a) No order form shall be filled if it:
    (1) Is not complete, legible, or properly prepared, executed, or 
endorsed; or
    (2) Shows any alteration, erasure, or change of any description.
    (b) If an order form cannot be filled for any reason under this 
section, the supplier shall return Copies 1 and 2 to the purchaser with 
a statement as to the reason (e.g., illegible or altered). A supplier 
may for any reason refuse to accept any order and if a supplier refuses 
to accept the order, a statement that the order is not accepted shall be 
sufficient for purposes of this paragraph.
    (c) When received by the purchaser, Copies 1 and 2 of the order form 
and the statement shall be attached to Copy 3 and retained in the files 
of the purchaser in accordance with Sec. 1305.13. A

[[Page 71]]

defective order form may not be corrected; it must be replaced by a new 
order form in order for the order to be filled.



Sec. 1305.12  Lost and stolen order forms.

    (a) If a purchaser ascertains that an unfilled order form has been 
lost, he shall execute another in triplicate and a statement containing 
the serial number and date of the lost form, and stating that the goods 
covered by the first order form were not received through loss of that 
order form. Copy 3 of the second form and a copy of the statement shall 
be retained with Copy 3 of the order form first executed. A copy of the 
statement shall be attached to Copies 1 and 2 of the second order form 
sent to the supplier. If the first order form is subsequently received 
by the supplier to whom it was directed, the supplier shall mark upon 
the face thereof ``Not accepted'' and return Copies 1 and 2 to the 
purchaser, who shall attach it to Copy 3 and the statement.
    (b) Whenever any used or unused order forms are stolen or lost 
(otherwise than in the course of transmission) by any purchaser or 
supplier, he/she shall immediately upon discovery of such theft or loss, 
report the same to the Special Agent in Charge of the Drug Enforcement 
Administration in the Divisional Office responsible for the area in 
which the registrant is located, stating the serial number of each form 
stolen or lost. If the theft or loss includes any original order forms 
received from purchasers and the supplier is unable to state the serial 
numbers of such order forms, he/she shall report the date or approximate 
date of receipt thereof and the names and addresses of the purchasers. 
If an entire book of order forms is lost or stolen, and the purchaser is 
unable to state the serial numbers of the order forms contained therein, 
he/she shall report, in lieu of the numbers of the forms contained in 
such book, the date or approximate date of issuance thereof. If any 
unused order form reported stolen or lost is subsequently recovered or 
found, the Special Agent in Charge of the Drug Enforcement 
Administration in the Divisional Office responsible for the area in 
which the registrant is located shall immediately be notified.

[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5319, 
Feb. 13, 1986; 62 FR 13964, Mar. 24, 1997]



Sec. 1305.13  Preservation of order forms.

    (a) The purchaser shall retain Copy 3 of each order form which has 
been filled. He/She shall also retain in his files all copies of each 
unaccepted or defective order form and each statement attached thereto.
    (b) The supplier shall retain Copy 1 of each order form which he/she 
has filled.
    (c) Order forms must be maintained separately from all other records 
of the registrant. Order forms are required to be kept available for 
inspection for a period of 2 years. If a purchaser has several 
registered locations, he/she must retain Copy 3 of the executed order 
forms and any attached statements or other related documents (not 
including unexecuted order forms which may be kept elsewhere pursuant to 
Sec. 1305.06(d)) at the registered location printed on the order form.
    (d) The supplier of carfentanil etorphine hydrochloride and 
diprenorphine shall maintain order forms for these substances separately 
from all other order forms and records required to be maintained by the 
registrant.

[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 39 FR 17839, May 21, 1974; 54 FR 33674, Aug. 16, 1989; 62 
FR 13964, Mar. 24, 1997]



Sec. 1305.14  Return of unused order forms.

    If the registration of any purchaser terminates (because the 
purchaser dies, ceases legal existence, discontinues business or 
professional practice, or changes his name or address as shown on his 
registration) or is suspended or revoked pursuant to Sec. 1301.36 of 
this chapter as to all controlled substances listed in Schedules I and 
II for which he/she is registered, he/she shall return

[[Page 72]]

all unused order forms for such substance to the nearest office of the 
Administration.

[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13964, 
Mar. 24, 1997]



Sec. 1305.15  Cancellation and voiding of order forms.

    (a) A purchaser may cancel part or all of an order on an order form 
by notifying the supplier in writing of such cancellation. The supplier 
shall indicate the cancellation on Copies 1 and 2 of the order form by 
drawing a line through the canceled items and printing ``canceled'' in 
the space provided for number of items shipped.
    (b) A supplier may void part or all of an order on an order form by 
notifying the purchaser in writing of such voiding. The supplier shall 
indicate the voiding in the manner prescribed for cancellation in 
paragraph (a) of this section.
    (c) No cancellation or voiding permitted by this section shall 
affect in any way contract rights of either the purchaser or the 
supplier.

[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1305.16  Special procedure for filling certain order forms.

    (a) The purchaser of carfentanil etorphine hydrochloride or 
diprenorphine shall submit copy 1 and 2 of the order form to the 
supplier and retain copy 3 in his own files.
    (b) The supplier, if he/she determines that the purchaser is a 
veterinarian engaged in zoo and exotic animal practice, wildlife 
management programs and/or research and authorized by the Administrator 
to handle these substances shall fill the order in accordance with the 
procedures set forth in Sec. 1305.09 except that:
    (1) Order forms for carfentanil etorphine hydrochloride and 
diprenorphine shall only contain these substances in reasonable 
quantities and
    (2) The substances shall only be shipped to the purchaser at the 
location printed by the Administration upon the order form under secure 
conditions using substantial packaging material with no markings on the 
outside which would indicate the content.

[39 FR 17839, May 21, 1974, as amended at 54 FR 33674, Aug. 16, 1989; 62 
FR 13964, Mar. 24, 1997]

    Effective Date Note: At 70 FR 16911, Apr. 1, 2005, part 1305 was 
revised, effective May 31, 2005. For the convenience of the user, the 
revised text is set forth as follows:



PART 1305_ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

                     Subpart A_General Requirements

Sec.
1305.01 Scope of part 1305.
1305.02 Definitions.
1305.03 Distributions requiring a Form 222 or digitally signed 
          electronic order.
1305.04 Persons entitled to order Schedule I and II controlled 
          substances.
1305.05 Power of attorney.
1305.06 Persons entitled to fill orders for Schedule I and II controlled 
          substances.
1305.07 Special procedure for filling certain orders.

                         Subpart B_DEA Form 222

1305.11 Procedure for obtaining DEA Forms 222.
1305.12 Procedure for executing DEA Forms 222.
1305.13 Procedure for filling DEA Forms 222.
1305.14 Procedure for endorsing DEA Forms 222.
1305.15 Unaccepted and defective DEA Forms 222.
1305.16 Lost and stolen DEA Forms 222.
1305.17 Preservation of DEA Forms 222.
1305.18 Return of unused DEA Forms 222.
1305.19 Cancellation and voiding of DEA Forms 222.

                       Subpart C_Electronic Orders

1305.21 Requirements for electronic orders.
1305.22 Procedure for filling electronic orders.
1305.23 Endorsing electronic orders.
1305.24 Central processing of orders.
1305.25 Unaccepted and defective electronic orders.
1305.26 Lost electronic orders.
1305.27 Preservation of electronic orders.
1305.28 Canceling and voiding electronic orders.
1305.29 Reporting to DEA.

    Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.

[[Page 73]]

                     Subpart A_General Requirements


Sec. 1305.01  Scope of part 1305.

    Procedures governing the issuance, use, and preservation of orders 
for Schedule I and II controlled substances are set forth generally by 
section 308 of the Act (21 U.S.C. 828) and specifically by the sections 
of this part.


Sec. 1305.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in the Act or part 1300 of this chapter.


Sec. 1305.03  Distributions requiring a Form 222 or a digitally signed 
          electronic order.

    Either a DEA Form 222 or its electronic equivalent as set forth in 
subpart C of this part and Part 1311 of this chapter is required for 
each distribution of a Schedule I or II controlled substance except for 
the following:
    (a) Distributions to persons exempted from registration under Part 
1301 of this chapter.
    (b) Exports from the United States that conform with the 
requirements of the Act.
    (c) Deliveries to a registered analytical laboratory or its agent 
approved by DEA.
    (d) Delivery from a central fill pharmacy, as defined in Sec. 
1300.01(b)(44) of this chapter, to a retail pharmacy.



Sec. 1305.04  Persons entitled to order Schedule I and II controlled 
          substances.

    (a) Only persons who are registered with DEA under section 303 of 
the Act (21 U.S.C. 823) to handle Schedule I or II controlled 
substances, and persons who are registered with DEA under section 1008 
of the Act (21 U.S.C. 958) to export these substances may obtain and use 
DEA Form 222 (order forms) or issue electronic orders for these 
substances. Persons not registered to handle Schedule I or II controlled 
substances and persons registered only to import controlled substances 
are not entitled to obtain Form 222 or issue electronic orders for these 
substances.
    (b) An order for Schedule I or II controlled substances may be 
executed only on behalf of the registrant named on the order and only if 
his or her registration for the substances being purchased has not 
expired or been revoked or suspended.



Sec. 1305.05  Power of attorney.

    (a) A registrant may authorize one or more individuals, whether or 
not located at his or her registered location, to issue orders for 
Schedule I and II controlled substances on the registrant's behalf by 
executing a power of attorney for each such individual, if the power of 
attorney is retained in the files, with executed Forms 222 where 
applicable, for the same period as any order bearing the signature of 
the attorney. The power of attorney must be available for inspection 
together with other order records.
    (b) A registrant may revoke any power of attorney at any time by 
executing a notice of revocation.
    (c) The power of attorney and notice of revocation must be similar 
to the following format:

        Power of Attorney for DEA Forms 222 and Electronic Orders

________________________________________________________________________
(Name of registrant)

________________________________________________________________________
(Address of registrant)

________________________________________________________________________
(DEA registration number)

    I, -------- (name of person granting power), the undersigned, who am 
authorized to sign the current application for registration of the 
above-named registrant under the Controlled Substances Act or Controlled 
Substances Import and Export Act, have made, constituted, and appointed, 
and by these presents, do make, constitute, and appoint -------- (name 
of attorney-in-fact), my true and lawful attorney for me in my name, 
place, and stead, to execute applications for Forms 222 and to sign 
orders for Schedule I and II controlled substances, whether these orders 
be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part 
1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and 
confirm all that said attorney must lawfully do or cause to be done by 
virtue hereof.
________________________________________________________________________
(Signature of person granting power)


I, -------- (name of attorney-in-fact), hereby affirm that I am the 
person named herein as attorney-in-fact and that the signature affixed 
hereto is my signature.

(signature of attorney-in-fact)


Witnesses:

    1. ------------

    2. ------------


Signed and dated on the -------- day of --------, (year), at -------- .

                          Notice of Revocation

    The foregoing power of attorney is hereby revoked by the 
undersigned, who is authorized to sign the current application for 
registration of the above-named registrant under the Controlled 
Substances Act or the Controlled Substances Import and Export Act. 
Written notice of this revocation has been given to the attorney-in-fact 
-------- this same day.
________________________________________________________________________
(Signature of person revoking power)

Witnesses:

    1. ------------

    2. ------------


[[Page 74]]


Signed and dated on the -------- day of -------- , (year), at -------- .

    (d) A power of attorney must be executed by the person who signed 
the most recent application for DEA registration or reregistration; the 
person to whom the power of attorney is being granted; and two 
witnesses.
    (e) A power of attorney must be revoked by the person who signed the 
most recent application for DEA registration or reregistration, and two 
witnesses.



Sec. 1305.06  Persons entitled to fill orders for Schedule I and II 
          controlled substances.

    An order for Schedule I and II controlled substances, whether on a 
DEA Form 222 or an electronic order, may be filled only by a person 
registered with DEA as a manufacturer or distributor of controlled 
substances listed in Schedule I or II pursuant to section 303 of the Act 
(21 U.S.C. 823) or as an importer of such substances pursuant to section 
1008 of the Act (21 U.S.C. 958), except for the following:
    (a) A person registered with DEA to dispense the substances, or to 
export the substances, if he/she is discontinuing business or if his/her 
registration is expiring without reregistration, may dispose of any 
Schedule I or II controlled substances in his/her possession with a DEA 
Form 222 or an electronic order in accordance with Sec. 1301.52 of this 
chapter.
    (b) A purchaser who has obtained any Schedule I or II controlled 
substance by either a DEA Form 222 or an electronic order may return the 
substance to the supplier of the substance with either a DEA Form 222 or 
an electronic order from the supplier.
    (c) A person registered to dispense Schedule II substances may 
distribute the substances to another dispenser with either a DEA Form 
222 or an electronic order only in the circumstances described in Sec. 
1307.11 of this chapter.
    (d) A person registered or authorized to conduct chemical analysis 
or research with controlled substances may distribute a Schedule I or II 
controlled substance to another person registered or authorized to 
conduct chemical analysis, instructional activities, or research with 
the substances with either a DEA Form 222 or an electronic order, if the 
distribution is for the purpose of furthering the chemical analysis, 
instructional activities, or research.
    (e) A person registered as a compounder of narcotic substances for 
use at off-site locations in conjunction with a narcotic treatment 
program at the compounding location, who is authorized to handle 
Schedule II narcotics, is authorized to fill either a DEA Form 222 or an 
electronic order for distribution of narcotic drugs to off-site narcotic 
treatment programs only.



Sec. 1305.07  Special procedure for filling certain orders.

    A supplier of carfentanil, etorphine hydrochloride, or 
diprenorphine, if he or she determines that the purchaser is a 
veterinarian engaged in zoo and exotic animal practice, wildlife 
management programs, or research, and is authorized by the Administrator 
to handle these substances, may fill the order in accordance with the 
procedures set forth in Sec. 1305.17 except that:
    (a) A DEA Form 222 or an electronic order for carfentanil, etorphine 
hydrochloride, and diprenorphine must contain only these substances in 
reasonable quantities.
    (b) The substances must be shipped, under secure conditions using 
substantial packaging material with no markings on the outside that 
would indicate the content, only to the purchaser's registered location.

                         Subpart B_DEA Form 222



Sec. 1305.11  Procedure for obtaining DEA Forms 222.

    (a) DEA Forms 222 are issued in mailing envelopes containing either 
seven or fourteen forms, each form containing an original, duplicate, 
and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, 
which is based on the business activity of the registrant, will be 
imposed on the number of DEA Forms 222, which will be furnished on any 
requisition unless additional forms are specifically requested and a 
reasonable need for such additional forms is shown.
    (b) Any person applying for a registration that would entitle him or 
her to obtain a DEA Form 222 may requisition the forms by so indicating 
on the application form; a DEA Form 222 will be supplied upon the 
registration of the applicant. Any person holding a registration 
entitling him or her to obtain a DEA Form 222 may requisition the forms 
for the first time by contacting any Division Office or the Registration 
Section of the Administration. Any person already holding a DEA Form 222 
may requisition additional forms on DEA Form 222a, which is mailed to a 
registrant approximately 30 days after each shipment of DEA Forms 222 to 
that registrant, or by contacting any Division Office or the 
Registration Section of the Administration. All requisition forms (DEA 
Form 222a) must be submitted to the DEA Registration Section.
    (c) Each requisition must show the name, address, and registration 
number of the registrant and the number of books of DEA Forms 222 
desired. Each requisition must be signed and dated by the same person 
who signed the most recent application for registration or for 
reregistration, or by any person authorized to obtain and execute DEA 
Forms 222 by a power of attorney under Sec. 1305.05.

[[Page 75]]

    (d) DEA Forms 222 will be serially numbered and issued with the 
name, address, and registration number of the registrant, the authorized 
activity, and schedules of the registrant. This information cannot be 
altered or changed by the registrant; any errors must be corrected by 
the Registration Section of the Administration by returning the forms 
with notification of the error.



Sec. 1305.12  Procedure for executing DEA Forms 222.

    (a) A purchaser must prepare and execute a DEA Form 222 
simultaneously in triplicate by means of interleaved carbon sheets that 
are part of the DEA Form 222. DEA Form 222 must be prepared by use of a 
typewriter, pen, or indelible pencil.
    (b) Only one item may be entered on each numbered line. An item must 
consist of one or more commercial or bulk containers of the same 
finished or bulk form and quantity of the same substance. The number of 
lines completed must be noted on that form at the bottom of the form, in 
the space provided. DEA Forms 222 for carfentanil, etorphine 
hydrochloride, and diprenorphine must contain only these substances.
    (c) The name and address of the supplier from whom the controlled 
substances are being ordered must be entered on the form. Only one 
supplier may be listed on any form.
    (d) Each DEA Form 222 must be signed and dated by a person 
authorized to sign an application for registration or a person granted 
power of attorney to sign a Form 222 under Sec. 1305.05. The name of 
the purchaser, if different from the individual signing the DEA Form 
222, must also be inserted in the signature space.
    (e) Unexecuted DEA Forms 222 may be kept and may be executed at a 
location other than the registered location printed on the form, 
provided that all unexecuted forms are delivered promptly to the 
registered location upon an inspection of the location by any officer 
authorized to make inspections, or to enforce, any Federal, State, or 
local law regarding controlled substances.



Sec. 1305.13  Procedure for filling DEA Forms 222.

    (a) A purchaser must submit Copy 1 and Copy 2 of the DEA Form 222 to 
the supplier and retain Copy 3 in the purchaser's files.
    (b) A supplier may fill the order, if possible and if the supplier 
desires to do so, and must record on Copies 1 and 2 the number of 
commercial or bulk containers furnished on each item and the date on 
which the containers are shipped to the purchaser. If an order cannot be 
filled in its entirety, it may be filled in part and the balance 
supplied by additional shipments within 60 days following the date of 
the DEA Form 222. No DEA Form 222 is valid more than 60 days after its 
execution by the purchaser, except as specified in paragraph (f) of this 
section.
    (c) The controlled substances must be shipped only to the purchaser 
and the location printed by the Administration on the DEA Form 222, 
except as specified in paragraph (f) of this section.
    (d) The supplier must retain Copy 1 of the DEA Form 222 for his or 
her files and forward Copy 2 to the Special Agent in Charge of the Drug 
Enforcement Administration in the area in which the supplier is located. 
Copy 2 must be forwarded at the close of the month during which the 
order is filled. If an order is filled by partial shipments, Copy 2 must 
be forwarded at the close of the month during which the final shipment 
is made or the 60-day validity period expires.
    (e) The purchaser must record on Copy 3 of the DEA Form 222 the 
number of commercial or bulk containers furnished on each item and the 
dates on which the containers are received by the purchaser.
    (f) DEA Forms 222 submitted by registered procurement officers of 
the Defense Supply Center of the Defense Logistics Agency for delivery 
to armed services establishments within the United States may be shipped 
to locations other than the location printed on the DEA Form 222, and in 
partial shipments at different times not to exceed six months from the 
date of the order, as designated by the procurement officer when 
submitting the order.



Sec. 1305.14  Procedure for endorsing DEA Forms 222.

    (a) A DEA Form 222, made out to any supplier who cannot fill all or 
a part of the order within the time limitation set forth in Sec. 
1305.13, may be endorsed to another supplier for filling. The 
endorsement must be made only by the supplier to whom the DEA Form 222 
was first made, must state (in the spaces provided on the reverse sides 
of Copies 1 and 2 of the DEA Form 222) the name and address of the 
second supplier, and must be signed by a person authorized to obtain and 
execute DEA Forms 222 on behalf of the first supplier. The first 
supplier may not fill any part of an order on an endorsed form. The 
second supplier may fill the order, if possible and if the supplier 
desires to do so, in accordance with Sec. 1305.13(b), (c), and (d), 
including shipping all substances directly to the purchaser.
    (b) Distributions made on endorsed DEA Forms 222 must be reported by 
the second supplier in the same manner as all other distributions except 
that where the name of the supplier is requested on the reporting form, 
the second supplier must record the name, address, and registration 
number of the first supplier.

[[Page 76]]



Sec. 1305.15  Unaccepted and defective DEA Forms 222.

    (a) A DEA Form 222 must not be filled if either of the following 
apply:
    (1) The order is not complete, legible, or properly prepared, 
executed, or endorsed.
    (2) The order shows any alteration, erasure, or change of any 
description.
    (b) If a DEA Form 222 cannot be filled for any reason under this 
section, the supplier must return Copies 1 and 2 to the purchaser with a 
statement as to the reason (e.g., illegible or altered).
    (c) A supplier may for any reason refuse to accept any order and if 
a supplier refuses to accept the order, a statement that the order is 
not accepted is sufficient for purposes of this paragraph.
    (d) When a purchaser receives an unaccepted order, Copies 1 and 2 of 
the DEA Form 222 and the statement must be attached to Copy 3 and 
retained in the files of the purchaser in accordance with Sec. 1305.17. 
A defective DEA Form 222 may not be corrected; it must be replaced by a 
new DEA Form 222 for the order to be filled.



Sec. 1305.16  Lost and stolen DEA Forms 222.

    (a) If a purchaser ascertains that an unfilled DEA Form 222 has been 
lost, he or she must execute another in triplicate and attach a 
statement containing the serial number and date of the lost form, and 
stating that the goods covered by the first DEA Form 222 were not 
received through loss of that DEA Form 222. Copy 3 of the second form 
and a copy of the statement must be retained with Copy 3 of the DEA Form 
222 first executed. A copy of the statement must be attached to Copies 1 
and 2 of the second DEA Form 222 sent to the supplier. If the first DEA 
Form 222 is subsequently received by the supplier to whom it was 
directed, the supplier must mark upon the face ``Not accepted'' and 
return Copies 1 and 2 to the purchaser, who must attach it to Copy 3 and 
the statement.
    (b) Whenever any used or unused DEA Forms 222 are stolen or lost 
(other than in the course of transmission) by any purchaser or supplier, 
the purchaser or supplier must immediately upon discovery of the theft 
or loss, report the theft or loss to the Special Agent in Charge of the 
Drug Enforcement Administration in the Divisional Office responsible for 
the area in which the registrant is located, stating the serial number 
of each form stolen or lost.
    (c) If the theft or loss includes any original DEA Forms 222 
received from purchasers and the supplier is unable to state the serial 
numbers of the DEA Forms 222, the supplier must report the date or 
approximate date of receipt and the names and addresses of the 
purchasers.
    (d) If an entire book of DEA Forms 222 is lost or stolen, and the 
purchaser is unable to state the serial numbers of the DEA Forms 222 in 
the book, the purchaser must report, in lieu of the numbers of the forms 
contained in the book, the date or approximate date of issuance.
    (e) If any unused DEA Form 222 reported stolen or lost is 
subsequently recovered or found, the Special Agent in Charge of the Drug 
Enforcement Administration in the Divisional Office responsible for the 
area in which the registrant is located must immediately be notified.



Sec. 1305.17  Preservation of DEA Forms 222.

    (a) The purchaser must retain Copy 3 of each executed DEA Form 222 
and all copies of unaccepted or defective forms with each statement 
attached.
    (b) The supplier must retain Copy 1 of each DEA Form 222 that it has 
filled.
    (c) DEA Forms 222 must be maintained separately from all other 
records of the registrant. DEA Forms 222 are required to be kept 
available for inspection for a period of two years. If a purchaser has 
several registered locations, the purchaser must retain Copy 3 of the 
executed DEA Form 222 and any attached statements or other related 
documents (not including unexecuted DEA Forms 222, which may be kept 
elsewhere under Sec. 1305.12(e)), at the registered location printed on 
the DEA Form 222.
    (d) The supplier of carfentanil, etorphine hydrochloride, and 
diprenorphine must maintain DEA Forms 222 for these substances 
separately from all other DEA Forms 222 and records required to be 
maintained by the registrant.



Sec. 1305.18  Return of unused DEA Forms 222.

    If the registration of any purchaser terminates (because the 
purchaser dies, ceases legal existence, discontinues business or 
professional practice, or changes the name or address as shown on the 
purchaser's registration) or is suspended or revoked under Sec. 1301.36 
of this chapter for all Schedule I and II controlled substances for 
which the purchaser is registered, the purchaser must return all unused 
DEA Forms 222 to the nearest office of the Administration.



Sec. 1305.19  Cancellation and voiding of DEA Forms 222.

    (a) A purchaser may cancel part or all of an order on a DEA Form 222 
by notifying the supplier in writing of the cancellation. The supplier 
must indicate the cancellation on Copies 1 and 2 of the DEA Form 222 by 
drawing a line through the canceled items and printing ``canceled'' in 
the space provided for number of items shipped.
    (b) A supplier may void part or all of an order on a DEA Form 222 by 
notifying the

[[Page 77]]

purchaser in writing of the voiding. The supplier must indicate the 
voiding in the manner prescribed for cancellation in paragraph (a) of 
this section.

                       Subpart C_Electronic Orders



Sec. 1305.21  Requirements for electronic orders.

    (a) To be valid, the purchaser must sign an electronic order for a 
Schedule I or II controlled substance with a digital signature issued to 
the purchaser, or the purchaser's agent, by DEA as provided in part 1311 
of this chapter.
    (b) The following data fields must be included on an electronic 
order for Schedule I and II controlled substances:
    (1) A unique number the purchaser assigns to track the order. The 
number must be in the following 9-character format: the last two digits 
of the year, X, and six characters as selected by the purchaser.
    (2) The purchaser's DEA registration number.
    (3) The name of the supplier.
    (4) The complete address of the supplier (may be completed by either 
the purchaser or the supplier).
    (5) The supplier's DEA registration number (may be completed by 
either the purchaser or the supplier).
    (6) The date the order is signed.
    (7) The name (including strength where appropriate) of the 
controlled substance product or the National Drug Code (NDC) number (the 
NDC number may be completed by either the purchaser or the supplier).
    (8) The quantity in a single package or container.
    (9) The number of packages or containers of each item ordered.
    (c) An electronic order may include controlled substances that are 
not in schedules I and II and non-controlled substances.



Sec. 1305.22  Procedure for filling electronic orders.

    (a) A purchaser must submit the order to a specific supplier. The 
supplier may initially process the order (e.g., entry of the order into 
the computer system, billing functions, inventory identification, etc.) 
centrally at any location, regardless of the location's registration 
with DEA. Following centralized processing, the supplier may distribute 
the order to one or more registered locations maintained by the supplier 
for filling. The registrant must maintain control of the processing of 
the order at all times.
    (b) A supplier may fill the order for a Schedule I or II controlled 
substance, if possible and if the supplier desires to do so and is 
authorized to do so under Sec. 1305.06.
    (c) A supplier must do the following before filling the order:
    (1) Verify the integrity of the signature and the order by using 
software that complies with Part 1311 of this chapter to validate the 
order.
    (2) Verify that the digital certificate has not expired.
    (3) Check the validity of the certificate holder's certificate by 
checking the Certificate Revocation List. The supplier may cache the 
Certificate Revocation List until it expires.
    (4) Verify the registrant's eligibility to order the controlled 
substances by checking the certificate extension data.
    (d) The supplier must retain an electronic record of every order, 
and, linked to each order, a record of the number of commercial or bulk 
containers furnished on each item and the date on which the supplier 
shipped the containers to the purchaser. The linked record must also 
include any data on the original order that the supplier completes. 
Software used to handle digitally signed orders must comply with part 
1311 of this chapter.
    (e) If an order cannot be filled in its entirety, a supplier may 
fill it in part and supply the balance by additional shipments within 60 
days following the date of the order. No order is valid more than 60 
days after its execution by the purchaser, except as specified in 
paragraph (h) of this section.
    (f) A supplier must ship the controlled substances to the registered 
location associated with the digital certificate used to sign the order, 
except as specified in paragraph (h) of this section.
    (g) When a purchaser receives a shipment, the purchaser must create 
a record of the quantity of each item received and the date received. 
The record must be electronically linked to the original order and 
archived.
    (h) Registered procurement officers of the Defense Supply Center of 
the Defense Logistics Agency may order controlled substances for 
delivery to armed services establishments within the United States. 
These orders may be shipped to locations other than the registered 
location, and in partial shipments at different times not to exceed six 
months from the date of the order, as designated by the procurement 
officer when submitting the order.



Sec. 1305.23  Endorsing electronic orders.

    A supplier may not endorse an electronic order to another supplier 
to fill.

Sec. 1305.24  Central processing of orders.

    (a) A supplier that has one or more registered locations and 
maintains a central processing computer system in which orders are 
stored may have one or more of the supplier's registered locations fill 
an electronic order if the supplier does the following:
    (1) Assigns each item on the order to a specific registered location 
for filling.

[[Page 78]]

    (2) Creates a record linked to the central file noting both which 
items a location filled and the location identity.
    (3) Ensures that no item is filled by more than one location.
    (4) Maintains the original order with all linked records on the 
central computer system.
    (b) A company that has central processing of orders must assign 
responsibility for filling parts of orders only to registered locations 
that the company owns and operates.



Sec. 1305.25  Unaccepted and defective electronic orders.

    (a) No electronic order may be filled if:
    (1) The required data fields have not been completed.
    (2) The order is not signed using a digital certificate issued by 
DEA.
    (3) The digital certificate used had expired or had been revoked 
prior to signature.
    (4) The purchaser's public key will not validate the digital 
signature.
    (5) The validation of the order shows that the order is invalid for 
any reason.
    (b) If an order cannot be filled for any reason under this section, 
the supplier must notify the purchaser and provide a statement as to the 
reason (e.g., improperly prepared or altered). A supplier may, for any 
reason, refuse to accept any order, and if a supplier refuses to accept 
the order, a statement that the order is not accepted is sufficient for 
purposes of this paragraph.
    (c) When a purchaser receives an unaccepted electronic order from 
the supplier, the purchaser must electronically link the statement of 
nonacceptance to the original order. The original order and the 
statement must be retained in accordance with Sec. 1305.27.
    (d) Neither a purchaser nor a supplier may correct a defective 
order; the purchaser must issue a new order for the order to be filled.



Sec. 1305.26  Lost electronic orders.

    (a) If a purchaser determines that an unfilled electronic order has 
been lost before or after receipt, the purchaser must provide, to the 
supplier, a signed statement containing the unique tracking number and 
date of the lost order and stating that the goods covered by the first 
order were not received through loss of that order.
    (b) If the purchaser executes an order to replace the lost order, 
the purchaser must electronically link an electronic record of the 
second order and a copy of the statement with the record of the first 
order and retain them.
    (c) If the supplier to whom the order was directed subsequently 
receives the first order, the supplier must indicate that it is ``Not 
Accepted'' and return it to the purchaser. The purchaser must link the 
returned order to the record of that order and the statement.



Sec. 1305.27  Preservation of electronic orders.

    (a) A purchaser must, for each order filled, retain the original 
signed order and all linked records for that order for two years. The 
purchaser must also retain all copies of each unaccepted or defective 
order and each linked statement.
    (b) A supplier must retain each original order filled and the linked 
records for two years.
    (c) If electronic order records are maintained on a central server, 
the records must be readily retrievable at the registered location.

Sec. 1305.28  Canceling and voiding electronic orders.

    (a) A supplier may void all or part of an electronic order by 
notifying the purchaser of the voiding. If the entire order is voided, 
the supplier must make an electronic copy of the order, indicate on the 
copy ``Void,'' and return it to the purchaser. The supplier is not 
required to retain a record of orders that are not filled.
    (b) The purchaser must retain an electronic copy of the voided 
order.
    (c) To partially void an order, the supplier must indicate in the 
linked record that nothing was shipped for each item voided.



Sec. 1305.29  Reporting to DEA.

    A supplier must, for each electronic order filled, forward either a 
copy of the electronic order or an electronic report of the order in a 
format that DEA specifies to DEA within two business days.



PART 1306_PRESCRIPTIONS--Table of Contents

                           General Information

Sec.
1306.01 Scope of part 1306.
1306.02 Definitions.
1306.03 Persons entitled to issue prescriptions.
1306.04 Purpose of issue of prescription.
1306.05 Manner of issuance of prescriptions.
1306.06 Persons entitled to fill prescriptions.
1306.07 Administering or dispensing of narcotic drugs.

               Controlled Substances Listed in Schedule II

1306.11 Requirement of prescription.
1306.12 Refilling prescriptions.
1306.13 Partial filling of prescriptions.
1306.14 Labeling of substances and filling of prescriptions.
1306.15 Provision of prescription information between retail pharmacies 
          and central fill pharmacies for prescriptions of Schedule II 
          controlled substances.

[[Page 79]]

        Controlled Substances Listed in Schedules III, IV, and V

1306.21 Requirement of prescription.
1306.22 Refilling of prescriptions.
1306.23 Partial filling of prescriptions.
1306.24 Labeling of substances and filling of prescriptions.
1306.25 Transfer between pharmacies of presription information for 
          Schedules III, IV, and V controlled substances for refill 
          purposes.
1306.26 Dispensing without prescription.
1306.27 Provision of prescription information between retail pharmacies 
          and central fill pharmacies for initial and refill 
          prescriptions of Schedule III, IV, or V controlled substances.

    Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.

    Source: 36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971, 
unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information



Sec. 1306.01  Scope of part 1306.

    Rules governing the issuance, filling and filing of prescriptions 
pursuant to section 309 of the Act (21 U.S.C. 829) are set forth 
generally in that section and specifically by the sections of this part.



Sec. 1306.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13964, Mar. 24, 1997]



Sec. 1306.03  Persons entitled to issue prescriptions.

    (a) A prescription for a controlled substance may be issued only by 
an individual practitioner who is:
    (1) Authorized to prescribe controlled substances by the 
jurisdiction in which he is licensed to practice his profession and
    (2) Either registered or exempted from registration pursuant to 
Sec. Sec. 1301.22(c) and 1301.23 of this chapter.
    (b) A prescription issued by an individual practitioner may be 
communicated to a pharmacist by an employee or agent of the individual 
practitioner.

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966, 
Mar. 24, 1997]



Sec. 1306.04  Purpose of issue of prescription.

    (a) A prescription for a controlled substance to be effective must 
be issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of his professional practice. The 
responsibility for the proper prescribing and dispensing of controlled 
substances is upon the prescribing practitioner, but a corresponding 
responsibility rests with the pharmacist who fills the prescription. An 
order purporting to be a prescription issued not in the usual course of 
professional treatment or in legitimate and authorized research is not a 
prescription within the meaning and intent of section 309 of the Act (21 
U.S.C. 829) and the person knowingly filling such a purported 
prescription, as well as the person issuing it, shall be subject to the 
penalties provided for violations of the provisions of law relating to 
controlled substances.
    (b) A prescription may not be issued in order for an individual 
practitioner to obtain controlled substances for supplying the 
individual practitioner for the purpose of general dispensing to 
patients.
    (c) A prescription may not be issued for the dispensing of narcotic 
drugs listed in any schedule for ``detoxification treatment'' or 
``maintenance treatment'' as defined in Section 102 of the Act (21 
U.S.C. 802).

[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 39 FR 37986, Oct. 25, 1974]



Sec. 1306.05  Manner of issuance of prescriptions.

    (a) All prescriptions for controlled substances shall be dated as 
of, and signed on, the day when issued and shall bear the full name and 
address of the patient, the drug name, strength, dosage form, quantity 
prescribed, directions for use and the name, address and registration 
number of the practitioner. Where a prescription is for gamma-
hydroxybutyric acid, the practitioner shall note on the face of the 
prescription the medical need of the patient for the prescription. A 
practitioner may sign a prescription in the same manner as he would sign 
a check or legal document (e.g., J.H. Smith or

[[Page 80]]

John H. Smith). Where an oral order is not permitted, prescriptions 
shall be written with ink or indelible pencil or typewriter and shall be 
manually signed by the practitioner. The prescriptions may be prepared 
by the secretary or agent for the signature of a practitioner, but the 
prescribing practitioner is responsible in case the prescription does 
not conform in all essential respects to the law and regulations. A 
corresponding liability rests upon the pharmacist, including a 
pharmacist employed by a central fill pharmacy, who fills a prescription 
not prepared in the form prescribed by DEA regulations.
    (b) An individual practitioner exempted from registration under 
Sec. 1301.22(c) of this chapter shall include on all prescriptions 
issued by him or her the registration number of the hospital or other 
institution and the special internal code number assigned to him or her 
by the hospital or other institution as provided in Sec. 1301.22(c) of 
this chapter, in lieu of the registration number of the practitioner 
required by this section. Each written prescription shall have the name 
of the physician stamped, typed, or handprinted on it, as well as the 
signature of the physician.
    (c) An official exempted from registration under Sec. 1301.22(c) 
shall include on all prescriptions issued by him his branch of service 
or agency (e.g., ``U.S. Army'' or ``Public Health Service'') and his 
service identification number, in lieu of the registration number of the 
practitioner required by this section. The service identification number 
for a Public Health Service employee is his Social Security 
identification number. Each prescription shall have the name of the 
officer stamped, typed, or handprinted on it, as well as the signature 
of the officer.

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 56 FR 25026, 
June 3, 1991; 60 FR 36641, July 18, 1995; 62 FR 13966, Mar. 24, 1997; 68 
FR 37410, June 24, 2003; 70 FR 294, Jan. 4, 2005]



Sec. 1306.06  Persons entitled to fill prescriptions.

    A prescription for a controlled substance may only be filled by a 
pharmacist, acting in the usual course of his professional practice and 
either registered individually or employed in a registered pharmacy, a 
registered central fill pharmacy, or registered institutional 
practitioner.

[68 FR 37410, June 24, 2003]



Sec. 1306.07  Administering or dispensing of narcotic drugs.

    (a) The administering or dispensing directly (but not prescribing) 
of narcotic drugs listed in any schedule to a narcotic drug dependent 
person for ``detoxification treatment'' or ``maintenance treatment'' as 
defined in section 102 of the Act (21 U.S.C. 802) shall be deemed to be 
within the meaning of the term ``in the course of his professional 
practice or research'' in section 308(e) and section 102(20) of the Act 
(21 U.S.C. 828 (e)): Provided, That the practitioner is separately 
registered with the Attorney General as required by section 303(g) of 
the Act (21 U.S.C. 823(g)) and then thereafter complies with the 
regulatory standards imposed relative to treatment qualification, 
security, records and unsupervised use of drugs pursuant to such Act.
    (b) Nothing in this section shall prohibit a physician who is not 
specifically registered to conduct a narcotic treatment program from 
administering (but not prescribing) narcotic drugs to a person for the 
purpose of relieving acute withdrawal symptoms when necessary while 
arrangements are being made for referral for treatment. Not more than 
one day's medication may be administered to the person or for the 
person's use at one time. Such emergency treatment may be carried out 
for not more than three days and may not be renewed or extended.
    (c) This section is not intended to impose any limitations on a 
physician or authorized hospital staff to administer or dispense 
narcotic drugs in a hospital to maintain or detoxify a person as an 
incidental adjunct to medical or surgical treatment of conditions other 
than addiction, or to administer or dispense narcotic drugs to persons 
with intractable pain in which no relief or cure is possible or none has 
been found after reasonable efforts.

[39 FR 37986, Oct. 25, 1974]

[[Page 81]]

               Controlled Substances Listed in Schedule II



Sec. 1306.11  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule II, which is a prescription drug as determined under the 
Federal Food, Drug, and Cosmetic Act, only pursuant to a written 
prescription signed by the practitioner, except as provided in paragraph 
(d) of this section. A prescription for a Schedule II controlled 
substance may be transmitted by the practitioner or the practitioner's 
agent to a pharmacy via facsimile equipment, provided that the original 
written, signed prescription is presented to the pharmacist for review 
prior to the actual dispensing of the controlled substance, except as 
noted in paragraph (e), (f), or (g) of this section. The original 
prescription shall be maintained in accordance with Sec. 1304.04(h) of 
this chapter.
    (b) An individual practitioner may administer or dispense directly a 
controlled substance listed in Schedule II in the course of his 
professional practice without a prescription, subject to Sec. 1306.07.
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
II only pursuant to a written prescription signed by the prescribing 
individual practitioner or to an order for medication made by an 
individual practitioner which is dispensed for immediate administration 
to the ultimate user.
    (d) In the case of an emergency situation, as defined by the 
Secretary in Sec. 290.10 of this title, a pharmacist may dispense a 
controlled substance listed in Schedule II upon receiving oral 
authorization of a prescribing individual practitioner, provided that:
    (1) The quantity prescribed and dispensed is limited to the amount 
adequate to treat the patient during the emergency period (dispensing 
beyond the emergency period must be pursuant to a written prescription 
signed by the prescribing individual practitioner);
    (2) The prescription shall be immediately reduced to writing by the 
pharmacist and shall contain all information required in Sec. 1306.05, 
except for the signature of the prescribing individual practitioner;
    (3) If the prescribing individual practitioner is not known to the 
pharmacist, he must make a reasonable effort to determine that the oral 
authorization came from a registered individual practitioner, which may 
include a callback to the prescribing individual practitioner using his 
phone number as listed in the telephone directory and/or other good 
faith efforts to insure his identity; and
    (4) Within 7 days after authorizing an emergency oral prescription, 
the prescribing individual practitioner shall cause a written 
prescription for the emergency quantity prescribed to be delivered to 
the dispensing pharmacist. In addition to conforming to the requirements 
of Sec. 1306.05, the prescription shall have written on its face 
``Authorization for Emergency Dispensing,'' and the date of the oral 
order. The written prescription may be delivered to the pharmacist in 
person or by mail, but if delivered by mail it must be postmarked within 
the 7 day period. Upon receipt, the dispensing pharmacist shall attach 
this prescription to the oral emergency prescription which had earlier 
been reduced to writing. The pharmacist shall notify the nearest office 
of the Administration if the prescribing individual practitioner fails 
to deliver a written prescription to him; failure of the pharmacist to 
do so shall void the authority conferred by this paragraph to dispense 
without a written prescription of a prescribing individual practitioner.
    (5) Central fill pharmacies shall not be authorized under this 
paragraph to prepare prescriptions for a controlled substance listed in 
Schedule II upon receiving an oral authorization from a retail 
pharmacist or an individual practitioner.
    (e) A prescription prepared in accordance with Sec. 1306.05 written 
for a Schedule II narcotic substance to be compounded for the direct 
administration to a patient by parenteral, intravenous, intramuscular, 
subcutaneous or intraspinal infusion may be transmitted by the 
practitioner or the practitioner's agent to the pharmacy by facsimile. 
The facsimile serves as the

[[Page 82]]

original written prescription for purposes of this paragraph (e) and it 
shall be maintained in accordance with Sec. 1304.04(h) of this chapter.
    (f) A prescription prepared in accordance with Sec. 1306.05 written 
for Schedule II substance for a resident of a Long Term Care Facility 
may be transmitted by the practitioner or the practitioner's agent to 
the dispensing pharmacy by facsimile. The facsimile serves as the 
original written prescription for purposes of this paragraph (f) and it 
shall be maintained in accordance with Sec. 1304.04(h).
    (g) A prescription prepared in accordance with Sec. 1306.05 written 
for a Schedule II narcotic substance for a patient enrolled in a hospice 
care program certified and/or paid for by Medicare under Title XVIII or 
a hospice program which is licensed by the state may be transmitted by 
the practitioner or the practitioner's agent to the dispensing pharmacy 
by facsimile. The practitioner or the practitioner's agent will note on 
the prescription that the patient is a hospice patient. The facsimile 
serves as the original written prescription for purposes of this 
paragraph (g) and it shall be maintained in accordance with Sec. 
1304.04(h).

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 53 FR 4964, 
Feb. 19, 1988; 59 FR 26111, May 19, 1994; 59 FR 30832, June 15, 1994; 62 
FR 13964, Mar. 24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410, June 
24, 2003]



Sec. 1306.12  Refilling prescriptions.

    The refilling of a prescription for a controlled substance listed in 
Schedule II is prohibited.



Sec. 1306.13  Partial filling of prescriptions.

    (a) The partial filling of a prescription for a controlled substance 
listed in Schedule II is permissible, if the pharmacist is unable to 
supply the full quantity called for in a written or emergency oral 
prescription and he makes a notation of the quantity supplied on the 
face of the written prescription (or written record of the emergency 
oral prescription). The remaining portion of the prescription may be 
filled within 72 hours of the first partial filling; however, if the 
remaining portion is not or cannot be filled within the 72-hour period, 
the pharmacist shall so notify the prescribing individual practitioner. 
No further quantity may be supplied beyond 72 hours without a new 
prescription.
    (b) A prescription for a Schedule II controlled substance written 
for a patient in a Long Term Care Facility (LTCF) or for a patient with 
a medical diagnosis documenting a terminal illness may be filled in 
partial quantities to include individual dosage units. If there is any 
question whether a patient may be classified as having a terminal 
illness, the pharmacist must contact the practitioner prior to partially 
filling the prescription. Both the pharmacist and the prescribing 
practitioner have a corresponding responsibility to assure that the 
controlled substance is for a terminally ill patient. The pharmacist 
must record on the prescription whether the patient is ``terminally 
ill'' or an ``LTCF patient.'' A prescription that is partially filled 
and does not contain the notation ``terminally ill'' or ``LTCF patient'' 
shall be deemed to have been filled in violation of the Act. For each 
partial filling, the dispensing pharmacist shall record on the back of 
the prescription (or on another appropriate record, uniformly 
maintained, and readily retrievable) the date of the partial filling, 
quantity dispensed, remaining quantity authorized to be dispensed, and 
the identification of the dispensing pharmacist. The total quantity of 
Schedule II controlled substances dispensed in all partial fillings must 
not exceed the total quantity prescribed. Schedule II prescriptions for 
patients in a LTCF or patients with a medical diagnosis documenting a 
terminal illness shall be valid for a period not to exceed 60 days from 
the issue date unless sooner terminated by the discontinuance of 
medication.
    (c) Information pertaining to current Schedule II prescriptions for 
patients in a LTCF or for patients with a medical diagnosis documenting 
a terminal illness may be maintained in a computerized system if this 
system has the capability to permit:
    (1) Output (display or printout) of the original prescription 
number, date of

[[Page 83]]

issue, identification of prescribing individual practitioner, 
identification of patient, address of the LTCF or address of the 
hospital or residence of the patient, identification of medication 
authorized (to include dosage, form, strength and quantity), listing of 
the partial fillings that have been dispensed under each prescription 
and the information required in Sec. 1306.13(b).
    (2) Immediate (real time) updating of the prescription record each 
time a partial filling of the prescription is conducted.
    (3) Retrieval of partially filled Schedule II prescription 
information is the same as required by Sec. 1306.22(b) (4) and (5) for 
Schedule III and IV prescription refill information.

(Authority: 21 U.S.C. 801, et seq.)

[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 54330, July 15, 1980; 56 FR 25027, June 3, 1991; 62 
FR 13965, Mar. 24, 1997]



Sec. 1306.14  Labeling of substances and filling of prescriptions.

    (a) The pharmacist filling a written or emergency oral prescription 
for a controlled substance listed in Schedule II shall affix to the 
package a label showing date of filling, the pharmacy name and address, 
the serial number of the prescription, the name of the patient, the name 
of the prescribing practitioner, and directions for use and cautionary 
statements, if any, contained in such prescription or required by law.
    (b) If the prescription is filled at a central fill pharmacy, the 
central fill pharmacy shall affix to the package a label showing the 
retail pharmacy name and address and a unique identifier, (i.e. the 
central fill pharmacy's DEA registration number) indicating that the 
prescription was filled at the central fill pharmacy, in addition to the 
information required under paragraph (a) of this section.
    (c) The requirements of paragraph (a) of this section do not apply 
when a controlled substance listed in Schedule II is prescribed for 
administration to an ultimate user who is institutionalized: Provided, 
That:
    (1) Not more than 7-day supply of the controlled substance listed in 
Schedule II is dispensed at one time;
    (2) The controlled substance listed in Schedule II is not in the 
possession of the ultimate user prior to the administration;
    (3) The institution maintains appropriate safeguards and records 
regarding the proper administration, control, dispensing, and storage of 
the controlled substance listed in Schedule II; and
    (4) The system employed by the pharmacist in filling a prescription 
is adequate to identify the supplier, the product, and the patient, and 
to set forth the directions for use and cautionary statements, if any, 
contained in the prescription or required by law.
    (d) All written prescriptions and written records of emergency oral 
prescriptions shall be kept in accordance with requirements of Sec. 
1304.04(h) of this chapter.

[36 FR 13368, July 21, 1971, as amended at 37 FR 15921, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13965, 
Mar. 24, 1997; 68 FR 37410, June 24, 2003]



Sec. 1306.15  Provision of prescription information between retail 

pharmacies and central fill pharmacies for prescriptions of Schedule 
II controlled 
          substances.

    Prescription information may be provided to an authorized central 
fill pharmacy by a retail pharmacy for dispensing purposes. The 
following requirements shall also apply:
    (a) Prescriptions for controlled substances listed in Schedule II 
may be transmitted electronically from a retail pharmacy to a central 
fill pharmacy including via facsimile. The retail pharmacy transmitting 
the prescription information must:
    (1) Write the word ``CENTRAL FILL'' on the face of the original 
prescription and record the name, address, and DEA registration number 
of the central fill pharmacy to which the prescription has been 
transmitted and, the name of the retail pharmacy pharmacist transmitting 
the prescription, and the date of transmittal;
    (2) Ensure that all information required to be on a prescription 
pursuant to Section 1306.05 of this part is transmitted to the central 
fill pharmacy (either on the face of the prescription or in the 
electronic transmission of information);

[[Page 84]]

    (3) Maintain the original prescription for a period of two years 
from the date the prescription was filled;
    (4) Keep a record of receipt of the filled prescription, including 
the date of receipt, the method of delivery (private, common or contract 
carrier) and the name of the retail pharmacy employee accepting 
delivery.
    (b) The central fill pharmacy receiving the transmitted prescription 
must:
    (1) Keep a copy of the prescription (if sent via facsimile) or an 
electronic record of all the information transmitted by the retail 
pharmacy, including the name, address, and DEA registration number of 
the retail pharmacy transmitting the prescription;
    (2) Keep a record of the date of receipt of the transmitted 
prescription, the name of the pharmacist filling the prescription, and 
the date of filling of the prescription;
    (3) Keep a record of the date the filled prescription was delivered 
to the retail pharmacy and the method of delivery (i.e. private, common 
or contract carrier).

[68 FR 37410, June 24, 2003]

        Controlled Substances Listed in Schedules III, IV, and V



Sec. 1306.21  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule III, IV, or V which is a prescription drug as determined 
under the Federal Food, Drug, and Cosmetic Act, only pursuant to either 
a written prescription signed by a practitioner or a facsimile of a 
written, signed prescription transmitted by the practitioner or the 
practitioner's agent to the pharmacy or pursuant to an oral prescription 
made by an individual practitioner and promptly reduced to writing by 
the pharmacist containing all information required in Sec. 1306.05, 
except for the signature of the practitioner.
    (b) An individual practitioner may administer or dispense directly a 
controlled substance listed in Schedule III, IV, or V in the course of 
his/her professional practice without a prescription, subject to Sec. 
1306.07.
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
III, IV, or V only pursuant to a written prescription signed by an 
individual practitioner, or pursuant to a facsimile of a written 
prescription or order for medication transmitted by the practitioner or 
the practitioner's agent to the institutional practitioner-pharmacist, 
or pursuant to an oral prescription made by an individual practitioner 
and promptly reduced to writing by the pharmacist (containing all 
information required in Section 1306.05 except for the signature of the 
individual practitioner), or pursuant to an order for medication made by 
an individual practitioner which is dispensed for immediate 
administration to the ultimate user, subject to Sec. 1306.07.

[62 FR 13965, Mar. 24, 1997]



Sec. 1306.22  Refilling of prescriptions.

    (a) No prescription for a controlled substance listed in Schedule 
III or IV shall be filled or refilled more than six months after the 
date on which such prescription was issued and no such prescription 
authorized to be refilled may be refilled more than five times. Each 
refilling of a prescription shall be entered on the back of the 
prescription or on another appropriate document. If entered on another 
document, such as a medication record, the document must be uniformly 
maintained and readily retrievable. The following information must be 
retrievable by the prescription number consisting of the name and dosage 
form of the controlled substance, the date filled or refilled, the 
quantity dispensed, initials of the dispensing pharmacist for each 
refill, and the total number of refills for that prescription. If the 
pharmacist merely initials and dates the back of the prescription it 
shall be deemed that the full face amount of the prescription has been 
dispensed. The prescribing practitioner may authorize additional refills 
of Schedule III or IV controlled substances on the original prescription 
through an oral refill authorization transmitted to the pharmacist 
provided the following conditions are met:
    (1) The total quantity authorized, including the amount of the 
original prescription, does not exceed five refills nor extend beyond 
six months from the

[[Page 85]]

date of issue of the original prescription.
    (2) The pharmacist obtaining the oral authorization records on the 
reverse of the original prescription the date, quantity of refill, 
number of additional refills authorized, and initials the prescription 
showing who received the authorization from the prescribing practitioner 
who issued the original prescription.
    (3) The quantity of each additional refill authorized is equal to or 
less than the quantity authorized for the initial filling of the 
original prescription.
    (4) The prescribing practitioner must execute a new and separate 
prescription for any additional quantities beyond the five refill, six-
month limitation.
    (b) As an alternative to the procedures provided by subsection (a), 
an automated data processing system may be used for the storage and 
retrieval of refill information for prescription orders for controlled 
substances in Schedule III and IV, subject to the following conditions:
    (1) Any such proposed computerized system must provide on-line 
retrieval (via CRT display or hard-copy printout) of original 
prescription order information for those prescription orders which are 
currently authorized for refilling. This shall include, but is not 
limited to, data such as the original prescription number, date of 
issuance of the original prescription order by the practitioner, full 
name and address of the patient, name, address, and DEA registration 
number of the practitioner, and the name, strength, dosage form, 
quantity of the controlled substance prescribed (and quantity dispensed 
if different from the quantity prescribed), and the total number of 
refills authorized by the prescribing practitioner.
    (2) Any such proposed computerized system must also provide on-line 
retrieval (via CRT display or hard-copy printout) of the current refill 
history for Schedule III or IV controlled substance prescription orders 
(those authorized for refill during the past six months.) This refill 
history shall include, but is not limited to, the name of the controlled 
substance, the date of refill, the quantity dispensed, the 
identification code, or name or initials of the dispensing pharmacist 
for each refill and the total number of refills dispensed to date for 
that prescription order.
    (3) Documentation of the fact that the refill information entered 
into the computer each time a pharmacist refills an original 
prescription order for a Schedule III or IV controlled substance is 
correct must be provided by the individual pharmacist who makes use of 
such a system. If such a system provides a hard-copy printout of each 
day's controlled substance prescription order refill data, that printout 
shall be verified, dated, and signed by the individual pharmacist who 
refilled such a prescription order. The individual pharmacist must 
verify that the data indicated is correct and then sign this document in 
the same manner as he would sign a check or legal document (e.g., J. H. 
Smith, or John H. Smith). This document shall be maintained in a 
separate file at that pharmacy for a period of two years from the 
dispensing date. This printout of the day's controlled substance 
prescription order refill data must be provided to each pharmacy using 
such a computerized system within 72 hours of the date on which the 
refill was dispensed. It must be verified and signed by each pharmacist 
who is involved with such dispensing. In lieu of such a printout, the 
pharmacy shall maintain a bound log book, or separate file, in which 
each individual pharmacist involved in such dispensing shall sign a 
statement (in the manner previously described) each day, attesting to 
the fact that the refill information entered into the computer that day 
has been reviewed by him and is correct as shown. Such a book or file 
must be maintained at the pharmacy employing such a system for a period 
of two years after the date of dispensing the appropriately authorized 
refill.
    (4) Any such computerized system shall have the capability of 
producing a printout of any refill data which the user pharmacy is 
responsible for maintaining under the Act and its implementing 
regulations. For example, this would include a refill-by-refill audit 
trail for any specified strength and dosage form of any controlled 
substance

[[Page 86]]

(by either brand or generic name or both). Such a printout must include 
name of the prescribing practitioner, name and address of the patient, 
quantity dispensed on each refill, date of dispensing for each refill, 
name or identification code of the dispensing pharmacist, and the number 
of the original prescription order. In any computerized system employed 
by a user pharmacy the central recordkeeping location must be capable of 
sending the printout to the pharmacy within 48 hours, and if a DEA 
Special Agent or Diversion Investigator requests a copy of such printout 
from the user pharmacy, it must, if requested to do so by the Agent or 
Investigator, verify the printout transmittal capability of its system 
by documentation (e.g., postmark).
    (5) In the event that a pharmacy which employs such a computerized 
system experiences system down-time, the pharmacy must have an auxiliary 
procedure which will be used for documentation of refills os Schedule 
III and IV controlled substance prescription orders. This auxiliary 
procedure must insure that refills are authorized by the original 
prescription order, that the maximum number of refills has not been 
exceeded, and that all of the appropriate data is retained for on-line 
data entry as soon as the computer system is available for use again.
    (c) When filing refill information for original prescription orders 
for Schedule III or IV controlled substances, a pharmacy may use only 
one of the two systems described in paragraphs (a) or (b) of this 
section.

[36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971. Redesignated at 
38 FR 26609, Sept. 24, 1973, and amended at 42 FR 28878, June 6, 1977; 
45 FR 44266, July 1, 1980; 52 FR 3605, Feb. 5, 1987; 62 FR 13966, Mar. 
24, 1997]



Sec. 1306.23  Partial filling of prescriptions.

    The partial filling of a prescription for a controlled substance 
listed in Schedule III, IV, or V is permissible, provided that:
    (a) Each partial filling is recorded in the same manner as a 
refilling,
    (b) The total quantity dispensed in all partial fillings does not 
exceed the total quantity prescribed, and
    (c) No dispensing occurs after 6 months after the date on which the 
prescription was issued.

[36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973, and amended at 51 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24, 
1997]



Sec. 1306.24  Labeling of substances and filing of prescriptions.

    (a) The pharmacist filling a prescription for a controlled substance 
listed in Schedule III, IV, or V shall affix to the package a label 
showing the pharmacy name and address, the serial number and date of 
initial filling, the name of the patient, the name of the practitioner 
issuing the prescription, and directions for use and cautionary 
statements, if any, contained in such prescription as required by law.
    (b) If the prescription is filled at a central fill pharmacy, the 
central fill pharmacy shall affix to the package a label showing the 
retail pharmacy name and address and a unique identifier, (i.e. the 
central fill pharmacy's DEA registration number) indicating that the 
prescription was filled at the central fill pharmacy, in addition to the 
information required under paragraph (a) of this section.
    (c) The requirements of paragraph (a) of this section do not apply 
when a controlled substance listed in Schedule III, IV, or V is 
prescribed for administration to an ultimate user who is 
institutionalized: Provided, That:
    (1) Not more than a 34-day supply or 100 dosage units, whichever is 
less, of the controlled substance listed in Schedule III, IV, or V is 
dispensed at one time;
    (2) The controlled substance listed in Schedule III, IV, or V is not 
in the possession of the ultimate user prior to administration;
    (3) The institution maintains appropriate safeguards and records the 
proper administration, control, dispensing, and storage of the 
controlled substance listed in Schedule III, IV, or V; and
    (4) The system employed by the pharmacist in filling a prescription 
is adequate to identify the supplier, the product and the patient, and 
to set forth the directions for use and cautionary statements, if any, 
contained in the prescription or required by law.

[[Page 87]]

    (d) All prescriptions for controlled substances listed in Schedules 
III, IV, and V shall be kept in accordance with Sec. 1304.04(h) of this 
chapter.

[62 FR 13965, Mar. 24, 1997, as amended at 68 FR 37411, June 24, 2003]



Sec. 1306.25  Transfer between pharmacies of prescription information 
for Schedules III, IV, and V controlled substances for refill purposes.

    (a) The transfer of original prescription information for a 
controlled substance listed in Schedules III, IV or V for the purpose of 
refill dispensing is permissible between pharmacies on a one time basis 
only. However, pharmacies electronically sharing a real-time, on-line 
database may transfer up to the maximum refills permitted by law and the 
prescriber's authorization. Transfers are subject to the following 
requirements:
    (1) The transfer is communicated directly between two licensed 
pharmacists and the transferring pharmacist records the following 
information:
    (i) Write the word ``VOID'' on the face of the invalidated 
prescription.
    (ii) Record on the reverse of the invalidated prescription the name, 
address and DEA registration number of the pharmacy to which it was 
transferred and the name of the pharmacist receiving the prescription 
information.
    (iii) Record the date of the transfer and the name of the pharmacist 
transferring the information.
    (b) The pharmacist receiving the transferred prescription 
information shall reduce to writing the following:
    (1) Write the word ``transfer'' on the face of the transferred 
prescription.
    (2) Provide all information required to be on a prescription 
pursuant to 21 CFR 1306.05 and include:
    (i) Date of issuance of original prescription;
    (ii) Original number of refills authorized on original prescription;
    (iii) Date of original dispensing;
    (iv) Number of valid refills remaining and date(s) and locations of 
previous refill(s);
    (v) Pharmacy's name, address, DEA registration number and 
prescription number from which the prescription information was 
transferred;
    (vi) Name of pharmacist who transferred the prescription.
    (vii) Pharmacy's name, address, DEA registration number and 
prescription number from which the prescription was originally filled;
    (3) The original and transferred prescription(s) must be maintained 
for a period of two years from the date of last refill.
    (c) Pharmacies electronically accessing the same prescription record 
must satisfy all information requirements of a manual mode for 
prescription transferral.
    (d) The procedure allowing the transfer of prescription information 
for refill purposes is permissible only if allowable under existing 
state or other applicable law.

[46 FR 48919, Oct. 5, 1981. Redesignated and amended at 62 FR 13966, 
Mar. 24, 1997]



Sec. 1306.26  Dispensing without prescription.

    A controlled substance listed in Schedules II, III, IV, or V which 
is not a prescription drug as determined under the Federal Food, Drug, 
and Cosmetic Act, may be dispensed by a pharmacist without a 
prescription to a purchaser at retail, provided that:
    (a) Such dispensing is made only by a pharmacist (as defined in part 
1300 of this chapter), and not by a nonpharmacist employee even if under 
the supervision of a pharmacist (although after the pharmacist has 
fulfilled his professional and legal responsibilities set forth in this 
section, the actual cash, credit transaction, or delivery, may be 
completed by a nonpharmacist);
    (b) Not more than 240 cc. (8 ounces) of any such controlled 
substance containing opium, nor more than 120 cc. (4 ounces) of any 
other such controlled substance nor more than 48 dosage units of any 
such controlled substance containing opium, nor more than 24 dosage 
units of any other such controlled substance may be dispensed at retail 
to the same purchaser in any given 48-hour period;
    (c) The purchaser is at least 18 years of age;
    (d) The pharmacist requires every purchaser of a controlled 
substance under this section not known to him to

[[Page 88]]

furnish suitable identification (including proof of age where 
appropriate);
    (e) A bound record book for dispensing of controlled substances 
under this section is maintained by the pharmacist, which book shall 
contain the name and address of the purchaser, the name and quantity of 
controlled substance purchased, the date of each purchase, and the name 
or initials of the pharmacist who dispensed the substance to the 
purchaser (the book shall be maintained in accordance with the 
recordkeeping requirement of Sec. 1304.04 of this chapter); and
    (f) A prescription is not required for distribution or dispensing of 
the substance pursuant to any other Federal, State or local law.
    (g) Central fill pharmacies may not dispense controlled substances 
to a purchaser at retail pursuant to this section.

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesigated and 
amended at 62 FR 13966, Mar. 24, 1997; 68 FR 37411, June 24, 2003]



Sec. 1306.27  Provision of prescription information between retail 

pharmacies and central fill pharmacies for initial and refill 
prescriptions of Schedule III, 
          IV, or V controlled substances.

    Prescription information may be provided to an authorized central 
fill pharmacy by a retail pharmacy for dispensing purposes. The 
following requirements shall also apply:
    (a) Prescriptions for controlled substances listed in Schedule III, 
IV or V may be transmitted electronically from a retail pharmacy to a 
central fill pharmacy including via facsimile. The retail pharmacy 
transmitting the prescription information must:
    (1) Write the word ``CENTRAL FILL'' on the face of the original 
prescription and record the name, address, and DEA registration number 
of the central fill pharmacy to which the prescription has been 
transmitted and the name of the retail pharmacy pharmacist transmitting 
the prescription, and the date of transmittal;
    (2) Ensure that all information required to be on a prescription 
pursuant to Sec. 1306.05 of this part is transmitted to the central 
fill pharmacy (either on the face of the prescription or in the 
electronic transmission of information);
    (3) Indicate in the information transmitted the number of refills 
already dispensed and the number of refills remaining;
    (4) Maintain the original prescription for a period of two years 
from the date the prescription was last refilled;
    (5) Keep a record of receipt of the filled prescription, including 
the date of receipt, the method of delivery (private, common or contract 
carrier) and the name of the retail pharmacy employee accepting 
delivery.
    (b) The central fill pharmacy receiving the transmitted prescription 
must:
    (1) Keep a copy of the prescription (if sent via facsimile) or an 
electronic record of all the information transmitted by the retail 
pharmacy, including the name, address, and DEA registration number of 
the retail pharmacy transmitting the prescription;
    (2) Keep a record of the date of receipt of the transmitted 
prescription, the name of the licensed pharmacist filling the 
prescription, and dates of filling or refilling of the prescription;
    (3) Keep a record of the date the filled prescription was delivered 
to the retail pharmacy and the method of delivery (i.e. private, common 
or contract carrier).

[68 FR 37411, June 24, 2003]



PART 1307_MISCELLANEOUS--Table of Contents

                           General Information

Sec.
1307.01 Definitions.
1307.02 Application of State law and other Federal law.
1307.03 Exceptions to regulations.

   Special Exceptions for Manufacture and Distribution of Controlled 
                               Substances

1307.11 Distribution by dispenser to another practitioner or reverse 
          distributor.
1307.12 Distribution to supplier or manufacturer.
1307.13 Incidental manufacture of controlled substances.

                    Disposal of Controlled Substances

1307.21 Procedure for disposing of controlled substances.
1307.22 Disposal of controlled substances by the Administration.

[[Page 89]]

                         Special Exempt Persons

1307.31 Native American Church.

    Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise noted.

    Source: 36 FR 7801, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information



Sec. 1307.01  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13966, Mar. 24, 1997]



Sec. 1307.02  Application of State law and other Federal law.

    Nothing in this chapter shall be construed as authorizing or 
permitting any person to do any act which such person is not authorized 
or permitted to do under other Federal laws or obligations under 
international treaties, conventions or protocols, or under the law of 
the State in which he/she desires to do such act nor shall compliance 
with such parts be construed as compliance with other Federal or State 
laws unless expressly provided in such other laws.

[62 FR 13966, Mar. 24, 1997]



Sec. 1307.03  Exceptions to regulations.

    Any person may apply for an exception to the application of any 
provision of this chapter by filing a written request stating the 
reasons for such exception. Requests shall be filed with the 
Administrator, Drug Enforcement Administration, Department of Justice, 
Washington, DC 20537. The Administrator may grant an exception in his 
discretion, but in no case shall he/she be required to grant an 
exception to any person which is otherwise required by law or the 
regulations cited in this section.

[62 FR 13966, Mar. 24, 1997]

   Special Exceptions for Manufacture and Distribution of Controlled 
                               Substances



Sec. 1307.11  Distribution by dispenser to another practitioner or 
reverse distributor.

    (a) A practitioner who is registered to dispense a controlled 
substance may distribute (without being registered to distribute) a 
quantity of such substance to--
    (1) Another practitioner for the purpose of general dispensing by 
the practitioner to patients, provided that--
    (i) The practitioner to whom the controlled substance is to be 
distributed is registered under the Act to dispense that controlled 
substance;
    (ii) The distribution is recorded by the distributing practitioner 
in accordance with Sec. 1304.22(c) of this chapter and by the receiving 
practitioner in accordance with Sec. 1304.22(c) of this chapter;
    (iii) If the substance is listed in Schedule I or II, an order form 
is used as required in part 1305 of this chapter; and
    (iv) The total number of dosage units of all controlled substances 
distributed by the practitioner pursuant to this section and Sec. 
1301.25 of this chapter during each calendar year in which the 
practitioner is registered to dispense does not exceed 5 percent of the 
total number of dosage units of all controlled substances distributed 
and dispensed by the practitioner during the same calendar year.
    (2) A reverse distributor who is registered to receive such 
controlled substances.
    (b) If, during any calendar year in which the practitioner is 
registered to dispense, the practitioner has reason to believe that the 
total number of dosage units of all controlled substances which will be 
distributed by him pursuant to paragraph (a)(1) of this section and 
Sec. 1301.25 of this chapter will exceed 5 percent of this total number 
of dosage units of all controlled substances distributed and dispensed 
by him during that calendar year, the practitioner shall obtain a 
registration to distribute controlled substances.

[68 FR 41229, July 11, 2003]

[[Page 90]]



Sec. 1307.12  Distribution to supplier or manufacturer.

    (a) Any person lawfully in possession of a controlled substance 
listed in any schedule may distribute (without being registered to 
distribute) that substance to the person from whom he/she obtained it or 
to the manufacturer of the substance, or, if designated, to the 
manufacturer's registered agent for accepting returns, provided that a 
written record is maintained which indicates the date of the 
transaction, the name, form and quantity of the substance, the name, 
address, and registration number, if any, of the person making the 
distribution, and the name, address, and registration number, if known, 
of the supplier or manufacturer. In the case of returning a controlled 
substance in Schedule I or II, an order form shall be used in the manner 
prescribed in part 1305 of this chapter and be maintained as the written 
record of the transaction. Any person not required to register pursuant 
to sections 302(c) or 1007(b)(1) of the Act (21 U.S.C. 822(c) or 
957(b)(1)) shall be exempt from maintaining the records required by this 
section.
    (b) Distributions referred to in paragraph (a) may be made through a 
freight forwarding facility operated by the person to whom the 
controlled substance is being returned provided that prior arrangement 
has been made for the return and the person making the distribution 
delivers the controlled substance directly to an agent or employee of 
the person to whom the controlled substance is being returned.

[65 FR 44679, July 19, 2000; 65 FR 45829, July 25, 2000, as amended at 
68 FR 41229, July 11, 2003]



Sec. 1307.13  Incidental manufacture of controlled substances.

    Any registered manufacturer who, incidentally but necessarily, 
manufactures a controlled substance as a result of the manufacture of a 
controlled substance or basic class of controlled substance for which he 
is registered and has been issued an individual manufacturing quota 
pursuant to part 1303 of this chapter (if such substance or class is 
listed in Schedule I or II) shall be exempt from the requirement of 
registration pursuant to part 1301 of this chapter and, if such 
incidentally manufactured substance is listed in Schedule I or II, shall 
be exempt from the requirement of an individual manufacturing quota 
pursuant to part 1303 of this chapter, if such substances are disposed 
of in accordance with Sec. 1307.21.

[36 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13967, Mar. 24, 1997]

                    Disposal of Controlled Substances



Sec. 1307.21  Procedure for disposing of controlled substances.

    (a) Any person in possession of any controlled substance and 
desiring or required to dispose of such substance may request assistance 
from the Special Agent in Charge of the Administration in the area in 
which the person is located for authority and instructions to dispose of 
such substance. The request should be made as follows:
    (1) If the person is a registrant, he/she shall list the controlled 
substance or substances which he/she desires to dispose of on DEA Form 
41, and submit three copies of that form to the Special Agent in Charge 
in his/her area; or
    (2) If the person is not a registrant, he/she shall submit to the 
Special Agent in Charge a letter stating:
    (i) The name and address of the person;
    (ii) The name and quantity of each controlled substance to be 
disposed of;
    (iii) How the applicant obtained the substance, if known; and
    (iv) The name, address, and registration number, if known, of the 
person who possessed the controlled substances prior to the applicant, 
if known.
    (b) The Special Agent in Charge shall authorize and instruct the 
applicant to dispose of the controlled substance in one of the following 
manners:
    (1) By transfer to person registered under the Act and authorized to 
possess the substance;
    (2) By delivery to an agent of the Administration or to the nearest 
office of the Administration;
    (3) By destruction in the presence of an agent of the Administration 
or other authorized person; or
    (4) By such other means as the Special Agent in Charge may determine 
to

[[Page 91]]

assure that the substance does not become available to unauthorized 
persons.
    (c) In the event that a registrant is required regularly to dispose 
of controlled substances, the Special Agent in Charge may authorize the 
registrant to dispose of such substances, in accordance with paragraph 
(b) of this section, without prior approval of the Administration in 
each instance, on the condition that the registrant keep records of such 
disposals and file periodic reports with the Special Agent in Charge 
summarizing the disposals made by the registrant. In granting such 
authority, the Special Agent in Charge may place such conditions as he 
deems proper on the disposal of controlled substances, including the 
method of disposal and the frequency and detail of reports.
    (d) This section shall not be construed as affecting or altering in 
any way the disposal of controlled substances through procedures 
provided in laws and regulations adopted by any State.

[36 FR 7801, Apr. 24, 1971, as amended at 37 FR 15922, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, 
Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997]



Sec. 1307.22  Disposal of controlled substances by the Administration.

    Any controlled substance delivered to the Administration under Sec. 
1307.21 or forfeited pursuant to section 511 of the Act (21 U.S.C. 881) 
may be delivered to any department, bureau, or other agency of the 
United States or of any State upon proper application addressed to the 
Administrator, Drug Enforcement Administration, Department of Justice, 
Washington, DC 20537 The application shall show the name, address, and 
official title of the person or agency to whom the controlled drugs are 
to be delivered, including the name and quantity of the substances 
desired and the purpose for which intended. The delivery of such 
controlled drugs shall be ordered by the Administrator, if, in his 
opinion, there exists a medical or scientific need therefor.

[38 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13967, Mar. 24, 1997]

                         Special Exempt Persons



Sec. 1307.31  Native American Church.

    The listing of peyote as a controlled substance in Schedule I does 
not apply to the nondrug use of peyote in bona fide religious ceremonies 
of the Native American Church, and members of the Native American Church 
so using peyote are exempt from registration. Any person who 
manufactures peyote for or distributes peyote to the Native American 
Church, however, is required to obtain registration annually and to 
comply with all other requirements of law.



PART 1308_SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents

                           General Information

Sec.
1308.01 Scope of part 1308.
1308.02 Definitions.
1308.03 Administration Controlled Substances Code Number.

                                Schedules

1308.11 Schedule I.
1308.12 Schedule II.
1308.13 Schedule III.
1308.14 Schedule IV.
1308.15 Schedule V.

                     Excluded Nonnarcotic Substances

1308.21 Application for exclusion of a nonnarcotic substance.
1308.22 Excluded substances.

                      Exempt Chemical Preparations

1308.23 Exemption of certain chemical preparations; application.
1308.24 Exemption chemical preparations.

          Excluded Veterinary Anabolic Steroid Implant Products

1308.25 Exclusion of a veterinary anabolic steroid implant product; 
          application.
1308.26 Excluded veterinary anabolic steroid implant products.

                     Exempted Prescription Products

1308.31 Application for exemption of a nonnarcotic prescription product.
1308.32 Exempted prescription products.

                    Exempt Anabolic Steroid Products

1308.33 Exemption of certain anabolic steroid products; application.
1308.34 Exempt anabolic steroid products.

[[Page 92]]

   Exempt cannabis plant material, and products made therefrom, that 
                      contain tetrahydrocannabinols

1308.35 Exemption of certain cannabis plant material, and products made 
          therefrom, that contain tetrahydrocannabinols.

                                Hearings

1308.41 Hearings generally.
1308.42 Purpose of hearing.
1308.43 Initiation of proceedings for rule-making.
1308.44 Request for hearing or appearance; waiver.
1308.45 Final order.
1308.46 Control required under international treaty.
1308.47 Control of immediate precursors.
1308.49 Emergency scheduling.

    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    Source: 38 FR 8254, Mar. 30, 1973, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information



Sec. 1308.01  Scope of part 1308.

    Schedules of controlled substances established by section 202 of the 
Act (21 U.S.C. 812), as they are changed, updated, and republished from 
time to time, are set forth in this part.



Sec. 1308.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13967, Mar. 24, 1997]



Sec. 1308.03  Administration Controlled Substances Code Number.

    (a) Each controlled substance, or basic class thereof, has been 
assigned an ``Administration Controlled Substances Code Number'' for 
purposes of identification of the substances or class on certain 
Certificates of Registration issued by the Administration pursuant to 
Sec. Sec. 1301.35 of this chapter and on certain order forms issued by 
the Administration pursuant to Sec. 1305.05(d) of this chapter. 
Applicants for procurement and/or individual manufacturing quotas must 
include the appropriate code number on the application as required in 
Sec. Sec. 1303.12(b) and 1303.22(a) of this chapter. Applicants for 
import and export permits must include the appropriate code number on 
the application as required in Sec. Sec. 1312.12(a) and 1312.22(a) of 
this chapter. Authorized registrants who desire to import or export a 
controlled substance for which an import or export permit is not 
required must include the appropriate Administration Controlled 
Substances Code Number beneath or beside the name of each controlled 
substance listed on the DEA Form 236 (Controlled Substance Import/Export 
Declaration) which is executed for such importation or exportation as 
required in Sec. Sec. 1312.18(c) and 1312.27(b) of this chapter.
    (b) Except as stated in paragraph (a) of this section, no applicant 
or registrant is required to use the Administration Controlled 
Substances Code Number for any purpose.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 51 FR 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997]

                                Schedules



Sec. 1308.11  Schedule I.

    (a) Schedule I shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Opiates. Unless specifically excepted or unless listed in 
another schedule, any of the following opiates, including their isomers, 
esters, ethers, salts, and salts of isomers, esters and ethers, whenever 
the existence of such isomers, esters, ethers and salts is possible 
within the specific chemical designation (for purposes of paragraph 
(b)(34) only, the term isomer includes the optical and geometric 
isomers):

(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-     9815
 piperidinyl]-N-phenylacetamide).................................
(2) Acetylmethadol...............................................   9601
(3) Allylprodine.................................................   9602
(4) Alphacetylmethadol (except levo-alphacetylmethadol also known   9603
 as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM)....
(5) Alphameprodine...............................................   9604
(6) Alphamethadol................................................   9605
(7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-   9814
 piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-
 propanilido) piperidine)........................................
(8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-     9832
 piperidinyl]-N-phenylpropanamide)...............................
(9) Benzethidine.................................................   9606
(10) Betacetylmethadol...........................................   9607

[[Page 93]]

 
(11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4-          9830
 piperidinyl]-N-phenylpropanamide)...............................
(12) Beta-hydroxy-3-methylfentanyl (other name: N-[1-(2-hydroxy-2-  9831
 phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide..........
(13) Betameprodine...............................................   9608
(14) Betamethadol................................................   9609
(15) Betaprodine.................................................   9611
(16) Clonitazene.................................................   9612
(17) Dextromoramide..............................................   9613
(18) Diampromide.................................................   9615
(19) Diethylthiambutene..........................................   9616
(20) Difenoxin...................................................   9168
(21) Dimenoxadol.................................................   9617
(22) Dimepheptanol...............................................   9618
(23) Dimethylthiambutene.........................................   9619
(24) Dioxaphetyl butyrate........................................   9621
(25) Dipipanone..................................................   9622
(26) Ethylmethylthiambutene......................................   9623
(27) Etonitazene.................................................   9624
(28) Etoxeridine.................................................   9625
(29) Furethidine.................................................   9626
(30) Hydroxypethidine............................................   9627
(31) Ketobemidone................................................   9628
(32) Levomoramide................................................   9629
(33) Levophenacylmorphan.........................................   9631
(34) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4-piperidyl]-  9813
 N-phenylpropanamide)............................................
(35) 3-methylthiofentanyl (N-[(3-methyl-1-(2-thienyl)ethyl-4-       9833
 piperidinyl]-N-phenylpropanamide)...............................
(36) Morpheridine................................................   9632
(37) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine).............   9661
(38) Noracymethadol..............................................   9633
(39) Norlevorphanol..............................................   9634
(40) Normethadone................................................   9635
(41) Norpipanone.................................................   9636
(42) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenethyl)-4-  9812
 piperidinyl] propanamide........................................
(43) PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine........   9663
(44) Phenadoxone.................................................   9637
(45) Phenampromide...............................................   9638
(46) Phenomorphan................................................   9647
(47) Phenoperidine...............................................   9641
(48) Piritramide.................................................   9642
(49) Proheptazine................................................   9643
(50) Properidine.................................................   9644
(51) Propiram....................................................   9649
(52) Racemoramide................................................   9645
(53) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]-   9835
 propanamide.....................................................
(54) Tilidine....................................................   9750
(55) Trimeperidine...............................................   9646
 

    (c) Opium derivatives. Unless specifically excepted or unless listed 
in another schedule, any of the following opium derivatives, its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation:

(1) Acetorphine..................................................   9319
(2) Acetyldihydrocodeine.........................................   9051
(3) Benzylmorphine...............................................   9052
(4) Codeine methylbromide........................................   9070
(5) Codeine-N-Oxide..............................................   9053
(6) Cyprenorphine................................................   9054
(7) Desomorphine.................................................   9055
(8) Dihydromorphine..............................................   9145
(9) Drotebanol...................................................   9335
(10) Etorphine (except hydrochloride salt).......................   9056
(11) Heroin......................................................   9200
(12) Hydromorphinol..............................................   9301
(13) Methyldesorphine............................................   9302
(14) Methyldihydromorphine.......................................   9304
(15) Morphine methylbromide......................................   9305
(16) Morphine methylsulfonate....................................   9306
(17) Morphine-N-Oxide............................................   9307
(18) Myrophine...................................................   9308
(19) Nicocodeine.................................................   9309
(20) Nicomorphine................................................   9312
(21) Normorphine.................................................   9313
(22) Pholcodine..................................................   9314
(23) Thebacon....................................................   9315
 

    (d) Hallucinogenic substances. Unless specifically excepted or 
unless listed in another schedule, any material, compound, mixture, or 
preparation, which contains any quantity of the following hallucinogenic 
substances, or which contains any of its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible within the specific chemical designation (for 
purposes of this paragraph only, the term ``isomer'' includes the 
optical, position and geometric isomers):

(1) Alpha-ethyltryptamine........................................   7249
  Some trade or other names: etryptamine; Monase; [alpha]-ethyl-
   1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; [alpha]-ET;
   and AET.
(2) 4-bromo-2,5-dimethoxy-amphetamine............................   7391
  Some trade or other names: 4-bromo-2,5-dimethoxy-[alpha]-
   methylphenethylamine; 4-bromo-2,5-DMA
(3) 4-Bromo-2,5-dimethoxyphenethylamine..........................   7392
  Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)-1-
   aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.
(4) 2,5-dimethoxyamphetamine.....................................   7396
  Some trade or other names: 2,5-dimethoxy-[alpha]-
   methylphenethylamine; 2,5-DMA
(5) 2,5-dimethoxy-4-ethylamphet-amine............................   7399
  Some trade or other names: DOET
(6) 2,5-dimethoxy-4-(n)-propylthiophenethylamine (other name: 2C-   7348
 T-7)............................................................
(7) 4-methoxyamphetamine.........................................   7411
  Some trade or other names: 4-methoxy-[alpha]-
   methylphenethylamine; paramethoxyamphetamine, PMA
(8) 5-methoxy-3,4-mdthylenedioxy-amphetamine.....................   7401
(9) 4-methyl-2,5-dimethoxy-amphetamine...........................   7395
  Some trade and other names: 4-methyl-2,5-dimethoxy-[alpha]-
   methylphenethylamine; ``DOM''; and ``STP''
(10) 3,4-methylenedioxy amphetamine..............................   7400
(11) 3,4-methylenedioxymethamphetamine (MDMA)....................   7405
(12) 3,4-methylenedioxy-N-ethylamphetamine (also known as N-ethyl-  7404
 alpha-methyl-3,4(methylenedioxy)phenethylamine, N-ethyl MDA,
 MDE, MDEA.......................................................
(13) N-hydroxy-3,4-methylenedioxyamphetamine (also known as N-      7402
 hydroxy-alpha-methyl-3,4(methylenedioxy)phenethylamine, and N-
 hydroxy MDA.....................................................
(14) 3,4,5-trimethoxy amphetamine................................   7390
(15) Alpha-methyltryptamine (other name: AMT)....................   7432
(16) Bufotenine..................................................   7433
  Some trade and other names: 3-([beta]-Dimethylaminoethyl)-5-
   hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-
   dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine
(17) Diethyltryptamine...........................................   7434

[[Page 94]]

 
  Some trade and other names: N,N-Diethyltryptamine; DET
(18) Dimethyltryptamine..........................................   7435
  Some trade or other names: DMT
(19) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT)   7439
(20) Ibogaine....................................................   7260
  Some trade and other names: 7-Ethyl-6,6[beta],7,8,9,10,12,13-
   octahydro-2-methoxy-6,9-methano-5H-pyrido [1', 2':1,2] azepino
   [5,4-b] indole; Tabernanthe iboga
(21) Lysergic acid diethylamide..................................   7315
(22) Marihuana...................................................   7360
(23) Mescaline...................................................   7381
(24) Parahexyl--7374; some trade or other names: 3-Hexyl-1-
 hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-
 dibenzo[b,d]pyran; Synhexyl.
(25) Peyote......................................................   7415
  Meaning all parts of the plant presently classified botanically
   as Lophophora williamsii Lemaire, whether growing or not, the
   seeds thereof, any extract from any part of such plant, and
   every compound, manufacture, salts, derivative, mixture, or
   preparation of such plant, its seeds or extracts
  (Interprets 21 USC 812(c), Schedule I(c) (12))
(26) N-ethyl-3-piperidyl benzilate...............................   7482
(27) N-methyl-3-piperidyl benzilate..............................   7484
(28) Psilocybin..................................................   7437
(29) Psilocyn....................................................   7438
(30) Tetrahydrocannabinols.......................................   7370
  Meaning tetrahydrocannabinols naturally contained in a plant of
   the genus Cannabis (cannabis plant), as well as synthetic
   equivalents of the substances contained in the cannabis plant,
   or in the resinous extractives of such plant, and/or synthetic
   substances, derivatives, and their isomers with similar
   chemical structure and pharmacological activity to those
   substances contained in the plant, such as the following:
  1 cis or trans tetrahydrocannabinol, and their optical isomers
  6 cis or trans tetrahydrocannabinol, and their optical isomers
  3, 4 cis or trans tetrahydrocannabinol, and its optical isomers
  (Since nomenclature of these substances is not internationally
   standardized, compounds of these structures, regardless of
   numerical designation of atomic positions covered.)
(31) Ethylamine analog of phencyclidine..........................   7455
  Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-
   phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)ethylamine,
   cyclohexamine, PCE
(32) Pyrrolidine analog of phencyclidine.........................   7458
  Some trade or other names: 1-(1-phenylcyclohexyl)-pyrrolidine,
   PCPy, PHP
(33) Thiophene analog of phencyclidine...........................   7470
  Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]-
   piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP
(34) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine......................   7473
  Some other names: TCPy
 

    (e) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system, including its salts, isomers, and 
salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation:

(1) gamma-hydroxybutyric acid (some other names include GHB;        2010
 gamma-hydroxybutyrate; 4-hydroxybutyrate; 4-hydroxybutanoic
 acid; sodium oxybate; sodium oxybutyrate).......................
(2) Mecloqualone.................................................   2572
(3) Methaqualone.................................................   2565
 

    (f) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system, including its salts, isomers, and 
salts of isomers:

(1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2-    1585
 oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine)...............
(2) N-Benzylpiperazine (some other names: BZP, 1-                   7493
 benzylpiperazine)...............................................
(3) Cathinone....................................................   1235
  Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-
   aminopropiophenone, 2-aminopropiophenone, and norephedrone
(4) Fenethylline.................................................   1503
(5) Methcathinone (Some other names: 2-(methylamino)-               1237
 propiophenone; alpha-(methylamino)propiophenone; 2-(methylamino)-
 1-phenylpropan-1-one; alpha-N-methylaminopropiophenone;
 monomethylpropion; ephedrone; N-methylcathinone;
 methylcathinone; AL-464; AL-422; AL-463 and UR1432), its salts,
 optical isomers and salts of optical isomers....................
(6) ()cis-4-methylaminorex (()cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine)........
(7) N-ethylamphetamine...........................................   1475
(8) N,N-dimethylamphetamine (also known as N,N-alpha-trimethyl-     1480
 benzeneethanamine; N,N-alpha-trimethylphenethylamine)...........
 

    (g) Temporary listing of substances subject to emergency scheduling. 
Any material, compound, mixture or preparation which contains any 
quantity of the following substances:

(1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide                    9818
 (benzylfentanyl), its optical isomers, salts and salts of
 isomers.........................................................
(2) N-[1-(2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide         9834
 (thenylfentanyl), its optical isolers, salts and salts of
 isomers.........................................................
 


[39 FR 22141, June 20, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.11, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1308.12  Schedule II.

    (a) Schedule II shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name

[[Page 95]]

designated, listed in this section. Each drug or substance has been 
assigned the Controlled Substances Code Number set forth opposite it.
    (b) Substances, vegetable origin or chemical synthesis. Unless 
specifically excepted or unless listed in another schedule, any of the 
following substances whether produced directly or indirectly by 
extraction from substances of vegetable origin, or independently by 
means of chemical synthesis, or by a combination of extraction and 
chemical synthesis:
    (1) Opium and opiate, and any salt, compound, derivative, or 
preparation of opium or opiate excluding apomorphine, thebaine-derived 
butorphanol, dextrorphan, nalbuphine, nalmefene, naloxone, and 
naltrexone, and their respective salts, but including the following:

(1) Raw opium....................................................   9600
(2) Opium extracts...............................................   9610
(3) Opium fluid..................................................   9620
(4) Powdered opium...............................................   9639
(5) Granulated opium.............................................   9640
(6) Tincture of opium............................................   9630
(7) Codeine......................................................   9050
(8) Dihydroetorphine.............................................   9334
(9) Ethylmorphine................................................   9190
(10) Etorphine hydrochloride.....................................   9059
(11) Hydrocodone.................................................   9193
(12) Hydromorphone...............................................   9150
(13) Metopon.....................................................   9260
(14) Morphine....................................................   9300
(15) Oxycodone...................................................   9143
(16) Oxymorphone.................................................   9652
(17) Thebaine....................................................   9333
 

    (2) Any salt, compound, derivative, or preparation thereof which is 
chemically equivalent or identical with any of the substances referred 
to in paragraph (b) (1) of this section, except that these substances 
shall not include the isoquinoline alkaloids of opium.
    (3) Opium poppy and poppy straw.
    (4) Coca leaves (9040) and any salt, compound, derivative or 
preparation of coca leaves (including cocaine (9041) and ecgonine (9180) 
and their salts, isomers, derivatives and salts of isomers and 
derivatives), and any salt, compound, derivative, or preparation thereof 
which is chemically equivalent or identical with any of these 
substances, except that the substances shall not include decocainized 
coca leaves or extraction of coca leaves, whhch extractions do not 
contain cocaine or ecgonine.
    (5) Concentrate of poppy straw (the crude extract of poppy straw in 
either liquid, solid or powder form which contains the phenanthrene 
alkaloids of the opium poppy), 9670.
    (c) Opiates. Unless specifically excepted or unless in another 
schedule any of the following opiates, including its isomers, esters, 
ethers, salts and salts of isomers, esters and ethers whenever the 
existence of such isomers, esters, ethers, and salts is possible within 
the specific chemical designation, dextrorphan and levopropoxyphene 
excepted:

(1) Alfentanil...................................................   9737
(2) Alphaprodine.................................................   9010
(3) Anileridine..................................................   9020
(4) Bezitramide..................................................   9800
(5) Bulk dextropropoxyphene (non-dosage forms)...................   9273
(6) Carfentanil..................................................   9743
(7) Dihydrocodeine...............................................   9120
(8) Diphenoxylate................................................   9170
(9) Fentanyl.....................................................   9801
(10) Isomethadone................................................   9226
(11) Levo-alphacetylmethadol.....................................   9648
  [Some other names: levo-alpha-acetylmethadol, levomethadyl
   acetate, LAAM]
(12) Levomethorphan..............................................   9210
(13) Levorphanol.................................................   9220
(14) Metazocine..................................................   9240
(15) Methadone...................................................   9250
(16) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl   9254
 butane..........................................................
(17) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-             9802
 diphenylpropane-carboxylic acid.................................
(18) Pethidine (meperidine)......................................   9230
(19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-                  9232
 phenylpiperidine................................................
(20) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-          9233
 carboxylate.....................................................
(21) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-       9234
 carboxylic acid.................................................
(22) Phenazocine.................................................   9715
(23) Piminodine..................................................   9730
(24) Racemethorphan..............................................   9732
(25) Racemorphan.................................................   9733
(26) Remifentanil................................................   9739
(27) Sufentanil..................................................   9740
 

    (d) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system:

(1) Amphetamine, its salts, optical isomers, and salts of its       1100
 optical isomers.................................................
(2) Methamphetamine, its salts, isomers, and salts of its isomers   1105
(3) Phenmetrazine and its salts..................................   1631
(4) Methylphenidate..............................................   1724
 

    (e) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system, including

[[Page 96]]

its salts, isomers, and salts of isomers whenever the existence of such 
salts, isomers, and salts of isomers is possible within the specific 
chemical designation:

(1) Amobarbital..................................................   2125
(2) Glutethimide.................................................   2550
(3) Pentobarbital................................................   2270
(4) Phencyclidine................................................   7471
(5) Secobarbital.................................................   2315
 

    (f) Hallucinogenic substances.

(1) Nabilone.....................................................   7379
  [Another name for nabilone: ()-trans-3-
   (1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-
   dimethyl-9H-dibenzo[b,d]pyran-9-one]
 

    (g) Immediate precursors. Unless specifically excepted or unless 
listed in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of the following substances:
    (1) Immediate precursor to amphetamine and methamphetamine:

(i) Phenylacetone................................................   8501
  Some trade or other names: phenyl-2-propanone; P2P; benzyl
   methyl ketone; methyl benzyl ketone;
 

    (2) Immediate precursors to phencyclidine (PCP):

(i) 1-phenylcyclohexylamine......................................   7460
(ii) 1-piperidinocyclohexanecarbonitrile (PCC)...................   8603
 


[39 FR 22142, June 20, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.12, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1308.13  Schedule III.

    (a) Schedule III shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous sxstem, including its salts, isomers 
(whether optical, position, or geometric), and salts of such isomers 
whenever the existence of such salts, isomers, and salts of isomers is 
possible within the specific chemical designation:

(1) Those compounds, mixtures, or preparations in dosage unit       1405
 form containing any stimulant substances listed in schedule II
 which compounds, mixtures, or preparations were listed on August
 25, 1971, as excepted compounds under Sec. 1308.32, and any
 other drug of the quantitative composition shown in that list
 for those drugs or which is the same except that it contains a
 lesser quantity of controlled substances........................
(2) Benzphetamine................................................   1228
(3) Chlorphentermine.............................................   1645
(4) Clortermine..................................................   1647
(5) Phendimetrazine..............................................   1615
 

    (c) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system:

(1) Any compound, mixture or preparation containing:
    (i) Amobarbital..............................................   2126
    (ii) Secobarbital............................................   2316
    (iii) Pentobarbital..........................................   2271
  or any salt thereof and one or more other active medicinal
   ingredients which are not listed in any schedule.
(2) Any suppository dosage form containing:
    (i) Amobarbital..............................................   2126
    (ii) Secobarbital............................................   2316
    (iii) Pentobarbital..........................................   2271
  or any salt of any of these drugs and approved by the Food and
   Drug Administration for marketing only as a suppository.
(3) Any substance which contains any quantity of a derivative of    2100
 barbituric acid or any salt thereof.............................
(4) Chlorhexadol.................................................   2510
(5) Any drug product containing gamma hydroxybutyric acid,          2012
 including its salts, isomers, and salts of isomers, for which an
 application is approved under section 505 of the Federal Food,
 Drug, and Cosmetic Act..........................................
(6) Ketamine, its salts, isomers, and salts of isomers...........   7285
  [Some other names for ketamine: ()-2-(2-
   chlorophenyl)-2-(methylamino)-cyclohexanone]
(7) Lysergic acid................................................   7300
(8) Lysergic acid amide..........................................   7310
(9) Methyprylon..................................................   2575
(10) Sulfondiethylmethane........................................   2600
(11) Sulfonethylmethane..........................................   2605
(12) Sulfonmethane...............................................   2610
(13) Tiletamine and zolazepam or any salt thereof................   7295
  Some trade or other names for a tiletamine-zolazepam
   combination product:
    Telazol......................................................
  Some trade or other names for tiletamine:
    2-(ethylamino)-2-(2-thienyl)-cyclohexanone...................
  Some trade or other names for zolazepam:
    4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-
     e] [1,4]-diazepin-7(1H)-one, flupyrazapon...................
 

    (d) Nalorphine 9400.
    (e) Narcotic drugs. Unless specifically excepted or unless listed in 
another schedule:

[[Page 97]]



(1) Any material, compound, mixture, or preparation containing
 any of the following narcotic drugs, or their salts calculated
 as the free anhydrous base or alkaloid, in limited quantities as
 set forth below:
    (i) Not more than 1.8 grams of codeine per 100 milliliters or   9803
     not more than 90 milligrams per dosage unit, with an equal
     or greater quantity of an isoquinoline alkaloid of opium....
    (ii) Not more than 1.8 grams of codeine per 100 milliliters     9804
     or not more than 90 milligrams per dosage unit, with one or
     more active, nonnarcotic ingredients in recognized
     therapeutic amounts.........................................
    (iii) Not more than 300 milligrams of dihydrocodeinone          9805
     (hydrocodone) per 100 milliliters or not more than 15
     milligrams per dosage unit, with a fourfold or greater
     quantity of an isoquinoline alkaloid of opium...............
    (iv) Not more than 300 milligrams of dihydrocodeinone           9806
     (hydrocodone) per 100 milliliters or not more than 15
     milligrams per dosage unit, with one or more active
     nonnarcotic ingredients in recognized therapeutic amounts...
    (v) Not more than 1.8 grams of dihydrocodeine per 100           9807
     milliliters or not more than 90 milligrams per dosage unit,
     with one or more active nonnarcotic ingredients in
     recognized therapeutic amounts..............................
    (vi) Not more than 300 milligrams of ethylmorphine per 100      9808
     milliliters or not more than 15 milligrams per dosage unit,
     with one or more active, nonnarcotic ingredients in
     recognized therapeutic amounts..............................
    (vii) Not more than 500 milligrams of opium per 100             9809
     milliliters or per 100 grams or not more than 25 milligrams
     per dosage unit, with one or more active, nonnarcotic
     ingredients in recognized therapeutic amounts...............
    (viii) Not more than 50 milligrams of morphine per 100          9810
     milliliters or per 100 grams, with one or more active,
     nonnarcotic ingredients in recognized therapeutic amounts...
 (2) Any material, compound, mixture, or preparation containing
 any of the following narcotic drugs or their salts, as set forth
 below:
    (i) Buprenorphine............................................   9064
    (ii) [Reserved]..............................................
 

    (f) Anabolic steroids. Unless specifically excepted or unless listed 
in another schedule, any material, compound, mixture, or preparation 
containing any quantity of the following substances, including its 
salts, isomers, and salts of isomers whenever the existence of such 
salts of isomers is possible within the specific chemical designation:

(1) Anabolic Steroids...............................................4000

    (g) Hallucinogenic substances. (1) Dronabinol (synthetic) in sesame 
oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug 
Administration approved product--7369.

[Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro-
6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-
(trans)-tetrahydrocannabinol]

    (2) [Reserved]

[39 FR 22142, June 20, 1974, as amended at 41 FR 43401, Oct. 1, 1976; 43 
FR 3359, Jan. 25, 1978; 44 FR 40888, July 13, l979; 46 FR 52334, Oct. 
27, 1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan. 21, 1987; 52 FR 
5952, Feb. 27, 1987; 56 FR 5754, Feb. 13, 1991; 56 FR 11932, Mar. 21, 
1991; 62 FR 13968, Mar. 24, 1997; 64 FR 35930, July 2, 1999; 64 FR 
37675, July 13, 1999; 65 FR 13238, Mar. 13, 2000; 65 FR 17440, Apr. 3, 
2000; 67 FR 62370, Oct. 7, 2002]



Sec. 1308.14  Schedule IV.

    (a) Schedule IV shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Narcotic drugs. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation 
containing any of the following narcotic drugs, or their salts 
calculated as the free anhydrous base or alkaloid, in limited quantities 
as set forth below:

(1) Not more than 1 milligram of difenoxin and not less than 25     9167
 micrograms of atropine sulfate per dosage unit..................
(2) Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-   9278
 methyl-2-propionoxybutane)......................................
 

    (c) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances, including its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation:

(1) Alprazolam..................................................    2882
(2) Barbital....................................................    2145
(3) Bromazepam..................................................    2748
(4) Camazepam...................................................    2749
(5) Chloral betaine.............................................    2460
(6) Chloral hydrate.............................................    2465
(7) Chlordiazepoxide............................................    2744
(8) Clobazam....................................................    2751
(9) Clonazepam..................................................    2737
(10) Clorazepate................................................    2768
(11) Clotiazepam................................................    2752
(12) Cloxazolam.................................................    2753
(13) Delorazepam................................................    2754
(14) Diazepam...................................................    2765
(15) Dichloralphenazone.........................................    2467
(16) Estazolam..................................................    2756
(17) Ethchlorvynol..............................................    2540
(18) Ethinamate.................................................    2545

[[Page 98]]

 
(19) Ethyl loflazepate..........................................    2758
(20) Fludiazepam................................................    2759
(21) Flunitrazepam..............................................    2763
(22) Flurazepam.................................................    2767
(23) Halazepam..................................................    2762
(24) Haloxazolam................................................    2771
(25) Ketazolam..................................................    2772
(26) Loprazolam.................................................    2773
(27) Lorazepam..................................................    2885
(28) Lormetazepam...............................................    2774
(29) Mebutamate.................................................    2800
(30) Medazepam..................................................    2836
(31) Meprobamate................................................    2820
(32) Methohexital...............................................    2264
(33) Methylphenobarbital (mephobarbital)........................    2250
(34) Midazolam..................................................    2884
(35) Nimetazepam................................................    2837
(36) Nitrazepam.................................................    2834
(37) Nordiazepam................................................    2838
(38) Oxazepam...................................................    2835
(39) Oxazolam...................................................    2839
(40) Paraldehyde................................................    2585
(41) Petrichloral...............................................    2591
(42) Phenobarbital..............................................    2285
(43) Pinazepam..................................................    2883
(44) Prazepam...................................................    2764
(45) Quazepam...................................................    2881
(46) Temazepam..................................................    2925
(47) Tetrazepam.................................................    2886
(48) Triazolam..................................................    2887
(49) Zaleplon...................................................    2781
(50) Zolpidem...................................................    2783
 

    (d) Fenfluramine. Any material, compound, mixture, or preparation 
which contains any quantity of the following substances, including its 
salts, isomers (whether optical, position, or geometric), and salts of 
such isomers, whenever the existence of such salts, isomers, and salts 
of isomers is possible:

(1) Fenfluramine.................................................   1670
 

    (e) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system, including its salts, isomers and 
salts of isomers:

(1) Cathine ((+)-norpseudoephedrine).............................   1230
(2) Diethylpropion...............................................   1610
(3) Fencamfamin..................................................   1760
(4) Fenproporex..................................................   1575
(5) Mazindol.....................................................   1605
(6) Mefenorex....................................................   1580
(7)Modafinil.....................................................   1680
(8) Pemoline (including organometallic complexes and chelates       1530
 thereof)........................................................
(9) Phentermine..................................................   1640
(10) Pipradrol...................................................   1750
(11) Sibutramine.................................................   1675
(12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane)...............   1635
 

    (f) Other substances. Unless specifically excepted or unless listed 
in another schedule, any material, compound, mixture or preparation 
which contains any quantity of the following substances, including its 
salts:

(1) Pentazocine..................................................   9709
(2) Butorphanol (including its optical isomers)..................   9720
 


[39 FR 22143, June 20, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.14, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1308.15  Schedule V.

    (a) Schedule V shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section.
    (b) Narcotic drugs. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation 
containing any of the following narcotic drugs and their salts, as set 
forth below:
    (1) [Reserved]
    (c) Narcotic drugs containing non-narcotic active medicinal 
ingredients. Any compound, mixture, or preparation containing any of the 
following narcotic drugs, or their salts calculated as the free 
anhydrous base or alkaloid, in limited quantities as set forth below, 
which shall include one or more non-narcotic active medicinal 
ingredients in sufficient proportion to confer upon the compound, 
mixture, or preparation valuable medicinal qualities other than those 
possessed by narcotic drugs alone:
    (1) Not more than 200 milligrams of codeine per 100 milliliters or 
per 100 grams.
    (2) Not more than 100 milligrams of dihydrocodeine per 100 
milliliters or per 100 grams.
    (3) Not more than 100 milligrams of ethylmorphine per 100 
milliliters or per 100 grams.
    (4) Not more than 2.5 milligrams of diphenoxylate and not less than 
25 micrograms of atropine sulfate per dosage unit.
    (5) Not more than 100 milligrams of opium per 100 milliliters or per 
100 grams.
    (6) Not more than 0.5 milligram of difenoxin and not less than 25 
micrograms of atropine sulfate per dosage unit.

[[Page 99]]

    (d) Stimulants. Unless specifically exempted or excluded or unless 
listed in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of the following substances 
having a stimulant effect on the central nervous system, including its 
salts, isomers and salts of isomers:

(1) Pyrovalerone...................................................1485.
(2) [Reserved]

[39 FR 22143, June 20, 1974, as amended at 43 FR 38383, Aug. 28, 1978; 
44 FR 40888, July 13, 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. 
28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, Apr. 4, 1988; 56 FR 
61372, Dec. 3, 1991; 67 FR 62370, Oct. 7, 2002]

                     Excluded Nonnarcotic Substances



Sec. 1308.21  Application for exclusion of a nonnarcotic substance.

    (a) Any person seeking to have any nonnarcotic substance which may, 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be 
lawfully sold over the counter without a prescription, excluded from any 
schedule, pursuant to section 201(g) (1) of the Act (21 U.S.C. 811 (g) 
(1)), may apply to the Administrator, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537.
    (b) An application for an exclusion under this section shall contain 
the following information:
    (1) The name and address of the applicant;
    (2) The name of the substance for which exclusion is sought; and
    (3) The complete quantitative composition of the substance.
    (c) Within a reasonable period of time after the receipt of an 
application for an exclusion under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of his 
application, and if not accepted, the reason therefore. The 
Administrator need not accept an application for filing if any of the 
requirements prescribed in paragraph (b) of this section is lacking or 
is not set forth as to be readily understood. If the applicant desires, 
he may amend the application to meet the requirements of paragraph (b) 
of this section. If the application is accepted for filing, the 
Administrator shall issue and publish in the Federal Register his order 
on the application, which shall include a reference to the legal 
authority under which the order is issued and the findings of fact and 
conclusions of law upon which the order is based. This order shall 
specify the date on which it shall take effect. The Administrator shall 
permit any interested person to file written comments on or objections 
to the order within 60 days of the date of publication of his order in 
the Federal Register. If any such comments or objections raise 
significant issues regarding any finding of fact or conclusion of law 
upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (d) The Administrator may at any time revoke any exclusion granted 
pursuant to section 201(g) of the Act (21 U.S.C. 811(g)) by following 
the procedures set forth in paragraph (c) of this section for handling 
an application for an exclusion which has been accepted for filing.



Sec. 1308.22  Excluded substances.

    The following nonnarcotic substances which may, under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the 
counter without a prescription, are excluded from all schedules pursuant 
to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):

                                          Excluded Nonnarcotic Products
----------------------------------------------------------------------------------------------------------------
                                                                                     Controlled       (mg or mg/
            Company                  Trade name         NDC code        Form          substance          ml)
----------------------------------------------------------------------------------------------------------------
Bioline Laboratories...........  Theophed..........      00719-1945  TB          Phenobarbital.....         8.00
Goldline Laboratories..........  Guiaphed Elixir...      00182-1377  EL          Phenobarbital.....         4.00
Goldline Laboratories..........  Tedrigen Tablets..      00182-0134  TB          Phenobarbital.....         8.00
Hawthorne Products Inc.........  Choate's Leg        ..............  LQ          Chloral hydrate...       246.67
                                  Freeze.
Parke-Davis & Co...............  Tedral............      00071-0230  TB          Phenobarbital.....         8.00

[[Page 100]]

 
Parke-Davis & Co...............  Tedral Elixir.....      00071-0242  EX          Phenobarbital.....        40.00
Parke-Davis & Co...............  Tedral S.A........      00071-0231  TB          Phenobarbital.....         8.00
Parke-Davis & Co...............  Tedral Suspension.      00071-0237  SU          Phenobarbital.....        80.00
Parmed Pharmacy................  Asma-Ese..........      00349-2018  TB          Phenobarbital.....         8.10
Rondex Labs....................  Azma-Aids.........      00367-3153  TB          Phenobarbital.....         8.00
Smith Kline Consumer...........  Benzedrex.........      49692-0928  IN          Propylhexedrine...       250.00
Sterling Drug, Inc.............  Bronkolixir.......      00057-1004  EL          Phenobarbital.....         0.80
Sterling Drug, Inc.............  Bronkotabs........      00057-1005  TB          Phenobarbital.....         8.00
Vicks Chemical Co..............  Vicks Inhaler.....      23900-0010  IN          I-Desoxyephedrine.       113.00
White Hall Labs................  Primatene (P-           00573-2940  TB          Phenobarbital.....         8.00
                                  tablets).
----------------------------------------------------------------------------------------------------------------


[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, l973, 
and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 
FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 
19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997]

                      Exempt Chemical Preparations



Sec. 1308.23  Exemption of certain chemical preparations; application.

    (a) The Administrator may, by regulation, exempt from the 
application of all or any part of the Act any chemical preparation or 
mixture containing one or more controlled substances listed in any 
schedule, which preparation or mixture is intended for laboratory, 
industrial, educational, or special research purposes and not for 
general administration to a human being or other animal, if the 
preparation or mixture either:
    (1) Contains no narcotic controlled substance and is packaged in 
such a form or concentration that the packaged quantity does not present 
any significant potential for abuse (the type of packaging and the 
history of abuse of the same or similar preparations may be considered 
in determining the potential for abuse of the preparation or mixture); 
or
    (2) Contains either a narcotic or nonnarcotic controlled substance 
and one or more adulterating or denaturing agents in such a manner, 
combination, quantity, proportion, or concentration, that the 
preparation or mixture does not present any potential for abuse. If the 
preparation or mixture contains a narcotic controlled substance, the 
preparation or mixture must be formulated in such a manner that it 
incorporates methods of denaturing or other means so that the 
preparation or mixture is not liable to be abused or have ill effects, 
if abused, and so that the narcotic substance cannot in practice be 
removed.
    (b) Any person seeking to have any preparation or mixture containing 
a controlled substance and one or more noncontrolled substances exempted 
from the application of all or any part of the Act, pursuant to 
paragraph (a) of this section, may apply to the Administrator, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (c) An application for an exemption under this section shall contain 
the following information:
    (1) The name, address, and registration number, if any, of the 
applicant;
    (2) The name, address, and registration number, if any, of the 
manufacturer or importer of the preparation or mixture, if not the 
applicant;
    (3) The exact trade name or other designation of the preparation or 
mixture;
    (4) The complete qualitative and quantitative composition of the 
preparation or mixture (including all active and inactive ingredients 
and all controlled and noncontrolled substances);
    (5) The form of the immediate container in which the preparation or 
mixture will be distributed with sufficient descriptive detail to 
identify the preparation or mixture (e.g., bottle, packet, vial, soft 
plastic pillow, agar gel plate, etc.);
    (6) The dimensions or capacity of the immediate container of the 
preparation or mixture;

[[Page 101]]

    (7) The label and labeling, as defined in part 1300 of this chapter, 
of the immediate container and the commercial containers, if any, of the 
preparation or mixture;
    (8) A brief statement of the facts which the applicant believes 
justify the granting of an exemption under this paragraph, including 
information on the use to which the preparation or mixture will be put;
    (9) The date of the application; and
    (10) Which of the information submitted on the application, if any, 
is deemed by the applicant to be a trade secret or otherwise 
confidential and entitled to protection under subsection 402(a)(8) of 
the Act (21 U.S.C. 842(a) (8)) or any other law restricting public 
disclosure of information.
    (d) The Administrator may require the applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted.
    (e) Within a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of his 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (c) or requested pursuant to paragraph (d) is 
lacking or is not set forth as to be readily understood. If the 
applicant desires, he may amend the application to meet the requirements 
of paragraphs (c) and (d) of this section. If the application is 
accepted for filing, the Administrator shall issue and publish in the 
Federal Register his order on the application, which shall include a 
reference to the legal authority under which the order is based. This 
order shall specify the date on which it shall take effect. The 
Administrator shall permit any interested person to file written 
comments on or objections to the order within 60 days of the date of 
publication of his order in the Federal Register. If any such comments 
or objections raise significant issues regarding any finding of fact or 
conclusion of law upon which the order is based, the Administrator shall 
immediately suspend the effectiveness of the order until he may 
reconsider the application in light of the comments and objections 
filed. Thereafter, the Administrator shall reinstate, revoke, or amend 
his original order as he determines appropriate.
    (f) The Administrator may at any time revoke or modify any exemption 
granted pursuant to this section by following the procedures set forth 
in paragraph (e) of this section for handling an application for an 
exemption which has been accepted for filing. The Administrator may also 
modify or revoke the criteria by which exemptions are granted (and 
thereby modify or revoke all preparations and mixtures granted under the 
old criteria) and modify the scope of exemptions at any time.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 46 FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, 1997]



Sec. 1308.24  Exempt chemical preparations.

    (a) The chemical preparations and mixtures approved pursuant to 
Sec. 1308.23 are exempt from application of sections 302, 303, 305, 
306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822-823, 
825-829, 952-954) and Sec. 1301.74 of this chapter, to the extent 
described in paragraphs (b) to (h) of this section. Substances set forth 
in paragraph (j) of this section shall be exempt from the application of 
sections 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 
U.S.C. 825-829, 952-954) and Sec. Sec. 1301.71--1301.73 and 1301.74 
(a), (b), (d), (e) and (f) of this chapter to the extent as hereinafter 
may be provided.
    (b) Registration and security: Any person who manufactures an exempt 
chemical preparation or mixture must be registered under the Act and 
comply with all relevant security requirements regarding controlled 
substances being used in the manufacturing process until the preparation 
or mixture is in the form described in paragraph (i) of this section. 
Any other person who handles an exempt chemical preparation after it is 
in the form described in paragraph (i) of this section is not required 
to be registered under the Act to handle that preparation, and the 
preparation is not required to be stored

[[Page 102]]

in accordance with security requirements regarding controlled 
substances.
    (c) Labeling: In lieu of the requirements set forth in part 1302 of 
this chapter, the label and the labeling of an exempt chemical 
preparation must be prominently marked with its full trade name or other 
description and the name of the manufacturer or supplier as set forth in 
paragraph (i) of this section, in such a way that the product can be 
readily identified as an exempt chemical preparation. The label and 
labeling must also include in a prominent manner the statement ``For 
industrial use only'' or ``For chemical use only'' or ``For in vitro use 
only--not for human or animal use'' or ``Diagnostic reagent--for 
professional use only'' or a comparable statement warning the person 
reading it that human or animal use is not intended. The symbol 
designating the schedule of the controlled substance is not required on 
either the label or the labeling of the exempt chemical preparation, nor 
is it necessary to list all ingredients of the preparation.
    (d) Records and reports: Any person who manufactures an exempt 
chemical preparation or mixture must keep complete and accurate records 
and file all reports required under part 1304 of this chapter regarding 
all controlled substances being used in the manufacturing process until 
the preparation or mixture is in the form described in paragraph (i) of 
this section. In lieu of records and reports required under part 1304 of 
this chapter regarding exempt chemical preparations, the manufacturer 
need only record the name, address, and registration number, if any, of 
each person to whom the manufacturer distributes any exempt chemical 
preparation. Each importer or exporter of an exempt narcotic chemical 
preparation must submit a semiannual report of the total quantity of 
each substance imported or exported in each calendar half-year within 30 
days of the close of the period to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration, Department of Justice, 
Washington, DC 20537. Any other person who handles an exempt chemical 
preparation after it is in the form described in paragraph (i) of this 
section is not required to maintain records or file reports.
    (e) Quotas, order forms, prescriptions, import, export, and 
transshipment requirements: Once an exempt chemical preparation is in 
the form described in paragraph (i) of this section, the requirements 
regarding quotas, order forms, prescriptions, import permits and 
declarations, export permit and declarations, and transshipment and 
intransit permits and declarations do not apply. These requirements do 
apply, however, to any controlled substances used in manufacturing the 
exempt chemical preparation before it is in the form described in 
paragraph (i) of this section.
    (f) Criminal penalties: No exemption granted pursuant to Sec. 
1308.23 affects the criminal liability for illegal manufacture, 
distribution, or possession of controlled substances contained in the 
exempt chemical preparation. Distribution, possession, and use of an 
exempt chemical preparation are lawful for registrants and 
nonregistrants only as long as such distribution, possession, or use is 
intended for laboratory, industrial, or educational purposes and not for 
immediate or subsequent administration to a human being or other animal.
    (g) Bulk materials: For materials exempted in bulk quantities, the 
Administrator may prescribe requirements other than those set forth in 
paragraphs (b) through (e) of this section on a case-by-case basis.
    (h) Changes in chemical preparations: Any change in the quantitative 
or qualitative composition of the preparation or mixture after the date 
of application, or change in the trade name or other designation of the 
preparation or mixture, set forth in paragraph (i) of this section, 
requires a new application for exemption.
    (i) A listing of exempt chemical preparations may be obtained by 
submitting a written request to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration, Washington, DC 20537.
    (j) The following substances are designated as exempt chemical 
preparations for the purposes set forth in this section.

[[Page 103]]

    (1) Chloral. When packaged in a sealed, oxygen-free environment, 
under nitrogen pressure, safeguarded against exposure to the air.
    (2) Emit\R\ Phenobarbital Enzyme Reagent B. In one liter quantities 
each with a 5 ml. retention sample for repackaging as an exempt chemical 
preparation only.

[38 FR 8255, Mar. 30, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.24, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.

          Excluded Veterinary Anabolic Steroid Implant Products



Sec. 1308.25  Exclusion of a veterinary anabolic steroid implant product; 
application.

    (a) Any person seeking to have any anabolic steroid product, which 
is expressly intended for administration through implants to cattle or 
other nonhuman species and which has been approved by the Secretary of 
Health and Human Services for such administration, identified as being 
excluded from any schedule, pursuant to section 102(41)(B)(i) of the Act 
(21 U.S.C. 802(41)(B)(i)), may apply to the Administrator, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (b) An application for any exclusion under this section shall be 
submitted in triplicate and contain the following information:
    (1) The name and address of the applicant;
    (2) The name of the product;
    (3) The chemical structural formula or description for any anabolic 
steroid contained in the product;
    (4) A complete description of dosage and quantitative composition of 
the dosage form;.
    (5) The conditions of use including whether or not Federal law 
restricts this product to use by or on the order of a licensed 
veterinarian;
    (6) A description of the delivery system in which the dosage form 
will be distributed with sufficient detail to identify the product (e.g. 
20 cartridge brown plastic belt);
    (7) The label and labeling of the immediate container and the 
commercial containers, if any, of the product;.
    (8) The name and address of the manufacturer of the dosage form if 
different from that of the applicant; and
    (9) Evidence that the product has been approved by the Secretary of 
Health and Human Services for administration through implant to cattle 
or other nonhuman species.
    (c) Within a reasonable period of time after the receipt of an 
application for an exclusion under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of the 
application, and if not accepted, the reason therefore. The 
Administrator need not accept an application for filing if any of the 
requirements prescribed in paragraph (b) of this section is lacking or 
is not set forth as to be readily understood. The applicant may amend 
the application to meet the requirements of paragraph (b) of this 
section. If the application is accepted for filing, the Administrator 
shall issue and have published in the Federal Register his order on the 
application, which shall include a reference to the legal authority 
under which the order is issued and the findings of fact and conclusions 
of law upon which the order is based. This order shall specify the date 
on which it will take effect. The Administrator shall permit any 
interested person to file written comments on or objections to the order 
within 60 days of the date of publication in the Federal Register. If 
any such comments or objections raise significant issues regarding any 
finding of fact or conclusion of law upon which the order is based, the 
Administrator shall immediately suspend the effectiveness of the order 
until he may reconsider the application in light of the comments and 
objections filed. Thereafter, the Administrator shall reinstate, revoke, 
or amend his original order as he determines appropriate.
    (d) The Administrator may at any time revoke or modify any 
designation of excluded status granted pursuant to this section by 
following the procedures set forth in paragraph (c) of this section for 
handling an application for

[[Page 104]]

an exclusion which has been accepted for filing.

[56 FR 42936, Aug. 30, 1991]



Sec. 1308.26  Excluded veterinary anabolic steroid implant products.

    (a) Products containing an anabolic steroid, that are expressly 
intended for administration through implants to cattle or other nonhuman 
species and which have been approved by the Secretary of Health and 
Human Services for such administration are excluded from all schedules 
pursuant to section 102(41)(B)(I) of the Act (21 U.S.C. 802(41)(B)(I)). 
A listing of the excluded products may be obtained by submitting a 
written request to the Drug and Chemical Evaluation Section, Drug 
Enforcement Administration, Washington DC 20537.
    (b) In accordance with section 102(41)(B)(ii) of the Act (21 U.S.C. 
802(41)(B)(ii)) if any person prescribes, dispenses, or distributes a 
product listed in paragraph (a) of this section for human use, such 
person shall be considered to have prescribed, dispensed, or distributed 
an anabolic steroid within the meaning of section 102(41)(A) of the Act 
(21 U.S.C. 802(41)(A)).

[56 FR 42936, Aug. 30, 1991, as amended at 57 FR 19534, May 7, 1992; 58 
FR 15088, Mar. 19, 1993; 62 FR 13967, Mar. 24, 1997]

                     Exempted Prescription Products



Sec. 1308.31  Application for exemption of a nonnarcotic prescription 
product.

    (a) Any person seeking to have any compound, mixture, or preparation 
containing any nonnarcotic controlled substance listed in Sec. 
1308.12(e), or in Sec. 1308.13 (b) or (c), or in Sec. 1308.14, or in 
Sec. 1308.15, exempted from application of all or any part of the Act 
pursuant to section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A). 
may apply to the Administrator, Drug Enforcement Administration, 
Washington, DC 20537, for such exemption.
    (b) An application for an exemption under this section shall contain 
the following information:
    (1) The complete quantitative composition of the dosage form.
    (2) Description of the unit dosage form together with complete 
labeling.
    (3) A summary of the pharmacology of the product including animal 
investigations and clinical evaluations and studies, with emphasis on 
the psychic and/or physiological dependence liability (this must be done 
for each of the active ingredients separately and for the combination 
product).
    (4) Details of synergisms and antagonisms among ingredients.
    (5) Deterrent effects of the noncontrolled ingredients.
    (6) Complete copies of all literature in support of claims.
    (7) Reported instances of abuse.
    (8) Reported and anticipated adverse effects.
    (9) Number of dosage units produced for the past 2 years.
    (c) Within a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or non-acceptance of the 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (b) of this section is lacking or is not set 
forth so as to be readily understood. If the applicant desires, he may 
amend the application to meet the requirements of paragraph (b) of this 
section. If accepted for filing, the Administrator shall publish in the 
Federal Register general notice of this proposed rulemaking in granting 
or denying the application. Such notice shall include a reference to the 
legal authority under which the rule is proposed, a statement of the 
proposed rule granting or denying an exemption, and, in the discretion 
of the Administrator, a summary of the subjects and issues involved. The 
Administrator shall permit any interested person to file written 
comments on or objections to the proposal and shall designate in the 
notice of proposed rule making the time during which such filings may be 
made. After consideration of the application and any comments on or 
objections to his proposed rulemaking, the Administrator shall issue and 
publish in the Federal Register his final order on the application, 
which shall set forth the findings of fact and conclusions of law upon 
which the order is based. This

[[Page 105]]

order shall specify the date on which it shall take effect, which shall 
not be less than 30 days from the date of publication in the Federal 
Register unless the Administrator finds that conditions of public health 
or safety necessitate an earlier effective date, in which event the 
Administrator shall specify in the order his findings as to such 
conditions.
    (d) The Administrator may revoke any exemption granted pursuant to 
section 201(g)(3)(A) of the Act (21 U.S.C. 811(g)(3)(A)) by following 
the procedures set forth in paragraph (c) of this section for handling 
an application for an exemption which has been accepted for filing.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 44 FR 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987]



Sec. 1308.32  Exempted prescription products.

    The compounds, mixtures, or preparations that contain a nonnarcotic 
controlled substance listed in Sec. 1308.12(e) or in Sec. 1308.13 (b) 
or (c) or in Sec. 1308.14 or in Sec. 1308.15 listed in the Table of 
Exempted Prescription Products have been exempted by the Administrator 
from the application of sections 302 through 305, 307 through 309, 1002 
through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) and 
Sec. Sec. 1301.13, 1301.22, and Sec. Sec. 1301.71 through 1301.76 of 
this chapter for administrative purposes only. An exception to the above 
is that those products containing butalbital shall not be exempt from 
the requirement of 21 U.S.C. 952-954 concerning importation, 
exportation, transshipment and in-transit shipment of controlled 
substances. Any deviation from the quantitative composition of any of 
the listed drugs shall require a petition of exemption in order for the 
product to be exempted. A listing of the Exempted Prescription Products 
may be obtained by submitting a written request to the Drug and Chemical 
Evaluation Section, Drug Enforcement Administration, Washington, DC 
20537.

[62 FR 13967, Mar. 24, 1997]

                    Exempt Anabolic Steroid Products



Sec. 1308.33  Exemption of certain anabolic steroid products; application.

    (a) The Administrator, upon the recommendation of the Secretary of 
Health and Human Services, may, by regulation, exempt from the 
application of all or any part of the Act any compound, mixture, or 
preparation containing an anabolic steroid as defined in part 1300 of 
this chapter if, because of its concentration, preparation, mixture or 
delivery system, it has no significant potential for abuse (Pub. L. 101-
647 section 1903(a)).
    (b) Any person seeking to have any compound, mixture, or preparation 
containing an anabolic steroid as defined in part 1300 of this chapter 
exempted from the application of all or any part of the Act, pursuant to 
paragraph (a) of this section, may apply to the Administrator, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (c) An application for an exemption under this section shall be 
submitted in triplicate and contain the following information:
    (1) The name and address of the applicant;
    (2) The name of the product;
    (3) The chemical structural formula or description for any anabolic 
steroid contained in the product;
    (4) The complete description of dosage and quantitative composition 
of the dosage form;
    (5) A description of the delivery system, if applicable;
    (6) The indications and conditions for use in which species, 
including whether or not this product is a prescription drug;
    (7) Information to facilitate identification of the dosage form, 
such as shape, color, coating, and scoring;
    (8) The label and labeling of the immediate container and the 
commercial containers, if any, of the product;
    (9) The units in which the dosage form is ordinarily available; and
    (10) The facts which the applicant believes justify:
    (i) A determination that the product has no significant potential 
for abuse and

[[Page 106]]

    (ii) a granting of an exemption under this section.
    (d) Within a reasonable period of time after the receipt of the 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of the 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (c) of this section is lacking or is not set 
forth so as to be readily understood. The applicant may amend the 
application to meet the requirements of paragraph (c) of this section. 
If accepted for filing, the Administrator will request from the 
Secretary for Health and Human Services his recommendation, as to 
whether such product which contains an anabolic steroid should be 
considered for exemption from certain portions of the Controlled 
Substances Act. On receipt of the recommendation of the Secretary, the 
Administrator shall make a determination as to whether the evidence 
submitted or otherwise available sufficiently establishes that the 
product possesses no significant potential for abuse. The Administrator 
shall issue and publish in the Federal Register his order on the 
application, which shall include a reference to the legal authority 
under which the order is issued, and the findings of fact and 
conclusions of law upon which the order is based. This order shall 
specify the date on which it will take effect. The Administrator shall 
permit any interested person to file written comments on or objections 
to the order within 60 days of the date of publication of his order in 
the Federal Register. If any such comments or objections raise 
significant issues regarding any finding of fact or conclusion of law 
upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (e) The Administrator may revoke any exemption granted pursuant to 
section 1903(a) of Public Law 101-647 by following the procedures set 
forth in paragraph (d) of this section for handling an application for 
an exemption which has been accepted for filing.

[56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. 31, 1992, as amended at 
62 FR 13968, Mar. 24, 1997]



Sec. 1308.34  Exempt anabolic steroid products.

    The list of compounds, mixtures, or preparations that contain an 
anabolic steroid that have been exempted by the Administrator from 
application of sections 302 through 309 and 1002 through 1004 of the Act 
(21 U.S.C. 822-829 and 952-954) and Sec. Sec. 1301.13, 1301.22, and 
1301.71 through 1301.76 of this chapter for administrative purposes only 
may be obtained by submitting a written request to the Drug and Chemical 
Evaluation Section, Drug Enforcement Administration, Washington, DC 
20537.

[62 FR 13967, Mar. 24, 1997]

   Exempt Cannabis Plant Material, and Products Made Therefrom, that 
                      Contain Tetrahydrocannabinols



Sec. 1308.35  Exemption of certain cannabis plant material, and products 
made therefrom, that contain tetrahydrocannabinols.

    (a) Any processed plant material or animal feed mixture containing 
any amount of tetrahydrocannabinols (THC) that is both:
    (1) Made from any portion of a plant of the genus Cannabis excluded 
from the definition of marijuana under the Act [i.e., the mature stalks 
of such plant, fiber produced from such stalks, oil or cake made from 
the seeds of such plant, any other compound, manufacture, salt, 
derivative, mixture, or preparation of such mature stalks (except the 
resin extracted therefrom), fiber, oil, or cake, or the sterilized seed 
of such plant which is incapable of germination] and
    (2) Not used, or intended for use, for human consumption, has been 
exempted by the Administrator from the application of the Act and this 
chapter.
    (b) As used in this section, the following terms shall have the 
meanings specified:
    (1) The term processed plant material means cannabis plant material 
that

[[Page 107]]

has been subject to industrial processes, or mixed with other 
ingredients, such that it cannot readily be converted into any form that 
can be used for human consumption.
    (2) The term animal feed mixture means sterilized cannabis seeds 
mixed with other ingredients (not derived from the cannabis plant) in a 
formulation that is designed, marketed, and distributed for animal 
consumption (and not for human consumption).
    (3) The term used for human consumption means either:
    (i) Ingested orally or
    (ii) Applied by any means such that THC enters the human body.
    (4) The term intended for use for human consumption means any of the 
following:
    (i) Designed by the manufacturer for human consumption;
    (ii) Marketed for human consumption; or
    (iii) Distributed, exported, or imported, with the intent that it be 
used for human consumption.
    (c) In any proceeding arising under the Act or this chapter, the 
burden of going forward with the evidence that a material, compound, 
mixture, or preparation containing THC is exempt from control pursuant 
to this section shall be upon the person claiming such exemption, as set 
forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to 
meet this burden with respect to a product or plant material that has 
not been expressly exempted from control by the Administrator pursuant 
to Sec. 1308.23, the person claiming the exemption must present 
rigorous scientific evidence, including well-documented scientific 
studies by experts trained and qualified to evaluate the effects of 
drugs on humans.

[66 FR 51544, Oct. 9, 2001]

                                Hearings



Sec. 1308.41  Hearings generally.

    In any case where the Administrator shall hold a hearing on the 
issuance, amendment, or repeal of rules pursuant to section 201 of the 
Act, the procedures for such hearing and accompanying proceedings shall 
be governed generally by the rulemaking procedures set forth in the 
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
section 201 of the Act (21 U.S.C. 811), by Sec. Sec. 1308.42-1308.51, 
and by Sec. Sec. 1316.41-1316.67 of this chapter.



Sec. 1308.42  Purpose of hearing.

    If requested by any interested person after proceedings are 
initiated pursuant to Sec. 1308.43, the Administrator shall hold a 
hearing for the purpose of receiving factual evidence and expert opinion 
regarding the issues involved in the issuance, amendment or repeal of a 
rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)). 
Extensive argument should not be offered into evidence but rather 
presented in opening or closing statements of counsel or in memoranda or 
proposed findings of fact and conclusions of law. Additional information 
relating to hearings to include waivers or modification of rules, 
request for hearing, burden of proof, time and place, and final order 
are set forth in part 1316 of this chapter.

[62 FR 13968, Mar. 24, 1997]



Sec. 1308.43  Initiation of proceedings for rulemaking.

    (a) Any interested person may submit a petition to initiate 
proceedings for the issuance, amendment, or repeal of any rule or 
regulation issuable pursuant to the provisions of section 201 of the 
Act.
    (b) Petitions shall be submitted in quintuplicate to the 
Administrator in the following form:

________________________________________________________________________
(Date)
Administrator, Drug Enforcement
Administration
Department of Justice,
Washington, DC 20537.
    Dear Sir: The undersigned ------------ hereby petitions the 
Administrator to initiate proceedings for the issuance (amendment or 
repeal) of a rule or regulation pursuant to section 201 of the 
Controlled Substances Act.
    Attached hereto and constituting a part of this petition are the 
following:
    (A) The proposed rule in the form proposed by the petitioner. (If 
the petitioner seeks the amendment or repeal of an existing rule, the 
existing rule, together with a reference to the section in the Code of 
Federal Regulations where it appears, should be included.)

[[Page 108]]

    (B) A statement of the grounds which the petitioner relies for the 
issuance (amendment or repeal) of the rule. (Such grounds shall include 
a reasonably concise statement of the facts relied upon by the 
petitioner, including a summary of any relevant medical or scientific 
evidence known to the petitioner.)
    All notices to be sent regarding this petition should be addressed 
to:

________________________________________________________________________

                                 (Name)

________________________________________________________________________

                            (Street Address)

________________________________________________________________________

                            (City and State)

    Respectfully yours,

________________________________________________________________________

                        (Signature of petitioner)

    (c) Within a reasonable period of time after the receipt of a 
petition, the Administrator shall notify the petitioner of his 
acceptance or nonacceptance of the petition, and if not accepted, the 
reason therefor. The Administrator need not accept a petition for filing 
if any of the requirements prescribed in paragraph (b) of this section 
is lacking or is not set forth so as to be readily understood. If the 
petitioner desires, he may amend the petition to meet the requirements 
of paragraph (b) of this section. If accepted for filing, a petition may 
be denied by the Administrator within a reasonable period of time 
thereafter if he finds the grounds upon which the petitioner relies are 
not sufficient to justify the initiation of proceedings.
    (d) The Administrator shall, before initiating proceedings for the 
issuance, amendment, or repeal of any rule either to control a drug or 
other substance, or to transfer a drug or other substance from one 
schedule to another, or to remove a drug or other substance entirely 
from the schedules, and after gathering the necessary data, request from 
the Secretary a scientific and medical evaluation and the Secretary's 
recommendations as to whether such drug or other substance should be so 
controlled, transferred, or removed as a controlled substance. The 
recommendations of the Secretary to the Administrator shall be binding 
on the Administrator as to such scientific and medical matters, and if 
the Secretary recommends that a drug or other substance not be 
controlled, the Administrator shall not control that drug or other 
substance.
    (e) If the Administrator determines that the scientific and medical 
evaluation and recommendations of the Secretary and all other relevant 
data constitute substantial evidence of potential for abuse such as to 
warrant control or additional control over the drug or other substance, 
or substantial evidence that the drug or other substances should be 
subjected to lesser control or removed entirely from the schedules, he 
shall initiate proceedings for control, transfer, or removal as the case 
may be.
    (f) If and when the Administrator determines to initiate 
proceedings, he shall publish in the Federal Register general notice of 
any proposed rule making to issue, amend, or repeal any rule pursuant to 
section 201 of the Act. Such published notice shall include a statement 
of the time, place, and nature of any hearings on the proposal in the 
event a hearing is requested pursuant to Sec. 1308.44. Such hearings 
may not be commenced until after the expiration of at least 30 days from 
the date the general notice is published in the Federal Register. Such 
published notice shall also include a reference to the legal authority 
under which the rule is proposed, a statement of the proposed rule, and, 
in the discretion of the Administrator, a summary of the subjects and 
issues involved.
    (g) The Administrator may permit any interested persons to file 
written comments on or objections to the proposal and shall designate in 
the notice of proposed rule making the time during which such filings 
may be made.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.44  Request for hearing or appearance; waiver.

    (a) Any interested person desiring a hearing on a proposed 
rulemaking, shall, within 30 days after the date of publication of 
notice of the proposed

[[Page 109]]

rulemaking in the Federal Register, file with the Administrator a 
written request for a hearing in the form prescribed in Sec. 1316.47 of 
this chapter.
    (b) Any interested person desiring to participate in a hearing 
pursuant to Sec. 1308.41 shall, within 30 days after the date of 
publication of the notice of hearing in the Federal Register, file with 
the Administrator a written notice of his intention to participate in 
such hearing in the form prescribed in Sec. 1316.48 of this chapter. 
Any person filing a request for a hearing need not also file a notice of 
appearance; the request for a hearing shall be deemed to be a notice of 
appearance.
    (c) Any interested person may, within the period permitted for 
filing a request for a hearing, file with the Administrator a waiver of 
an opportunity for a hearing or to participate in a hearing, together 
with a written statement regarding his position on the matters of fact 
and law involved in such hearing. Such statement, if admissible, shall 
be made a part of the record and shall be considered in light of the 
lack of opportunity for cross-examination in determining the weight to 
be attached to matters of fact asserted therein.
    (d) If any interested person fails to file a request for a hearing; 
or if he so files and fails to appear at the hearing, he shall be deemed 
to have waived his opportunity for the hearing or to participate in the 
hearing, unless he shows good cause for such failure.
    (e) If all interested persons waive or are deemed to waive their 
opportunity for the hearing or to participate in the hearing, the 
Administrator may cancel the hearing, if scheduled, and issue his final 
order pursuant to Sec. 1308.45 without a hearing.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.45  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall cause to be 
published in the Federal Register his order in the proceeding, which 
shall set forth the final rule and the findings of fact and conclusions 
of law upon which the rule is based. This order shall specify the date 
on which it shall take effect, which shall not be less than 30 days from 
the date of publication in the Federal Register unless the Administrator 
finds that conditions of public health or safety necessitate an earlier 
effective date, in which event the Administrator shall specify in the 
order his findings as to such conditions.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.46  Control required under international treaty.

    Pursuant to section 201(d) of the Act (21 U.S.C. 811(d) ), where 
control of a substance is required by U.S. obligations under 
international treaties, conventions, or protocols in effect on May 1, 
1971, the Administrator shall issue and publish in the Federal Register 
an order controlling such substance under the schedule he deems most 
appropriate to carry out obligations. Issuance of such an order shall be 
without regard to the findings required by subsections 201(a) or 202(b) 
of the Act (21 U.S.C. 811(a) or 812(b)) and without regard to the 
procedures prescribed by Sec. 1308.41 or subsections 201 (a) and (b) of 
the Act (21 U.S.C. 811 (a) and (b)). An order controlling a substance 
shall become effective 30 days from the date of publication in the 
Federal Register, unless the Administrator finds that conditions of 
public health or safety necessitate an earlier effective date, in which 
event the Administrator shall specify in the order his findings as to 
such conditions.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.47  Control of immediate precursors.

    Pursuant to section 201(e) of the Act (21 U.S.C. 811(e)), the 
Administrator may, without regard to the findings required by subsection 
201(a) or 202 (b) of the Act (21 U.S.C. 811(a) or 812(b)) and without 
regard to the procedures prescribed by Sec. 1308.41 or subsections 201 
(a) and (b) of the Act (21 U.S.C. 811(a) and (b)), issue and publish in 
the Federal Register an order controlling an

[[Page 110]]

immediate precursor. The order shall designate the schedule in which the 
immediate precursor is to be placed, which shall be the same schedule in 
which the controlled substance of which it is an immediate precursor is 
placed or any other schedule with a higher numerical designation. An 
order controlling an immediate precursor shall become effective 30 days 
from the date of publication in the Federal Register, unless the 
Administrator finds that conditions of public health or safety 
necessitate an earlier effective date, in which event the Administrator 
shall specify in the order his findings as to such conditions.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.49  Emergency scheduling.

    Pursuant to 21 U.S.C. 811(h) and without regard to the requirements 
of 21 U.S.C. 811(b) relating to the scientific and medical evaluation of 
the Secretary of Health and Human Services, the Administrator may place 
a substance into Schedule I on a temporary basis, if he determines that 
such action is necessary to avoid an imminent hazard to the public 
safety. An order issued under this section may not be effective before 
the expiration of 30 days from:
    (a) The date of publication by the Administrator of a notice in the 
Federal Register of his intention to issue such order and the grounds 
upon which such order is to be issued, and
    (b) The date the Administrator has transmitted notification to the 
Secretary of Health and Human Services of his intention to issue such 
order. An order issued under this section shall be vacated upon the 
conclusion of a subsequent rulemaking proceeding initiated under section 
201(a) (21 U.S.C. 811(a)) with respect to such substance or at the end 
of one year from the effective date of the order scheduling the 
substance, except that during the pendency of proceedings under section 
201(a) (21 U.S.C. 811(a)) with respect to the substance, the 
Administrator may extend the temporary scheduling for up to six months.

[51 FR 15318, Apr. 23, 1986. Redesignated and amended at 62 FR 13968, 
Mar. 24, 1997]



PART 1309_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND 
EXPORTERS OF LIST I CHEMICALS--Table of Contents

                           General Information

Sec.
1309.01 Scope of part 1309.
1309.02 Definitions.
1309.03 Information; special instructions.

                Fees for Registration and Reregistration

1309.11 Fee amounts.
1309.12 Time and method of payment; refund.

                      Requirements for Registration

1309.21 Persons required to register.
1309.22 Separate registration for independent activities.
1309.23 Separate registration for separate locations.
1309.24 Waiver of registration requirement for certain activities.
1309.25 Temporary exemption from registration for chemical registration 
          applicants.
1309.26 Exemption of law enforcement officials.

                      Application for Registration

1309.31 Time for application for registration; expiration date.
1309.32 Application forms; contents, signature.
1309.33 Filing of application; joint filings.
1309.34 Acceptance for filing; defective applications.
1309.35 Additional information.
1309.36 Amendments to and withdrawals of applications.

  Action on Applications for Registration: Revocation or Suspension of 
                              Registration

1309.41 Administrative review generally.
1309.42 Certificate of registration; denial of registration.
1309.43 Suspension or revocation of registration.
1309.44 Suspension of registration pending final order.
1309.45 Extension of registration pending final order.
1309.46 Order to show cause.

                                Hearings

1309.51 Hearings generally.
1309.52 Purpose of hearing.
1309.53 Request for hearing or appearance; waiver.
1309.54 Burden of proof.
1309.55 Time and place of hearing.

[[Page 111]]

         Modification, Transfer and Termination of Registration

1309.61 Modification in registration.
1309.62 Termination of registration.
1309.63 Transfer of registration.

                          Security Requirements

1309.71 General security requirements.
1309.72 Felony conviction; employer responsibilities.
1309.73 Employee responsibility to report diversion.

    Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877, 958.

    Source: 60 FR 32454, June 22, 1995, unless otherwise noted.

                           General Information



Sec. 1309.01  Scope of part 1309.

    Procedures governing the registration of manufacturers, 
distributors, importers and exporters of List I chemicals pursuant to 
Sections 102, 302, 303, 1007 and 1008 of the Act (21 U.S.C. 802, 822, 
823, 957 and 958) are set forth generally by those sections and 
specifically by the sections of this part.



Sec. 1309.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13968, Mar. 24, 1997]



Sec. 1309.03  Information; special instructions.

    Information regarding procedures under these rules and instructions 
supplementing these rules will be furnished upon request by writing to 
the Drug Enforcement Administration, Chemical Operations Section, Office 
of Diversion Control, Washington, D.C. 20537.

                Fees for Registration and Reregistration



Sec. 1309.11  Fee amounts.

    (a) For each initial registration to manufacture for distribution, 
distribute, import, or export, the applicant shall pay a fee of $595 for 
a annual registration.
    (b) For each reregistration to manufacture for distribution, 
distribute, import, or export, the registrant shall pay a fee of $477 
for an annual registration.
    (c) For each initial registration to conduct business as a retail 
distributor the applicant shall pay an application processing fee of $7 
and an investigation fee of $248, for an annual registration.
    (d) For each reregistration to conduct business as a retail 
distributor the registrant shall pay a fee of $116.



Sec. 1309.12  Time and method of payment; refund.

    (a) For each application for registration or reregistration to 
manufacture for distribution, distribute, import, or export, the 
applicant shall pay the fee when the application for registration or 
reregistration is submitted for filing.
    (b) For retail the distributor initial applications, the applicant 
shall pay the application processing fee when the application for 
registration is submitted for filing. The investigation fee shall be 
paid within 30 days after DEA notifies the applicant that the 
preregistration investigation has been scheduled.
    (c) For retail distributor reregistration applications, the 
registrant shall pay the fee when the application for reregistration is 
submitted for filing.
    (d) Payments should be made in the form of a personal, certified, or 
cashier's check or money order made payable to ``Drug Enforcement 
Administration.'' Payments made in the form of stamps, foreign currency, 
or third party endorsed checks will not be accepted. These application 
fees are not refundable.

[60 FR 32454, June 22, 1995; 60 FR 35264, July 6, 1995]

                      Requirements for Registration



Sec. 1309.21  Persons required to register.

    (a) Every person who distributes, imports, or exports any List I 
chemical, other than those List I chemicals contained in a product 
exempted under Sec. 1300.02(b)(28)(i)(D) of this chapter (irrespective 
of the threshold provisions under Sec. 1300.02(b)(28)(i)(D)(2) of this 
chapter), or who proposes to engage in

[[Page 112]]

the distribution, importation, or exportation of any List I chemical, 
shall obtain annually a registration specific to the List I chemicals to 
be handled, unless exempted by law or pursuant to Sec. Sec. 1309.24 
through 1309.26 of this part. Only persons actually engaged in such 
activities are required to obtain a registration; related or affiliated 
persons who are not engaged in such activities are not required to be 
registered. (For example, a stockholder or parent corporation of a 
corporation distributing List I chemicals is not required to obtain a 
registration.)
    (b) Every person who distributes or exports a List I chemical they 
have manufactured, other than a List I chemical contained in a product 
exempted under Sec. 1300.02(b)(28)(i)(D) of this chapter, or proposes 
to distribute or export a List I chemical they have manufactured, shall 
obtain annually a registration specific to the List I chemicals to be 
handled, unless exempted by law or pursuant to Sec. Sec. 1309.24 
through 1309.26 of this part.

[67 FR 14860, Mar. 28, 2002]



Sec. 1309.22  Separate registration for independent activities.

    (a) The following groups of activities are deemed to be independent 
of each other:
    (1) Retail distributing of List I chemicals;
    (2) Non-Retail distributing of List I chemicals;
    (3) Importing List I chemicals; and
    (4) Exporting List I chemicals.
    (b) Every person who engages in more than one group of independent 
activities shall obtain a separate registration for each group of 
activities, unless otherwise exempted by the Act or Sec. Sec. 1309.24 
through 1309.26, except that a person registered to import any List I 
chemical shall be authorized to distribute that List I chemical after 
importation, but no other chemical that the person is not registered to 
import.

[60 FR 32454, June 22, 1995, as amended at 61 FR 32926, June 26, 1996; 
67 FR 14860, Mar. 28, 2002]



Sec. 1309.23  Separate registration for separate locations.

    (a) A separate registration is required for each principal place of 
business at one general physical location where List I chemicals are 
distributed, imported, or exported by a person.
    (b) The following locations shall be deemed to be places not subject 
to the registration requirement:
    (1) A warehouse where List I chemicals are stored by or on behalf of 
a registered person, unless such chemicals are distributed directly from 
such warehouse to locations other than the registered location from 
which the chemicals were originally delivered; and
    (2) An office used by agents of a registrant where sales of List I 
chemicals are solicited, made, or supervised but which neither contains 
such chemicals (other than chemicals for display purposes) nor serves as 
a distribution point for filling sales orders.



Sec. 1309.24  Waiver of registration requirement for certain activities.

    (a) The requirement of registration is waived for any agent or 
employee of a person who is registered to engage in any group of 
independent activities, if such agent or employee is acting in the usual 
course of his or her business or employment.
    (b) The requirement of registration is waived for any person who 
distributes a product containing a List I chemical that is regulated 
pursuant to Sec. 1300.02(b)(28)(i)(D), if that person is registered 
with the Administration to manufacture, distribute or dispense a 
controlled substance.
    (c) The requirement of registration is waived for any person who 
imports or exports a product containing a List I chemical that is 
regulated pursuant to Sec. 1300.02(b)(28)(i)(D), if that person is 
registered with the Administration to engage in the same activity with a 
controlled substance.
    (d) The requirement of registration is waived for any person who 
distributes a prescription drug product containing a List I chemical 
that is regulated pursuant to Sec. 1300.02(b)(28)(i)(D) of this 
chapter.
    (e) The requirement of registration is waived for any retail 
distributor whose activities with respect to List I chemicals are 
limited to the distribution of below-threshold quantities of a

[[Page 113]]

pseudoephedrine, phenylpropanolamine, or combination ephedrine product 
that is regulated pursuant to Sec. 1300.02(b)(28)(i)(D) of this 
chapter, in a single transaction to an individual for legitimate medical 
use, irrespective of whether the form of packaging of the product meets 
the definition of ``ordinary over-the-counter pseudoephedrine or 
phenylpropanolamine product'' under Sec. 1300.02(b)(31) of this 
chapter.
    (f) The requirement of registration is waived for any person whose 
activities with respect to List I chemicals are limited to the 
distribution of red phosphorus, white phosphorus, or hypophosphorous 
acid (and its salts) to: another location operated by the same firm 
solely for internal end-use; or an EPA or State licensed waste treatment 
or disposal firm for the purpose of waste disposal.
    (g) The requirement of registration is waived for any person whose 
distribution of red phosphorus or white phosphorus is limited solely to 
residual quantities of chemical returned to the producer, in reusable 
rail cars and intermodal tank containers which conform to International 
Standards Organization specifications (with capacities greater than or 
equal to 2,500 gallons in a single container).
    (h) The requirement of registration is waived for any manufacturer 
of a List I chemical, if that chemical is produced solely for internal 
consumption by the manufacturer and there is no subsequent distribution 
or exportation of the List I chemical.
    (i) If any person exempted under paragraph (b), (c), (d), (e), (f) 
or (g) of this section also engages in the distribution, importation or 
exportation of a List I chemical, other than as described in such 
paragraph, the person shall obtain a registration for such activities, 
as required by Sec. 1309.21 of this part.
    (j) The Administrator may, upon finding that continuation of the 
waiver would not be in the public interest, suspend or revoke a waiver 
granted under paragraph (b), (c), (d), (e), (f) or (g) of this section 
pursuant to the procedures set forth in Sec. Sec. 1309.43 through 
1309.46 and 1309.51 through 1309.55 of this part. In considering the 
revocation or suspension of a person's waiver granted pursuant to 
paragraph (b) or (c) of this section, the Administrator shall also 
consider whether action to revoke or suspend the person's controlled 
substance registration pursuant to 21 U.S.C. 824 is warranted.
    (k) Any person exempted from the registration requirement under this 
section shall comply with the security requirements set forth in 
Sec. Sec. 1309.71-1309.73 of this part and the recordkeeping and 
reporting requirements set forth under parts 1310 and 1313 of this 
chapter.

[67 FR 14860, Mar. 28, 2002, as amended at 68 FR 37414, June 24, 2003; 
68 FR 57803, Oct. 7, 2003]



Sec. 1309.25  Temporary exemption from registration for chemical 
registration applicants.

    (a) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a combination 
ephedrine product is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before July 12, 1997. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in this part 1309 and parts 1310, and 1313 of this chapter 
remain in full force and effect.
    (b) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a 
pseudoephedrine or phenylpropanolamine drug product is temporarily 
exempted from the registration requirement, provided that the person 
submits a proper application for registration on or before October 3, 
1997. The exemption will remain in effect for each person who has made 
such application until the Administration has approved or denied that 
application. This exemption applies only to registration; all other 
chemical control requirements set forth in this part 1309 and parts 1310 
and 1313 of this chapter remain in full force and effect.

[67 FR 14860, Mar. 28, 2002]

[[Page 114]]



Sec. 1309.26  Exemption of law enforcement officials.

    (a) The requirement of registration is waived for the following 
persons in the circumstances described in this section:
    (1) Any officer or employee of the Administration, any officer of 
the U.S. Customs Service, any officer or employee of the United States 
Food and Drug Administration, any other Federal officer who is lawfully 
engaged in the enforcement of any Federal law relating to listed 
chemicals, controlled substances, drugs or customs, and is duly 
authorized to possess and distribute List I chemicals in the course of 
official duties; and
    (2) Any officer or employee of any State, or any political 
subdivision or agency thereof, who is engaged in the enforcement of any 
State or local law relating to listed chemicals and controlled 
substances and is duly authorized to possess and distribute List I 
chemicals in the course of his official duties.
    (b) Any official exempted by this section may, when acting in the 
course of official duties, possess any List I chemical and distribute 
any such chemical to any other official who is also exempted by this 
section and acting in the course of official duties.

                      Application for Registration



Sec. 1309.31  Time for application for registration; expiration date.

    (a) Any person who is required to be registered and who is not so 
registered may apply for registration at any time. No person required to 
be registered shall engage in any activity for which registration is 
required until the application for registration is approved and a 
Certificate of Registration is issued by the Administrator to such 
person.
    (b) Any person who is registered may apply to be reregistered not 
more than 60 days before the expiration date of his registration.
    (c) At the time a person is first registered, that person shall be 
assigned to one of twelve groups, which shall correspond to the months 
of the year. The expiration date of the registrations of all registrants 
within any group will be the last day of the month designated for that 
group. In assigning any of the above persons to a group, the 
Administration may select a group the expiration date of which is less 
than one year from the date such business activity was registered. If 
the person is assigned to a group which has an expiration date less than 
eleven months from the date of which the person is registered, the 
registration shall not expire until one year from that expiration date; 
in all other cases, the registration shall expire on the expiration date 
following the date on which the person is registered.



Sec. 1309.32  Application forms; contents; signature.

    (a) Any person who is required to be registered pursuant to Sec. 
1309.21 and is not so registered, shall apply on DEA Form 510.
    (b) Any person who is registered pursuant to Section 1309.21, shall 
apply for reregistration on DEA Form 510a.
    (c) DEA Form 510 may be obtained at any divisional office of the 
Administration or by writing to the Registration Unit, Drug Enforcement 
Administration, Department of Justice, Post Office Box 28083, Central 
Station, Washington, DC 20005. DEA Form 510a will be mailed to each List 
I chemical registrant approximately 60 days before the expiration date 
of his or her registration; if any registered person does not receive 
such forms within 45 days before the expiration date of the 
registration, notice must be promptly given of such fact and DEA Form 
510a must be requested by writing to the Registration Unit of the 
Administration at the foregoing address.
    (d) Each application for registration shall include the 
Administration Chemical Code Number, as set forth in Sec. 1310.02 of 
this chapter, for each List I chemical to be distributed, imported, or 
exported.
    (e) Registration shall not entitle a person to engage in any 
activity with any List I chemical not specified in his or her 
application.
    (f) Each application shall include all information called for in the 
form, unless the item is not applicable, in which case this fact shall 
be indicated.

[[Page 115]]

    (g) Each application, attachment, or other document filed as part of 
an application, shall be signed by the applicant, if an individual; by a 
partner of the applicant, if a partnership; or by an officer of the 
applicant, if a corporation, corporate division, association, trust or 
other entity. An applicant may authorize one or more individuals, who 
would not otherwise be authorized to do so, to sign applications for the 
applicant by filing with the application or other document a power of 
attorney for each such individual. The power of attorney shall be signed 
by a person who is authorized to sign applications under this paragraph 
and shall contain the signature of the individual being authorized to 
sign the application or other document. The power of attorney shall be 
valid until revoked by the applicant.



Sec. 1309.33  Filing of application; joint filings.

    (a) All applications for registration shall be submitted for filing 
to the Registration Unit, Drug Enforcement Administration, Chemical 
Registration/ODC, Post Office Box 2427, Arlington, Virginia 22202-2427. 
The appropriate registration fee and any required attachments must 
accompany the application.
    (b) Any person required to obtain more than one registration may 
submit all applications in one package. Each application must be 
complete and must not refer to any accompanying application for required 
information.



Sec. 1309.34  Acceptance for filing; defective applications.

    (a) Applications submitted for filing are dated upon receipt. If 
found to be complete, the application will be accepted for filing. 
Applications failing to comply with the requirements of this part will 
not generally be accepted for filing. In the case of minor defects as to 
completeness, the Administrator may accept the application for filing 
with a request to the applicant for additional information. A defective 
application will be returned to the applicant within 10 days of receipt 
with a statement of the reason for not accepting the application for 
filing. A defective application may be corrected and resubmitted for 
filing at any time.
    (b) Accepting an application for filing does not preclude any 
subsequent request for additional information pursuant to Sec. 1309.35 
and has no bearing on whether the application will be granted.



Sec. 1309.35  Additional information.

    The Administrator may require an applicant to submit such documents 
or written statements of fact relevant to the application as he deems 
necessary to determine whether the application should be granted. The 
failure of the applicant to provide such documents or statements within 
a reasonable time after being requested to do so shall be deemed to be a 
waiver by the applicant of an opportunity to present such documents or 
facts for consideration by the Administrator in granting or denying the 
application.



Sec. 1309.36  Amendments to and withdrawals of applications.

    (a) An application may be amended or withdrawn without permission of 
the Administration at any time before the date on which the applicant 
receives an order to show cause pursuant to Sec. 1309.46. An 
application may be amended or withdrawn with permission of the 
Administrator at any time where good cause is shown by the applicant or 
where the amendment or withdrawal is in the public interest.
    (b) After an application has been accepted for filing, the request 
by the applicant that it be returned or the failure of the applicant to 
respond to official correspondence regarding the application, including 
a request that the applicant submit the required fee, when sent by 
registered or certified mail, return receipt requested, shall be deemed 
to be a withdrawal of the application.

[[Page 116]]

  Action on Applications for Registration: Revocation or Suspension of 
                              Registration



Sec. 1309.41  Administrative review generally.

    The Administrator may inspect, or cause to be inspected, the 
establishment of an applicant or registrant, pursuant to subpart A of 
part 1316 of this chapter. The Administrator shall review the 
application for registration and other information gathered by the 
Administrator regarding an applicant in order to determine whether the 
applicable standards of Section 303 of the Act (21 U.S.C. 823) have been 
met by the applicant.



Sec. 1309.42  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration (DEA 
Form 511) to an applicant if the issuance of registration or 
reregistration is required under the applicable provisions of section 
303 of the Act (21 U.S.C. 823). In the event that the issuance of 
registration or reregistration is not required, the Administrator shall 
deny the application. Before denying any application, the Administrator 
shall issue an order to show cause pursuant to Section 1309.46 and, if 
requested by the applicant, shall hold a hearing on the application 
pursuant to Sec. 1309.51.
    (b) The Certificate of Registration (DEA Form 511) shall contain the 
name, address, and registration number of the registrant, the activity 
authorized by the registration, the amount of fee paid, and the 
expiration date of the registration. The registrant shall maintain the 
certificate of registration at the registered location in a readily 
retrievable manner and shall permit inspection of the certificate by any 
official, agent or employee of the Administration or of any Federal, 
State, or local agency engaged in enforcement of laws relating to List I 
chemicals or controlled substances.



Sec. 1309.43  Suspension or revocation of registration.

    (a) The Administrator may suspend any registration pursuant to 
section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he 
determines.
    (b) The Administrator may revoke any registration pursuant to 
section 304(a) of the Act (21 U.S.C. 824(a)).
    (c) Before revoking or suspending any registration, the 
Administrator shall issue an order to show cause pursuant to Section 
1309.46 and, if requested by the registrant, shall hold a hearing 
pursuant to Section 1309.51. Notwithstanding the requirements of this 
Section, however, the Administrator may suspend any registration pending 
a final order pursuant to Sec. 1309.44.
    (d) Upon service of the order of the Administrator suspending or 
revoking registration, the registrant shall immediately deliver his or 
her Certificate of Registration to the nearest office of the 
Administration. Also, upon service of the order of the Administrator 
revoking or suspending registration, the registrant shall, as instructed 
by the Administrator:
    (1) Deliver all List I chemicals in his or her possession that were 
obtained under the authority of a registration or an exemption from 
registration granted by the Administrator by regulation, to the nearest 
office of the Administration or to authorized agents of the 
Administration; or
    (2) Place all such List I chemicals in his or her possession under 
seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).
    (e) In the event that revocation or suspension is limited to a 
particular chemical or chemicals, the registrant shall be given a new 
Certificate of Registration for all substances not affected by such 
revocation or suspension; no fee shall be required for the new 
Certificate of Registration. The registrant shall deliver the old 
Certificate of Registration to the nearest office of the Administration. 
Also, upon service of the order of the Administrator revoking or 
suspending registration with respect to a particular chemical or 
chemicals, the registrant shall, as instructed by the Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular chemical 
or chemicals in his or her possession that were obtained under the 
authority of a registration or an exemption from registration granted by 
the Administrator by regulation,

[[Page 117]]

which are affected by the revocation or suspension; or
    (2) Place all of such chemicals under seal as described in section 
304(f) of the Act (21 U.S.C. 824(f)).

[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]



Sec. 1309.44  Suspension of registration pending final order.

    (a) The Administrator may suspend any registration simultaneously 
with or at any time subsequent to the service upon the registrant of an 
order to show cause why such registration should not be revoked or 
suspended, in any case where he finds that there is an imminent danger 
to the public health or safety. If the Administrator so suspends, he 
shall serve with the order to show cause pursuant to Sec. 1309.46 an 
order of immediate suspension that shall contain a statement of his 
findings regarding the danger to public health or safety.
    (b) Upon service of the order of immediate suspension, the 
registrant shall promptly return his Certificate of Registration to the 
nearest office of the Administration. Also, upon service of the order of 
immediate suspension, the registrant shall, as instructed by the 
Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular chemical 
or chemicals in his or her possession that were obtained under the 
authority of a registration or an exemption from registration granted by 
the Administrator by regulation, which are affected by the revocation or 
suspension; or
    (2) Place all of such chemicals under seal as described in section 
304(f) of the Act (21 U.S.C. 824(f)).
    (c) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the revocation or suspension, including any 
judicial review thereof, unless sooner withdrawn by the Administrator or 
dissolved by a court of competent jurisdiction. Any registrant whose 
registration is suspended under this section may request a hearing on 
the revocation or suspension of his registration at a time earlier than 
specified in the order to show cause pursuant to Section 1309.46, which 
request shall be granted by the Administrator, who shall fix a date for 
such hearing as early as reasonably possible.

[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]



Sec. 1309.45  Extension of registration pending final order.

    In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before the 
date on which the existing registration is due to expire, and the 
Administrator has issued no order on the application on the date on 
which the existing registration is due to expire, the existing 
registration of the applicant shall automatically be extended and 
continue in effect until the date on which the Administrator so issues 
his order. The Administrator may extend any other existing registration 
under the circumstances contemplated in this section even though the 
registrant failed to apply for reregistration at least 45 days before 
expiration of the existing registration, with or without request by the 
registrant, if the Administrator finds that such extension is not 
inconsistent with the public health and safety.



Sec. 1309.46  Order to show cause.

    (a) If, upon examination of the application for registration from 
any applicant and other information gathered by the Administration 
regarding the applicant, the Administrator is unable to make the 
determinations required by the applicable provisions of section 303 of 
the Act (21 U.S.C. 823) to register the applicant, the Administrator 
shall serve upon the applicant an order to show cause why the 
application for registration should not be denied.
    (b) If, upon information gathered by the Administration regarding 
any registrant, the Administrator determines that the registration of 
such registrant is subject to suspension or revocation pursuant to 
section 304 of the Act (21 U.S.C. 824), the Administrator shall serve 
upon the registrant an order to show cause why the registration should 
not be revoked or suspended.

[[Page 118]]

    (c) The order to show cause shall call upon the applicant or 
registrant to appear before the Administrator at a time and place stated 
in the order, which shall not be less than 30 days after the date of 
receipt of the order. The order to show cause shall also contain a 
statement of the legal basis for such hearing and for the denial, 
revocation, or suspension of registration and a summary of the matters 
of fact and law asserted.
    (d) Upon Receipt of an order to show cause, the applicant or 
registrant must, if he desires a hearing, file a request for a hearing 
pursuant to Sec. 1309.54. If a hearing is requested, the Administrator 
shall hold a hearing at the time and place stated in the order, pursuant 
to Sec. 1309.51.
    (e) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.

                                Hearings



Sec. 1309.51  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing on any 
registration or application therefore, the procedures for such hearing 
shall be governed generally by the adjudication procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
sections 303 and 304 of the Act (21 U.S.C. 823-824), by Sec. Sec. 
1309.52 through 1309.57, and by the procedures for administrative 
hearings under the Act set forth in Sec. Sec. 1316.41 through 1316.67 
of this chapter.
    (b) Any hearing under this part shall be independent of, and not in 
lieu of, criminal prosecutions or other proceedings under the Act or any 
other law of the United States.



Sec. 1309.52  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall hold a hearing for the purpose of receiving factual evidence 
regarding the issues involved in the denial, revocation, or suspension 
of any registration. Extensive argument should not be offered into 
evidence but rather presented in opening or closing statements of 
counsel or in memoranda or proposed findings of fact and conclusions of 
law.



Sec. 1309.53  Request for hearing or appearance; waiver.

    (a) Any person entitled to a hearing pursuant to Sec. Sec. 1309.42 
and 1309.43 and desiring a hearing shall, within 30 days after the date 
of receipt of the order to show cause, file with the Administrator a 
written request for a hearing in the form prescribed in Sec. 1316.47 of 
this chapter.
    (b) Any person entitled to a hearing pursuant to Sec. Sec. 1309.42 
and 1309.43 may, within the period permitted for filing a request for a 
hearing, file with the Administrator a waiver of an opportunity for a 
hearing, together with a written statement regarding his position on the 
matters of fact and law involved in such hearing. Such statement, if 
admissible, shall be made a part of the record and shall be considered 
in light of the lack of opportunity for cross-examination in determining 
the weight to be attached to matters of fact asserted therein.
    (c) If any person entitled to a hearing pursuant to Sec. Sec. 
1309.42 and 1309.43 fails to file a request for a hearing, or if he so 
files and fails to appear at the hearing, he shall be deemed to have 
waived his opportunity for the hearing, unless he shows good cause for 
such failure.
    (d) If any person entitled to a hearing waives or is deemed to waive 
his or her opportunity for the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to Sec. 
1309.57 without a hearing.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1309.54  Burden of proof.

    (a) At any hearing for the denial of a registration, the 
Administration shall have the burden of proving that the requirements 
for such registration pursuant to section 303 of the Act (21 U.S.C. 823) 
are not satisfied.
    (b) At any hearing for the revocation or suspension of a 
registration, the Administration shall have the burden of proving that 
the requirements for such revocation or suspension pursuant to section 
304(a) of the Act (21 U.S.C. 824(a)) are satisfied.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

[[Page 119]]



Sec. 1309.55  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
order to show cause or notice of hearing published in the Federal 
Register (unless expedited pursuant to Section 1309.44(c)) but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

         Modification, Transfer and Termination of Registration



Sec. 1309.61  Modification in registration.

    Any registrant may apply to modify his or her registration to 
authorize the handling of additional List I chemicals or to change his 
or her name or address, by submitting a letter of request to the Drug 
Enforcement Administration, Chemical Registration/ODC, Post Office Box 
2427, Arlington, Virginia 22202-2427. The letter shall contain the 
registrant's name, address, and registration number as printed on the 
certificate of registration, and the List I chemicals to be added to his 
registration or the new name or address and shall be signed in 
accordance with Sec. 1309.32(g). No fee shall be required to be paid 
for the modification. The request for modification shall be handled in 
the same manner as an application for registration. If the modification 
in registration is approved, the Administrator shall issue a new 
certificate of registration (DEA Form 511) to the registrant, who shall 
maintain it with the old certificate of registration until expiration.



Sec. 1309.62  Termination of registration.

    (a) The registration of any person shall terminate if and when such 
person dies, ceases legal existence, or discontinues business or 
professional practice. Any registrant who cases legal existence or 
discontinues business or professional practice shall promptly notify the 
Special Agent in Charge of the Administration in the area in which the 
person is located of such fact and seek authority and instructions to 
dispose of any List I chemicals obtained under the authority of that 
registration.
    (b) The Special Agent in Charge shall authorize and instruct the 
person to dispose of the List I chemical in one of the following 
manners:
    (1) By transfer to person registered under the Act and authorized to 
possess the substances;
    (2) By delivery to an agent of the Administration or to the nearest 
office of the Administration;
    (3) By such other means as the Special Agent in Charge may determine 
to assure that the substance does not become available to unauthorized 
persons.

[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]



Sec. 1309.63  Transfer of registration.

    No registration or any authority conferred thereby shall be assigned 
or otherwise transferred except upon such conditions as the 
Administrator may specifically designate and then only pursuant to his 
written consent.

                          Security Requirements



Sec. 1309.71  General security requirements.

    (a) All applicants and registrants shall provide effective controls 
and procedures to guard against theft and diversion of List I chemicals. 
Specific attention shall be paid to storage of and controlling access to 
List I chemicals as follows:
    (1) Chemicals shall be stored in containers sealed in such a manner 
as to indicate any attempts at tampering with the container. Where 
chemicals cannot be stored in sealed containers, access to the chemicals 
should be controlled through physical means or through human or 
electronic monitoring.
    (2) In retail settings open to the public where drugs containing 
ephedrine as the sole active medicinal ingredient are distributed, such 
drugs will be stocked behind a counter where only employees have access.
    (b) In evaluating the effectiveness of security controls and 
procedures, the Administrator shall consider the following factors:

[[Page 120]]

    (1) The type, form, and quantity of List I chemicals handled;
    (2) The location of the premises and the relationship such location 
bears on the security needs;
    (3) The type of building construction comprising the facility and 
the general characteristics of the building or buildings;
    (4) The availability of electronic detection and alarm systems;
    (5) the extent of unsupervised public access to the facility;
    (6) The adequacy of supervision over employees having access to List 
I chemicals;
    (7) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel in areas where 
List I chemicals are processed or stored;
    (8) The adequacy of the registrant's or applicant's systems for 
monitoring the receipt, distribution, and disposition of List I 
chemicals in its operations.
    (c) Any registrant or applicant desiring to determine whether a 
proposed system of security controls and procedures is adequate may 
submit materials and plans regarding the proposed security controls and 
procedures either to the Special Agent in Charge in the region in which 
the security controls and procedures will be used, or to the Chemical 
Operations Section Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537.

[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997; 
67 FR 14861, Mar. 28, 2002]



Sec. 1309.72  Felony conviction; employer responsibilities.

    (a) The registrant shall exercise caution in the consideration of 
employment of persons who will have access to listed chemicals, who have 
been convicted of a felony offense relating to controlled substances or 
listed chemicals, or who have, at any time, had an application for 
registration with the DEA denied, had a DEA registration revoked, or 
surrendered a DEA registration for cause. (For purposes of this 
subsection, the term ``for cause'' means a surrender in lieu of, or as a 
consequence of, any Federal or State administrative, civil or criminal 
action resulting from an investigation of the individual's handling of 
controlled substances or listed chemicals.) The registrant should be 
aware of the circumstances regarding the action against the potential 
employee and the rehabilitative efforts following the action. The 
registrant shall assess the risks involved in employing such persons, 
including the potential for action against the registrant pursuant to 
Sec. 1309.43, If such person is found to have diverted listed 
chemicals, and, in the event of employment, shall institute procedures 
to limit the potential for diversion of List I chemicals.
    (b) It is the position of DEA that employees who possess, sell, use 
or divert listed chemicals or controlled substances will subject 
themselves not only to State or Federal prosecution for any illicit 
activity, but shall also immediately become the subject of independent 
action regarding their continued employment. The employer will assess 
the seriousness of the employee's violation, the position of 
responsibility held by the employee, past record of employment, etc., in 
determining whether to suspend, transfer, terminate or take other action 
against the employee.



Sec. 1309.73  Employee responsibility to report diversion.

    Reports of listed chemical diversion by fellow employees is not only 
a necessary part of an overall employee security program but also serves 
the public interest at large. It is, therefore, the position of DEA that 
an employee who has knowledge of diversion from his employer by a fellow 
employee has an obligation to report such information to a responsible 
security official of the employer. The employer shall treat such 
information as confidential and shall take all reasonable steps to 
protect the confidentiality of the information and the identity of the 
employee furnishing information. A failure to report information of 
chemical diversion will be considered in determining the feasibility of 
continuing to allow an employee to work in an area with access to 
chemicals. The employer shall inform all employees concerning this 
policy.

[[Page 121]]



PART 1310_RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
--Table of Contents

Sec.
1310.01 Definitions.
1310.02 Substances covered.
1310.03 Persons required to keep records and file reports.
1310.04 Maintenance of records.
1310.05 Reports.
1310.06 Content of records and reports.
1310.07 Proof of identity.
1310.08 Excluded transactions.
1310.09 Temporary exemption from registration.
1310.10 Removal of the exemption of drugs distributed under the Food, 
          Drug and Cosmetic Act.
1310.11 Reinstatement of exemption for drug products distributed under 
          the Food, Drug and Cosmetic Act.
1310.12 Exempt chemical mixtures.
1310.13 Exemption of chemical mixtures; application.
1310.14 Exemption of drug products containing ephedrine and 
          therapeutically significant quantities of another active 
          medicinal ingredient.
1310.15 Exempt drug products containing ephedrine and therapeutically 
          significant quantities of another active medicinal ingredient.
1310.21 Sale by Federal departments or agencies of chemicals which could 
          be used to manufacture controlled substances.

    Authority: 21 U.S.C. 802, 827(h), 830, 871(b) 890.

    Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.



Sec. 1310.01  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13968, Mar. 24, 1997]



Sec. 1310.02  Substances covered.

    The following chemicals have been specifically designated by the 
Administrator of the Drug Enforcement Administration as the listed 
chemicals subject to the provisions of this part and parts 1309 and 1313 
of this chapter. Each chemical has been assigned the DEA Chemical Code 
Number set forth opposite it.
    (a) List I chemicals

(1) Anthranilic acid, its esters, and its salts.....................8530
(2) Benzyl cyanide..................................................8735
(3) Ephedrine, its salts, optical isomers, and salts of optical isomers 
                                                                    8113
(4) Ergonovine and its salts........................................8675
(5) Ergotamine and its salts........................................8676
(6) N-Acetylanthranilic acid, its esters, and its salts.............8522
(7) Norpseudoephedrine, its salts, optical isomers, and salts of optical 
isomers.............................................................8317
(8) Phenylacetic acid, its esters, and its salts....................8791
(9) Phenylpropanolamine, its salts, optical isomers, and salts of 
optical isomers.....................................................1225
(10) Piperidine and its salts.......................................2704
(11) Pseudoephedrine, its salts, optical isomers, and salts of optical 
isomers.............................................................8112
(12) 3,4-Methylenedioxyphenyl-2-propanone...........................8502
(13) Methylamine and its salts......................................8520
(14) Ethylamine and its salts.......................................8678
(15) Propionic anhydride............................................8328
(16) Isosafrole.....................................................8704
(17) Safrole........................................................8323
(18) Piperonal......................................................8750
(19) N-Methylephedrine, its salts, optical isomers, and salts of optical 
isomers (N-Methylephedrine).........................................8115
(20) N-Methylpseudoephedrine, its salts, optical isomers, and salts of 
optical isomers.....................................................8119
(21) Hydriodic Acid.................................................6695
(22) Benzaldehyde...................................................8256
(23) Nitroethane....................................................6724
(24) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2 (3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid 
lactone; gamma-hydroxybutyric acid lactone).........................2011
(25) Red phosphorus.................................................6795
(26) White phosphorus (Other names: Yellow Phosphorus)..............6796
(27) Hypophosphorous acid and its salts (Including ammonium 
hypophosphite, calcium hypophosphite, iron hypophosphite, potassium 
hypophosphite, manganese hypophosphite, magnesium hypophosphite and 
sodium hypophosphite)...............................................6797

    (b) List II chemicals:
(1) Acetic anhydride................................................8519
(2) Acetone.........................................................6532
(3) Benzyl chloride.................................................8570
(4) Ethyl ether.....................................................6584
(5) Potassium permanganate..........................................6579
(6) 2-Butanone (or Methyl Ethyl Ketone or MEK)......................6714
(7) Toluene.........................................................6594

[[Page 122]]

(8) Hydrochloric acid (including anhydrous hydrogen chloride).......6545
(9) Sulfuric acid...................................................6552
(10) Methyl Isobutyl Ketone (MIBK)..................................6715
(11) Iodine.........................................................6699

    (c) The Administrator may add or delete a substance as a listed 
chemical by publishing a final rule in the Federal Register following a 
proposal which shall be published at least 30 days prior to the final 
rule.
    (d) Any person may petition the Administrator to have any substance 
added or deleted from paragraphs (a) or (b) of this section.
    (e) Any petition under this section shall contain the following 
information:
    (1) The name and address of the petitioner;
    (2) The name of the chemical to which the petition pertains;
    (3) The name and address of the manufacturer(s) of the chemical (if 
known);
    (4) A complete statement of the facts which the petitioner believes 
justifies the addition or deletion of the substance from paragraphs (a) 
or (b) of this section;
    (5) The date of the petition.
    (f) The Administrator may require the petitioner to submit such 
documents or written statements of fact relevant to the petition as he 
deems necessary in making a determination.
    (g) Within a reasonable period of time after the receipt of the 
petition, the Administrator shall notify the petitioner of his decision 
and the reason therefor. The Administrator need not accept a petition if 
any of the requirements prescribed in paragraph (e) of this section or 
requested pursuant to paragraph (f) of this section are lacking or are 
not clearly set forth as to be readily understood. If the petitioner 
desires, he may amend and resubmit the petition to meet the requirements 
of paragraphs (e) and (f) of this section.
    (h) If a petition is granted or the Administrator, upon his own 
motion, proposes to add or delete substances as listed chemicals as set 
forth in paragraph (c) of this section, he shall issue and publish in 
the Federal Register a proposal to add or delete a substance as a listed 
chemical. The Administrator shall permit any interested person to file 
written comments regarding the proposal within 30 days of the date of 
publication of his order in the Federal Register. The Administrator will 
consider any comments filed by interested persons and publish a final 
rule in accordance with his decision in the matter.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991; 
57 FR 43615, Sept. 22, 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, 
June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65 
FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001]



Sec. 1310.03  Persons required to keep records and file reports.

    (a) Each regulated person who engages in a regulated transaction 
involving a listed chemical, a tableting machine, or an encapsulating 
machine shall keep a record of the transaction as specified by Sec. 
1310.04 and file reports as specified by Sec. 1310.05. However, a non-
regulated person who acquires listed chemicals for internal consumption 
or ``end use'' and becomes a regulated person by virtue of infrequent or 
rare distribution of a listed chemical from inventory, shall not be 
required to maintain receipt records of listed chemicals under this 
section.
    (b) Each regulated person who manufactures a List I or List II 
chemical shall file reports regarding such manufacture as specified in 
Section 1310.05.
    (c) Each regulated person who engages in a transaction with a 
nonregulated person or who engages in an export transaction that 
involves ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid, including drug products containing these chemicals, 
and uses or attempts to use the Postal Service or any private or 
commercial carrier must file monthly reports of each such transaction as 
specified in Sec. 1310.05 of this part.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 8277, Feb. 28, 1991; 61 
FR 14023, Mar. 29, 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, Oct. 
7, 2003; 70 FR 294, Jan. 4, 2005]



Sec. 1310.04  Maintenance of records.

    (a) Every record required to be kept subject to Sec. 1310.03 for a 
List I chemical, a tableting machine, or an encapsulating machine shall 
be kept by the

[[Page 123]]

regulated person for 2 years after the date of the transaction.
    (b) Every record required to be kept subject to Section 1310.03 for 
List II chemical shall be kept by the regulated person for two years 
after the date of the transaction.
    (c) A record under this section shall be kept at the regulated 
person's place of business where the transaction occurred, except that 
records may be kept at a single, central location of the regulated 
person if the regulated person has notified the Administration of the 
intention to do so. Written notification must be submitted by registered 
or certified mail, return receipt requested, to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the records 
are required to be kept.
    (d) The records required to be kept under this section shall be 
readily retrievable and available for inspection and copying by 
authorized employees of the Administration under the provisions of 21 
U.S.C. 880.
    (e) The regulated person with more than one place of business where 
records are required to be kept shall devise a system to detect any 
party purchasing from several individual locations of the regulated 
person thereby seeking to avoid the application of the cumulative 
threshold or evading the requirements of the Act.
    (f) For those listed chemicals for which thresholds have been 
established, the quantitative threshold or the cumulative amount for 
multiple transactions within a calendar month, to be utilized in 
determining whether a receipt, sale, importation or exportation is a 
regulated transaction is as follows:
    (1) List I chemicals:
    (i) Except as provided in paragraph (f)(1)(ii) of this section, the 
following thresholds have been established for List I chemicals.

------------------------------------------------------------------------
                 Chemical                     Threshold by base weight
------------------------------------------------------------------------
(A) Anthranilic acid, its esters, and its   30 kilograms.
 salts.
(B) Benzyl cyanide........................  1 kilogram.
(C) Ergonovine and its salts..............  10 grams.
(D) Ergotamine and its salts..............  20 grams.
(E) N-Acetylanthranilic acid, its esters,   40 kilograms.
 and its salts.
(F) Norpseudoephedrine, its salts, optical  2.5 kilograms.
 isomers, and salts of optical isomers.
(G) Phenylacetic acid, its esters, and its  1 kilogram.
 salts.
(H) Phenylpropanolamine, its salts,         2.5 kilograms.
 optical isomers, and salts of optical
 isomers.
(I) Piperidine and its salts..............  500 grams.
(J) Pseudoephedrine, its salts, optical     1 kilogram.
 isomers, and salts of optical isomers.
(K) 3,4-Methylenedioxyphenyl-2-propanone..  4 kilograms.
(L) Methylamine and its salts.............  1 kilogram.
(M) Ethylamine and its salts..............  1 kilogram.
(N) Propionic anhydride...................  1 gram.
(O) Isosafrole............................  4 kilograms.
(P) Safrole...............................  4 kilograms.
(Q) Piperonal.............................  4 kilograms.
(R) N-Methylephedrine, its salts, optical   1 kilogram.
 isomers, and salts of optical isomers (N-
 Methylephedrine).
(S) N-Methylpseudoephedrine, its salts,     1 kilogram.
 optical isomers, and salts of optical
 isomers.
(T) Hydriodic Acid........................  1.7 kilograms (or 1 liter by
                                             volume).
(U) Benzaldehyde..........................  4 kilograms.
(V) Nitroethane...........................  2.5 kilograms.
------------------------------------------------------------------------

    (ii) Notwithstanding the thresholds established in paragraphs 
(f)(1)(i) and (g) of this section, the following thresholds will apply 
for the following List I chemicals that are contained in drug products 
that are regulated pursuant to Sec. 1300.02(b)(28)(i)(D) of this 
chapter (thresholds for retail distributors and distributors required to 
report under Sec. 1310.03(c) of this part are for a single transaction; 
the cumulative threshold provision does not apply. All other 
distributions are subject to the cumulative threshold provision.):

------------------------------------------------------------------------
                 Chemical                        Threshold by weight
------------------------------------------------------------------------
(A) Ephedrine, its salts, optical isomers,  No threshold. All
 and salts of optical isomers as the sole    transactions regulated.
 therapeutically significant medicinal
 ingredient.
(B) Ephedrine, its salts, optical isomers,
 and salts of optical isomers in
 combination with therapeutically
 significant amounts of another medicinal
 ingredient:
    (1) Distributions by retail             24 grams.
     distributors.
    (2) Distributions by persons required   24 grams.
     to report under Sec. 1310.03(c) of
     this part.
    (3) All other domestic distributions    1 kilogram.
     (other than paragraphs (f)(1)(ii)(B)
     (1) and (2) of this section).
    (4) Imports and Exports...............  1 kilogram

[[Page 124]]

 
(C) Pseudoephedrine, its salts, optical
 isomers, and salts of optical isomers
 (other than ordinary over-the-counter
 products):
    (1) Distributions by retail             9 grams, and sold in package
     distributors.                           sizes of not more than 3
                                             grams of pseudoephedrine
                                             base.
    (2) Distributions by persons required   9 grams, and sold in package
     to report under Sec. 1310.03(c) of    sizes of not more than 3
     this part.                              grams of pseudoephedrine
                                             base.
    (3) All other domestic distributions,   1 kilogram.
     (other than paragraphs (f)(1)(ii)(C)
     (1) and (2) of this section).
    (4) Imports and Exports...............  1 kilogram.
(D) Pseudoephedrine, its salts, optical
 isomers, and salts of optical isomers
 (ordinary over-the-counter products):
    (1) Distributions by retail             Exempt.
     distributors.
    (2) Distributions by persons required   9 grams, and sold in package
     to report under Sec. 1310.03(c) of    sizes of not more than 3
     this part.                              grams of pseudoephedrine
                                             base.
    (3) All other domestic distributions    1 kilogram.
     (other than paragraphs (f)(1)(ii)(D)
     (1) and (2) of this section).
    (4) Imports and Exports...............  1 kilogram.
(E) Phenylpropanolamine, its salts,
 optical isomers, and salts of optical
 isomers (other than ordinary over-the-
 counter products):
    (1) Distributions by retail             9 grams, and sold in package
     distributors.                           sizes of not more than 3
                                             grams of
                                             phenylpropanolamine base.
    (2) Distributions by persons required   9 grams, and sold in package
     to report under Sec. 1310.03(c) of    sizes of not more than 3
     this part.                              grams of
                                             phenylpropanolamine base.
    (3) All other domestic distributions    2.5 kilograms.
     (other than paragraphs (f)(1)(ii)(E)
     (1) and (2) of this section).
    (4) Imports and Exports...............  2.5 kilograms.
(F) Phenylpropanolamine, its salts,
 optical isomers, and salts of optical
 isomers (ordinary over-the-counter
 products):
    (1) Distributions by retail             Exempt.
     distributors.
    (2) Distributions by persons required   9 grams, and sold in package
     to report under Sec. 1310.03(c) of    sizes of not more than 3
     this part.                              grams of
                                             phenylpropanolamine base.
    (3) All other domestic distributions    2.5 kilograms.
     (other than paragraphs (f)(1)(ii)(F)
     (1) and (2) of this section).
    (4) Imports and Exports...............  2.5 kilograms.
------------------------------------------------------------------------

    (2) List II Chemicals:
    (i) Imports and Exports

----------------------------------------------------------------------------------------------------------------
                Chemical                         Threshold by volume                  Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride...................  250 gallons........................  1,023 kilograms.
(B) Acetone............................  500 gallons........................  1,500 kilograms.
(C) Benzyl chloride....................  N/A................................  4 kilograms.
(D) Ethyl ether........................  500 gallons........................  1,364 kilograms.
(E) Potassium permanganate.............  N/A................................  500 kilograms.
(F) 2-Butanone (MEK)...................  500 gallons........................  1,455 kilograms.
(G) Toluene............................  500 gallons........................  1,591 kilograms.
----------------------------------------------------------------------------------------------------------------

    (ii) Domestic Sales

----------------------------------------------------------------------------------------------------------------
                Chemical                         Threshold by volume                  Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride...................  250 gallons........................  1,023 kilograms.
(B) Acetone............................  50 gallons.........................  150 kilograms.
(C) Benzyl chloride....................  N/A................................  1 kilogram.
(D) Ethyl ether........................  50 gallons.........................  135.8 kilograms.
(E) Potassium permanganate.............  N/A................................  55 kilograms.
(F) 2-Butanone (MEK)...................  50 gallons.........................  145 kilograms.
(G) Toluene............................  50 gallons.........................  159 kilograms.
(H) Iodine.............................  N/A................................  0.4 kilograms.

[[Page 125]]

 
(I) Anhydrous Hydrogen chloride........  N/A................................  0.0 kilograms.
----------------------------------------------------------------------------------------------------------------

    (iii) The cumulative threshold is not applicable to domestic sales 
of Acetone, 2-Butanone (MEK), and Toluene.
    (iv) Exports, Transshipments and International Transactions to 
Designated Countries as Set Forth in Sec. 1310.08(b).

------------------------------------------------------------------------
                                    Threshold by
            Chemical                   volume        Threshold by weight
------------------------------------------------------------------------
(A) Hydrochloric acid..........  50 gallons
    (1) Anhydrous Hydrogen       ..................  27 kilograms.
     chloride.
(B) Sulfuric acid..............  50 gallons
------------------------------------------------------------------------

    (v) Export and International Transactions to Designated Countries, 
and Importations for Transshipment or Transfer to Designated Countries

------------------------------------------------------------------------
                                    Threshold by
            Chemical                   volume        Threshold by weight
------------------------------------------------------------------------
(A) Methyl Isobutyl Ketone       500 gallons.......  1523 kilograms.
 (MIBK).
(B) Reserved.
------------------------------------------------------------------------

    (g) For listed chemicals for which no thresholds have been 
established, the size of the transaction is not a factor in determining 
whether the transaction meets the definition of a regulated transaction 
as set forth in Sec. 1300.02(b)(28) of this chapter. All such 
transactions, regardless of size, are subject to recordkeeping and 
reporting requirements as set forth in this part and notification 
provisions as set forth in part 1313 of this chapter.
    (1) Listed chemicals for which no thresholds have been established:
    (i) Ephedrine, its salts, optical isomers and salts of optical 
isomers
    (ii) Red phosphorus
    (iii) White phosphorus (Other names: Yellow Phosphorus)
    (iv) Hypophosphorous acid and its salts
    (v) gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid 
lactone; gamma-hydroxybutyric acid lactone)
    (2) [Reserved]
    (h) The thresholds and conditions in paragraphs (f) and (g) of this 
section will apply to transactions involving regulated chemical 
mixtures. For purposes of determining whether the weight or volume of a 
chemical mixture meets or exceeds the applicable quantitative threshold, 
the following rules apply:
    (1) For chemical mixtures containing List I chemicals or List II 
chemicals other than those in paragraph (h)(2) of this section, the 
threshold is determined by the weight of the listed chemical in the 
chemical mixture.
    (2) For the List II chemicals acetone, ethyl ether, 2-butanone, 
toluene, and methyl isobutyl ketone, the threshold is determined by the 
weight of the entire chemical mixture.
    (3) If two or more listed chemicals are present in a chemical 
mixture, and the quantity of any of these chemicals equals or exceeds 
the threshold applicable to that chemical, then the transaction is 
regulated.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991; 
57 FR 43615, Sept. 22, 1992; 59 FR 51367, Oct. 11, 1994; 60 FR 19510, 
Apr. 19, 1995; 60 FR 32460, June 22, 1995; 60 FR 42436, Aug. 16, 1995; 
62 FR 5917, Feb. 10, 1997; 65 FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 
17, 2001; 67 FR 14861, Mar. 28, 2002; 68 FR 11472, Mar. 11, 2003; 68 FR 
23203, May 1, 2003; 68 FR 53292, Sept. 10, 2003; 68 FR 57804, Oct. 7, 
2003; 69 FR 74970, Dec. 15, 2004]



Sec. 1310.05  Reports.

    (a) Each regulated person shall report to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the regulated 
person making the report is located, as follows:
    (1) Any regulated transaction involving an extraordinary quantity of 
a listed chemical, an uncommon method of payment or delivery, or any 
other circumstance that the regulated person believes may indicate that 
the listed chemical will be used in violation of this part.
    (2) Any proposed regulated transaction with a person whose 
description or other identifying characteristic the

[[Page 126]]

Administration has previously furnished to the regulated person.
    (3) Any unusual or excessive loss or disappearance of a listed 
chemical under the control of the regulated person. The regulated person 
responsible for reporting a loss in-transit is the supplier.
    (4) Any domestic regulated transaction in a tableting machine or an 
encapsulating machine.
    (b) Each report submitted pursuant to paragraph (a) of this section 
shall, whenever possible, be made orally to the DEA Divisional Office 
for the area in which the regulated person making the report is located 
at the earliest practicable opportunity after the regulated person 
becomes aware of the circumstances involved and as much in advance of 
the conclusion of the transaction as possible. Written reports of 
transactions listed in paragraphs (a)(1), (a)(3) and (a)(4) of this 
section will subsequently be filed as set forth in Sec. 1310.06 within 
15 days after the regulated person becomes aware of the circumstances of 
the event. A transaction may not be completed with a person whose 
description or identifying characteristic has previously been furnished 
to the regulated person by the Administration unless the transaction is 
approved by the Administration.
    (c) Each regulated person who imports or exports a tableting 
machine, or encapsulation machine, shall file a report (not a 486) of 
such importation or exportation with the Administration at the following 
address on or before the date of importation or exportation: Drug 
Enforcement Administration, P.O. Box 27284, Washington, DC 20038. In 
order to facilitate the importation or exportation of any tableting 
machine or encapsulating machine and implement the purpose of the Act, 
regulated persons may wish to report to the Administration as far in 
advance as possible. A copy of the report may be transmitted directly to 
the Drug Enforcement Administration through electronic facsimile media. 
Any tableting machine or encapsulating machine may be imported or 
exported if that machine is needed for medical, commercial, scientific, 
or other legitimate uses. However, an importation or exportation of a 
tableting machine or encapsulating machine may not be completed with a 
person whose description or identifying characteristic has previously 
been furnished to the regulated person by the Administration unless the 
transaction is approved by the Administration.
    (d) Each regulated bulk manufacturer of a listed chemical shall 
submit manufacturing, inventory and use data on an annual basis as set 
forth in Sec. 1310.06(h). This data shall be submitted annually to the 
Drug and Chemical Evaluation Section, Drug Enforcement Administration 
(DEA), Washington, D.C. 20537, on or before the 15th day of March of the 
year immediately following the calendar year for which submitted. A 
business entity which manufactures a listed chemical may elect to report 
separately by individual location or report as an aggregate amount for 
the entire business entity provided that they inform the DEA of which 
method they will use. This reporting requirement does not apply to drug 
or other products which are exempted under Sec. Sec. 1310.01(f)(1)(iv) 
or 1310.01(f)(1)(v) except as set forth in Sec. 1310.06(h)(5). Bulk 
manufacturers that produce a listed chemical solely for internal 
consumption shall not be required to report for that listed chemical. 
For purposes of these reporting requirements, internal consumption shall 
consist of any quantity of a listed chemical otherwise not available for 
further resale or distribution. Internal consumption shall include (but 
not be limited to) quantities used for quality control testing, 
quantities consumed in-house or production losses. Internal consumption 
does not include the quantities of a listed chemical consumed in the 
production of exempted products. If an existing standard industry report 
contains the information required in Sec. 1310.06(h) and such 
information is separate or readily retrievable from the report, that 
report may be submitted in satisfaction of this requirement. Each report 
shall be submitted to the DEA under company letterhead and signed by an 
appropriate, responsible official. For purposes of this paragraph only, 
the term regulated bulk manufacturer of a listed chemical means a person 
who manufactures a listed chemical by means of

[[Page 127]]

chemical synthesis or by extraction from other substances. The term bulk 
manufacturer does not include persons whose sole activity consists of 
the repackaging or relabeling of listed chemical products or the 
manufacture of drug dosage form products which contain a listed 
chemical.
    (e) Each regulated person required to report pursuant to Sec. 
1310.03(c) of this part shall either:
    (1) Submit a written report, containing the information set forth in 
Sec. 1310.06(i) of this part, on or before the 15th day of each month 
following the month in which the distributions took place. The report 
shall be submitted under company letterhead, signed by the person 
authorized to sign the registration application forms on behalf of the 
registrant, to the Chemical Control Section, Office of Diversion 
Control, Drug Enforcement Administration, Washington, DC 20537; or
    (2) Upon request to and approval by the Administration, submit the 
report in electronic form, either via computer disk or direct electronic 
data transmission, in such form as the Administration shall direct. 
Requests to submit reports in electronic form should be submitted to the 
Chemical Control Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, ATTN: Electronic Reporting.
    (f) Except as provided in paragraph (g) of this section, the 
following distributions to nonregulated persons, and the following 
export transactions, are not subject to the reporting requirements in 
Sec. 1310.03(c):
    (1) Distributions of sample packages of drug products when those 
packages contain not more than two solid dosage units or the equivalent 
of two dosage units in liquid form, not to exceed 10 milliliters of 
liquid per package, and not more than one package is distributed to an 
individual or residential address in any 30-day period.
    (2) Distributions of drug products by retail distributors that may 
not include face-to-face transactions to the extent that such 
distributions are consistent with the activities authorized for a retail 
distributor as specified in Sec. 1300.02(b)(29) of this chapter.
    (3) Distributions of drug products to a resident of a long term care 
facility or distributions of drug products to a long term care facility 
for dispensing to or for use by a resident of that facility.
    (4) Distributions of drug products in accordance with a valid 
prescription.
    (5) Exports which have been reported to the Administrator under 
Sec. Sec. 1313.31 and 1313.32 of this chapter or which are subject to a 
waiver granted under Sec. 1313.21 of this chapter.
    (g) The Administrator may revoke any or all of the exemptions listed 
in paragraph (f) of this section for an individual regulated person if 
the Administrator finds that drug products distributed by the regulated 
person are being used in violation of the regulations in this chapter or 
the Controlled Substances Act. The Administrator will notify the 
regulated person of the revocation, as provided in Sec. 1313.41(a) of 
this chapter. The revocation will be effective upon receipt of the 
notice by the person. The regulated person has the right to an expedited 
hearing regarding the revocation, as provided in Sec. 1313.56(a) of 
this chapter.

[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2461, Jan. 22, 1992; 61 
FR 14024, Mar. 29, 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, Mar. 
24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR 49569, July 31, 2002; 68 FR 
57804, Oct. 7, 2003]



Sec. 1310.06  Content of records and reports.

    (a) Each record required by Sec. 1310.03 shall include the 
following:
    (1) The name, address, and, if required, DEA registration number of 
each party to the regulated transaction.
    (2) The date of the regulated transaction.
    (3) The name, quantity and form of packaging of the listed chemical 
or a description of the tableting machine or encapsulating machine 
(including make, model and serial number).
    (4) The method of transfer (company truck, picked up by customer, 
etc.).
    (5) The type of identification used by the purchaser and any unique 
number on that identification.

[[Page 128]]

    (b) For purposes of this section, normal business records shall be 
considered adequate if they contain the information listed in paragraph 
(a) of this section and are readily retrievable from other business 
records of the regulated person. For prescription drug products, 
prescription and hospital records kept in the normal course of medical 
treatment shall be considered adequate for satisfying the requirements 
of paragraph (a) of this section with respect to dispensing to patients, 
and records required to be maintained pursuant to the Federal Food and 
Drug Administration regulations relating to the distribution of 
prescription drugs, as set forth in 21 CFR part 205, shall be considered 
adequate for satisfying the requirements of paragraph (a) of this 
section with respect to distributions.
    (c) Each report required by Section 1310.05(a) shall include the 
information as specified by Section 1310.06(a) and, where obtainable, 
the registration number of the other party, if such party is registered. 
A report submitted pursuant to Sec. 1310.05(a)(1) or (a)(4) must also 
include a description of the circumstances leading the regulated person 
to make the report, such as the reason that the method of payment was 
uncommon or the loss unusual. If the report is for a loss or 
disappearance under Sec. 1310.05(a)(4), the circumstances of such loss 
must be provided (in-transit, theft from premises, etc.)
    (d) A suggested format for the reports is provided below:

                                Supplier:

Registration Number_____________________________________________________
Name____________________________________________________________________
Business Address________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Business Phone__________________________________________________________

                               Purchaser:

Registration Number_____________________________________________________
Name____________________________________________________________________
Business Address________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Business Phone__________________________________________________________
Identification__________________________________________________________

         Shipping Address (if different than purchaser Address):

Street__________________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Date of Shipment________________________________________________________
Name of Listed Chemical(s)______________________________________________
Quantity and Form of Packaging__________________________________________

                         Description of Machine:

Make____________________________________________________________________
Model___________________________________________________________________
Serial ________________________________________________________
Method of Transfer______________________________________________________

                        If Loss or Disappearance:

Date of Loss____________________________________________________________
Type of Loss____________________________________________________________
Description of Circumstances____________________________________________


Public reporting burden for this collection of information is estimated 
to average ten minutes per response, including the time for reviewing 
instructions, searching existing data sources, gathering and maintaining 
the data needed, and completing and reviewing the collection of 
information. Send comments regarding this burden estimate or any other 
aspect of this collection of information, including suggestions for 
reducing this burden to the Drug Enforcement Administration, Records 
Management Section, Washington, D.C. 20537; and to the Office of 
Management and Budget, Paperwork Reduction Project No. 1117-0024, 
Washington, D.C. 20503.
    (e) Each report of an importation of a tableting machine or an 
encapsulating machine required by Sec. 1310.05(c) shall include the 
following information:
    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the regulated person; the name, 
address, telephone number, telex number, and, where available, the 
facsimile number of the import broker or forwarding agent, if any:
    (2) The description of each machine (including make, model, and 
serial number) and the number of machines being received;
    (3) The proposed import date, and the first U.S. Customs Port of 
Entry; and
    (4) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the

[[Page 129]]

consignor in the foreign country of exportation.
    (f) Each report of an exportation of a tableting machine or an 
encapsulating machine required by Sec. 1310.05(c) shall include the 
following information:
    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the regulated person; the name, 
address, telephone number, telex number, and, where available, the 
facsimile number of the export broker, if any;
    (2) The description of each machine (including make, model, and 
serial number) and the number of machines being shipped;
    (3) The proposed export date, the U.S. Customs Port of exportation, 
and the foreign Port of Entry; and
    (4) The name, address, telephone, telex, and, where available, the 
facsimile number of the consignee in the country where the shipment is 
destined; the name(s) and address(es) of any intermediate consignee(s).
    (g) Declared exports of machines which are refused, rejected, or 
otherwise deemed undeliverable may be returned to the U.S. exporter of 
record. A brief written report outlining the circumstances must be sent 
to the Drug Enforcement Administration, P.O. Box 27284, Washington, DC 
20038, following the return within a reasonable time. This provision 
does not apply to shipments that have cleared foreign customs, been 
delivered, and accepted by the foreign consignee. Returns to third 
parties in the United States will be regarded as imports.
    (h) Each annual report required by Section 1310.05(d) shall provide 
the following information for each listed chemical manufactured:
    (1) The name, address and chemical registration number (if any) of 
the manufacturer and person to contact for information.
    (2) The aggregate quantity of each listed chemical that the company 
manufactured during the preceding calendar year.
    (3) The year-end inventory of each listed chemical as of the close 
of business on the 31st day of December of each year. (For each listed 
chemical, if the prior period's ending inventory has not previously been 
reported to DEA, this report should also detail the beginning inventory 
for the period.) For purposes of this requirement, inventory shall 
reflect the quantity of listed chemicals, whether in bulk or non-exempt 
product form, held in storage for later distribution. Inventory does not 
include waste material for destruction, material stored as an in-process 
intermediate or other in-process material.
    (4) The aggregate quantity of each listed chemical used for internal 
consumption during the preceding calendar year, unless the chemical is 
produced solely for internal consumption.
    (5) The aggregate quantity of each listed chemical manufactured 
which becomes a component of a product exempted from Section 
1310.01(f)(1)(iv) or 1310.01(f)(1)(v) during the preceding calendar 
year.
    (6) Data shall identify the specific isomer, salt or ester when 
applicable but quantitative data shall be reported as anhydrous base or 
acid in kilogram units of measure.
    (i) Each monthly report required by Sec. 1310.05(e) of this part 
shall provide the following information for each distribution:
    (1) Supplier name and registration number.
    (2) Purchaser's name and address.
    (3) Name/address shipped to (if different from purchaser's name/
address).
    (4) Name of the chemical and total amount shipped (i.e. 
Pseudoephedrine, 250 grams).
    (5) Date of shipment.
    (6) Product name (if drug product).
    (7) Dosage form (if drug product) (i.e., pill, tablet, liquid).
    (8) Dosage strength (if drug product) (i.e., 30mg, 60mg, per dose 
etc.).
    (9) Number of dosage units (if drug product) (100 doses per 
package).
    (10) Package type (if drug product) (bottle, blister pack, etc.).
    (11) Number of packages (if drug product) (10 bottles).
    (12) Lot number (if drug product).
    (j) Information provided in reports required by Sec. 1310.05(e) of 
this part which is exempt from disclosure under section 552(a) of Title 
5, by reason of section 552(b)(6) of Title 5, will be provided the same 
protections from disclosure as are provided in section 310(c) of

[[Page 130]]

the Act (21 U.S.C. 830(c)) for confidential business information.

[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2462, Jan. 22, 1992; 59 
FR 51364, Oct. 11, 1994; 60 FR 32461, June 22, 1995; 61 FR 14024, Mar. 
29, 1996; 61 FR 32926, June 26, 1996; 67 FR 14862, Mar. 28, 2002; 67 FR 
49569, July 31, 2002]



Sec. 1310.07  Proof of identity.

    (a) Each regulated person who engages in a regulated transaction 
must identify the other party to the transaction. For domestic 
transaction, this shall be accomplished by having the other party 
present documents which would verify the identity, or registration 
status if a registrant, of the other party to the regulated person at 
the time the order is placed. For export transactions, this shall be 
accomplished by good faith inquiry through reasonably available research 
documents or publicly available information which would indicate the 
existence of the foreign customer. No proof of identity is required for 
foreign suppliers.
    (b) The regulated person must verify the existence and apparent 
validity of a business entity ordering a listed chemical, tableting 
machine or encapsulating machine. For domestic transactions, this may be 
accomplished by such methods as checking the telephone directory, the 
local credit bureau, the local Chamber of Commerce or the local Better 
Business Bureau, or, if the business entity is a registrant, by 
verification of the registration. For export transactions, a good faith 
inquiry to verify the existence and apparent validity of a foreign 
business entity may be accomplished by such methods as verifying the 
business telephone listing through international telephone information, 
the firm's listing in international or foreign national chemical 
directories or other commerce directories or trade publications, 
confirmation through foreign subsidiaries of the U.S. regulated person, 
verification through the country of destination's embassy Commercial 
Attache, or official documents provided by the purchaser which confirm 
the existence and apparent validity of the business entity.
    (c) When transacting business with a new representative of a firm, 
the regulated person must verify the claimed agency status of the 
representative.
    (d) For sales to individuals or cash purchasers, the type of 
documents and other evidence of proof must consist of at least a 
signature of the purchaser, a driver's license and one other form of 
identification. Any exports to individuals or exports paid in cash are 
suspect and should be handled as such. For such exports, the regulated 
person shall diligently obtain from the purchaser or independently seek 
to confirm clear documentation which proves the person is properly 
identified such as through foreign identity documents, driver's license, 
passport information and photograph, etc. Any regulated person who fails 
to adequately prove the identity of the other party to the transaction 
may be subject to the specific penalties provided for violations of law 
related to regulated transactions in listed chemicals.
    (e) For a new customer who is not an individual or cash customer, 
the regulated person shall establish the identity of the authorized 
purchasing agent or agents and have on file that person's signature, 
electronic password, or other identification. Once the authorized 
purchasing agent has been established, the agent list may be updated 
annually rather than on each order. The regulated person must ensure 
that shipments are not made unless the order is placed by an authorized 
agent of record.
    (f) With respect to electronic orders, the identity of the purchaser 
shall consist of a computer password, identification number or some 
other means of identification consistent with electronic orders and with 
Sec. 1310.07(e).

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32461, June 22, 1995]



Sec. 1310.08  Excluded transactions.

    Pursuant to 21 U.S.C. 802(39)(A)(iii), regulation of the following 
transactions has been determined to be unnecessary for the enforcement 
of the Chemical Diversion and Trafficking Act and, therefore, they have 
been excluded from the definitions of regulated transactions:
    (a) Domestic and import transactions of hydrochloric and sulfuric 
acids but

[[Page 131]]

not including anhydrous hydrogen chloride.
    (b) Exports, transshipments, and international transactions of 
hydrochloric (including anhydrous hydrogen chloride) and sulfuric acids, 
except for exports, transshipments and international transactions to the 
following countries:
    (1) Argentina
    (2) Bolivia
    (3) Brazil
    (4) Chile
    (5) Colombia
    (6) Ecuador
    (7) French Guiana
    (8) Guyana
    (9) Panama
    (10) Paraguay
    (11) Peru
    (12) Suriname
    (13) Uruguay
    (14) Venezuela
    (c) Domestic transactions of Methyl Isobutyl Ketone (MIBK).
    (d) Import transactions of Methyl Isobutyl Ketone (MIBK) destined 
for the United States.
    (e) Export transactions, international transactions, and import 
transactions for transshipment or transfer of Methyl Isobutyl Ketone 
(MIBK) destined for Canada or any country outside of the Western 
Hemisphere.
    (f) Import and export transactions of iodine.
    (g) Import transactions of anhydrous hydrogen chloride.
    (h) Domestic distribution of anhydrous hydrogen chloride weighing 
12,000 pounds (net weight) or more in a single container.
    (i) Domestic distribution of anhydrous hydrogen chloride by 
pipeline.
    (j) Domestic and international return shipments of reusable 
containers from customer to producer containing residual quantities of 
red phosphorus or white phosphorus in rail cars and intermodal tank 
containers which conform to International Standards Organization 
specifications (with capacities greater than or equal to 2,500 gallons 
in a single container).
    (k) Domestic, import, and export distributions of gamma-
butyrolactone weighing 4,000 kilograms (net weight) or more in a single 
container.
    (l) Domestic and import transactions in chemical mixtures that 
contain acetone, ethyl ether, 2-butanone, or toluene unless regulated 
because of being formulated with another listed chemical above the 
concentration limit.

[57 FR 43615, Sept. 22, 1992, as amended at 60 FR 19510, Apr. 19, 1995; 
60 FR 32461, June 22, 1995; 62 FR 13968, Mar. 24, 1997; 65 FR 47316, 
Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 37414, June 24, 2003; 68 
FR 53292, Sept. 10, 2003; 69 FR 74971, Dec. 15, 2004]



Sec. 1310.09  Temporary exemption from registration.

    (a) Each person required by section 302 of the act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a combination 
ephedrine product is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before July 12, 1997. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in parts 1309, 1310, and 1313 of this chapter remain in full 
force and effect.
    (b) Each person required by section 302 of the act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a drug product 
that contains pseudoephedrine or phenylpropanolamine that is regulated 
pursuant to Sec. 1300.02(b)(28)(1)(D) of this chapter is temporarily 
exempted from the registration requirement, provided that the person 
submits a proper application for registration on or before December 3, 
1997. The exemption will remain in effect for each person who has made 
such application until the Administration has approved or denied that 
application. This exemption applies only to registration; all other 
chemical control requirements set forth in parts 1309, 1310, and 1313 of 
this chapter remain in full force and effect.
    (c) Each person required by section 302 of the act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export GBL is 
temporarily exempted from the registration requirement, provided that 
the DEA receives a proper

[[Page 132]]

application for registration on or before July 24, 2000. The exemption 
will remain in effect for each person who has made such application 
until the Administration has approved or denied that application. This 
exemption applies only to registration; all other chemical control 
requirements set forth in parts 1309, 1310, and 1313 of this chapter 
remain in full force and effect.
    (d) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export the List I 
chemicals red phosphorus, white phosphorus, and hypophosphorous acid 
(and its salts), is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before December 17, 2001. The exemption will remain 
in effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in parts 1309, 1310, and 1313 of this chapter remain in full 
force and effect.
    (e) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export regulated 
chemical mixtures which contain ephedrine, N-methylephedrine, N-
methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or 
pseudoephedrine, pursuant to Sec. Sec. 1310.12 and 1310.13, is 
temporarily exempted from the registration requirement, provided that 
DEA receives a proper application for registration or application for 
exemption on or before June 30, 2003. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in parts 1309, 1310, and 1313 of this chapter remain in full 
force and effect. Any person who distributes, imports or exports a 
chemical mixture whose application for exemption is subsequently denied 
by DEA must obtain a registration with DEA. A temporary exemption from 
the registration requirement will also be provided for these persons, 
provided that DEA receives a properly completed application for 
registration on or before 30 days following the date of official DEA 
notification that the application for exemption has not been approved. 
The temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
    (f) Except for chemical mixtures containing the listed chemicals in 
paragraph (e) of this section, each person required by section 302 of 
the Act (21 U.S.C. 822) to obtain a registration to distribute, import, 
or export regulated chemical mixtures, pursuant to Sec. Sec. 1310.12 
and 1310.13, is temporarily exempted from the registration requirement, 
provided that DEA receives a proper application for registration or 
application for exemption on or before February 14, 2005. The exemption 
will remain in effect for each person who has made such application 
until the Administration has approved or denied that application. This 
exemption applies only to registration; all other chemical control 
requirements set forth in parts 1309, 1310, and 1313 of this chapter 
remain in full force and effect.
    (g) Any person who distributes, imports, or exports a chemical 
mixture whose application for exemption is subsequently denied by DEA 
must obtain a registration with DEA. A temporary exemption from the 
registration requirement will also be provided for these persons, 
provided that DEA receives a properly completed application for 
registration on or before 30 days following the date of official DEA 
notification that the application for exemption has not been approved. 
The temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.

[62 FR 27693, May 21, 1997, as amended at 62 FR 53960, Oct. 17, 1997; 65 
FR 21647, Apr. 24, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, May 1, 
2003; 69 FR 74971, Dec. 15, 2004]



Sec. 1310.10  Removal of the exemption of drugs distributed under the 
Food, Drug and Cosmetic Act.

    (a) The Administrator may remove from exemption under Sec. 
1310.01(b)(28)(i)(D) any drug or group of drugs that the Administrator 
finds

[[Page 133]]

is being diverted to obtain a listed chemical for use in the illicit 
production of a controlled substance. In removing a drug or group of 
drugs from the exemption the Administrator shall consider:
    (1) The scope, duration, and significance of the diversion;
    (2) Whether the drug or group of drugs is formulated in such a way 
that it cannot be easily used in the illicit production of a controlled 
substance; and
    (3) Whether the listed chemical can be readily recovered from the 
drug or group of drugs.
    (b) Upon determining that a drug or group of drugs should be removed 
from the exemption under paragraph (a) of this section, the 
Administrator shall issue and publish in the Federal Register his 
proposal to remove the drug or group of drugs from the exemption, which 
shall include a reference to the legal authority under which the 
proposal is based. The Administrator shall permit any interested person 
to file written comments on or objections to the proposal. After 
considering any comments or objections filed, the Administrator shall 
publish in the Federal Register his final order.
    (c) The Administrator shall limit the removal of a drug or group of 
drugs from exemption under paragraph (a) of this section to the most 
identifiable type of the drug or group of drugs for which evidence of 
diversion exists unless there is evidence, based on the pattern of 
diversion and other relevant factors, that the diversion will not be 
limited to that particular drug or group of drugs.
    (d) Any manufacturer seeking reinstatement of a particular drug 
product that has been removed from an exemption may apply to the 
Administrator for reinstatement of the exemption for that particular 
drug product on the grounds that the particular drug product is 
manufactured and distributed in a manner that prevents diversion. In 
determining whether the exemption should be reinstated the Administrator 
shall consider:
    (1) The package sizes and manner of packaging of the drug product;
    (2) The manner of distribution and advertising of the drug product;
    (3) Evidence of diversion of the drug product;
    (4) Any actions taken by the manufacturer to prevent diversion of 
the drug product; and
    (5) Such other factors as are relevant to and consistent with the 
public health and safety, including the factors described in paragraph 
(a) of this section as applied to the drug product.
    (e) Within a reasonable period of time after receipt of the 
application for reinstatement of the exemption, the Administrator shall 
notify the applicant of his acceptance or non-acceptance of his 
application, and if not accepted, the reason therefor. If the 
application is accepted for filing, the Administrator shall issue and 
publish in the Federal Register his order on the reinstatement of the 
exemption for the particular drug product, which shall include a 
reference to the legal authority under which the order is based. This 
order shall specify the date on which it shall take effect. The 
Administrator shall permit any interested person to file written 
comments on or objections to the order. If any such comments raise 
significant issues regarding any finding of fact or conclusion of law 
upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (f) Unless the Administrator has evidence that the drug product is 
being diverted, as determined by applying the factors set forth in 
paragraph (a) of this section, and the Administrator so notifies the 
applicant, transactions involving a specific drug product will not be 
considered regulated transactions during the following periods:
    (1) While a bonafide application for reinstatement of exemption 
under paragraph (d) of this section for the specific drug product is 
pending resolution, provided that the application for reinstatement is 
filed not later than 60 days after the publication of the final order 
removing the exemption; and
    (2) For a period of 60 days following the Administrator's denial of 
an application for reinstatement.

[[Page 134]]

    (g) An order published by the Administrator in the Federal Register, 
pursuant to paragraph (e) of this section, to reinstate an exemption may 
be modified or revoked with respect to a particular drug product upon a 
finding that:
    (1) Applying the factors set forth in paragraph (a) of this section 
to the particular drug product, the drug product is being diverted; or
    (2) There is a significant change in the data that led to the 
issuance of the final rule.

[60 FR 32461, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997; 
67 FR 14862, Mar. 28, 2002]



Sec. 1310.11  Reinstatement of exemption for drug products distributed 
under the Food, Drug and Cosmetic Act.

    (a) The Administrator has reinstated the exemption for the drug 
products listed in paragraph (e) of this section from application of 
sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822-823, 
830, and 957-958), to the extent described in paragraphs (b), (c), and 
(d) of this section.
    (b) No reinstated exemption granted pursuant to 1310.10 affects the 
criminal liability for illegal possession or distribution of listed 
chemicals contained in the exempt drug product.
    (c) Changes in exempt drug product compositions: Any change in the 
quantitative or qualitative composition, trade name or other designation 
of an exempt drug product listed in paragraph (d) requires a new 
application for reinstatement of the exemption.
    (d) The following drug products, in the form and quantity listed in 
the application submitted (indicated as the ``date'') are designated as 
reinstated exempt drug products for the purposes set forth in this 
section:

                                              Exempt Drug Products
----------------------------------------------------------------------------------------------------------------
               Supplier                      Product name                 Form                     Date
----------------------------------------------------------------------------------------------------------------
[Reserved]...........................  .......................  .......................  .......................
----------------------------------------------------------------------------------------------------------------


[60 FR 32462, June 22, 1995]



Sec. 1310.12  Exempt chemical mixtures.

    (a) The chemical mixtures meeting the criteria in paragraphs (c) or 
(d) of this section are exempted by the Administrator from application 
of sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822, 
823, 830, 957 and 958) to the extent described in paragraphs (b) and (c) 
of this section.
    (b) No exemption granted pursuant to this Sec. 1310.12 or Sec. 
1310.13 affects the criminal liability for illegal possession, 
distribution, exportation, or importation of listed chemicals contained 
in the exempt chemical mixture or the civil liability for unlawful acts 
related to exempt chemical mixtures, including distribution in violation 
of 21 U.S.C. 842(a)(11).
    (c) Mixtures containing a listed chemical in concentrations equal to 
or less than those specified in the ``Table of Concentration Limits'' 
are designated as exempt chemical mixtures for the purpose set forth in 
this section. The concentration is determined for liquid-liquid mixtures 
by using the volume or weight and for mixtures containing solids or 
gases by using the unit of weight.

                                          Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
                                             DEA
                                           chemical          Concentration              Special conditions
                                         code number
----------------------------------------------------------------------------------------------------------------
                                                List I Chemicals
----------------------------------------------------------------------------------------------------------------
N-Acetylanthranilic acid, its salts and         8522  20% by Weight.............  Concentration based on any
 esters.                                                                           combination of N-
                                                                                   acetylanthranilic acid and
                                                                                   its salts and esters.
Anthranilic acid, and its salts and             8530  50% by Weight.............  Concentration is based on any
 esters.                                                                           combination of anthranilic
                                                                                   acid and its salts and
                                                                                   esters.
Benzaldehyde...........................         8256  50% by Weight or Volume...
Benzyl cyanide.........................         8570  20% by Weight or Volume...
Ephedrine, its salts, optical isomers,          8113  5% by Weight, net weight    Concentration based on any
 and salts of optical isomers.                         includes capsule, if any.   combination of ephedrine,
                                                                                   pseudoephedrine, and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers.
Ergonovine and its salts...............         8675  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of ergonovine,
                                                                                   including its salts, are not
                                                                                   exempt.

[[Page 135]]

 
Ergotamine and its salts...............         8676  Not exempt at any           Chemical mixtures containing
                                                       concentration.              amount of any ergotamine,
                                                                                   including its salts, are not
                                                                                   exempt.
Ethylamine and its salts...............         8678  20% by Weight or Volume...  Ethylamine or its salts in an
                                                                                   inert carrier solvent is not
                                                                                   considered a mixture.
                                                                                   Concentration is based on
                                                                                   ethylamine in the mixture and
                                                                                   not the combination of
                                                                                   ethylamine and carrier
                                                                                   solvent, if any.
Hydriodic acid.........................         6695  20% by Weight or Volume...
Isosafrole.............................         8704  20% by Weight or Volume...  Concentration in a mixture
                                                                                   cannot exceed 20% if taken
                                                                                   alone or in any combination
                                                                                   with safrole.
Methylamine and its salts..............         8520  20% by Weight.............  Methylamine or its salts in an
                                                                                   inert carrier solvent is not
                                                                                   considered a mixture. Weight
                                                                                   is based on methylamine in
                                                                                   the mixture and not the
                                                                                   combined weight of carrier
                                                                                   solvent, if any.
3,4-Methylenedioxyphenyl-2-propanone...         8502  20% by Weight.............
N-Methylephedrine, its salts, optical           8115  0.1% by Weight............  Concentration based on any
 isomers, and salts of optical isomers.                                            combination of salts N-
                                                                                   methylephedrine, N-
                                                                                   methylpseudoephedrine and
                                                                                   their salts, optical isomers
                                                                                   and salts of optical isomers.
N-Methylpseudoephedrine, its salts,             8119  0.1% by Weight............  Concentration based on any
 optical isomers, and salts of optical                                             combination of N-
 isomers.                                                                          methylpseudoephedrine, N-
                                                                                   methylephedrine, and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers.
Nitroethane............................         6724  20% by Weight or Volume...
Norpseudoephedrine, its salts, optical          8317  0.6% by Weight............  Concentration based on any
 isomers, and salts of optical isomers.                                            combination of
                                                                                   norpseudoephedrine,
                                                                                   phenylpropanolamine and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers.
Phenylacetic acid, and its salts and            8791  40% by Weight.............  Concentration is based on any
 esters.                                                                           combination of phenylacetic
                                                                                   acid and its salts and
                                                                                   esters.
 
Phenylpropanolamine, its salts, optical         1225  0.6% by Weight............  Concentration based on any
 isomers, and salts of optical isomers.                                            combination of
                                                                                   phenylpropanolamine,
                                                                                   norpseudoephedrine and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers.
Piperidine, and its salts..............         2704  20% by Weight or Volume...  Concentration based on any
                                                                                   combination of piperidine and
                                                                                   its salts. Concentration
                                                                                   based on weight if a solid,
                                                                                   weight or volume if a liquid.
Piperonal..............................         8750  20% by Weight or Volume...
Propionic anhydride....................         8328  20% by Weight or Volume...
Pseudoephedrine, its salts, optical             8112  5% by Weight, net weight    Concentration based on any
 isomers, and salts of optical isomers.                includes capsule, if any.   combination of
                                                                                   pseudoephedrine, ephedrine,
                                                                                   and their salts, optical
                                                                                   isomers and salts of optical
                                                                                   isomers.
Safrole................................         8323  20% by Volume.............  Concentration in a mixture
                                                                                   cannot exceed 20% if taken
                                                                                   alone or in any combination
                                                                                   with isosafrole.
----------------------------------------
                                                List II Chemicals
----------------------------------------------------------------------------------------------------------------
Acetic Anhydride.......................         8519  20% by Weight or Volume...
Acetone................................         6532  35% by Weight or Volume...  Exports only; Limit applies to
                                                                                   acetone or any combination of
                                                                                   acetone, ethyl ether, 2-
                                                                                   butanone, methyl isobutyl
                                                                                   ketone, and toluene if
                                                                                   present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
Benzyl chloride........................         8568  20% by Weight or Volume...
2-butanone.............................         6714  35% by Weight or Volume...  Exports only; Limit applies to
                                                                                   2-butanone or any combination
                                                                                   of acetone, ethyl ether, 2-
                                                                                   butanone, methyl isobutyl
                                                                                   ketone, and toluene if
                                                                                   present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
Ethyl ether............................         6584  35% by Weight or Volume...  Exports only; Limit applies to
                                                                                   ethyl ether or any
                                                                                   combination of acetone, ethyl
                                                                                   ether, 2-butanone, methyl
                                                                                   isobutyl ketone, and toluene
                                                                                   if present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
Hydrochloric acid......................         6545  20% by Weight or Volume...  Hydrogen chloride in an inert
                                                                                   carrier solvent, such as
                                                                                   aqueous or alcoholic
                                                                                   solutions, is not considered
                                                                                   a mixture. Weight is based on
                                                                                   hydrogen chloride in the
                                                                                   mixture and not the combined
                                                                                   weight of the carrier
                                                                                   solvent, if any.

[[Page 136]]

 
Methyl isobutyl ketone.................         6715  35% by Weight or Volume...  Exports only pursuant to Sec.
                                                                                    1310.08; Limit applies to
                                                                                   methyl isobutyl ketone or any
                                                                                   combination of acetone, ethyl
                                                                                   ether, 2-butanone, methyl
                                                                                   isobutyl ketone, and toluene
                                                                                   if present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
Potassium permanganate.................         6579  15% by Weight.............
Sulfuric acid..........................         6552  20% by Weight or Volume...  Sulfuric acid in an inert
                                                                                   carrier solvent, such as
                                                                                   aqueous or alcoholic
                                                                                   solutions, is not considered
                                                                                   a mixture. Weight is based on
                                                                                   sulfuric acid in the mixture
                                                                                   and not the combined weight
                                                                                   of the carrier solvent, if
                                                                                   any.
Toluene................................          594  35% by Weight or Volume...  Exports only; Limit applies to
                                                                                   toluene or any combination of
                                                                                   acetone, ethyl ether, 2-
                                                                                   butanone, methyl isobutyl
                                                                                   ketone, and toluene if
                                                                                   present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
----------------------------------------------------------------------------------------------------------------

    (d) The following categories of chemical mixtures are automatically 
exempt from the provisions of the Controlled Substances Act as described 
in paragraph (a) of this section:
    (1) Harvested plant material that contains ephedrine, N-
methylephedrine, N-methylpseudoephedrine, norpseudoephedrine, 
phenylpropanolamine, and/or pseudoephedrine, that is in its natural 
state or has been processed in a way (such as grinding, chopping, 
mulching or cutting) that preserves the natural constituents in the 
ratios that are found in the plant's natural state. Plant material 
subjected to chemical or physical extraction, concentration, chemical 
reaction, or other treatment that alters the plant's natural 
constituents or the ratios of the plant constituents are not exempt.
    (2) Chemical mixtures that are distributed directly to an 
incinerator for destruction or directly to an authorized waste recycler 
or reprocessor where such distributions are documented on United States 
Environmental Protection Agency Form 8700-22; persons distributing the 
mixture to the incinerator or recycler must maintain and make available 
to agents of the Administration, upon request, such documentation for a 
period of no less than two years.
    (3) Completely formulated paints and coatings: Completely formulated 
paints and coatings are only those formulations that contain all the 
components of the paint or coating for use in the final application 
without the need to add any additional substances except a thinner if 
needed in certain cases. A completely formulated paint or coating is 
defined as any clear or pigmented liquid, liquefiable or mastic 
composition designed for application to a substrate in a thin layer that 
is converted to a clear or opaque solid protective, decorative, or 
functional adherent film after application. Included in this category 
are clear coats, topcoats, primers, varnishes, sealers, adhesives, 
lacquers, stains, shellacs, inks, and temporary protective coatings.
    (e) The Administrator may, at any time, terminate or modify the 
exemption for any chemical mixture which has been granted an exemption 
pursuant to the concentration limits as specified in paragraph (c) of 
this section or pursuant to the category exemption as specified in 
paragraph (d) of this section. In terminating or modifying an exemption, 
the Administrator shall issue, and publish in the Federal Register, 
notification of the removal of an exemption for a product or group of 
products for which evidence of diversion has been found, as well as the 
date on which the termination of exemption shall take effect. The 
Administrator shall permit any interested party to file written comments 
on or objections to the order within 60 days of the date of publication 
of the order in the Federal Register. If any such comments or objections 
raise significant issues regarding any finding of fact or conclusion of 
law upon which the order is

[[Page 137]]

based, the Administrator shall immediately suspend the effectiveness of 
the order until he may reconsider the order in light of comments and 
objections filed. Thereafter, the Administrator shall reinstate, 
terminate, or amend the original order as determined appropriate.
    (f) The Administrator may modify any part of the criteria for 
exemption as specified in paragraphs (c) and (d) of this section upon 
evidence of diversion or attempted diversion. In doing so, the 
Administrator shall issue and publish a Notice of Proposed Rulemaking in 
the Federal Register. The Administrator shall permit any interested 
persons to file written comments on or objections to the proposal. After 
considering any comments or objections filed, the Administrator shall 
publish in the Federal Register a final order.

[68 FR 23204, May 1, 2003, as amended at 69 FR 74971, Dec. 15, 2004]



Sec. 1310.13  Exemption of chemical mixtures; application.

    (a) The Administrator may, by publication of a Final Rule in the 
Federal Register, exempt from the application of all or any part of the 
Act a chemical mixture consisting of two or more chemical components, at 
least one of which is not a List I or List II chemical, if:
    (1) The mixture is formulated in such a way that it cannot be easily 
used in the illicit production of a controlled substance; and
    (2) The listed chemical or chemicals contained in the chemical 
mixture cannot be readily recovered.
    (b) Any manufacturer seeking an exemption for a chemical mixture, 
not exempt under Sec. 1310.12, from the application of all or any part 
of the Act, may apply to the Administrator, Drug Enforcement 
Administration, Department of Justice, Washington, DC 20537.
    (c) An application for exemption under this section shall contain 
the following information:
    (1) The name, address, and registration number, if any, of the 
applicant;
    (2) The date of the application;
    (3) The exact trade name(s) of the applicant's chemical mixture and:
    (i) If the applicant formulates or manufactures the chemical mixture 
for other entities, the exact trade names of the chemical mixtures and 
the names of the entities for which the chemical mixtures were prepared; 
and
    (ii) If a group of mixtures (e.g. formulations having identical 
function and containing the same listed chemical(s)), the information 
required in paragraph (c)(3)(i) of this section and a brief narrative of 
their use.
    (4) (i) The complete qualitative and quantitative composition of the 
chemical mixture (including all listed and all non-listed chemicals); or
    (ii) If a group of mixtures, the concentration range for the listed 
chemical and a listing of all non-listed chemicals with respective 
concentration ranges.
    (5) (i) The chemical and physical properties of the mixture and how 
they differ from the properties of the listed chemical or chemicals; and
    (ii) If a group of mixtures, how the group's properties differ from 
the properties of the listed chemical.
    (6) A statement that the applicant believes justifies an exemption 
for the chemical mixture or group of mixtures. The statement must 
explain how the chemical mixture(s) meets the exemption criteria set 
forth in paragraph (a) of this section.
    (7) A statement that the applicant accepts the right of the 
Administrator to terminate exemption from regulation for the chemical 
mixture(s) granted exemption under this section.
    (8) The identification of any information on the application that is 
considered by the applicant to be a trade secret or confidential and 
entitled to protection under U.S. laws restricting the public disclosure 
of such information.
    (d) The Administrator may require the applicant to submit such 
additional documents or written statements of fact relevant to the 
application that he deems necessary for determining if the application 
should be granted.
    (e) Within 30 days after the receipt of an application for an 
exemption under this section, the Administrator will notify the 
applicant of acceptance or rejection of the application. If the 
application is not accepted, an explanation will be provided. The 
Administrator is not required to accept an application if any 
information required pursuant to

[[Page 138]]

paragraph (c) of this section or requested pursuant to paragraph (d) of 
this section is lacking or not readily understood. The applicant may, 
however, amend the application to meet the requirements of paragraphs 
(c) and (d) of this section. If the exemption is granted, the applicant 
shall be notified in writing and the Administrator shall issue, and 
publish in the Federal Register, an order on the application. This order 
shall specify the date on which it shall take effect. The Administrator 
shall permit any interested person to file written comments on or 
objections to the order. If any comments or objections raise significant 
issues regarding any findings of fact or conclusions of law upon which 
the order is based, the Administrator may suspend the effectiveness of 
the order until he has reconsidered the application in light of the 
comments and objections filed. Thereafter, the Administrator shall 
reinstate, terminate, or amend the original order as deemed appropriate.
    (f) The Administrator may, at any time, terminate or modify an 
exemption for any product pursuant to paragraph (e) of this section. In 
terminating or modifying an exemption, the Administrator shall issue, 
and publish in the Federal Register, notification of the removal of an 
exempt product or group of exempt products for which evidence of 
diversion has been found. This order shall specify the date on which the 
termination of exemption shall take effect. The Administrator shall 
permit any interested party to file written comments on or objections to 
the order within 60 days of the date of publication of the order in the 
Federal Register. If any such comments or objections raise significant 
issues regarding any finding of fact or conclusion of law upon which the 
order is based, the Administrator may suspend the effectiveness of the 
order until he has reconsidered the order in light of comments and 
objections filed. Thereafter, the Administrator shall reinstate, 
terminate, or amend the original order as determined appropriate.
    (g) A manufacturer of an exempted chemical mixture shall notify DEA 
in writing, of any change in the quantitative or qualitative composition 
of a chemical mixture that has been granted an exemption by application. 
Changes include those greater than the range of concentration given in 
the application or that remove non-listed chemical(s) given in the 
application as part of the formulation. A new application will be 
required only if reformulation results in a new product having a 
different commercial application or can no longer be defined as part of 
a group of exempted chemicals. DEA must be notified of reformulation at 
least 30 days in advance of marketing the reformulated mixture. For a 
change in name or other designation, code, or any identifier, a written 
notification is required. DEA must be notified of any changes at least 
60 days in advance of the effective date for the change.
    (h) Each manufacturer seeking exemption must apply for such an 
exemption. A formulation granted exemption by publication in the Federal 
Register will not be exempted for all manufacturers.
    (i) The following chemical mixtures, in the form and quantity listed 
in the application submitted (indicated as the ``date'' ) are designated 
as exempt chemical mixtures for the purposes set forth in this section 
and are exempted by the Administrator from application of sections 302, 
303, 310, 1007, and 1008 of the Act (21 U.S.C. 822, 823, 830, 957 and 
958):

                                            Exempt Chemical Mixtures
----------------------------------------------------------------------------------------------------------------
                      Manufacturer                        Product name \1\         Form               Date
----------------------------------------------------------------------------------------------------------------
[Reserved]
----------------------------------------------------------------------------------------------------------------
\1\ Designate product line if a group.


[[Page 139]]


[68 FR 23204, May 1, 2003]



Sec. 1310.14  Exemption of drug products containing ephedrine and 

therapeutically significant quantities of another active medicinal 
ingredient.

    (a) Any manufacturer of a drug product containing ephedrine in 
combination with another active medicinal ingredient, the product 
formulation of which is not listed in the compendiums set forth in Sec. 
1310.01(b)(28)(i)(D)(1), may request that the Administrator exempt the 
product as one which contains ephedrine together with a therapeutically 
significant quantity of another active medicinal ingredient.
    (b) An application for an exemption under this section shall contain 
the following information:
    (1) The name and address of the applicant;
    (2) The exact trade name of the drug product for which exemption is 
sought;
    (3) The complete quantitative and qualitative composition of the 
drug product;
    (4) A brief statement of the facts which the applicant believes 
justify the granting of an exemption under this section; and
    (5) Certification by the applicant that the product may be lawfully 
marketed or distributed under the Food, Drug, and Cosmetic Act.
    (6) The identification of any information on the application which 
is considered by the applicant to be a trade secret or confidential and 
entitled to protection under U.S. laws restricting the public disclosure 
of such information by government employees.
    (c) The Administrator may require the applicant to submit such 
additional documents or written statements of fact relevant to the 
application which he deems necessary for determining if the application 
should be granted.
    (d) Within a reasonable period of time after the receipt of a 
completed application for an exemption under this section, the 
Administrator shall notify the applicant of acceptance or non-acceptance 
of the application. If the application is not accepted, an explanation 
will be provided. The Administrator is not required to accept an 
application if any of the information required in paragraph (b) of this 
section or requested pursuant to paragraph (c) of this section is 
lacking or not readily understood. The applicant may, however, amend the 
application to meet the requirements of paragraphs (b) and (c) of this 
section. If the application is accepted for filing, the Administrator 
shall issue and publish in the Federal Register an order on the 
application, which shall include a reference to the legal authority 
under which the order is based. This order shall specify the date on 
which it shall take effect. The Administrator shall permit any 
interested person to file written comments on or objections to the 
order. If any comments or objections raise significant issues regarding 
any findings of fact or law upon which the order is based, the 
Administrator shall immediately suspend the effectiveness of the order 
until he may reconsider the application in light of the comments and 
objections filed. Thereafter, the Administrator shall reinstate, revoke, 
or amend the original order as deemed appropriate.

[60 FR 32462, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]



Sec. 1310.15  Exempt drug products containing ephedrine and therapeutically 
significant quantities of another active medicinal ingredient.

    (a) The drug products containing ephedrine and therapeutically 
significant quantities of another active medicinal ingredient listed in 
paragraph (e) of this section have been exempted by the Administrator 
from application of sections 302, 303, 310, 1007, and 1008 of the Act 
(21 U.S.C. 822-3, 830, and 957-8) to the extent described in paragraphs 
(b), (c), and (d) of this section.
    (b) No exemption granted pursuant to 1310.14 affects the criminal 
liability for illegal possession or distribution of listed chemicals 
contained in the exempt drug product.
    (c) Changes in drug product compositions: Any change in the 
quantitative or qualitative composition of an exempt drug product listed 
in paragraph (d) requires a new application for exemption.
    (d) In addition to the drug products listed in the compendium set 
forth in Sec. 1310.01(b)(28)(i)(D)(1), the following

[[Page 140]]

drug products, in the form and quantity listed in the application 
submitted (indicated as the ``date'') are designated as exempt drug 
products for the purposes set forth in this section:

Exempt Drug Products Containing Ephedrine and Therapeutically Significant Quantities of Another Active Medicinal
                                                   Ingredient
----------------------------------------------------------------------------------------------------------------
               Supplier                      Product name                 Form                     Date
----------------------------------------------------------------------------------------------------------------
[Reserved]...........................
----------------------------------------------------------------------------------------------------------------


[60 FR 32463, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]



Sec. 1310.21  Sale by Federal departments or agencies of chemicals 
which could be used to manufacture controlled substances.

    (a) A Federal department or agency may not sell from the stocks of 
the department or agency any chemical which, as determined by the 
Administrator of the Drug Enforcement Administration, could be used in 
the manufacture of a controlled substance, unless the Administrator 
certifies in writing to the head of the department or agency that there 
is no reasonable cause to believe that the sale of the specific chemical 
to a specific person would result in the illegal manufacture of a 
controlled substance. For purposes of this requirement, reasonable cause 
to believe means that the Administration has knowledge of facts which 
would cause a reasonable person to reasonably conclude that a chemical 
would be diverted to the illegal manufacture of a controlled substance.
    (b) A Federal department or agency must request certification by 
submitting a written request to the Administrator, Drug Enforcement 
Administration, Washington, DC 20537, Attention: Domestic Chemical 
Control Unit (ODID). A request for certification may be transmitted 
directly to the Drug Enforcement Administration, Domestic Chemical 
Control Unit through electronic facsimile media. A request for 
certification must be submitted no later than fifteen calendar days 
before the proposed sale is to take place. In order to facilitate the 
sale of chemicals from Federal departments' or agencies' stocks, Federal 
departments or agencies may wish to submit requests as far in advance of 
the fifteen calendar days as possible. The written notification of the 
proposed sale must include:
    (1) The name and amount of the chemical to be sold;
    (2) The name and address of the prospective bidder;
    (3) The name and address of the prospective end-user, in cases where 
a sale is being brokered;
    (4) Point(s) of contact for the prospective bidder and, where 
appropriate, prospective end-user; and
    (5) The end use of the chemical.
    (c) Within fifteen calendar days of receipt of a request for 
certification, the Administrator will certify in writing to the head of 
the Federal department or agency that there is, or is not, reasonable 
cause to believe that the sale of the specific chemical to the specific 
bidder and end-user would result in the illegal manufacture of a 
controlled substance. In making this determination, the following 
factors must be considered:
    (1) Past experience of the prospective bidder or end-user in the 
maintenance of effective controls against diversion of listed chemicals 
into other than legitimate medical, scientific, and industrial channels;
    (2) Compliance of the prospective bidder or end-user with applicable 
Federal, state and local law;
    (3) Prior conviction record of the prospective bidder or end-user 
relating to listed chemicals or controlled substances under Federal or 
state laws; and
    (4) Such other factors as may be relevant to and consistent with the 
public health and safety.
    (d) If the Administrator certifies to the head of a Federal 
department or agency that there is no reasonable cause to believe that 
the sale of a specific chemical to a prospective bidder and end-user 
will result in the illegal manufacture of a controlled substance, that 
certification will be effective for one year from the date of issuance 
with respect to further sales of the same chemical to the same 
prospective bidder and end-user, unless the Administrator notifies the 
head of the Federal department or agency in writing that the 
certification is withdrawn. If the

[[Page 141]]

certification is withdrawn, DEA will also provide written notice to the 
bidder and end-user, which will contain a statement of the legal and 
factual basis for this determination.
    (e) If the Administrator determines there is reasonable cause to 
believe the sale of the specific chemical to a specific bidder and end-
user would result in the illegal manufacture of a controlled substance, 
DEA will provide written notice to the head of a Federal department or 
agency refusing to certify the proposed sale under the authority of 21 
U.S.C. 890. DEA also will provide, within fifteen calendar days of 
receiving a request for certification from a Federal department or 
agency, the same written notice to the prospective bidder and end-user, 
and this notice also will contain a statement of the legal and factual 
basis for the refusal of certification. The prospective bidder and end-
user may, within thirty calendar days of receipt of notification of the 
refusal, submit written comments or written objections to the 
Administrator's refusal. At the same time, the prospective bidder and 
end-user also may provide supporting documentation to contest the 
Administrator's refusal. If such written comments or written objections 
raise issues regarding any finding of fact or conclusion of law upon 
which the refusal is based, the Administrator will reconsider the 
refusal of the proposed sale in light of the written comments or written 
objections filed. Thereafter, within a reasonable time, the 
Administrator will withdraw or affirm the original refusal of 
certification as he determines appropriate. The Administrator will 
provide written reasons for any affirmation of the original refusal. 
Such affirmation of the original refusal will constitute a final 
decision for purposes of judicial review under 21 U.S.C. 877.
    (f) If the Administrator determines there is reasonable cause to 
believe that an existing certification should be withdrawn, DEA will 
provide written notice to the head of a Federal department or agency of 
such withdrawal under the authority of 21 U.S.C. 890. DEA also will 
provide, within fifteen calendar days of withdrawal of an existing 
certification, the same written notice to the bidder and end-user, and 
this notice also will contain a statement of the legal and factual basis 
for the withdrawal. The bidder and end-user may, within thirty calendar 
days of receipt of notification of the withdrawal of the existing 
certification, submit written comments or written objections to the 
Administrator's withdrawal. At the same time, the bidder and end-user 
also may provide supporting documentation to contest the Administrator's 
withdrawal. If such written comments or written objections raise issues 
regarding any finding of fact or conclusion of law upon which the 
withdrawal of the existing certification is based, the Administrator 
will reconsider the withdrawal of the existing certification in light of 
the written comments or written objections filed. Thereafter, within a 
reasonable time, the Administrator will withdraw or affirm the original 
withdrawal of the existing certification as he determines appropriate. 
The Administrator will provide written reasons for any affirmation of 
the original withdrawal of the existing certification. Such affirmation 
of the original withdrawal of the existing certification will constitute 
a final decision for purposes of judicial review under 21 U.S.C. 877.

[68 FR 62737, Nov. 6, 2003]



PART 1311_DIGITAL CERTIFICATES--Table of Contents

                            Subpart A_General

Sec.
1311.01 Scope.
1311.02 Definitions.
1311.05 Standards for technologies for electronic transmission of 
          orders.
1311.08 Incorporation by reference.

Subpart B_Obtaining and Using Digital Certificates for Electronic Orders

1311.10 Eligibility to obtain a CSOS digital certificate.
1311.15 Limitations on CSOS digital certificates.
1311.20 Coordinators for CSOS digital certificate holders.
1311.25 Requirements for obtaining a CSOS digital certificate.
1311.30 Requirements for storing and using a private key for digitally 
          signing orders.
1311.35 Number of CSOS digital certificates needed.
1311.40 Renewal of CSOS digital certificates.

[[Page 142]]

1311.45 Requirements for registrants that allow powers of attorney to 
          obtain CSOS digital certificates under their DEA registration.
1311.50 Requirements for recipients of digitally signed orders.
1311.55 Requirements for systems used to process digitally signed 
          orders.
1311.60 Recordkeeping.

    Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless 
otherwise noted.

    Source: 70 FR 16915, Apr. 1, 2005, unless otherwise noted.

    Effective Date Note: At 70 FR 16915, Apr. 1, 2005, part 1311 was 
added, effective May 31, 2005.



                            Subpart A_General



Sec. 1311.01  Scope.

    This part sets forth the rules governing the use of digital 
signatures and the protection of private keys by registrants.



Sec. 1311.02  Definitions.

    For the purposes of this chapter:
    Biometric authentication means authentication based on measurement 
of the individual's physical features or repeatable actions where those 
features or actions are both unique to the individual and measurable.
    Cache means to download and store information on a local server or 
hard drive.
    Certificate Policy means a named set of rules that sets forth the 
applicability of the specific digital certificate to a particular 
community or class of application with common security requirements.
    Certificate Revocation List (CRL) means a list of revoked, but 
unexpired certificates issued by a Certification Authority.
    Certification Authority (CA) means an organization that is 
responsible for verifying the identity of applicants, authorizing and 
issuing a digital certificate, maintaining a directory of public keys, 
and maintaining a Certificate Revocation List.
    CSOS means controlled substance ordering system.
    Digital certificate means a data record that, at a minimum:
    (1) Identifies the certification authority issuing it;
    (2) Names or otherwise identifies the certificate holder;
    (3) Contains a public key that corresponds to a private key under 
the sole control of the certificate holder;
    (4) Identifies the operational period; and
    (5) Contains a serial number and is digitally signed by the 
Certification Authority issuing it.
    Digital signature means a record created when a file is 
algorithmically transformed into a fixed length digest that is then 
encrypted using an asymmetric cryptographic private key associated with 
a digital certificate. The combination of the encryption and algorithm 
transformation ensure that the signer's identity and the integrity of 
the file can be confirmed.
    Electronic signature means a method of signing an electronic message 
that identifies a particular person as the source of the message and 
indicates the person's approval of the information contained in the 
message.
    FIPS means Federal Information Processing Standards. These Federal 
standards, as incorporated by reference in Sec. 1311.08, prescribe 
specific performance requirements, practices, formats, communications 
protocols, etc., for hardware, software, data, etc.
    FIPS 140-2, as incorporated by reference in Sec. 1311.08, means a 
Federal standard for security requirements for cryptographic modules.
    FIPS 180-2, as incorporated by reference in Sec. 1311.08, means a 
Federal secure hash standard.
    FIPS 186-2, as incorporated by reference in Sec. 1311.08, means a 
Federal standard for applications used to generate and rely upon digital 
signatures.
    Key pair means two mathematically related keys having the properties 
that:
    (1) One key can be used to encrypt a message that can only be 
decrypted using the other key; and
    (2) Even knowing one key, it is computationally infeasible to 
discover the other key.
    NIST means the National Institute of Standards and Technology.
    Private key means the key of a key pair that is used to create a 
digital signature.

[[Page 143]]

    Public key means the key of a key pair that is used to verify a 
digital signature. The public key is made available to anyone who will 
receive digitally signed messages from the holder of the key pair.
    Public Key Infrastructure (PKI) means a structure under which a 
Certification Authority verifies the identity of applicants, issues, 
renews, and revokes digital certificates, maintains a registry of public 
keys, and maintains an up-to-date Certificate Revocation List.



Sec. 1311.05  Standards for technologies for electronic transmission 
of orders.

    (a) A registrant or a person with power of attorney to sign orders 
for Schedule I and II controlled substances may use any technology to 
sign and electronically transmit orders if the technology provides all 
of the following:
    (1) Authentication: The system must enable a recipient to positively 
verify the signer without direct communication with the signer and 
subsequently demonstrate to a third party, if needed, that the sender's 
identity was properly verified.
    (2) Nonrepudiation: The system must ensure that strong and 
substantial evidence is available to the recipient of the sender's 
identity, sufficient to prevent the sender from successfully denying 
having sent the data. This criterion includes the ability of a third 
party to verify the origin of the document.
    (3) Message integrity: The system must ensure that the recipient, or 
a third party, can determine whether the contents of the document have 
been altered during transmission or after receipt.
    (b) DEA has identified the following means of electronically signing 
and transmitting order forms as meeting all of the standards set forth 
in paragraph (a) of this section.
    (1) Digital signatures using Public Key Infrastructure (PKI) 
technology.
    (2) [Reserved]



Sec. 1311.08  Incorporation by reference.

    (a) The following standards are incorporated by reference:
    (1) FIPS 140-2, Security Requirements for Cryptographic Modules, May 
25, 2001, as amended by Change Notices 2 through 4, December 3, 2002.
    (i) Annex A: Approved Security Functions for FIPS PUB 140-2, 
Security Requirements for Cryptographic Modules, September 23, 2004.
    (ii) Annex B: Approved Protection Profiles for FIPS PUB 140-2, 
Security Requirements for Cryptographic Modules, November 4, 2004.
    (iii) Annex C: Approved Random Number Generators for FIPS PUB 140-2, 
Security Requirements for Cryptographic Modules, January 31, 2005.
    (iv) Annex D: Approved Key Establishment Techniques for FIPS PUB 
140-2, Security Requirements for Cryptographic Modules, February 23, 
2004.
    (2) FIPS 180-2, Secure Hash Standard, August 1, 2002, as amended by 
change notice 1, February 25, 2004.
    (3) FIPS 186-2, Digital Signature Standard, January 27, 2000, as 
amended by Change Notice 1, October 5, 2001.
    (b) These standards are available from the National Institute of 
Standards and Technology, Computer Security Division, Information 
Technology Laboratory, National Institute of Standards and Technology, 
100 Bureau Drive, Gaithersburg, MD 20899-8930 and are available at 
http://csrc.nist.gov/.
    (c) These incorporations by reference were approved by the Director 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be inspected at the Drug Enforcement Administration, 
600 Army Navy Drive, Arlington, VA 22202 or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call (202) 741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.



Subpart B_Obtaining and Using Digital Certificates for Electronic Orders



Sec. 1311.10  Eligibility to obtain a CSOS digital certificate.

    The following persons are eligible to obtain a CSOS digital 
certificate from the DEA Certification Authority to sign electronic 
orders for controlled substances.

[[Page 144]]

    (a) The person who signed the most recent DEA registration 
application or renewal application and a person authorized to sign a 
registration application.
    (b) A person granted power of attorney by a DEA registrant to sign 
orders for one or more schedules of controlled substances.



Sec. 1311.15  Limitations on CSOS digital certificates.

    (a) A CSOS digital certificate issued by the DEA Certification 
Authority will authorize the certificate holder to sign orders for only 
those schedules of controlled substances covered by the registration 
under which the certificate is issued.
    (b) When a registrant, in a power of attorney letter, limits a 
certificate applicant to a subset of the registrant's authorized 
schedules, the registrant is responsible for ensuring that the 
certificate holder signs orders only for that subset of schedules.



Sec. 1311.20  Coordinators for CSOS digital certificate holders.

    (a) Each registrant, regardless of number of digital certificates 
issued, must designate one or more responsible persons to serve as that 
registrant's CSOS coordinator regarding issues pertaining to issuance 
of, revocation of, and changes to digital certificates issued under that 
registrant's DEA registration. While the coordinator will be the main 
point of contact between one or more DEA registered locations and the 
CSOS Certification Authority, all digital certificate activities are the 
responsibility of the registrant with whom the digital certificate is 
associated. Even when an individual registrant, i.e., an individual 
practitioner, is applying for a digital certificate to order controlled 
substances a CSOS Coordinator must be designated; though in such a case, 
the individual practitioner may also serve as the coordinator.
    (b) Once designated, coordinators must identify themselves, on a 
one-time basis, to the Certification Authority. If a designated 
coordinator changes, the Certification Authority must be notified of the 
change and the new responsibilities assumed by each of the registrant's 
coordinators, if applicable. Coordinators must complete the application 
that the DEA Certification Authority provides and submit the following:
    (1) Two copies of identification, one of which must be a government-
issued photographic identification.
    (2) A copy of each current DEA Certificate of Registration (DEA form 
223) for each registered location for which the coordinator will be 
responsible or, if the applicant (or their employer) has not been issued 
a DEA registration, a copy of each application for registration of the 
applicant or the applicant's employer.
    (3) The applicant must have the completed application notarized and 
forward the completed application and accompanying documentation to the 
DEA Certification Authority.
    (c) Coordinators will communicate with the Certification Authority 
regarding digital certificate applications, renewals and revocations. 
For applicants applying for a digital certificate from the DEA 
Certification Authority, and for applicants applying for a power of 
attorney digital certificate for a DEA registrant, the registrant's 
Coordinator must verify the applicant's identity, review the application 
package, and submit the completed package to the Certification 
Authority.



Sec. 1311.25  Requirements for obtaining a CSOS digital certificate.

    (a) To obtain a certificate to use for signing electronic orders for 
controlled substances, a registrant or person with power of attorney for 
a registrant must complete the application that the DEA Certification 
Authority provides and submit the following:
    (1) Two copies of identification, one of which must be a government-
issued photographic identification.
    (2) A current listing of DEA registrations for which the individual 
has authority to sign controlled substances orders.
    (3) A copy of the power of attorney from the registrant, if 
applicable.
    (4) An acknowledgment that the applicant has read and understands 
the Subscriber Agreement and agrees to the statement of subscriber 
obligations that DEA provides.

[[Page 145]]

    (b) The applicant must provide the completed application to the 
registrant's coordinator for CSOS digital certificate holders who will 
review the application and submit the completed application and 
accompanying documentation to the DEA Certification Authority.
    (c) When the Certification Authority approves the application, it 
will send the applicant a one-time use reference number and access code, 
via separate channels, and information on how to use them. Using this 
information, the applicant must then electronically submit a request for 
certification of the public digital signature key. After the request is 
approved, the Certification Authority will provide the applicant with 
the signed public key certificate.
    (d) Once the applicant has generated the key pair, the Certification 
Authority must prove that the user has possession of the key. For public 
keys, the corresponding private key must be used to sign the certificate 
request. Verification of the signature using the public key in the 
request will serve as proof of possession of the private key.



Sec. 1311.30  Requirements for storing and using a private key for 
digitally signing orders.

    (a) Only the certificate holder may access or use his or her digital 
certificate and private key.
    (b) The certificate holder must provide FIPS-approved secure storage 
for the private key, as discussed by FIPS 140-2, 180-2, 186-2, and 
accompanying change notices and annexes, as incorporated by reference in 
Sec. 1311.08.
    (c) A certificate holder must ensure that no one else uses the 
private key. While the private key is activated, the certificate holder 
must prevent unauthorized use of that private key.
    (d) A certificate holder must not make back-up copies of the private 
key.
    (e) The certificate holder must report the loss, theft, or 
compromise of the private key or the password, via a revocation request, 
to the Certification Authority within 24 hours of substantiation of the 
loss, theft, or compromise. Upon receipt and verification of a signed 
revocation request, the Certification Authority will revoke the 
certificate. The certificate holder must apply for a new certificate 
under the requirements of Sec. 1311.25.



Sec. 1311.35  Number of CSOS digital certificates needed.

    A purchaser of Schedule I and II controlled substances must obtain a 
separate CSOS certificate for each registered location for which the 
purchaser will order these controlled substances.



Sec. 1311.40  Renewal of CSOS digital certificates.

    (a) A CSOS certificate holder must generate a new key pair and 
obtain a new CSOS digital certificate when the registrant's DEA 
registration expires or whenever the information on which the 
certificate is based changes. This information includes the registered 
name and address, the subscriber's name, and the schedules the 
registrant is authorized to handle. A CSOS certificate will expire on 
the date on which the DEA registration on which the certificate is based 
expires.
    (b) The Certification Authority will notify each CSOS certificate 
holder 45 days in advance of the expiration of the certificate holder's 
CSOS digital certificate.
    (c) If a CSOS certificate holder applies for a renewal before the 
certificate expires, the certificate holder may renew electronically 
twice. For every third renewal, the CSOS certificate holder must submit 
a new application and documentation, as provided in Sec. 1311.25.
    (d) If a CSOS certificate expires before the holder applies for a 
renewal, the certificate holder must submit a new application and 
documentation, as provided in Sec. 1311.25.



Sec. 1311.45  Requirements for registrants that allow powers of attorney 
to obtain CSOS digital certificates under their DEA registration.

    (a) A registrant that grants power of attorney must report to the 
DEA Certification Authority within 6 hours of either of the following 
(advance notice may be provided, where applicable):
    (1) The person with power of attorney has left the employ of the 
institution.

[[Page 146]]

    (2) The person with power of attorney has had his or her privileges 
revoked.
    (b) A registrant must maintain a record that lists each person 
granted power of attorney to sign controlled substances orders.



Sec. 1311.50  Requirements for recipients of digitally signed orders.

    (a) The recipient of a digitally signed order must do the following 
before filling the order:
    (1) Verify the integrity of the signature and the order by having 
the system validate the order.
    (2) Verify that the certificate holder's CSOS digital certificate 
has not expired by checking the expiration date against the date the 
order was signed.
    (3) Check the validity of the certificate holder's certificate by 
checking the Certificate Revocation List.
    (4) Check the certificate extension data to determine whether the 
sender has the authority to order the controlled substance.
    (b) A recipient may cache Certificate Revocation Lists for use until 
they expire.



Sec. 1311.55  Requirements for systems used to process digitally signed 
orders.

    (a) A CSOS certificate holder and recipient of an electronic order 
may use any system to write, track, or maintain orders provided that the 
system has been enabled to process digitally signed documents and that 
it meets the requirements of paragraph (b) or (c) of this section.
    (b) A system used to digitally sign Schedule I or II orders must 
meet the following requirements:
    (1) The cryptographic module must be FIPS 140-2, Level 1 validated, 
as incorporated by reference in Sec. 1311.08.
    (2) The digital signature system and hash function must be compliant 
with FIPS 186-2 and FIPS 180-2, as incorporated by reference in Sec. 
1311.08.
    (3) The private key must be stored on a FIPS 140-2 Level 1 validated 
cryptographic module using a FIPS-approved encryption algorithm, as 
incorporated by reference in Sec. 1311.08.
    (4) The system must use either a user identification and password 
combination or biometric authentication to access the private key. 
Activation data must not be displayed as they are entered.
    (5) The system must set a 10-minute inactivity time period after 
which the certificate holder must reauthenticate the password to access 
the private key.
    (6) For software implementations, when the signing module is 
deactivated, the system must clear the plain text private key from the 
system memory to prevent the unauthorized access to, or use of, the 
private key.
    (7) The system must be able to digitally sign and transmit an order.
    (8) The system must have a time system that is within five minutes 
of the official National Institute of Standards and Technology time 
source.
    (9) The system must archive the digitally signed orders and any 
other records required in part 1305 of this chapter, including any 
linked data.
    (10) The system must create an order that includes all data fields 
listed under Sec. 1305.21(b) of this chapter.
    (c) A system used to receive, verify, and create linked records for 
orders signed with a CSOS digital certificate must meet the following 
requirements:
    (1) The cryptographic module must be FIPS 140-2, Level 1 validated, 
as incorporated by reference in Sec. 1311.08.
    (2) The digital signature system and hash function must be compliant 
with FIPS 186-2 and FIPS 180-2, as incorporated by reference in Sec. 
1311.08.
    (3) The system must determine that an order has not been altered 
during transmission. The system must invalidate any order that has been 
altered.
    (4) The system must validate the digital signature using the 
signer's public key. The system must invalidate any order in which the 
digital signature cannot be validated.
    (5) The system must validate that the DEA registration number 
contained in the body of the order corresponds to the registration 
number associated with the specific certificate by separately generating 
the hash value of the registration number and certificate subject 
distinguished name serial number and comparing that hash value to the 
hash value contained in the certificate extension for the DEA 
registration number. If the hash values are not

[[Page 147]]

equal the system must invalidate the order.
    (6) The system must check the Certificate Revocation List 
automatically and invalidate any order with a certificate listed on the 
Certificate Revocation List.
    (7) The system must check the validity of the certificate and the 
Certification Authority certificate and invalidate any order that fails 
these validity checks.
    (8) The system must have a time system that is within five minutes 
of the official National Institute of Standards and Technology time 
source.
    (9) The system must check the substances ordered against the 
schedules that the registrant is allowed to order and invalidate any 
order that includes substances the registrant is not allowed to order.
    (10) The system must ensure that an invalid finding cannot be 
bypassed or ignored and the order filled.
    (11) The system must archive the order and associate with it the 
digital certificate received with the order.
    (12) If a registrant sends reports on orders to DEA, the system must 
create a report in the format DEA specifies, as provided in Sec. 
1305.29 of this chapter.
    (d) For systems used to process CSOS orders, the system developer or 
vendor must have an initial independent third-party audit of the system 
and an additional independent third-party audit whenever the signing or 
verifying functionality is changed to determine whether it correctly 
performs the functions listed under paragraphs (b) and (c) of this 
section. The system developer must retain the most recent audit results 
and retain the results of any other audits of the software completed 
within the previous two years.



Sec. 1311.60  Recordkeeping.

    (a) A supplier and purchaser must maintain records of CSOS 
electronic orders and any linked records for two years. Records may be 
maintained electronically. Records regarding controlled substances that 
are maintained electronically must be readily retrievable from all other 
records.
    (b) Electronic records must be easily readable or easily rendered 
into a format that a person can read. They must be made available to the 
Administration upon request.
    (c) CSOS certificate holders must maintain a copy of the subscriber 
agreement that the Certification Authority provides for the life of the 
certificate.



PART 1312_IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES--Table 
of Contents

Sec.
1312.01 Scope of part 1312.
1312.02 Definitions.

                  Importation of Controlled Substances

1312.11 Requirement of authorization to import.
1312.12 Application for import permit.
1312.13 Issuance of import permit.
1312.14 Distribution of copies of import permit.
1312.15 Shipments in greater or less amount than authorized.
1312.16 Cancellation of permit; expiration date.
1312.17 Special report from importers.
1312.18 Contents of import declaration.
1312.19 Distribution of import declaration.

                  Exportation of Controlled Substances

1312.21 Requirement of authorization to export.
1312.22 Application for export permit.
1312.23 Issuance of export permit.
1312.24 Distribution of copies of export permit.
1312.25 Expiration date.
1312.26 Records required of exporter.
1312.27 Contents of special controlled substances invoice.
1312.28 Distribution of special controlled substances invoice.
1312.29 Domestic release prohibited.
1312.30 Schedule III, IV, and V non-narcotic controlled substances 
          requiring an import and export permit.

     Transshipment and In-Transit Shipment of Controlled Substances

1312.31 Schedule I: Application for prior written approval.
1312.32 Schedules II, III, IV: Advance notice.

                                Hearings

1312.41 Hearings generally.
1312.42 Purpose of hearing.
1312.43 Waiver or modification of rules.
1312.44 Request for hearing or appearance; waiver.
1312.45 Burden of proof.
1312.46 Time and place of hearing.
1312.47 Final order.


[[Page 148]]


    Authority: 21 U.S.C. 952, 953, 954, 957, 958.

    Source: 36 FR 7815, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.



Sec. 1312.01  Scope of part 1312.

    Procedures governing the importation, exportation, transshipment and 
intransit shipment of controlled substances pursuant to section 1002, 
1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are governed 
generally by those sections and specifically by the sections of this 
part.



Sec. 1312.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13969, Mar. 24, 1997]

                  Importation of Controlled Substances



Sec. 1312.11  Requirement of authorization to import.

    (a) No person shall import or cause to be imported any controlled 
substance listed in Schedule I or II or any narcotic controlled 
substance listed in Schedule III, IV or V or any non-narcotic controlled 
substance in Schedule III which the Administrator has specifically 
designated by regulation in Sec. 1312.30 of this part or any non-
narcotic controlled substance in Schedule IV or V which is also listed 
in Schedule I or II of the Convention on Psychotropic Substances unless 
and until such person is properly registered under the Act (or exempt 
from registration) and the Administrator has issued him a permit to do 
so pursuant to Sec. 1312.13 of this part.
    (b) No person shall import or cause to be imported any non-narcotic 
controlled substance listed in Schedule III, IV or V, excluding those 
described in paragraph (a) of this section, unless and until such person 
is properly registered under the Act (or exempt from registration) and 
has filed an import declaration to do so with the Administrator, 
pursuant to Sec. 1312.18 of this part.
    (c) When an import permit or declaration is required, a separate 
permit or declaration must be obtained for each consignment of 
controlled substances to be imported.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17289, 
May 7, 1987]



Sec. 1312.12  Application for import permit.

    (a) An application for a permit to import controlled substances 
shall be made on DEA Form 357. DEA Form 357 may be obtained from, and 
shall be filed with, the Drug Enforcement Administration, Drug 
Operations Section, Washington, DC 20537. Each application shall show 
the date of execution; the registration number of the importer; a 
detailed description of each controlled substance to be imported 
including the drug name, dosage form, National Drug Code (NDC) number, 
the Administration Controlled Substance Code Number as set forth in part 
1308 of this chapter, the number and size of packages or containers, the 
name and quantity of the controlled substance contained in any finished 
dosage units, and the net quantity of any controlled substance 
(expressed in anhydrous acid, base or alkaloid) given in kilograms or 
parts thereof. The application shall also include the following:
    (1) The name, address, and business of the consignor, if known at 
the time application is submitted, but if unknown at that time, the fact 
should be indicated and the name and address afterwards furnished to the 
Administrator as soon as ascertained by the importer;
    (2) The foreign port of exportation (i.e., the place where the 
article will begin its journey of exportation to the United States);
    (3) The port of entry into the United States;
    (4) The latest date said shipment will leave said foreign port;
    (5) The stock on hand of the controlled substance desired to be 
imported;
    (6) The name of the importing carrier or vessel (if known, or if 
unknown it should be stated whether shipment will be made by express, 
freight, or otherwise, imports of controlled substances in Schedules I 
or II and narcotic drugs

[[Page 149]]

in Schedules III, IV, or V by mail being prohibited);
    (7) The total tentative allotment to the importer of such controlled 
substance for the current calendar year;
    (8) The total number of kilograms of said allotment for which 
permits have previously been issued and the total quantity of controlled 
substance actually imported during the current year to date.
    (b) If desired, alternative foreign ports of exportation within the 
same country may be indicated upon the application (e.g., (1) Calcutta, 
(2) Bombay). If a formal permit is issued pursuant to such application, 
it will bear the names of the two ports in the order given in the 
application and will authorize shipment from either port. Alternate 
ports in different countries will not be authorized in the same permit.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 43218, 
Dec. 11, 1974; 45 FR 74715, Nov. 12, 1980; 51 FR 5319 and 5320, Feb. 13, 
1986; 52 FR 17289, May 7, 1987; 62 FR 13969, Mar. 24, 1997]



Sec. 1312.13  Issuance of import permit.

    (a) The Administrator may authorize importation of any controlled 
substance listed in Schedule I or II or any narcotic drug listed in 
Schedule III, IV, or V if he finds:
    (1) That the substance is crude opium, poppy straw, concentrate of 
poppy straw, or coca leaves, in such quantity as the Administrator finds 
necessary to provide for medical, scientific, or other legitimate 
purposes;
    (2) That the substance is necessary to provide for medical and 
scientific needs or other legitimate needs of the United States during 
an emergency where domestic supplies of such substance or drug are found 
to be inadequate, or in any case in which the Administrator finds that 
competition among domestic manufacturers of the controlled substance is 
inadequate and will not be rendered adequate by the registration of 
additional manufacturers under section 303 of the Controlled Substances 
Act (21 U.S.C. 823); or
    (3) That the domestic supply of any controlled substance is 
inadequate for scientific studies, and that the importation of that 
substance for scientific purposes is only for delivery to officials of 
the United Nations, of the United States, or of any State, or to any 
person registered or exempted from registration under sections 1007 and 
1008 of the Act (21 U.S.C. 957 and 958).
    (4) That the importation of the controlled substance is for 
ballistics or other analytical or scientific purposes, and that the 
importation of that substance is only for delivery to officials of the 
United Nations, of the United States, or of any State, or to any person 
registered or exempted from registration under sections 1007 and 1008 of 
the Act (21 U.S.C. 957 and 958).
    (b) The Administrator may require that such non-narcotic controlled 
substances in Schedule III as he shall designate by regulation in Sec. 
1312.30 of this part be imported only pursuant to the issuance of an 
import permit. The Administrator may authorize the importation of such 
substances if he finds that the substance is being imported for medical, 
scientific or other legitimate uses.
    (c) If a non-narcotic substance listed in Schedule IV or V is also 
listed in Schedule I or II of the Convention on Psychotropic Substances, 
1971, it shall be imported only pursuant to the issuance of an import 
permit. The Administrator may authorize the importation of such 
substances if it is found that the substance is being imported for 
medical, scientific or other legitimate uses.
    (d) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.
    (e) Each import permit shall be issued in sextuplet and serially 
numbered, with all six copies bearing the same serial number and being 
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc., 
respectively. All

[[Page 150]]

copies of import permits shall bear the signature of the Director or his 
delegate, and facsimiles of signatures shall not be used. No permit 
shall be altered or changed by any person after being signed by the 
Administrator or his delegate and any change or alteration upon the face 
of any permit after it shall have been signed by the Administrator or 
his delegate shall render it void and of no effect. Permits are not 
transferable. Each copy of the permit shall have printed or stamped 
thereon the disposition to be made thereof. Each permit shall be dated 
and shall certify that the importer named therein is thereby permitted 
as a registrant under the Act, to import, through the port named, one 
shipment of not to exceed the specified quantity of the named controlled 
substances, shipment to be made before a specified date. Not more than 
one shipment shall be made on a single import permit. The permit shall 
state that the Administrator is satisfied that the consignment proposed 
to be imported is required for legitimate purposes.
    (f) Notwithstanding paragraphs (a)(1) and (a)(2) of this section, 
the Administrator shall permit, pursuant to 21 U.S.C. 952(a)(1) or 
(a)(2)(A), the importation of approved narcotic raw material (opium, 
poppy straw and concentrate of poppy straw) having as its source:
    (1) Turkey,
    (2) India,
    (3) Yugoslavia,
    (4) France,
    (5) Poland,
    (6) Hungary, and
    (7) Australia.
    (g) At least eighty (80) percent of the narcotic raw material 
imported into the United States shall have as its original source Turkey 
and India. Except under conditions of insufficient supplies of narcotic 
raw materials, not more than twenty (20) percent of the narcotic raw 
material imported into the United States annually shall have as its 
source Yugoslavia, France, Poland, Hungary and Australia.

[36 FR 23624, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 41776, 
Aug. 18, 1981; 52 FR 17289, May 7, 1987]



Sec. 1312.14  Distribution of copies of import permit.

    Copies of the import permit shall be distributed and serve purposes 
as follows:
    (a) The original and quintuplet copies (Copy 1 and Copy 5) shall be 
transmitted by the Administration to the importer, who shall retain the 
quintuplet copy (Copy 5) on file as his record of authority for the 
importation, and shall transmit the original copy (Copy 1) to the 
foreign exporter. The foreign exporter will submit the original copy 
(Copy 1) to the proper governmental authority in the exporting country, 
if required, as a prerequisite to the issuance of an export 
authorization. This copy of the permit will accompany the shipment. Upon 
arrival of the imported merchandise, the District Director of the U.S. 
Customs Service at the port of entry will, after appraising the 
merchandise, forward the original copy (Copy 1) to the Drug Operations 
Section with a report on the reverse side of such copy, showing the name 
of the port of importation, date prepared, name and net quantity of each 
substance, and report of analysis of the merchandise entered.
    (b) The duplicate copy (Copy 2) shall be forwarded by the 
Administration to the proper governmental authorities of the exporting 
country.
    (c) The quadruplet copy (Copy 4) shall be forwarded by the 
Administration to the District Director of the U.S. Customs Service at 
the U.S. port of entry, which shall be the customs port of destination 
in the case of shipments transported under immediate transportation 
entries, in order that the District Director may compare it with the 
original copy (Copy 1) and the bill of lading upon arrival of the 
merchandise. If a discrepancy is noted between corresponding items upon 
different copies of a permit bearing the same serial number when 
compared by the District Director, he shall refuse to permit entry of 
the merchandise until the facts are communicated to the Administration 
and further instructions are received.

[[Page 151]]

    (d) The triplicate copy (Copy 3) and sextuplet copy (Copy 6) shall 
be retained by the Administration.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 
FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 
30, 1988; 62 FR 13969, Mar. 24, 1997]



Sec. 1312.15  Shipments in greater or less amount than authorized.

    (a) If the shipment made under an import permit is greater than the 
maximum amount authorized to be imported under the permit, as determined 
at the weighing by the District Director of the U.S. Customs Service, 
such difference shall be seized subject to forfeiture, pending an 
explanation; except that shipments of substances exceeding the maximum 
authorized amount by less than 1 percent may be released to the importer 
upon the filing by him of an amended import permit. If the substance is 
included in Schedule I, it will be summarily forfeited to the 
Government.
    (b) If the shipment made under the permit is less than the maximum 
amount authorized to be imported under the permit as determined at the 
weighing by the District Director of the U.S. Customs Service, such 
difference, when ascertained by the Administration, shall be recredited 
to the tentative allotment against which the quantity covered by the 
permit was charged, and the balance of any such tentative allotment with 
any such recredits will remain available to the importer to whom made 
(unless previously revoked in whole or in part), for importations 
pursuant to any permit or permits as are requested and issued during the 
remainder of the calendar year to which the allotment is applicable. No 
permit shall be issued for importation of a quantity of controlled 
substances as a charge against the tentative allotment for a given 
calendar year, after the close of such calendar year, unless the 
Director of the Administration decides to make an exception for good 
cause shown.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 46 FR 28841, May 29, 1981]



Sec. 1312.16  Cancellation of permit; expiration date.

    (a) A permit may be canceled after being issued, at the request of 
the importer, provided no shipment has been made thereunder. In the 
event that a permit is lost, the Administrator may, upon the production 
by the importer of satisfactory proof, by affidavit or otherwise, issue 
a duplicate permit. Nothing in this part shall affect the right, hereby 
reserved by the Administrator, to cancel a permit at any time for proper 
cause.
    (b) An import permit shall not be valid after the date specified 
therein, and in no event shall the date be subsequent to 6 months after 
the date the permit is issued. Any unused import permit shall be 
returned for cancellation by the registrant to the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]



Sec. 1312.17  Special report from importers.

    Whenever requested by the Administrator, importers shall render to 
him not later than 30 days after receipt of the request therefor a 
statement under oath of the stocks of controlled substances on hand as 
of the date specified by the Administrator in his request, and, if 
desired by the Administrator, an estimate of the probable requirements 
for legitimate uses of the importer for any subsequent period that may 
be designated by the Administrator. In lieu of any special statement 
that may be considered necessary, the Administrator may accept the 
figures given upon the reports subsequent by said importer under part 
1304 of this chapter.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13969, Mar. 24, 1997]



Sec. 1312.18  Contents of import declaration.

    (a) Any non-narcotic controlled substance listed in Schedule III, 
IV, or V, not subject to the requirement of an import permit pursuant to 
Sec. 1312.13 (b)

[[Page 152]]

or (c) of this chapter, may be imported if that substance is needed for 
medical, scientific or other legitimate uses in the United States, and 
will be imported pursuant to a controlled substances import declaration.
    (b) Any person registered or authorized to import and desiring to 
import any non-narcotic controlled substance in Schedules III, IV, or V 
which is not subject to the requirement of an import permit as described 
in paragraph (a) of this section, must furnish a controlled substances 
import declaration on DEA Form 236 to the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537, not later 
than 15 calendar days prior to the proposed date of importation and 
distribute four copies of same as hereinafter directed in Sec. 1312.19.
    (c) DEA Form 236 must be executed in quintuplicate and will include 
the following information:
    (1) The name, address, and registration number of the importer; and 
the name and address and registration number of the import broker, if 
any; and
    (2) A complete description of the controlled substances to be 
imported, including drug name, dosage form, National Drug Code (NDC) 
number, the Administration Controlled Substances Code Number as set 
forth in part 1308 of this chapter, the number and size of packages or 
containers, the name and quantity of the controlled substance contained 
in any finished dosage units, and the net quantity of any controlled 
substance (expressed in anhydrous acid, base, or alkaloid) given in 
kilograms or parts thereof; and
    (3) The proposed import date, the foreign port of exportation to the 
United States, the port of entry, and the name, address, and 
registration number of the recipient in the United States; and
    (4) The name and address of the consignor in the foreign country of 
exportation, and any registration or license numbers if the consignor is 
required to have such numbers either by the country of exportation or 
under U.S. law.
    (d) Notwithstanding the time limitations included in paragraph (a) 
of this section, an applicant may obtain a special waiver of these time 
limitations in emergency or unusual instances, provided that a specific 
confirmation is received from the Administrator or his delegate advising 
the registrant to proceed pursuant to the special waiver.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 
FR 13969, Mar. 24, 1997]



Sec. 1312.19  Distribution of import declaration.

    The required five copies of the controlled substances import 
declaration will be distributed as follows:
    (a) Copy 1, Copy 2, and Copy 3 shall be transmitted to the foreign 
shipper. The foreign shipper will submit Copy 1 to the proper 
governmental authority in the foreign country, if required as a 
prerequisite to export authorization. Copy 1 will then accompany the 
shipment to its destination, and shall be retained on file by the 
importer. Copy 2 shall be detached and retained by the appropriate 
customs official of the foreign country. Copy 3 shall be removed by the 
District Director of the U.S. Customs Service at the port of entry, who 
shall sign and date the certification of customs on Copy 3, noting any 
changes from the entries made by the importer, and shall then forward 
that copy to the Drug Operations Section of the Administration.
    (b) Copy 4 shall be forwarded, within the time limit required in 
Sec. 1312.18, directly to the Drug Enforcement Administration, Drug 
Operations Section, Washington, DC 20537.
    (c) Copy 5 shall be retained by the importer on file as his record 
of authority for the importation.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971; 37 
FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and 
further amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 
1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]

                  Exportation of Controlled Substances



Sec. 1312.21  Requirement of authorization to export.

    (a) No person shall in any manner export or cause to be exported 
from the United States any controlled substance

[[Page 153]]

listed in Schedule I or II, or any narcotic substance listed in Schedule 
III or IV, or any non-narcotic substance in Schedule III which the 
Administrator has specifically designated by regulation in Sec. 1312.30 
of this part or any non-narcotic substance in Schedule IV or V which is 
also listed in Schedule I or II of the Convention on Psychotropic 
Substances unless and until such person is properly registered under the 
Act (or exempted from registration) and the Administrator has issued a 
permit pursuant to Sec. 1312.23 of this part.
    (b) No person shall in any manner export or cause to be exported 
from the United States any non-narcotic controlled substance listed in 
Schedule III, IV, or V, excluding those described in paragraph (a) of 
this section, or any narcotic controlled substance listed in Schedule V, 
unless and until such person is properly registered under the Act (or 
exempted from registration) and has furnished a special controlled 
substance export invoice as provided by section 1003 of the Act (21 
U.S.C. 953(e)) to the Administrator pursuant to Sec. 1312.28 of this 
part.
    (c) A separate authorization repuest is obtained for each 
consignment of such controlled substances to be exported.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290, 
May 7, 1987]



Sec. 1312.22  Application for export permit.

    (a) An application for a permit to export controlled substances 
shall be made on DEA Form 161 which may be obtained from, and shall be 
filed with, the Drug Enforcement Administration, Drug Operations 
Section, Washington, DC 20537. Each application shall show the 
exporter's name, address, and registration number; a detailed 
description of each controlled substance desired to be exported 
including the drug name, dosage form, National Drug Code (NDC) number, 
the Administration Controlled Substance Code Number as set forth in part 
1308 of this chapter, the number and size of packages or containers, the 
name and quantity of the controlled substance contained in any finished 
dosage units, and the quantity of any controlled substance (expressed in 
anhydrous acid, base, or alkaloid) given in kilograms or parts thereof. 
The application shall include the name, address, and business of the 
consignee, foreign port of entry, the port of exportation, the 
approximate date of exportation, the name of the exporting carrier or 
vessel (if known, or if unknown it should be stated whether shipment 
will be made by express, freight, or otherwise, exports of controlled 
substances by mail being prohibited), the date and number, if any, of 
the supporting foreign import license or permit accompanying the 
application, and the authority by whom such foreign license or permit 
was issued. The application shall also contain an affidavit that the 
packages are labeled in conformance with obligations of the United 
States under international treaties, conventions, or protocols in effect 
on May 1, 1971, and that, to the best of affiant's knowledge and belief, 
the controlled substances therein are to be applied exclusively to 
medical or scientific uses within the country to which exported, will 
not be reexported therefrom and that there is an actual need for the 
controlled substance for medical or scientific uses within such country. 
In the case of exportation of crude cocaine, the affidavit may state 
that to the best of knowledge and belief, the controlled substances will 
be processed within the country to which exported, either for medical or 
scientific use within that country or for reexportation in accordance 
with the laws of that country to another for medical or scientific use 
within that country. The application shall be signed and dated by the 
exporter and shall contain the address from which the substances will be 
shipped for exportation.
    (b) There shall also be submitted with the application any import 
license or permit (and a translation thereof if in a foreign language) 
or a certified copy of any such license or permit issued by competent 
authorities in the country of destination, or other documentary evidence 
deemed adequate by the Administrator, showing that the merchandise is 
consigned to an authorized permittee, that it is to be applied 
exclusively to medical or scientific use

[[Page 154]]

within the country of destination, that it will not be reexported from 
such country, and that there is an actual need for the controlled 
substance for medical or scientific use within such country. (In the 
case of exportation of bulk coca leaf alkaloid, the submitted evidence 
need only show the material outlined in paragraph (a) of this section 
for such exportations.)

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, 1997]



Sec. 1312.23  Issuance of export permit.

    (a) The Administrator may authorize exportation of any controlled 
substance listed in Schedule I or II or any narcotic controlled 
substance listed in Schedule III or IV if he finds that such exportation 
is permitted by subsections 1003(a), (b), (c), or (d) of the Act (21 
U.S.C. 953 (a), (b), (c), or (d).
    (b) The Administrator may require that such non-narcotic controlled 
substances in Schedule III as shall be designated by regulation in Sec. 
1312.30 of this part be exported only pursuant to the issuance of an 
export permit. The Administrator may authorize the exportation of such 
substances if he finds that such exportation is permitted by section 
1003(e) of the Act (21 U.S.C. 953(e)).
    (c) If a non-narcotic substance listed in Schedule IV or V is also 
listed in Schedule I or II of the Convention on Psychotropic Substances, 
it shall be exported only pursuant to the issuance of an export permit. 
The Administrator may authorize the exportation of such substances if he 
finds that such exportation is permitted by section 1003(e) of the Act 
(21 U.S.C. 953(e)).
    (d) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.
    (e) Each export permit shall be issued in septuplet and serially 
numbered, with all seven copies bearing the same serial number and being 
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc., 
respectively. Each export permit shall be predicated upon an import 
certificate or other documentary evidence. Export permits are not 
transferable.
    (f) No export permit shall be issued for the exportation of any 
narcotic drug to any country when the Administrator has information to 
show that the estimates submitted with respect to that country for the 
current period, under the Narcotic Limitation Convention of 1931, or the 
Single Convention on Narcotic Drugs of 1961, have been, or, considering 
the quantity proposed to be imported, will be exceeded. If it shall 
appear through subsequent advice received from the International 
Narcotic Control Board of the United Nations that the estimates of the 
country of destination have been adjusted to permit further importation 
of the narcotic drug, an export permit may then be issued if otherwise 
permissible.

[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290, 
May 7, 1987]



Sec. 1312.24  Distribution of copies of export permit.

    Copies of the export permit shall be distributed and serve purposes 
as follows:
    (a) The original, duplicate, and triplicate copies (Copy 1, Copy 2, 
and Copy 3) shall be transmitted by the Administration to the exporter 
who will retain the triplicate copy (Copy 3) as his record of authority 
for the exportation. The exporter shall present to the District Director 
of the U.S. Customs Service at the port of export and at the time of 
shipment, the original and duplicate copies (Copy 1 and Copy 2). After 
endorsing the port of export on the reverse side of the original and 
duplicate copies (Copy 1 and Copy 2) the District Director shall forward 
the endorsed original copy (Copy 1) with the shipment, and return the 
endorsed duplicate copy (Copy 2) to the Drug Enforcement Administration, 
Drug Operations Section, Washington, DC 20537.

[[Page 155]]

    (b) The quadruplet copy (Copy 4) shall be forwarded by the 
Administrator to the District Director of the U.S. Customs Service at 
the port of export for comparison with the original copy (Copy 1) and 
for retention for the customs record.
    (c) The quintuplet copy (Copy 5) shall be forwarded by the 
Administration to the officer in the country of destination who issued 
the import certificate, or other documentary evidence upon which the 
export permit is founded.
    (d) The sextuplet and septuplet copies (Copy 6 and Copy 7) shall be 
retained by the Administration.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 
FR 13969, Mar. 24, 1997]



Sec. 1312.25  Expiration date.

    An export permit shall not be valid after the date specified 
therein, which date shall conform to the expiration date specified in 
the supporting import certificate or other documentary evidence upon 
which the export permit is founded, but in no event shall the date be 
subsequent to 6 months after the date the permit is issued. Any unused 
export permit shall be returned by the permittee to the Drug Operations 
Section for cancellation.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]



Sec. 1312.26  Records required of exporter.

    The exporter shall keep a record of any serial numbers that might 
appear on packages of narcotic drugs in quantities of one ounce or more 
in such a manner as will identify the foreign consignee, along with Copy 
3 of the export permit.



Sec. 1312.27  Contents of special controlled substances invoice.

    (a) A person registered or authorized to export any non-narcotic 
controlled substance listed in Schedule III, IV, or V, which is not 
subject to the requirement of an export permit pursuant to Sec. 1312.23 
(b) or (c), or any person registered or authorized to export any 
controlled substance in Schedule V, must furnish a special controlled 
substances export invoice on DEA Form 236 to the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537, not less 
than 15 calendar days prior to the proposed date of exportation, and 
distribute four copies of same as hereinafter directed in Sec. 1312.28 
of this part.
    (b) This invoice must be executed by the exporter in quintuplicate 
and include the following information.
    (1) The name, address, and registration number, if any, of the 
exporter; and the name, address and registration number of the exporter 
broker, if any; and
    (2) A complete description of the controlled substances to be 
exported including the drug name, dosage form, National Drug Code (NDC) 
number, the Administration Controlled Substances Code Number as set 
forth in part 1308 of this chapter, the number and size of packages or 
containers, the name and quantity of the controlled substance contained 
in finished dosage units, and the net quantity of any controlled 
substance (expressed in anhydrous acid, base, or alkaloid) given in 
kilograms or parts thereof; and
    (3) The proposed export date, the port of exportation, the foreign 
port of entry, the carriers and shippers involved, method of shipment, 
the name of the vessel if applicable, and the name, address, and 
registration number, if any, of any forwarding agent utilized; and
    (4) The name and address of the consignee in the country of 
destination, and any registration or license number if the consignee is 
required to have such numbers either by the country of destination or 
under United States law. In addition, documentation must be provided to 
show that:
    (i) The consignee is authorized under the laws and regulations of 
the country of destination to receive the controlled substances, and 
that
    (ii) The substance is being imported for consumption within the 
importing country to satisfy medical, scientific or other legitimate 
purposes, and that
    (5) The reexport of non-narcotic controlled substances in Schedules 
III and

[[Page 156]]

IV, and controlled substances in Schedule V is not permitted under the 
authority of 21 U.S.C. 953(e), except as provided below:
    (i) Bulk substances will not be reexported in the same form as 
exported from the United States, i.e, the material must undergo further 
manufacturing process. This further manufactured material may only be 
reexported to a country of ultimate consumption.
    (ii) Finished dosage units, if reexported, will be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
country of destination.
    (iii) Any reexportation be made known to DEA at the time the initial 
DEA Form 236, Controlled Substances Import/Export Declaration is 
completed, by checking the box marked ``other'' on the certification. 
The following information will be furnished in the remarks section:
    (A) Indicate ``for reexport''.
    (B) Indicate if reexport is bulk or finished dosage units.
    (C) Indicate product name, dosage strength, commercial package size, 
and quantity.
    (D) Indicate name of consignee, complete address, and expected 
shipment date, as well as, the name and address of the ultimate 
consignee in the country to where the substances will be reexported.
    (E) A statement that the consignee in the country of ultimate 
destination is authorized under the laws and regulations of the country 
of ultimate destination to receive the controlled substances.
    (iv) Shipments which have been exported from the United States and 
are refused by the consignee in the country of destination, or are 
otherwise unacceptable or undeliverable, may be returned to the 
registered exporter in the United States upon authorization of the Drug 
Enforcement Administration. In this circumstance, the exporter in the 
United States shall file a written request for reexport, along with a 
completed DEA Form 236, Import Declaration with the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537. A brief 
summary of the facts that warrant the return of the substance to the 
United States along with an authorization from the country of export 
will be included with the request. DEA will evaluate the request after 
considering all the facts as well as the exporter's registration status 
with DEA. The substance may be returned to the United States only after 
affirmative authorization is issued in writing by DEA.
    (c) Notwithstanding the time limitations included in paragraph (a) 
of this section, a registrant may obtain a special waiver of these time 
limitations in emergency or unusual instances; provided that a specific 
confirmation is received from the Administrator or his delegate advising 
the registrant to proceed pursuant to the special waiver.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 
FR 13969, Mar. 24, 1997]



Sec. 1312.28  Distribution of special controlled substances invoice.

    The required five copies of the special controlled substances export 
invoice, DEA (or BND) Form 236, will be distributed as follows:
    (a) Copy 1 shall accompany the shipment and remain with the shipment 
to its destination.
    (b) Copy 2 shall accompany the shipment and will be detached and 
retained by appropriate customs officials at the foreign country of 
destination.
    (c) Copy 3 shall accompany the shipment and will be detached by the 
District Director of the U.S. Customs Service at the port of 
exportation, who shall sign and date the certification of customs on 
such Copy 3, noting any changes from the entries made by the exporter, 
and shall then promptly forward Copy 3 to the Drug Control Section of 
the Administration.
    (d) Copy 4 shall be forwarded, within the time limit required in 
Sec. 1312.27 of this part, directly to the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537. The 
documentation required by Sec. 1312.27(b)(4) of this part must be 
attached to this copy.

[[Page 157]]

    (e) Copy 5 shall be retained by the exporter on file as his record 
of authority for the exportation.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17291, May 7, 1987; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]



Sec. 1312.29  Domestic release prohibited.

    An exporter or a forwarding agent acting for an exporter must either 
deliver the controlled substances to the port or border, or deliver the 
controlled substances to a bonded carrier approved by the consignor for 
delivery to the port or border, and may not, under any other 
circumstances, release a shipment of controlled substances to anyone, 
including the foreign consignee or his agent, within the United States.



Sec. 1312.30  Schedule III, IV, and V non-narcotic controlled substances 
requiring an import and export permit.

    The following Schedule III, IV, and V non-narcotic controlled 
substances have been specifically designated by the Administrator of the 
Drug Enforcement Administration as requiring import and export permits 
pursuant to sections 1002(b)(2) and 1003(e)(3) of the Act (21 U.S.C. 
952(b)(2) and 953(e)(3)):
    (a) Dronabinol (synthetic) in sesame oil and encapsulated in a soft 
gelatin capsule in a U.S. Food and Drug Administration approved product.
    (b) [Reserved]

[52 FR 17291, May 7, 1987, as amended at 64 FR 35930, July 2, 1999]

     Transshipment and In-Transit Shipment of Controlled Substances



Sec. 1312.31  Schedule I: Application for prior written approval.

    (a) A controlled substance listed in schedule I may be imported into 
the United States for transshipment, or may be transferred or 
transshipped within the United States for immediate exportation, 
provided that:
    (1) The controlled substance is necessary for scientific, medical, 
or other legitimate purposes in the country of destination, and
    (2) A transshipment permit has been issued by the Administrator.
    (b) An application for a transshipment permit must be submitted to 
the Drug Enforcement Administration, Drug Operations Section, 
Washington, DC 20537, at least 30 days, or in the case of an emergency 
as soon as practicable, prior to the expected date of importation, 
transfer or transshipment. Each application shall contain the following:
    (1) The date of execution;
    (2) The identification and description of the controlled substance;
    (3) The net quantity thereof;
    (4) The number and size of the controlled substance containers;
    (5) The name, address, and business of the foreign exporter;
    (6) The foreign port of exportation;
    (7) The approximate date of exportation;
    (8) The identification of the exporting carrier;
    (9) The name, address and business of the importer, transferor, or 
transshipper;
    (10) The registration number, if any, of the importer, transferor or 
transshipper;
    (11) The U.S. port of entry;
    (12) The approximate date of entry;
    (13) The name, address and business of the consignee at the foreign 
port of entry;
    (14) The shipping route from the U.S. port of exportation to the 
foreign port of entry;
    (15) The approximate date of receipt by the consignee at the foreign 
port of entry; and
    (16) The signature of the importer, transferor or transshipper, or 
his agent accompanied by the agent's title.
    (c) An application shall be accompanied by an export license, 
permit, or a certified copy of the export license, permit, or other 
authorization, issued by a competent authority of the country of origin 
(or other documentary evidence deemed adequate by the Administrator).
    (d) An application shall be accompanied by an import license or 
permit or a certified copy of such license or permit issued by a 
competent authority of the country of destination (or other documentary 
evidence deemed

[[Page 158]]

adequate by the Administrator), indicating that the controlled 
substance:
    (1) Is to be applied exclusively to scientific, medical or other 
legitimate uses within the country of destination;
    (2) Will not be exported from such country; and
    (3) Is needed therein because there is an actual shortage thereof 
and a demand therefor for scientific, medical or other legitimate uses 
within such country.
    (e) Verification by an American consular officer of the signatures 
on a foreign import license or permit shall be required, if such license 
or permit does not bear the seal of the authority signing them.
    (f) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.
    (g) The Administrator shall, within 21 days from the date of receipt 
of the application, either grant or deny the application. The applicant 
shall be accorded an opportunity to amend the application, with the 
Administrator either granting or denying the amended application within 
7 days of its receipt. If the Administrator does not grant or deny the 
application within 21 days of its receipt, or in the case of an amended 
application, within 7 days of its receipt, the application shall be 
deemed approved and the applicant may proceed.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 
FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 
30, 1988; 62 FR 13969, Mar. 24, 1997]



Sec. 1312.32  Schedules II, III, IV: Advance notice.

    (a) A controlled substance listed in Schedules II, III, or IV may be 
imported into the United States for transshipment, or may be transferred 
or transshipped within the United States for immediate exportation, 
provided that written notice is submitted to the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537, at least 
15 days prior to the expected date of importation, transfer or 
transshipment.
    (b) Each advance notice shall contain those items required by Sec. 
1312.31 (b) and (c).

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]

                                Hearings



Sec. 1312.41  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing 
regarding the denial of an application for an import, export or 
transshipment permit, the procedures for such hearing shall be governed 
generally by the adjudication procedures set forth in the Administrative 
Procedure Act (5 U.S.C. 551-559) and specifically by sections 1002 and 
1003 of the Act (21 U.S.C. 952 and 953), by Sec. Sec. 1312.42-1312.47, 
and by the procedures for administrative hearings under the Act set 
forth in Sec. Sec. 1316.41- 1316.67 of this chapter.
    (b) [Reserved]

[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.42  Purpose of hearing.

    (a) If requested by a person applying for an import, export, or 
transshipment permit, the Administrator shall hold a hearing for the 
purpose of receiving factual evidence regarding the issues involved in 
the issuance or denial of such permit to such person.
    (b) Extensive argument should not be offered into evidence but 
rather presented in opening or closing statements of counsel or in 
memoranda or proposed findings of fact and conclusions of law.

[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

[[Page 159]]



Sec. 1312.43  Waiver or modification of rules.

    The Administrator of the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.

[36 FR 23625, Dec. 11, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973]



Sec. 1312.44  Request for hearing or appearance; waiver.

    (a) Any applicant entitled to a hearing pursuant to Sec. 1312.42 
and who desires a hearing on the denial of his application for an 
import, export, or transshipment permit shall, within 30 days after the 
date of receipt of the denial of his application, file with the 
Administrator a written request for a hearing in the form prescribed in 
Sec. 1316.47 of this chapter.
    (b) Any applicant entitled to a hearing pursuant to Sec. 1312.42 
may, within the period permitted for filing a request for a hearing, 
file with the Administrator a waiver of an opportunity for a hearing, 
together with a written statement regarding his position on the matters 
of fact and law involved in such hearing. Such statement, if admissible, 
shall be made a part of the record and shall be considered in light of 
the lack of opportunity for cross-examination in determining the weight 
to be attached to matters of fact asserted therein.
    (c) If any applicant entitled to a hearing pursuant to Sec. 1312.42 
fails to appear at the hearing, he shall be deemed to have waived his 
opportunity for the hearing unless he shows good cause for such failure.
    (d) If the applicant waives or is deemed to have waived this 
opportunity for the hearing, the Administrator may cancel the hearing, 
if scheduled, and issue his final order pursuant to Sec. 1312.47 
without a hearing.

[37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.45  Burden of proof.

    At any hearing on the denial of an application for an import, 
export, or transshipment permit, the Administrator shall have the burden 
of proving that the requirements for such permit pursuant to sections 
1002, 1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are not 
satisfied.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.46  Time and place of hearing.

    (a) If any applicant for an import, export, or transshipment permit 
requests a hearing on the issuance or denial of his application, the 
Administrator shall hold such hearing. Notice of the hearing shall be 
given to the applicant of the time and place at least 30 days prior to 
the hearing, unless the applicant waives such notice and requests the 
hearing be held at an earlier time, in which case the Administrator 
shall fix a date for such hearing as early as reasonably possible.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.47  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order on 
the issuance or denial of the application for and import, export, or 
transshipment permit. The order shall include the findings of fact and 
conclusions of law upon which the order is based. The Administrator 
shall serve one copy of his order upon the applicant.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

[[Page 160]]



PART 1313_IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL 
CHEMICALS--Table of Contents

Sec.
1313.01 Scope.
1313.02 Definitions.

                     Importation of Listed Chemicals

1313.12 Requirement of authorization to import.
1313.13 Contents of import declaration.
1313.14 Distribution of import declaration.
1313.15 Waiver of 15-day advance notice for regular importers.

                     Exportation of Listed Chemicals

1313.21 Requirement of authorization to export.
1313.22 Contents of export declaration.
1313.23 Distribution of export declaration.
1313.24 Waiver of 15-day advance notice for chemical exporters.
1313.25 Foreign import restrictions.

  Transshipments, In-Transit Shipments and International Transactions 
                       Involving Listed Chemicals

1313.31 Advance notice of importation for transshipment or transfer.
1313.32 Requirement of authorization for international transactions.
1313.33 Contents of an international transaction declaration.
1313.34 Distribution of the international transaction declaration.
1313.41 Suspension of shipments.

                                Hearings

1313.51 Hearings generally.
1313.52 Purpose of hearing.
1313.53 Waiver of modification of rules.
1313.54 Request for hearing.
1313.55 Burden of proof.
1313.56 Time and place of hearing.
1313.57 Final order.

    Authority: 21 U.S.C. 802, 830, 871(b), 971.

    Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.



Sec. 1313.01  Scope.

    Procedures governing the importation, exportation, transshipment and 
in-transit shipment of listed chemicals pursuant to section 1018 of the 
Act (21 U.S.C. 971) are governed generally by that section and 
specifically by the sections of this part.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]



Sec. 1313.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13969, Mar. 24, 1997]

                     Importation of Listed Chemicals



Sec. 1313.12  Requirement of authorization to import.

    (a) Each regulated person who imports a listed chemical that meets 
or exceeds the threshold quantities identified in Sec. 1310.04(f) or is 
a listed chemical for which no threshold has been established as 
identified in Sec. 1310.04(g) of this chapter, shall notify the 
Administrator of the importation not later than 15 days before the 
transaction is to take place.
    (b) A completed DEA Form 486 must be received at the following 
address not later than 15 days prior to the importation: Drug 
Enforcement Administration, P.O. Box 27284, Washington, DC 20038. A copy 
of the completed DEA Form 486 may be transmitted directly to the Drug 
Enforcement Administration, Chemical Control Section, through electronic 
facsimile media not later than 15 days prior to the importation.
    (c) The 15-day advance notification requirement for listed chemical 
imports may be waived for:
    (1) Any regulated person who has satisfied the requirements for 
reporting to the Administration as a regular importer of such listed 
chemicals; or
    (2) A specific listed chemical, as set forth in paragraph (f) of 
this section, for which the Administrator determines that advance 
notification is not necessary for effective chemical diversion control.
    (d) For imports where advance notification is waived pursuant to 
paragraph (c)(1) of this section, the DEA Form 486 must be received by 
the Drug Enforcement Administration, Chemical Operations Section, on or 
before the date of importation through use of the mailing address listed 
in Sec. 1313.12(b) or through use of electronic facsimile media.
    (e) For importations where advance notification is waived pursuant 
to paragraph (c)(2) of this section no DEA

[[Page 161]]

Form 486 is required, however, the regulated person shall submit 
quarterly reports to the Drug Enforcement Administration, Chemical 
Operations Section, P.O. Box 27284, Washington, DC 20038, by no later 
than the 15th day of the month following the end of each quarter. The 
report shall contain the following information regarding each individual 
importation:
    (1) The name of the listed chemical;
    (2) The quantity and date imported;
    (3) The name and full business address of the supplier;
    (4) The foreign port of embarkation; and
    (5) The port of entry.
    (f) The 15 day advance notification requirement set forth in 
paragraph (a) has been waived for imports of the following listed 
chemicals:
    (1) Acetone.
    (2) 2-Butanone (or Methyl Ethyl Ketone or MEK).
    (3) Toluene.

[54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 
FR 32464, June 22, 1995; 66 FR 46520, Sept. 6, 2001; 67 FR 49569, July 
31, 2002]



Sec. 1313.13  Contents of import declaration.

    (a) Any List I or List II chemical listed in Sec. 1310.02 of this 
chapter may be imported if that chemical is necessary for medical, 
commercial, scientific, or other legitimate uses within the United 
States. Chemical importations into the United States for immediate 
transfer/transshipment outside the United States must comply with the 
procedures set forth in Sec. 1313.31.
    (b) Any regulated person who desires to import a threshold or 
greater quantity of a listed chemical shall notify the Administration 
through procedures set forth in Sec. 1313.12 and distribute three 
copies of DEA Form 486 as directed in Sec. 1313.14.
    (c) The DEA Form 486 must be executed in triplicate and must include 
the following information:
    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the chemical importer; the name, 
address, telephone, telex, and where available, the facsimile number of 
the broker or forwarding agent (if any); and
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each chemical as it is designated 
in 1310.02 of this chapter, the size or weight of container, the number 
of containers, the net weight of each listed chemical given in kilograms 
or parts thereof; and the gross weight of the shipment given in 
kilograms or parts thereof; and
    (3) The proposed import date, the foreign port of exportation and 
the first U.S. Customs Port of Entry; and
    (4) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the consignor in the foreign country 
of exportation.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]



Sec. 1313.14  Distribution of import declaration.

    The required three copies of the listed chemical import declaration 
(DEA Form 486) will be distributed as follows:
    (a) Copy 1 shall be retained on file by the regulated person as the 
official record of import. Import declaration forms involving a List I 
chemical must be retained for four years; declaration forms for List II 
chemical must be retained for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 6053 of the Chemical 
Diversion and Trafficking Act of 1988, as specified in Sec. 1313.12.
    (c) Copy 3 shall be presented to the U.S. Customs Sevice along with 
the customs entry. If the import is a regulated transaction for which 
the 15-day advance notice requirement has been waived, the regulated 
person shall declare this information to the U.S. Customs Service 
Official by checking the block on the DEA Form 486 designated for this 
purpose.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]



Sec. 1313.15  Waiver of 15-day advance notice for regular importers.

    (a) Each regulated person seeking designation as a ``regular 
importer'' shall provide, by certified mail return

[[Page 162]]

receipt requested, to the Administration such information as is required 
under Sec. 1300.02(b)(13), documenting their status as a regular 
importer.
    (b) Each regulated person making application under paragraph (a) of 
this section shall be considered a ``regular importer'' for purposes of 
waiving the 15-day advance notice, 30 days after receipt of the 
application by the Administration, as indicated on the return receipt, 
unless the regulated person is otherwise notified in writing by the 
Administration.
    (c) The Administrator, may, at any time, disqualify a regulated 
person's status as a regular importer on the grounds that the chemical 
being imported may be diverted to the clandestine manufacture of a 
controlled substance.
    (d) Unless the Administration notifies the chemical importer to the 
contrary, the qualification of a regular importer of any one of these 
three chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that 
importer as a regular importer of all three of these chemicals.
    (e) All chemical importers shall be required to file a DEA Form 486 
as required by Section 1313.12.

[60 FR 32464, June 22, 1995, as amended at 62 FR 13969, Mar. 24, 1997]

                     Exportation of Listed Chemicals



Sec. 1313.21  Requirement of authorization to export.

    (a) No person shall export or cause to be exported from the United 
States any chemical listed in Sec. 1310.02 of this chapter, which meets 
or exceeds the threshold quantities identified in Sec. 1310.04(f) or is 
a listed chemical for which no threshold has been established as 
identified in Sec. 1310.04(g) of this chapter, until such time as the 
Administrator has been notified. Notification must be made not later 
than 15 days before the transaction is to take place. In order to 
facilitate the export of listed chemicals and implement the purpose of 
the Act, regulated persons may wish to provide notification to the 
Administration as far in advance of the 15 days as possible.
    (b) A completed DEA Form 486 must be received at the following 
address not later than 15 days prior to the exportation: Drug 
Enforcement Administration, P.O. Box 27284, Washington, DC 20038. A copy 
of the completed DEA Form 486 may be transmitted directly to the Drug 
Enforcement Administration, Chemical Control Section, through electronic 
facsimile media not later than 15 days prior to the exportation.
    (c) The 15-day advance notification requirement for listed chemical 
exports may be waived for:
    (1) Any regulated person who has satisfied the requirements of 
Section 1313.24 for reporting to the Administration an established 
business relationship with a foreign customer as defined in Sec. 
1300.02(b)(12).
    (2) A specific listed chemical to a specified country, as set forth 
in paragraph (f) of this section, for which the Administrator determines 
that advance notification is not necessary for effective chemical 
diversion control.
    (d) For exports where advance notification is waived pursuant to 
paragraph (c)(1) of this section, the DEA Form 486 must be received by 
the Drug Enforcement Administration, Chemical Operations Section, on or 
before the date of exportation through use of the mailing address listed 
in Section 1313.12(b) or through use of electronic facsimile media.
    (e) For exportations where advance notification is waived pursuant 
to paragraph (c)(2) of this section, no DEA Form 486 is required, 
however, the regulated person shall file quarterly reports to the Drug 
Enforcement Administration, Chemical Control Section, P.O. Box 27284, 
Washington, DC 20038, by no later than the 15th day of the month 
following the end of each quarter. The report shall contain the 
following information regarding each individual exportation:
    (1) The name of the listed chemical;
    (2) The quantity and date exported;
    (3) The name and full business address of the foreign customer;
    (4) The port of embarkation; and
    (5) The foreign port of entry.
    (f) The 15 day advance notification requirement set forth in 
paragraph (a) of this section has been waived for exports of the 
following listed chemicals to the following countries:

[[Page 163]]



------------------------------------------------------------------------
             Name of Chemical                          Country
------------------------------------------------------------------------
[Reserved]................................  ............................
------------------------------------------------------------------------

    (g) No person shall export or cause to be exported any listed 
chemical, knowing or having reasonable cause to believe the export is in 
violation of the laws of the country to which the chemical is exported 
or the chemical will be used to manufacture a controlled substance in 
violation of the Act or the laws of the country to which the chemical is 
exported. The Administration will publish a notice of foreign import 
restrictions for listed chemicals of which DEA has knowledge as provided 
in Sec. 1313.25.

[54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 
FR 32464, June 22, 1995; 62 FR 13969, Mar. 24, 1997; 66 FR 46520, Sept. 
6, 2001; 67 FR 49569, July 31, 2002]



Sec. 1313.22  Contents of export declaration.

    (a) Any List I or List II chemical listed in Sec. 1310.02 of this 
chapter which meets or exceeds the quantitative threshold criteria 
established in Sec. 1310.04(f) of this chapter may be exported if that 
chemical is needed for medical, commercial, scientific, or other 
legitimate uses.
    (b) Any regulated person who desires to export a threshold or 
greater quantity of a listed chemical shall notify the Administration 
through procedures outlined in Sec. 1313.21 and distribute three copies 
of DEA Form 486 as directed in Sec. 1313.23.
    (c) The DEA Form 486 must be executed in triplicate and must include 
all the following information:
    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the chemical exporter; the name, 
address, telephone number, telex number, and, where available, the 
facsimile number of the export broker, if any;
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each listed chemical as it is 
designated in Sec. 1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof;
    (3) The proposed export date, the U.S. Customs port of exportation, 
and the foreign port of entry; and
    (4) The name, address, telephone, telex, and where available, the 
facsimile number of the consignee in the country where the chemical 
shipment is destined; the name(s) and address(es) of any intermediate 
consignee(s).
    (d) Notwithstanding the time limitations included in paragraph (b) 
of this section, a regulated person may receive a waiver of the 15-day 
advance notification requirement following the procedures outlined in 
Sec. 1313.24.
    (e) Declared exports of listed chemicals which are refused, 
rejected, or otherwise deemed undeliverable may be returned to the U.S. 
chemical exporter of record. A brief written notification (this does not 
require a DEA Form 486) outlining the circumstances must be sent to the 
Drug Enforcement Administration, P.O. Box 27284, Washington, DC 20038, 
following the return within a reasonable time. This provision does not 
apply to shipments that have cleared foreign customs, been delivered, 
and accepted by the foreign consignee. Returns to third parties in the 
United States will be regarded as imports.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 67 
FR 49569, July 31, 2002]



Sec. 1313.23  Distribution of export declaration.

    The required three copies of the listed chemical export declaration 
(DEA Form 486) will be distributed as follows:
    (a) Copy 1 shall be retained on file by the chemical exporters as 
the official record of export. Export declaration forms involving a List 
I chemical must be retained for four years; declaration forms for list 
II chemical must be retained for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 6053 of the Chemical 
Diversion and Trafficking Act of 1988, as specified in Sec. 1313.21
    (c) Copy 3 shall be presented to the U.S. Customs Service at the 
port of

[[Page 164]]

exit for each export of a listed chemical or chemicals on or before the 
day of exportation, and when possible, along with the Shippers Export 
Declaration.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 61 
FR 51004, Sept. 30, 1996]



Sec. 1313.24  Waiver of 15-day advance notice for chemical exporters.

    (a) Each regulated person shall provide to the Administration the 
identity and information listed in Sec. 1300.02(b)(12) for an 
established business relationship with a foreign customer not later than 
August 31, 1989.
    (b) Not later than October 31, 1989, each regular customer so 
identified in notifications made under Sec. 1313.24(a) shall be a 
regular customer for purposes of waiving the 15-day advance notice 
requirement, unless the regulated person is otherwise notified in 
writing by the Administration.
    (c) Each foreign customer identified on an initial DEA Form 486 
submitted after the effective date of the implementation of part 1313 
shall, after the expiration of the 15-day period, qualify as a regular 
customer, unless the Administration otherwise notifies the regulated 
person in writing.
    (d) Unless the Administration notifies the chemical exporter to the 
contrary, the qualification of a regular customer for any one of these 
three chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that 
customer as a regular customer for all three of these chemicals.
    (e) The Administrator may notify any chemical exporter that a 
regular customer has been disqualified or that a new customer for whom a 
notification has been submitted is not to be accorded the status of a 
regular customer. In the event of a disqualification of an established 
regular customer, the chemical exporter will be notified in writing of 
the reasons for such action.

Public reporting (one-time) burden for this collection of information is 
estimated to average four hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing and collection 
of information. Send comments regarding this burden estimate or any 
other aspect of this collection of information, including suggestions 
for reducing this burden to the Drug Enforcement Administration, Records 
Management Section, Washington, DC 20537; and to the Office of 
Management and Budget, Paperwork Reduction Project No. 1117-0025, 
Washington, DC 20503.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 55077, Oct. 24, 1991; 62 
FR 13969, Mar. 24, 1997]



Sec. 1313.25  Foreign import restrictions.

    Any export from the United States in violation of the law of the 
country to which the chemical is exported is subject to the penalties of 
Title 21 United States Code 960(d).

  Transshipments, In-Transit Shipments and International Transactions 
                       Involving Listed Chemicals



Sec. 1313.31  Advance notice of importation for transshipment or transfer.

    (a) A quantity of a chemical listed in Sec. 1310.02 of this chapter 
that meets or exceeds the threshold reporting requirements found in 
Sec. 1310.04(f) of this chapter may be imported into the United States 
for transshipment, or may be transferred or transshipped within the 
United States for immediate exportation, provided that advance notice is 
given to the Administration.
    (b) Advance notification must be provided to the Drug Enforcement 
Administration, P.O. Box 27284, Washington, DC 20038, not later than 15 
days prior to the proposed date the listed chemical will transship or 
transfer through the United States. The written notification (not a DEA 
Form 486) shall contain the following information:
    (1) The date the notice was executed;
    (2) The complete name and description of the listed chemical as it 
appears on the label or container.
    (3) The name of the listed chemical as designated by Sec. 1310.02 
of this chapter.
    (4) The number of containers and the size or weight of the container 
for each listed item;

[[Page 165]]

    (5) The new weight of each listed chemical given in kilograms or 
parts thereof;
    (6) The gross weight of the shipment given in kilograms or parts 
thereof;
    (7) The name, address, telephone number, telex number, business of 
the foreign exporter and, where available, the facsimile number;
    (8) The foreign port of exportation;
    (9) The approximate date of exportation;
    (10) The complete identification of the exporting carrier;
    (11) The name, address, business, telephone number, telex number, 
and, where available, the facsimile number of the importer, transferor, 
or transshipper;
    (12) The U.S. port of entry;
    (13) The approximate date of entry;
    (14) The name, address, telephone number, telex number, business of 
the consignee and, where available, facsimile number of the consignee at 
the foreign port of entry;
    (15) The shipping route from the U.S. port of exportation to the 
foreign port of entry at final destination;
    (16) The approximate date of receipt by the consignee at the foreign 
port of entry; and
    (17) The signature of the importer, transferor or transshipper, or 
his agent, accompanied by the agent's title.
    (c) Unless notified to the contrary prior to the expected date of 
delivery, the importation for transshipment or transfer is considered 
approved.
    (d) No waiver of the 15-day advance notice will be given for imports 
of listed chemicals in quantities meeting or exceeding threshold 
quantities for transshipment or transfer outside the United States.

[54 FR 31665, Aug. 1, 1989, as amended at 67 FR 49569, July 31, 2002]



Sec. 1313.32  Requirement of authorization for international transactions.

    (a) A broker or trader shall notify the Administrator prior to an 
international transaction involving a listed chemical which meets or 
exceeds the threshold amount identified in Section 1310.04 of this 
chapter, in which the broker or trader participates. Notification must 
be made no later than 15 days before the transaction is to take place. 
In order to facilitate an international transaction involving listed 
chemicals and implement the purpose of the Act, regulated persons may 
wish to provide advance notification to the Administration as far in 
advance of the 15 days as possible.
    (b)(1) A completed DEA Form 486 must be received at the following 
address not later than 15 days prior to the international transaction:

Drug Enforcement Administration, P.O. Box 27284, Washington, D.C. 20038

    (2) A copy of the DEA Form 486 may be transmitted directly to the 
Drug Enforcement Administration, Chemical Operations Section, through 
electronic facsimile media not later than 15 days prior to the 
exportation.
    (c) No person shall serve as a broker or trader for an international 
transaction involving a listed chemical knowing or having reasonable 
cause to believe that the transaction is in violation of the laws of the 
country to which the chemical is exported or the chemical will be used 
to manufacture a controlled substance in violation of the laws of the 
country to which the chemical is exported. The Administration will 
publish a notice of foreign import restrictions for listed chemicals of 
which DEA has knowledge as provided in Section 1313.25.

[60 FR 32465, June 22, 1995; 61 FR 17566, Apr. 22, 1996; 67 FR 49569, 
July 31, 2002]



Sec. 1313.33  Contents of an international transaction declaration.

    (a) An international transaction involving a chemical listed in 
Sec. 1310.02 of this chapter which meets the threshold criteria 
established in Sec. 1310.04 of this chapter may be arranged by a broker 
or trader if the chemical is needed for medical, commercial, scientific, 
or other legitimate uses.
    (b) Any broker or trader who desires to arrange an international 
transaction involving a listed chemical which meets the criteria set 
forth in Section 1310.04 shall notify the Administration through the 
procedures outlined in Section 1313.32(b).
    (c) The DEA Form 486 must be executed in triplicate and must include 
all the following information:

[[Page 166]]

    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the chemical exporter; the name, 
address, telephone number, telex number, and, where available, the 
facsimile number of the chemical importer;
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each listed chemical as it is 
designated in Section 1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof;
    (3) The proposed export date, the port of exportation, and the port 
of importation; and
    (4) The name, address, telephone, telex, and where available, the 
facsimile number, of the consignee in the country where the chemical 
shipment is destined; the name(s) and address(es) of any intermediate 
consignee(s).

[60 FR 32465, June 22, 1995]



Sec. 1313.34  Distribution of the international transaction declaration.

    The required three copies of the DEA Form 486 will be distributed as 
follows:
    (a) Copies 1 and 3 shall be retained on file by the broker or trader 
as the official record of the international transaction. Declaration 
forms involving List I chemicals shall be retained for List II chemicals 
shall be retained for four years; declaration forms for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 1313.32.

[60 FR 32465, June 22, 1995; 60 FR 35264, July 6, 1995]



Sec. 1313.41  Suspension of shipments.

    (a) The Administrator may suspend any importation or exportation of 
a chemical listed in Sec. 1310.02 of this chapter based on evidence 
that the chemical proposed to be imported or exported may be diverted to 
the clandestine manufacture of a controlled substance. If the 
Administrator so suspends, he shall provide written notice of such 
suspension to the regulated person. Such notice shall contain a 
statement of the legal and factual basis for the order.
    (b) Upon service of the order of suspension, the regulated person to 
whom the order applies under paragraph (a) of this section must, if he 
desires a hearing, file a written request for a hearing pursuant to 
Sec. Sec. 1313.51-1313.57.

                                Hearings



Sec. 1313.51  Hearings generally.

    In any case where a regulated person requests a hearing regarding 
the suspension of a shipment of a listed chemical, the procedures for 
such hearing shall be governed generally by the procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
section 6053 of the Chemical Diversion and Trafficking Act (Pub. L. 100-
690), by 21 CFR 1313.52-1313.57, and by the procedures for 
administrative hearings under the Controlled Substances Act set forth in 
Sec. Sec. 1316.41-1316.67 of this chapter.



Sec. 1313.52  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall cause a hearing to be held for the purpose of receiving factual 
evidence regarding the issues involved in the suspension of shipments 
within 45 days of the date of the request, unless the requesting party 
requests an extension of time.



Sec. 1313.53  Waiver of modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.



Sec. 1313.54  Request for hearing.

    (a) Any person entitled to a hearing pursuant to Sec. 1313.52 and 
desiring a hearing shall, within 30 days after receipt of the notice to 
suspend the shipment, file with the Administrator a written request for 
a hearing in the

[[Page 167]]

form prescribed in Sec. 1316.47 of this chapter.
    (b) If any person entitled to a hearing or to participate in a 
hearing pursuant to Sec. 1313.41 fails to file a request for a hearing 
or a notice of appearance, or if he so files and fails to appear at the 
hearing, he shall be deemed to have waived his opportunity for the 
hearing or to participate in the hearing, unless he shows good cause for 
such failure.
    (c) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to Sec. 
1313.57.



Sec. 1313.55  Burden of proof.

    At any hearing regarding the suspension of shipments, the Agency 
shall have the burden of proving that the requirements of this part for 
such suspension are satisfied.



Sec. 1313.56  Time and place of hearing.

    (a) If any regulated person requests a hearing on the suspension of 
shipments, a hearing will be scheduled no later than 45 days after the 
request is made, unless the regulated person requests an extension to 
this date.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.



Sec. 1313.57  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order 
regarding the suspension of shipment. The order shall include the 
findings of fact and conclusions of law upon which the order is based. 
The Administrator shall serve one copy of his order upon each party in 
the hearing.

                       PARTS 1314-1315 [RESERVED]



PART 1316_ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES--Table 
of Contents

                  Subpart A_Administrative Inspections

Sec.
1316.01 Scope of subpart A.
1316.02 Definitions.
1316.03 Authority to make inspections.
1316.04 Exclusion from inspection.
1316.05 Entry.
1316.06 Notice of inspection.
1316.07 Requirement for administrative inspection warrant; exceptions.
1316.08 Consent to inspection.
1316.09 Application for administrative inspection warrant.
1316.10 Administrative probable cause.
1316.11 Execution of warrants.
1316.12 Refusal to allow inspection with an administrative warrant.
1316.13 Frequency of administrative inspections.

        Subpart B_Protection of Researchers and Research Subjects

1316.21 Definitions.
1316.22 Exemption.
1316.23 Confidentiality of identity of research subjects.
1316.24 Exemption from prosecution for researchers.

                    Subpart C_Enforcement Proceedings

1316.31 Authority for enforcement proceeding.
1316.32 Notice of proceeding; time and place.
1316.33 Conduct of proceeding.
1316.34 Records of proceeding.

                    Subpart D_Administrative Hearings

1316.41 Scope of subpart D.
1316.42 Definitions.
1316.43 Information; special instructions.
1316.44 Waiver or modification of rules.
1316.45 Filings; address; hours.
1316.46 Inspection of record.
1316.47 Request for hearing.
1316.48 Notice of appearance.
1316.49 Waiver of hearing.
1316.50 Appearance; representation; authorization.
1316.51 Conduct of hearing and parties; ex parte communications.
1316.52 Presiding officer.
1316.53 Time and place of hearing.
1316.54 Prehearing conference.
1316.55 Prehearing ruling.
1316.56 Burden of proof.
1316.57 Submission of documentary evidence and affidavits and 
          identification of witnesses subsequent to prehearing 
          conference.

[[Page 168]]

1316.58 Summary of testimony; affidavits.
1316.59 Submission and receipt of evidence.
1316.60 Objections; offer of proof.
1316.61 Exceptions to rulings.
1316.62 Appeal from ruling of presiding officer.
1316.63 Official transcript; index; corrections.
1316.64 Proposed findings of fact and conclusions of law.
1316.65 Report and record.
1316.66 Exceptions.
1316.67 Final order.
1316.68 Copies of petitions for judicial review.

       Subpart E_Seizure, Forfeiture, and Disposition of Property

1316.71 Definitions.
1316.72 Officers who will make seizures.
1316.73 Custody and other duties.
1316.74 Appraisement.
1316.75 Advertisement.
1316.76 Requirements as to claim and bond.
1316.77 Administrative forfeiture.
1316.78 Judicial forfeiture.
1316.79 Petitions for remission or mitigation of forfeiture.
1316.80 Time for filing petitions.
1316.81 Handling of petitions.

     Subpart F_Expedited Forfeiture Proceedings for Certain Property

1316.90 Purpose and scope.
1316.91 Definitions.
1316.92 Petition for expedited release in an administrative forfeiture 
          action.
1316.93 Ruling on petition for expedited release in an administrative 
          forfeiture action.
1316.94 Posting of substitute res in an administrative forfeiture 
          action.
1316.95 Petition for expedited release of a conveyance in a judicial 
          forfeiture action.
1316.96 Ruling on a petition for expedited release of a conveyance in a 
          judicial forfeiture action.
1316.97 Initiating judicial forfeiture proceeding against a conveyance 
          within 60 days of the filing of a claim and cost bond.
1316.98 Substitute res bond in a judicial forfeiture action against a 
          conveyance.
1316.99 Notice provisions.

    Source: 36 FR 7820, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.



                  Subpart A_Administrative Inspections

    Authority: 21 U.S.C. 822(f), 830(a), 871(b), 880, 958(f), 965.



Sec. 1316.01  Scope of subpart A.

    Procedures regarding administrative inspections and warrants 
pursuant to sections 302(f), 510, 1008(d), and 1015 of the Act (21 
U.S.C. 822(f), 880, 958(d), and 965) are governed generally by those 
sections and specifically by the sections of this subpart.



Sec. 1316.02  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act 
(84 Stat. 1285; 21 U.S.C. 951).
    (b) The term Administration means the Drug Enforcement 
Administration.
    (c) The term controlled premises means--
    (1) Places where original or other records or documents required 
under the Act are kept or required to be kept, and
    (2) Places, including factories, warehouses, or other establishments 
and conveyances, where persons registered under the Act or exempted from 
registration under the Act, or regulated persons may lawfully hold, 
manufacture, or distribute, dispense, administer, or otherwise dispose 
of controlled substances or listed chemicals or where records relating 
to those activities are maintained.
    (d) The term Administrator means the Administrator of the 
Administration. The Administrator has been delegated authority under the 
Act by the Attorney General (28 CFR 0.100).
    (e) The term inspector means an officer or employee of the 
Administration authorized by the Administrator to make inspections under 
the Act.
    (f) The term register and registration refer to registration 
required and permitted by sections 303 and 1008 of the Act (21 U.S.C. 
823 and 958).
    (g) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 60 FR 32465, June 22, 1995; 60 FR 36334, July 14, 1995; 62 
FR 13969, Mar. 24, 1997]

[[Page 169]]



Sec. 1316.03  Authority to make inspections.

    In carrying out his functions under the Act, the Administrator, 
through his inspectors, is authorized in accordance with sections 510 
and 1015 of the Act (21 U.S.C. 880 and 965) to enter controlled premises 
and conduct administrative inspections thereof, for the purpose of:
    (a) Inspecting, copying, and verifying the correctness of records, 
reports, or other documents required to be kept or made under the Act 
and regulations promulgated under the Act, including, but not limited 
to, inventory and other records required to be kept pursuant to part 
1304 of this chapter, order form records required to be kept pursuant to 
part 1305 of this chapter, prescription and distribution records 
required to be kept pursuant to part 1306 of this chapter, records of 
listed chemicals, tableting machines, and encapsulating machines 
required to be kept pursuant to part 1310 of this chapter, import/export 
records of listed chemicals required to be kept pursuant to part 1313 of 
this chapter, shipping records identifying the name of each carrier used 
and the date and quantity of each shipment, and storage records 
identifying the name of each warehouse used and the date and quantity of 
each storage.
    (b) Inspecting within reasonable limits and to a reasonable manner 
all pertinent equipment, finished and unfinished controlled substances, 
listed chemicals, and other substances or materials, containers, and 
labeling found at the controlled premises relating to this Act;
    (c) Making a physical inventory of all controlled substances and 
listed chemicals on-hand at the premises;
    (d) Collecting samples of controlled substances or listed chemicals 
(in the event any samples are collected during an inspection, the 
inspector shall issue a receipt for such samples on DEA Form 84 to the 
owner, operator, or agent in charge of the premises);
    (e) Checking of records and information on distribution of 
controlled substances or listed chemicals by the registrant or regulated 
person (i.e., has the distribution of controlled substances or listed 
chemicals increased markedly within the past year, and if so why);
    (f) Except as provided in Sec. 1316.04, all other things therein 
(including records, files, papers, processes, controls and facilities) 
appropriate for verification of the records, reports, documents referred 
to above or otherwise bearing on the provisions of the Act and the 
regulations thereunder.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 51 FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, 1990; 60 
FR 32465, June 22, 1995]



Sec. 1316.04  Exclusion from inspection.

    (a) Unless the owner, operator or agent in charge of the controlled 
premises so consents in writing, no inspection authorized by these 
regulations shall extend to:
    (1) Financial data:
    (2) Sales data other than shipping data; or
    (3) Pricing data.
    (b) [Reserved]



Sec. 1316.05  Entry.

    An inspection shall be carried out by an inspector. Any such 
inspector, upon (a) stating his purpose and (b) presenting to the owner, 
operator or agent in charge of the premises to be inspected (1) 
appropriate credentials, and (2) written notice of his inspection 
authority under Sec. 1316.06 of this chapter, and (c) receiving 
informed consent under Sec. 1316.08 or through the use of 
administrative warrant issued under Sec. Sec. 1316.09-1316.13, shall 
have the right to enter such premises and conduct inspections at 
reasonable times and in a reasonable manner.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, l973; 62 FR 13970, Mar. 24, 1997]



Sec. 1316.06  Notice of inspection.

    The notice of inspection (DEA (or DNB) Form 82) shall contain:
    (a) The name and title of the owner, operator, or agent in charge of 
the controlled premises;
    (b) The controlled premises name;
    (c) The address of the controlled premises to be inspected;
    (d) The date and time of the inspection;

[[Page 170]]

    (e) A statement that a notice of inspection is given pursuant to 
section 510 of the Act (21 U.S.C. 880);
    (f) A reproduction of the pertinent parts of section 510 of the Act; 
and
    (g) The signature of the inspector.



Sec. 1316.07  Requirement for administrative inspection warrant; exceptions.

    In all cases where an inspection is contemplated, an administrative 
inspection warrant is required pursuant to section 510 of the Act (21 
U.S.C. 880), except that such warrant shall not be required for 
establishments applying for initial registration under the Act, for the 
inspection of books and records pursuant to an administrative subpoena 
issued in accordance with section 506 of the Act (21 U.S.C. 876) nor for 
entries in administrative inspections (including seizures of property):
    (a) With the consent of the owner, operator, or agent in charge of 
the controlled premises as set forth in Sec. 1316.08;
    (b) In situations presenting imminent danger to health or safety;
    (c) In situations involving inspection of conveyances where there is 
reasonable cause to obtain a warrant;
    (d) In any other exceptional or emergency circumstance or time or 
opportunity to apply for a warrant is lacking; or
    (e) In any other situations where a warrant is not constitutionally 
required.



Sec. 1316.08  Consent to inspection.

    (a) An administrative inspection warrant shall not be required if 
informed consent is obtained from the owner, operator, or agent in 
charge of the controlled premises to be inspected.
    (b) Wherever possible, informed consent shall consist of a written 
statement signed by the owner, operator, or agent in charge of the 
premises to be inspected and witnessed by two persons. The written 
consent shall contain the following information:
    (1) That he (the owner, operator, or agent in charge of the 
premises) has been informed of his constitutional right not to have an 
administrative inspection made without an administrative inspection 
warrant;
    (2) That he has right to refuse to consent to such an inspection;
    (3) That anything of an incriminating nature which may be found may 
be seized and used against him in a criminal prosecution;
    (4) That he has been presented with a notice of inspection as set 
forth in Sec. 1316.06;
    (5) That the consent is given by him is voluntary and without 
threats of any kind; and
    (6) That he may withdraw his consent at any time during the course 
of inspection.
    (c) The written consent shall be produced in duplicate and be 
distributed as follows:
    (1) The original will be retained by the inspector; and
    (2) The duplicate will be given to the person inspected.

[36 FR 7820, Apr. 24, 1971, as amended at 37 FR 15924, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1316.09  Application for administrative inspection warrant.

    (a) An administrative inspection warrant application shall be 
submitted to any judge of the United States or of a State court of 
record, or any United States magistrate and shall contain the following 
information:
    (1) The name and address of the controlled premises to be inspected;
    (2) A statement of statutory authority for the administrative 
inspection warrant, and that the fact that the particular inspection in 
question is designed to insure compliance with the Act and the 
regulations promulgated thereunder;
    (3) A statement relating to the nature and extent of the 
administrative inspection, including, where necessary, a request to 
seize specified items and/or to collect samples of finished or 
unfinished controlled substances or listed chemicals;
    (4) A statement that the establishment either:
    (i) Has not been previously inspected, or
    (ii) Was last inspected on a particular date.

[[Page 171]]

    (b) The application shall be submitted under oath to an appropriate 
judge or magistrate.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973; 60 FR 32466, June 22, 1995]



Sec. 1316.10  Administrative probable cause.

    If the judge or magistrate is satisfied that ``administrative 
probable cause,'' as defined in section 510(d)(1) of the Act (21 U.S.C. 
880(d)(1)) exists, he shall issue an administrative warrant. 
Administrative probable cause shall not mean criminal probable cause as 
defined by Federal statute or case law.



Sec. 1316.11  Execution of warrants.

    An administrative inspection warrant shall be executed and returned 
as required by, and any inventory or seizure made shall comply with the 
requirements of, section 510(d)(3) of the Act (21 U.S.C. 880(d)(3)). The 
inspection shall begin as soon as is practicable after the issuance of 
the administrative inspection warrant and shall be completed with 
reasonable promptness. The inspection shall be conducted during regular 
business hours and shall be completed in a reasonable manner.



Sec. 1316.12  Refusal to allow inspection with an administrative warrant.

    If a registrant or any person subject to the Act refuses to permit 
execution of an administrative warrant or impedes the inspector in the 
execution of that warrant, he shall be advised that such refusal or 
action constitutes a violation of section 402(a)(6) of the Act (21 
U.S.C. 842(a)(6)). If he persists and the circumstances warrant, he 
shall be arrested and the inspection shall commence or continue.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13970, Mar. 24, 1997]



Sec. 1316.13  Frequency of administrative inspections.

    Except where circumstances otherwise dictate, it is the intent of 
the Administration to inspect all manufacturers of controlled substances 
listed in Schedules I and II and distributors of controlled substances 
listed in Schedule I once each year. Distributors of controlled 
substances listed in Schedules II through V and manufacturers of 
controlled substances listed in Schedules III through V shall be 
inspected as circumstances may require, based in part on the 
registrant's history of compliance with the requirements of this chapter 
and maintenance of effective controls and procedures to guard against 
the diversion of controlled substances.

[62 FR 13969, Mar. 24, 1997]



        Subpart B_Protection of Researchers and Research Subjects

    Authority: 21 U.S.C. 830, 871(b).



Sec. 1316.21  Definitions.

    As used in this part, the following terms shall have the meanings 
specified:
    (a) The term investigative personnel includes managers, Diversion 
Investigators, attorneys, analysts and support personnel employed by the 
Drug Enforcement Administration who are involved in the processing, 
reviewing and analyzing of declarations and other relevant documents or 
data relative to regulated transactions or are involved in conducting 
investigations initiated pursuant to the receipt of such declarations, 
documents or data.
    (b) The term law enforcement personnel means Special Agents employed 
by the Drug Enforcement Administration who, in the course of their 
official duties, gain knowledge of information which is confidential 
under such section.

[54 FR 31670, Aug. 1, 1989]



Sec. 1316.22  Exemption.

    (a) Any person who is aggrieved by a disclosure of information in 
violation of subsection (c)(1) of Section 310 of the Controlled 
Substances Act (21 U.S.C. 830) may bring a civil action against the 
violator for appropriate relief.
    (b) Notwithstanding the provision of paragraph (a), a civil action 
may not be brought under such paragraph against

[[Page 172]]

investigative or law enforcement personnel of the Drug Enforcement 
Administration.

[54 FR 31670, Aug. 1, 1989]



Sec. 1316.23  Confidentiality of identity of research subjects.

    (a) Any person conducting a bona fide research project directly 
related to the enforcement of the laws under the jurisdiction of the 
Attorney General concerning drugs or other substances which are or may 
be subject to control under the Controlled Substances Act (84 Stat. 
1242; 21 U.S.C. 801) who intends to maintain the confidentiality of the 
identity of those persons who are the subjects of such research may 
petition the Administrator of the Drug Enforcement Administration for a 
grant of confidentiality: Providing, That:
    (1) The Attorney General is authorized to carry out such research 
under the provisions of Section 502(a) (2-6) of the Controlled 
Substances Act of 1970 (21 U.S.C. 872(a) (2-6)); and the research is 
being conducted with funds provided in whole or part by the Department 
of Justice; or
    (2) The research is of a nature that the Attorney General would be 
authorized to carry out under the provisions of Section 502(a) (2-6) of 
the Controlled Substances Act (21 U.S.C. 872(a) (2-6), and is being 
conducted with funds provided from sources outside the Department of 
Justice.
    (b) All petitions for Grants of Confidentiality shall be addressed 
to the Administrator, Drug Enforcement Administration, Washington, DC 
20537, and shall contain the following:
    (1) A statement as to whether the research protocol requires the 
manufacture, production, import, export, distribution, dispensing, 
administration, or possession of controlled substances, and if so the 
researcher's registration number or a statement that an application for 
such registration has been submitted to DEA;
    (2) The location of the research project;
    (3) The qualifications of the principal investigator;
    (4) A general description of the research or a copy of the research 
protocol;
    (5) The source of funding for the research project;
    (6) A statement as to the risks posed to the research subjects by 
the research procedures and what protection will be afforded to the 
research subjects;
    (7) A statement as to the risks posed to society in general by the 
research procedures and what measures will be taken to protect the 
interests of society;
    (8) A specific request to withhold the names and/or any other 
identifying characteristics of the research subjects; and
    (9) Statements establishing that a grant of confidentiality is 
necessary to the successful completion of the research project.
    (c) The grant of confidentiality of identity of research subjects 
shall consist of a letter issued by the Administrator, which shall 
include:
    (1) The researcher's name and address.
    (2) The researcher's registration number, if applicable.
    (3) The title and purpose of the research.
    (4) The location of the research project.
    (5) An authorization for all persons engaged in the research to 
withhold the names and identifying characteristics of persons who are 
the subjects of such research, stating that persons who obtain this 
authorization may not be compelled in any Federal, State, or local 
civil, criminal, administrative, legislative, or other proceeding to 
identify the subjects of such research for which this authorization was 
obtained.
    (6) The limits of this authorization, if any.
    (7) A statement to the effect that the grant of confidentiality of 
identity of research subjects shall be perpetual but shall pertain only 
to the subjects of the research described in the research protocol, the 
description of the research submitted to DEA, or as otherwise 
established by DEA.
    (d) Within 30 days of the date of completion of the research 
project, the researcher shall so notify the Administrator. The 
Administrator shall issue another letter including the information 
required in paragraph (c) of this

[[Page 173]]

section and stating the starting and finishing dates of the research for 
which the confidentiality of identity of research subjects was granted; 
upon receipt of this letter, the research shall return the original 
letter of exemption.

[42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, 
as amended at 62 FR 13970, Mar. 24, 1997]



Sec. 1316.24  Exemption from prosecution for researchers.

    (a) Upon registration of an individual to engage in research in 
controlled substances under the Controlled Substances Act (84 Stat. 
1242; 21 U.S.C. 801), the Administrator of the Drug Enforcement 
Administration, on his own motion or upon request in writing from the 
Secretary or from the researcher or researching practitioner, may exempt 
the registrant when acting within the scope of his registration, from 
prosecution under Federal, State, or local laws for offenses relating to 
possession, distribution or dispensing of those controlled substances 
within the scope of his exemption. However, this exemption does not 
diminish any requirement of compliance with the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 301).
    (b) All petitions for Grants of Exemption from Prosecution for the 
Researcher shall be addressed to the Administrator, Drug Enforcement 
Administration, 1405 I Street NW., Washington, DC 20537 and shall 
contain the following:
    (1) The researcher's registration number if any, for the project;
    (2) The location of the research project;
    (3) The qualifications of the principal investigator;
    (4) A general description of the research or a copy of the research 
protocol;
    (5) The source of funding for the research project;
    (6) A statement as to the risks posed to the research subjects by 
the research procedures and what protection will be afforded to the 
research subjects;
    (7) A statement as to the risks posed to society in general by the 
research procedures and what measures will be taken to protect the 
interests of society;
    (8) A specific request for exemption from prosecution by Federal, 
State, or local authorities for offenses related to the possession, 
distribution, and dispensing of controlled substances in accord with the 
procedures described in the research protocol;
    (9) A statement establishing that a grant of exemption from 
prosecution is necessary to the successful completion of the research 
project.
    (c) Any researcher or practitioner proposing to engage in research 
requesting both exemption from prosecution and confidentiality of 
identity of research subjects may submit a single petition incorporating 
the information required in Sec. Sec. 1316.23(b) and 1316.24(b).
    (d) The exemption shall consist of a letter issued by the 
Administrator, which shall include:
    (1) The researcher's name and address;
    (2) The researcher's registration number for the research project;
    (3) The location of the research project;
    (4) A concise statement of the scope of the researcher's 
registration;
    (5) Any limits of the exemption; and
    (6) A statement that the exemption shall apply to all acts done in 
the scope of the exemption while the exemption is in effect. The 
exemption shall remain in effect until completion of the research 
project or until the registration of the researcher is either revoked or 
suspended or his renewal of registration is denied. However, the 
protection afforded by the grant of exemption from prosecution during 
the research period shall be perpetual.
    (e) Within 30 days of the date of completion of the research 
project, the researcher shall so notify the Administrator. The 
Administrator shall issue another letter including the information 
required in paragraph (d) of this section and stating the date of which 
the period of exemption concluded; upon receipt of this letter the 
researcher shall return the original letter of exemption.

[42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, 
as amended at 62 FR 13970, Mar. 24, 1997]

[[Page 174]]



                    Subpart C_Enforcement Proceedings

    Authority: 21 U.S.C. 871(b), 883.



Sec. 1316.31  Authority for enforcement proceeding.

    A hearing may be ordered or granted by any Special Agent in Charge 
of the Drug Enforcement Administration, at his discretion, to permit any 
person against whom criminal and/or civil action is contemplated under 
the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) or the 
Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 
951) an opportunity to present his views and his proposals for bringing 
his alleged violations into compliance with the law. Such hearing will 
also permit him to show cause why prosecution should not be instituted, 
or to present his views on the contemplated proceeding.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]



Sec. 1316.32  Notice of proceeding; time and place.

    Appropriate notice designating the time and place for the hearing 
shall be given to the person. Upon request, timely and properly made, by 
the person to whom notice has been given, the time or place of the 
hearing, or both, may be changed if the request states reasonable 
grounds for such change. Such request shall be addressed to the Special 
Agent in Charge who issued the notice.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]



Sec. 1316.33  Conduct of proceeding.

    Presentation of views at a hearing under this subpart shall be 
private and informal. The views presented shall be confined to matters 
relevant to bringing violations into compliance with the Act or to other 
contemplated proceedings under the Act. These views may be presented 
orally or in writing by the person to whom the notice was given, or by 
his authorized representative.



Sec. 1316.34  Records of proceeding.

    A formal record, either verbatim or summarized, of the hearing may 
be made at the discretion of the Special Agent in Charge. If a verbatim 
record is to be made, the person attending the hearing will be so 
advised prior to the start of the hearing.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]



                    Subpart D_Administrative Hearings

    Authority: 21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.



Sec. 1316.41  Scope of subpart D.

    Procedures in any administrative hearing held under the Act are 
governed generally by the rule making and/or adjudication procedures set 
forth in the Administrative Procedure Act (5 U.S.C. 551-559) and 
specifically by the procedures set forth in this subpart, except where 
more specific regulations (set forth in Sec. Sec. 1301.51-1301.57, 
Sec. Sec. 1303.31-1303.37, Sec. Sec. 1308.41-1308.51, Sec. Sec. 
1311.51-1311.53, Sec. Sec. 1312.41-1312.47, or Sec. Sec. 1313.51-
1313.57) apply.

[36 FR 7820, Apr. 24, 1971, as amended at 37 FR 15924, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13970, 
Mar. 24, 1997]



Sec. 1316.42  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act 
(84 Stat. 1285; 21 U.S.C. 951).
    (b) The term Administrator means the Administrator of the 
Administration. The Administrator has been delegated authority under the 
Act by the Attorney General (28 CFR 0.100).
    (c) The term hearing means any hearing held pursuant to the Act.
    (d) The term Hearing Clerk means the hearing clerk of the 
Administration.
    (e) The term person includes an individual, corporation, government 
or governmental subdivision or agency,

[[Page 175]]

business trust, partnership, association or other legal entity.
    (f) The term presiding officer means an administrative law judge 
qualified and appointed as provided in the Administrative Procedure Act 
(5 U.S.C. 556).
    (g) The term proceeding means all actions involving a hearing, 
colmencing with the publication by the Administrator of the notice of 
proposed rule making or the issuance of an order to show cause.
    (h) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.

[36 FR 7820, Apr. 24, 1971, as amended at 38 FR 757, Jan. 4, 1973. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13969, 
Mar. 24, 1997]



Sec. 1316.43  Information; special instructions.

    Information regarding procedure under these rules and instructions 
supplementing these rules in special instances will be furnished by the 
Hearing Clerk upon request.



Sec. 1316.44  Waiver or modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this subpart by 
notice in advance of the hearing, if he determines that no party in the 
hearing will be unduly prejudiced and the ends of justice will thereby 
be served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.



Sec. 1316.45  Filings; address; hours.

    Documents required or permitted to be filed in, and correspondence 
relating to, hearings governed by the regulations in this chapter shall 
be filed with the Hearing Clerk, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537. This office is open Monday 
through Friday from 8:30 a.m. to 5 p.m. eastern standard or daylight 
saving time, whichever is effective in the District of Columbia at the 
time, except on national legal holidays. Documents shall be dated and 
deemed filed upon receipt by the Hearing Clerk.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 55 FR 27464, July 3, 1990]



Sec. 1316.46  Inspection of record.

    (a) The record bearing on any proceeding, except for material 
described in subsection (b) of this section, shall be available for 
inspection and copying by any person entitled to participate in such 
proceeding, during office hours in the office of the Hearing Clerk, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (b) The following material shall not be available for inspection as 
part of the record:
    (1) A research protocol filed with an application for registration 
to conduct research with controlled substances listed in Schedule I, 
pursuant to Sec. 1301.32 (a)(6) of this chapter, if the applicant 
requests that the protocol be kept confidential;
    (2) An outline of a production or manufacturing process filed with 
an application for registration to manufacture a new narcotic controlled 
substance, pursuant to Sec. 1301.33 of this chapter, if the applicant 
requests that the outline be kept confidential;
    (3) Any confidential or trade secret information disclosed in 
conjunction with an application for registration, or in reports filed 
while registered, or acquired in the course of an investigation, 
entitled to protection under subsection 402(a) (8) of the Act (21 U.S.C. 
842(a) (8)) or any other law restricting public disclosure of 
information; and
    (4) Any material contained in any investigatory report, memorandum, 
or file, or case report compiled by the Administration.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13970, Mar. 24, 1997]



Sec. 1316.47  Request for hearing.

    (a) Any person entitled to a hearing and desiring a hearing shall, 
within the period permitted for filing, file a request for a hearing in 
the following form:

------------ (Date)


[[Page 176]]


Administrator, Drug Enforcement Administration, United States Department 
of Justice, Washington, DC 20537, Attention: DEA Federal Register 
Representative.

    Dear Sir: The undersigned -------------------- (Name of person) 
hereby requests a hearing in the matter of: ------------------------ 
(Identification of the proceeding).
    (A) (State with particularity the interest of the person in the 
proceeding.)
    (B) (State with particularity the objections or issues, if any, 
concerning which the person desires to be heard.)
    (C) (State briefly the position of the person with regard to the 
particular objections or issues.)
    All notices to be sent pursuant to the proceeding should be 
addressed to:
________________________________________________________________________

                                 (Name)

________________________________________________________________________

                            (Street address)

________________________________________________________________________

                            (City and State)

    Respectfully yours,
________________________________________________________________________

                          (Signature of person)

    (b) The Administrative Law Judge, upon request and showing of good 
cause, may grant a reasonable extension of the time allowed for response 
to an Order to Show Cause.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1316.47, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1316.48  Notice of appearance.

    Any person entitled to a hearing and desiring to appear in any 
hearing, shall, if he has not filed a request for hearing, file within 
the time specified in the notice of proposed rule making, a written 
notice of appearance in the following form:

------------ (Date)

Administrator, Drug Enforcement Administration, United States Department 
of Justice, Washington, DC 20537, Attention: DEA Federal Register 
Representative.

    Dear Sir: Please take notice that -------------------- (Name of 
person) will appear in the matter of: ------------------------ 
(Identification of the proceeding).
    (A) (State with particularity the interest of the person in the 
proceeding.)
    (B) (State with particularity the objections or issues, if any, 
concerning which the person desires to be heard.)
    (C) (State briefly the position of the person with regard to the 
particular objections or issues.)
    All notices to be sent pursuant to this appearance should be 
addressed to:

________________________________________________________________________

                                 (Name)

________________________________________________________________________

                            (Street address)

________________________________________________________________________

                            (City and State)

    Respectfully yours,

________________________________________________________________________

                          (Signature of person)

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 40 FR 57210, 
Dec. 8, 1975]



Sec. 1316.49  Waiver of hearing.

    Any person entitled to a hearing may, within the period permitted 
for filing a request for hearing or notice of appearance, waiver of an 
opportunity for a hearing, together with a written statement regarding 
his position on the matters of fact and law involved in such hearing. 
Such statement, if admissible, shall be made a part of the record and 
shall be considered in light of the lack of opportunity for cross-
examination in determining the weight to be attached to matters of fact 
asserted therein.



Sec. 1316.50  Appearance; representation; authorization.

    Any person entitled to appear in a hearing may appear in person or 
by a representative in any proceeding or hearing and may be heard with 
respect to matters relevant to the issues under consideration. A 
representative must either be an employee of the person or an attorney 
at law who is a member of the bar, in good standing, of any State, 
territory, or the District of Columbia, and admitted to practice before 
the highest court of that jurisdiction. Any

[[Page 177]]

representative may be required by the Administrator or the presiding 
officer to present a notarized power of attorney showing his authority 
to act in such representative capacity and/or an affidavit or 
certificate of admission to practice.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1316.51  Conduct of hearing and parties; ex parte communications.

    (a) Hearings shall be conducted in an informal but orderly manner in 
accordance with law and the directions of the presiding officer.
    (b) Participants in any hearing and their representatives, whether 
or not members of the bar, shall conduct themselves in accordance with 
judicial standards of practice and ethics and the directions of the 
presiding officer. Refusal to comply with this section shall constitute 
grounds for immediate exclusion from any hearing.
    (c) If any official of the Administration is contacted by any 
individual in private or public life concerning any substantive matter 
which is the subject of any hearing, at any time after the date on which 
the proceedings commence, the official who is contacted shall prepare a 
memorandum setting forth the substance of the conversation and shall 
file this memorandum in the appropriate public docket file. The 
presiding officer and employees of the Administration shall comply with 
the requirements of 5 U.S.C. 554(d) regarding ex parte communications 
and participation in any hearing.



Sec. 1316.52  Presiding officer.

    A presiding officer, designated by the Administrator, shall preside 
over all hearings. The functions of the presiding officer shall commence 
upon his designation and terminate upon the certification of the record 
to the Administrator. The presiding officer shall have the duty to 
conduct a fair hearing, to take all necessary action to avoid delay, and 
to maintain order. He shall have all powers necessary to these ends, 
including (but not limited to) the power to:
    (a) Arrange and change the date, time, and place of hearings (other 
than the time and place prescribed in Sec. 1301.56) and prehearing 
conferences and issue notice thereof.
    (b) Hold conferences to settle, simplify, or determine the issues in 
a hearing, or to consider other matters that may aid in the expeditious 
disposition of the hearing.
    (c) Require parties to state their position in writing with respect 
to the various issues in the hearing and to exchange such statements 
with all other parties.
    (d) Sign and issue subpoenas to compel the attendance of witnesses 
and the production of documents and materials to the extent necessary to 
conduct administrative hearings pending before him.
    (e) Examine witnesses and direct witnesses to testify.
    (f) Receive, rule on, exclude, or limit evidence.
    (g) Rule on procedural items pending before him.
    (h) Take any action permitted to the presiding officer as authorized 
by this part or by the provisions of the Administrative Procedure Act (5 
U.S.C. 551-559).

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 42 FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, 1997]



Sec. 1316.53  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
notice of hearing published in the Federal Register but thereafter it 
may be moved to a different place and may be continued from day to day 
or recessed to a later day without notice other than announcement 
thereof by the presiding officer at the hearing.



Sec. 1316.54  Prehearing conference.

    The presiding officer on his own motion, or on the motion of any 
party for good cause shown, may direct all parties to appear at a 
specified time and place for a conference for:
    (a) The simplification of the issues.
    (b) The possibility of obtaining stipulations, admission of facts, 
and documents.
    (c) The possibility of limiting the number of expert witnesses.

[[Page 178]]

    (d) The identification and, if practicable, the scheduling of all 
witnesses to be called.
    (e) The advance submission at the prehearing conference of all 
documentary evidence and affidavits to be marked for identification.
    (f) Such other matters as may aid in the expeditious disposition of 
the hearing.



Sec. 1316.55  Prehearing ruling.

    The presiding officer may have the prehearing conference reported 
verbatim and shall make a ruling reciting the action taken at the 
conference, the agreements made by the parties, the schedule of 
witnesses, and a statement of the issues for hearing. Such ruling shall 
control the subsequent course of the hearing unless modified by a 
subsequent ruling.



Sec. 1316.56  Burden of proof.

    At any hearing, the proponent for the issuance, amendment, or repeal 
of any rule shall have the burden of proof.



Sec. 1316.57  Submission of documentary evidence and affidavits and 
identification of witnesses subsequent to prehearing conference.

    All documentary evidence and affidavits not submitted and all 
witnesses not identified at the prehearing conference shall be submitted 
or identified to the presiding officer as soon as possible, with a 
showing that the offering party had good cause for failing to so submit 
or identify at the prehearing conference. If the presiding officer 
determines that good cause does exist, the documents or affidavits shall 
be submitted or witnesses identified to all parties sufficiently in 
advance of the offer of such documents or affidavits or witnesses at the 
hearing to avoid prejudice or surprise to the other parties. If the 
presiding officer determines that good cause does not exist, he may 
refuse to admit as evidence such documents or affidavits or the 
testimony of such witnesses.



Sec. 1316.58  Summary of testimony; affidavits.

    (a) The presiding officer may direct that summaries of the direct 
testimony of witnesses be prepared in writing and served on all parties 
in advance of the hearing. Witnesses will not be permitted to read 
summaries of their testimony into the record and all witnesses shall be 
available for cross-examination. Each witness shall, before proceeding 
to testify, be sworn or make affirmation.
    (b) Affidavits submitted at the prehearing conference or pursuant to 
Sec. 1316.57 with good cause may be examined by all parties and 
opposing affidavits may be submitted to the presiding officer within a 
period of time fixed by him. Affidavits admitted into evidence shall be 
considered in light of the lack of opportunity for cross-examination in 
determining the weight to be attached to statements made therein.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1316.59  Submission and receipt of evidence.

    (a) The presiding officer shall admit only evidence that is 
competent, relevant, material and not unduly repetitious.
    (b) Opinion testimony shall be admitted when the presiding officer 
is satisfied that the witness is properly qualified.
    (c) The authenticity of all documents submitted in advance shall be 
deemed admitted unless written objection thereto is filed with the 
presiding officer, except that a party will be permitted to challenge 
such authenticity at a later time upon a showing of good cause for 
failure to have filed such written objection.
    (d) Samples, if otherwise admissible into evidence, may be displayed 
at the hearing and may be described for purposes of the record, or may 
be admitted in evidence as exhibits.
    (e) Where official notice is taken or is to be taken of a material 
fact not appearing in the evidence of record, any party, on timely 
request, shall be afforded opportunity to controvert such fact.
    (f) The presiding officer shall file as exhibits copies of the 
following documents:
    (1) The order to show cause or notice of hearing;

[[Page 179]]

    (2) Any notice of waiver or modification of rules made pursuant to 
Sec. 1316.44 or otherwise;
    (3) Any waiver of hearing (together with any statement filed 
therewith) filed pursuant to Sec. 1316.49 or otherwise;
    (4) The prehearing ruling, if any, made pursuant to Sec. 1316.55;
    (5) Any other document necessary to show the basis for the hearing.



Sec. 1316.60  Objections; offer of proof.

    If any party in the hearing objects to the admission or rejection of 
any evidence or to other limitation of the scope of any examination or 
cross-examination, he shall state briefly the grounds for such objection 
without extended argument or debate thereon except as permitted by the 
presiding officer. A ruling of the presiding officer on any such 
objection shall be a part of the transcript together with such offer of 
proof as has been made if a proper foundation has been laid for its 
admission. An offer of proof made in connection with an objection taken 
to any ruling of the presiding officer rejecting or excluding proffered 
oral testimony shall consist of a statement of the substance of the 
evidence which the party contends would be adduced by such testimony; 
and, if the excluded evidence consists of evidence in documentary or 
written form a copy of such evidence shall be marked for identification 
and shall accompany the records as the offer of proof.



Sec. 1316.61  Exceptions to rulings.

    Exceptions to rulings of the presiding officer are unnecessary. It 
is sufficient that a party, at the time the ruling of the presiding 
officer is sought, makes known the action that he desires the presiding 
officer to take, or his objection to an action taken, and his grounds 
therefor.



Sec. 1316.62  Appeal from ruling of presiding officer.

    Rulings of the presiding officer may not be appealed to the 
Administrator prior to his consideration of the entire hearing, except 
with the consent of the presiding officer and where he certifies on the 
record or in writing that the allowance of an interlocutory appeal is 
clearly necessary to prevent exceptional delay, expense, or prejudice to 
any party or substantial detriment to the public interest. If an appeal 
is allowed, any party in the hearing may file a brief in quintuplicate 
with the Administrator within such period that the presiding officer 
directs. No oral argument will be heard unless the Administrator directs 
otherwise.



Sec. 1316.63  Official transcript; index; corrections.

    (a) Testimony given at a hearing shall be reported verbatim. The 
Administration will make provision for a stenographic record of the 
testimony and for such copies of the transcript thereof as it requires 
for its own purpose.
    (b) At the close of the hearing, the presiding officer shall afford 
the parties and witnesses time (not longer than 30 days, except in 
unusual cases) in which to submit written proposed corrections of the 
transcript, pointing out errors that may have been made in transcribing 
the testimony. The presiding officer shall promptly thereafter order 
such corrections made as in his judgment are required to make the 
transcript conform to the testimony.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 50 FR 2046, 
Jan. 15, 1985]



Sec. 1316.64  Proposed findings of fact and conclusions of law.

    Any party in the hearing may file in quintuplicate proposed findings 
of fact and conclusions of law within the time fixed by the presiding 
officer. Any party so filing shall also serve one copy of his proposed 
findings and conclusion upon each other party in the hearing. The party 
shall include a statement of supporting reasons for the proposed 
findings and conclusions, together with evidence of record (including 
specific and complete citations of the pages of the transcript and 
exhibits) and citations of authorities relied upon.



Sec. 1316.65  Report and record.

    (a) As soon as practicable after the time for the parties to file 
proposed findings of fact and conclusions of law has expired, the 
presiding officer shall

[[Page 180]]

prepare a report containing the following:
    (1) His recommended rulings on the proposed findings of fact and 
conclusions of law;
    (2) His recommended findings of fact and conclusions of law, with 
the reasons therefore; and
    (3) His recommended decision.
    (b) The presiding officer shall serve a copy of his report upon each 
party in the hearing. The report shall be considered to have been served 
when it is mailed to such party or its attorney of record.
    (c) Not less than twenty-five days after the date on which he caused 
copies of his report to be served upon the parties, the presiding 
officer shall certify to the Administrator the record, which shall 
contain the transcript of testimony, exhibits, the findings of fact and 
conclusions of law proposed by the parties, the presiding officer's 
report, and any exceptions thereto which may have been filed by the 
parties.

[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 44 FR 55332, Sept. 26, 1979]



Sec. 1316.66  Exceptions.

    (a) Within twenty days after the date upon which a party is served a 
copy of the report of the presiding officer, such party may file with 
the Hearing Clerk, Office of the Administrative Law Judge, exceptions to 
the recommended decision, findings of fact and conclusions of law 
contained in the report. The party shall include a statement of 
supporting reasons for such exceptions, together with evidence of record 
(including specific and complete citations of the pages of the 
transcript and exhibits) and citations of the authorities relied upon.
    (b) The Hearing Clerk shall cause such filings to become part of the 
record of the proceeding.
    (c) The Administrative Law Judge may, upon the request of any party 
to a proceeding, grant time beyond the twenty days provided in paragraph 
(a) of this section for the filing of a response to the exceptions filed 
by another party if he determines that no party in the hearing will be 
unduly prejudiced and that the ends of justice will be served thereby. 
Provided however, that each party shall be entitled to only one filing 
under this section; that is, either a set of exceptions or a response 
thereto.

[44 FR 55332, Sept. 26, 1979]



Sec. 1316.67  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall cause to be 
published in the Federal Register his final order in the proceeding, 
which shall set forth the final rule and the findings of fact and 
conclusions of law upon which the rule is based. This order shall 
specify the date on which it shall take effect, which date shall not be 
less than 30 days from the date of publication in the Federal Register 
unless the Administrator finds that the public interest in the matter 
necessitates an earlier effective date, in which event the Administrator 
shall specify in the order his findings as to the conditions which led 
him to conclude that an earlier effective date was required.

[44 FR 42179, July 19, 1979, as amended at 44 FR 55332, Sept. 26, 1979]



Sec. 1316.68  Copies of petitions for judicial review.

    Copies of petitions for judicial review, filed pursuant to section 
507 of the Act (21 U.S.C. 877) shall be delivered to and served upon the 
Administrator in quintuplicate. The Administrator shall certify the 
record of the hearing and shall file the certified record in the 
appropriate U.S. Court of Appeals.

[36 FR 7820, Apr. 24, 1971. Redesignated at 44 FR 42179, July 19, 1979]



       Subpart E_Seizure, Forfeiture, and Disposition of Property

    Authority: 21 U.S.C 871(b), 881, 965, 19 U.S.C. 1606, 1607, 1608, 
1610, 1613, 1618, 28 U.S.C. 509, 510.



Sec. 1316.71  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21

[[Page 181]]

U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 
Stat. 1285; 21 U.S.C. 951).
    (b) The term custodian means the officer required under Sec. 
1316.72 to take custody of particular property which has been seized 
pursuant to the Act.
    (c) The term property means a controlled substance, raw material, 
product, container, equipment, money or other asset, vessel, vehicle, or 
aircraft within the scope of the Act.
    (d) The terms seizing officer, officer seizing, etc., mean any 
officer, authorized and designated by Sec. 1316.72 to carry out the 
provisions of the Act, who initially seizes property or adopts a seizure 
initially made by any other officer or by a private person.
    (e) The term Special Agents-in-Charge means Drug Enforcement 
Administration Special Agents-in-Charge or Resident Agents in Charge and 
Federal Bureau of Investigation Special Agents-in-Charge.
    (f) Any term not defined in this section shall have the definition 
set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 20096, Mar. 27, 1980; 47 FR 43370, Oct. 1, 1982; 49 
FR 28701, July 16, 1984; 62 FR 13969, Mar. 24, 1997]



Sec. 1316.72  Officers who will make seizures.

    For the purpose of carrying out the provisions of the Act, all 
special agents of the Drug Enforcement Administration and the Federal 
Bureau of Investigation are authorized and designated to seize such 
property as may be subject to seizure.

[47 FR 43370, Oct. 1, 1982]



Sec. 1316.73  Custody and other duties.

    An officer seizing property under the Act shall store the property 
in a location designated by the custodian, generally in the judicial 
district of seizure. The Special Agents-in-Charge are designated as 
custodians to receive and maintain in storage all property seized 
pursuant to the Act, are authorized to dispose of any property pursuant 
to the Act and any other applicable statutes or regulations relative to 
disposal, and to perform such other duties regarding such seized 
property as are appropriate, including the impound release of property 
pursuant to 28 CFR 0.101(c).

[47 FR 43370, Oct. 1, 1982]



Sec. 1316.74  Appraisement.

    The custodian shall appraise the property to determine the domestic 
value at the time and place of seizure. The domestic value shall be 
considered the price at which such or similar property is freely offered 
for sale. If there is no market for the property at the place of 
seizure, the domestic value shall be considered the value in the 
principal market nearest the place of seizure.

(Authority: Sec. 606, 46 Stat. 754 (19 U.S.C. 1606))

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 52 FR 41418, Oct. 28, 1987]



Sec. 1316.75  Advertisement.

    (a) If the appraised value does not exceed the monetary amount set 
forth in title 19, United States Code, Section 1607; the seized 
merchandise is any monetary instrument within the meaning of section 
5312(a)(3) of title 31 of the United States Code; or if a conveyance 
used to import, export or otherwise transport or store any controlled 
substance is involved, the custodian or DEA Asset Forfeiture Section 
shall cause a notice of the seizure and of the intention to forfeit and 
sell or otherwise dispose of the property to be published once a week 
for at least 3 successive weeks in a newspaper of general circulation in 
the judicial district in which the processing for forfeiture is brought.
    (b) The notice shall: (1) Describe the property seized and show the 
motor and serial numbers, if any; (2) state the time, cause, and place 
of seizure; and (3) state that any person desiring to claim the property 
may, within 20 days from the date of first publication of the notice, 
file with the custodian or DEA Asset Forfeiture Section a claim to the 
property and a bond with satisfactory

[[Page 182]]

sureties in the sum of $5,000 or ten percent of the value of the claimed 
property whichever is lower, but not less than $250.

(Authority: Sec. 607, 46 Stat. 754, as amended (19 U.S.C. 1607); Pub. L. 
98-473, Pub. L. 98-573)

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 44 FR 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 
FR 50643, Dec. 31, 1984; 52 FR 24446, July 1, 1987; 56 FR 8686, Mar. 1, 
1991]



Sec. 1316.76  Requirements as to claim and bond.

    (a) The bond shall be rendered to the United States, with sureties 
to be approved by the custodian or DEA Asset Forfeiture Section, 
conditioned that in the case of condemnation of the property the obligor 
shall pay all costs and expenses of the proceedings to obtain such 
condemnation. When the claim and bond are received by the custodian or 
DEA Asset Forfeiture Section, he shall, after finding the documents in 
proper form and the sureties satisfactory, transmit the documents, 
together with a description of the property and a complete statement of 
the facts and circumstances surrounding the seizure, to the United 
States Attorney for the judicial district in which the proceeding for 
forfeiture is brought. If the documents are not in satisfactory 
condition when first received, a reasonable time for correction may be 
allowed. If correction is not made within a reasonable time the 
documents may be treated as nugatory, and the case shall proceed as 
though they had not been tendered.
    (b) The filing of the claim and the posting of the bond does not 
entitle the claimant to possession of the property, however, it does 
stop the administrative forfeiture proceedings. The bond posted to cover 
corts may be in cash, certified check, or satisfactory sureties. The 
costs and expenses secured by the bond are such as are incurred after 
the filing of the bond including storage cost, safeguarding, court fees, 
marshal's costs, etc.

(Authority: Sec. 608, 46 Stat. 755 (19 U.S.C. 1608); Pub. L. 98-473, 
Pub. L. 98-573)

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 49 FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; 56 
FR 8686, Mar. 1, 1991]



Sec. 1316.77  Administrative forfeiture.

    (a) For property seized by officers of the Drug Enforcement 
Administration, if the appraised value does not exceed the 
jurisdictional limits in Sec. 1316.75(a), and a claim and bond are not 
filed within the 20 days hereinbefore mentioned, the DEA Special Agent-
in-Charge or DEA Asset Forfeiture Section shall declare the property 
forfeited. The DEA Special Agent-in-Charge or DEA Asset Forfeiture 
Section shall prepare the Declaration of Forfeiture and forward it to 
the Administrator of the Administration as notification of the action he 
has taken. Thereafter, the property shall be retained in the district of 
the DEA Special Agent-in-Charge or DEA Asset Forfeiture Section or 
delivered elsewhere for official use, or otherwise disposed of, in 
accordance with official instructions received by the DEA Special Agent-
in-Charge or DEA Asset Forfeiture Section.
    (b) For property seized by officers of the Federal Bureau of 
Investigation, if the appraised value does not exceed the jurisdictional 
limits in Sec. 1316.75(a), and a claim and bond are not filed within 
the 20 days hereinbefore mentioned, the FBI Property Management Officer 
shall declare the property forfeited. The FBI Property Management 
Officer shall prepare the Declaration of Forfeiture. Thereafter, the 
property shall be retained in the field office or delivered elsewhere 
for official use, or otherwise disposed of, in accordance with the 
official instructions of the FBI Property Management Officer.

(Authority: 28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d); Pub. L. 98-
473, Pub. L. 98-573)

[48 FR 35087, Aug. 3, 1983, as amended at 49 FR 1178, Jan. 10, 1984; 49 
FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, Mar. 24, 
1997]



Sec. 1316.78  Judicial forfeiture.

    If the appraised value is greater than the jurisdictional limits in 
Sec. 1316.75(a) or a claim and satisfactory bond have been received for 
property the jurisdictional limits in Sec. 1316.76, the custodian or 
DEA Asset Forfeiture Section shall transmit a description of the 
property and a complete statement of the facts

[[Page 183]]

and circumstances surrounding the seizure to the U.S. Attorney for the 
judicial district in which the proceeding for forfeiture is sought for 
the purpose of instituting condemnation proceedings. The U.S. Attorney 
shall also be furnished the newspaper advertisements required by Sec. 
1316.75. The Forfeiture Counsel of DEA shall make applications to the 
U.S. District Courts to place property in official DEA use.

(Authority: Sec. 610, 46 Stat. 755 (19 U.S.C. 1610); Pub. L. 98-473, 
Pub. L. 98-573)

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 44 FR 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 
FR 32174, Aug. 13, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 
1991]



Sec. 1316.79  Petitions for remission or mitigation of forfeiture.

    (a) Any person interested in any property which has been seized, or 
forfeited either administratively or by court proceedings, may file a 
petition for remission or mitigation of the forfeiture. Such petition 
shall be filed in triplicate with the DEA Asset Forfeiture Section or 
Special Agent-in-Charge of the DEA or FBI, depending upon which agency 
seized the property, for the judicial district in which the proceeding 
for forfeiture is brought. It shall be addressed to the Director of the 
FBI or the Administrator of the DEA, depending upon which agency seized 
the property, if the property is subject to administrative forfeiture 
pursuant to Sec. 1316.77, and addressed to the Attorney General if the 
property is subject to judicial forfeiture pursuant to Sec. 1316.78. 
The petition must be executed and sworn to by the person alleging 
interest in the property.
    (b) The petition shall include the following: (1) A complete 
description of the property, including motor and serial numbers, if any, 
and the date and place of seizure; (2) the petitioner's interest in the 
property, which shall be supported by bills of sale, contracts, 
mortgages, or other satisfactory documentary evidence; and, (3) the 
facts and circumstances, to be established by satisfactory proof, relied 
upon by the petitioner to justify remission or mitigation.
    (c) Where the petition is for restoration of the proceeds of sale, 
or for value of the property placed in official use, it must be 
supported by satisfactory proof that the petitioner did not know of the 
seizure prior to the declaration of condemnation of forfeiture and was 
in such circumstances as prevented him from knowing of the same.

(Authority: Secs. 613, 618, 46 Stat. 756, 757, as amended (19 U.S.C. 
1613, 1618; 28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d)); Pub. L. 
98-473, Pub. L. 98-573)

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 48 FR 35088, Aug. 3, 1983; 49 FR 1178, Jan. 10, 1984; 49 
FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991]



Sec. 1316.80  Time for filing petitions.

    (a) In order to be considered as seasonably filed, a petition for 
remission or mitigation of forfeiture should be filed within 30 days of 
the receipt of the notice of seizure. If a petition for remission or 
mitigation of forfeiture has not been received within 30 days of the 
notice of seizure, the property will either be placed in official 
service or sold as soon as it is forfeited. Once property is placed in 
official use, or is sold, a petition for remission or mitigation of 
forfeiture can no longer be accepted.
    (b) A petition for restoration of proceeds of sale, or for the value 
of property placed in official use, must be filed within 90 days of the 
sale of the property, or within 90 days of the date the property is 
placed in official use.

(Authority: Secs. 613, 618, 46 Stat. 756, 757, as amended (19 U.S.C. 
1613, 1618); Pub. L. 98-473, Pub. L. 98-573)

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 49 FR 50643, Dec. 31, 1984]



Sec. 1316.81  Handling of petitions.

    Upon receipt of a petition, the custodian or DEA Asset Forfeiture 
System shall request an appropriate investigation. The petition and the 
report of investigation shall be forwarded to the Director of the FBI or 
to the Administrator of the DEA, depending upon which agency seized the 
property. If the petition involves a case which has been referred to the 
U.S. Attorney for the institution of court proceedings, the custodian or 
DEA Asset Forfeiture System shall transmit the petition to

[[Page 184]]

the U.S. Attorney for the judicial district in which the proceeding for 
forfeiture is brought. He shall notify the petitioner of this action.

(Authority: 28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d); Pub. L. 98-
473, Pub. L. 98-573)

[48 FR 35088, Aug. 3, 1983, as amended at 49 FR 1178, Jan. 10, 1984; 49 
FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, Mar. 24, 
1997]



     Subpart F_Expedited Forfeiture Proceedings for Certain Property

    Authority: 21 U.S.C. 822, 871, 872, 880, 881, 881-1, 883, 958, 965; 
19 U.S.C. 1606, 1607, 1608, 1610, 1613, 1618; 28 U.S.C. 509, 510; Pub. 
L. No. 100-690, sec. 6079, 6080.

    Source: 54 FR 37610, Sept. 11, 1989, unless otherwise noted.



Sec. 1316.90  Purpose and scope.

    (a) The following definitions, regulations, and criteria are 
designed to establish and implement procedures required by sections 6079 
and 6080 of the Anti-Drug Abuse Act of 1988, Public Law No. 100-690 (102 
Stat. 4181). They are intended to supplement existing law and procedures 
relative to the forfeiture of property under the identified statutory 
authority. The provisions of these regulations do not affect the 
existing legal and equitable rights and remedies of those with an 
interest in property seized for forfeiture, nor do these provisions 
relieve interested parties from their existing obligations and 
responsibilities in pursuing their interests through such courses of 
action. These regulations are intended to reflect the intent of Congress 
to minimize the adverse impact on those entitled to legal or equitable 
relief occasioned by the prolonged detention of property subject to 
forfeiture due to violations of law involving personal use quantities of 
controlled substances, and conveyances seized for drug-related offenses. 
The definition of personal use quantities of a controlled substance as 
contained herein is intended to distinguish between those quantities 
small in amount which are generally considered to be possessed for 
personal consumption and not for further distribution, and those larger 
quantities generally considered to be subject to further distribution.
    (b) In this regard, for violations involving the possession of 
personal use quantities of a controlled substance, section 6079(b)(2) 
requires either that administrative forfeiture be completed within 21 
days of the seizure of the property, or alternatively, that procedures 
are established that provide a means by which an individual entitled to 
relief may initiate an expedited administrative review of the legal and 
factual basis of the seizure for forfeiture. Should an individual 
request relief pursuant to these regulations and be entitled to the 
return of the seized property, such property shall be returned 
immediately following that determination, and the administrative 
forfeiture process shall cease. Should the individual not be entitled to 
the return of the seized property, however, the administrative 
forfeiture of that property shall proceed. The owner may, in any event, 
obtain release of property pending the administrative forfeiture by 
submitting to the agency making the determination, property sufficient 
to preserve the government's vested interest for purposes of the 
administrative forfeiture.
    (c) Section 6080 requires a similar expedited review by the Attorney 
General or his representative in those instances where a conveyance is 
being forfeited in a civil judicial proceeding following its seizure for 
a drug-related offense.



Sec. 1316.91  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Appraised Value means the estimated domestic price at 
the time of seizure at which such or similar property is freely offered 
for sale.
    (b) The term Commercial Fishing Industry Vessel means a vessel that:
    (1) Commercially engages in the catching, taking, or harvesting of 
fish or an activity that can reasonably be expected to result in the 
catching, taking, or harvesting of fish;
    (2) Commercially prepares fish or fish products other than by 
gutting, decapitating, gilling, skinning, shucking, icing, freezing, or 
brine chilling; or

[[Page 185]]

    (3) Commercially supplies, stores, refrigerates, or transports fish, 
fish products, or materials directly related to fishing or the 
preparation of fish to or from a fishing, fish processing, or fish 
tender vessel or fish processing facility.
    (c) The term Controlled Substance has the meaning given in section 
802 of title 21, United States Code (U.S.C.).
    (d) The term Drug-Related Offense means any proscribed offense which 
involves the possession, distribution, manufacture, cultivation, sale, 
transfer, or the attempt or conspiracy to possess, distribute, 
manufacture, cultivate, sell or transfer any substance the possession of 
which is prohibited by Title 21, U.S.C.
    (e) The term Immediately means within 20 days of the filing of a 
petition for expedited release by an owner.
    (f) The term Interested Party means one who was in legal possession 
of the property at the time of seizure and is entitled to legal 
possession at the time of the granting of the petition for expedited 
release. This includes a lienholder (to the extent of his interest in 
the property) whose claim is in writing (except for a maritime lien 
which need not be in writing), unless the collateral is in the posession 
of the secured party. The agreement securing such lien must create or 
provide for a security interest in the collateral, describe the 
collateral, and be signed by the debtor.
    (g) The term Legal and Factual Basis of the Seizure means a 
statement of the applicable law under which the property is seized, and 
a statement of the circumstances of the seizure sufficiently precise to 
enable an owner or other interested party to identify the date, place, 
and use or acquisition which makes the property subject to forfeiture.
    (h) The term Normal and Customary Manner means that inquiry 
suggested by particular facts and circumstances which would customarily 
be undertaken by a reasonably prudent individual in a like or similar 
situation. Actual knowledge of such facts and circumstances is 
unnecessary, and implied, imputed, or constructive knowledge is 
sufficient. An established norm, standard, or custom is persuasive but 
not conclusive or controlling in determining whether an owner acted in a 
normal and customary manner to ascertain how property would be used by 
another legally in possession of the property. The failure to act in a 
normal and customary manner as defined herein will result in the denial 
of a petition for expedited release of the property and is intended to 
have the desirable effect of inducing owners of the property to exercise 
greater care in transferring possession of their property.
    (i) The term Owner means one having a legal and possessory interest 
in the property seized for forfeiture. Even though one may hold primary 
and direct title to the property seized, such person may not have 
sufficient actual beneficial interest in the property to support a 
petition as owner if the facts indicate that another person had dominion 
and control over the property.
    (j) The term Personal Use Quantities means possession of controlled 
substances in circumstances where there is no other evidence of an 
intent to distribute, of to facilitate the manufacturing, compounding, 
processing, delivering, importing or exporting of any controlled 
substance. Evidence of personal use quantities shall not include 
sweepings or other evidence of possession of quantities of a controlled 
substance for other than personal use.
    (1) Such other evidence shall include:
    (i) Evidence, such as drug scales, drug distribution paraphernalia, 
drug records, drug packaging material, method of drug packaging, drug 
``cutting'' agents and other equipment, that indicates an intent to 
process, package or distribute a controlled substance;
    (ii) Information from reliable sources indicating possession of a 
controlled substance with intent to distribute;
    (iii) The arrest and/or conviction record of the person or persons 
in actual or constructive possession of the controlled substance for 
offenses under Federal, State or local law that indicates an intent to 
distribute a controlled substance;
    (iv) The controlled substance is related to large amounts of cash or 
any amount of prerecorded government funds;

[[Page 186]]

    (v) The controlled substance is possessed under circumstances that 
indicate such a controlled substance is a sample intended for 
distribution in anticipation of a transaction involving large 
quantities, or is part of a larger delivery; or
    (vi) Statements by the possessor, or otherwise attributable to the 
possessor, including statements of conspirators, that indicate 
possession with intent to distribute.
    (2) Possession of a controlled substance shall be presumed to be for 
personal use when there are no indicia of illicit drug trafficking or 
distribution such as, but not limited to, the factors listed above and 
the amounts do not exceed the following quantities:
    (i) One gram of a mixture of substance containing a detectable 
amount of heroin;
    (ii) One gram of a mixture or substance containing a detectable 
amount of--
    (A) Coca leaves, except coba leaves and extracts of coca leaves frol 
which cocaine, ecgonine, and derivations of ecgonine or their salts have 
been removed;
    (B) Cocaine, its salts, optical and geometric isomers, and salts of 
isomers;
    (C) Ecgonine, its derivatives, their salts, isomers, and salts of 
isomers; or
    (D) Any compound, mixture or preparation which contains any quantity 
of any of the substances referred to in paragraphs (j)(2)(ii)(A) through 
(j)(2)(ii)(C) of this section;
    (iii) \1/10\th gram of a mixture or substance described in paragraph 
(j)(2)(ii) of this section which contains cocaine base;
    (iv) \1/10\th gram of a mixture or substance containing a detectable 
amount of phencyclidine (PCP);
    (v) 500 micrograms of a mixture or substance containing a detectable 
amount of lysergic acid diethylamide (LSD);
    (vi) One ounce of a mixture of substance containing a detectable 
amount of marihuana;
    (vii) One gram of methamphetamine, its salts, isomers, and salts of 
its isomers, or one gram of a mixture or substance containing a 
detectable amount of methamphetamine, its salts, isomers, or salts of 
its isomers.
    (3) The possession of a narcotic, a depressant, a stimulant, a 
hallucinogen or cannabis-controlled substance will be considered in 
excess of personal use quantities if the dosage unit amount possessed 
provides the same or greater equivalent efficacy as described in 
paragraph (j)(2) of this section.
    (k) The term Property means property subject to forfeiture under 
title 21, U.S.C., sections 881(a) (4), (6), and (7); title 19, U.S.C., 
section 1595a, and; title 49, U.S.C. App., section 782.
    (l) The term Seizing Agency means the Federal agency which has 
seized the property or adopted the seizure of another agency, and has 
the responsibility for administratively forfeiting the property;
    (m) The term Statutory Rights or Defenses to the Forfeiture means 
all legal and equitable rights and remedies available to a claimant of 
property seized for forfeiture.
    (n) The term Sworn to as used in Sec. Sec. 1316.92(e) and 1316.95(c) 
refers to the oath as provided by Title 28, U.S.C., section 1746.



Sec. 1316.92  Petition for expedited release in an administrative 
forfeiture action.

    (a) Where property is seized for administrative forfeiture involving 
controlled substances in personal use quantities the owner may petition 
the seizing agency for expedited release of the property.
    (b) Where property described in paragraph (a) of this section is a 
commercial fishing industry vessel proceeding to or from a fishing area 
or intermediate port of call or actually engaged in fishing operations, 
which would be subject to seizure for administrative forfeiture for a 
violation of law involving controlled substances in personal use 
quantities, a summons to appear shall be issued in lieu of a physical 
seizure. The vessel shall report to the port designated in the summons. 
The seizing agency shall be authorized to effect administrative 
forfeiture as if the vessel had been physically seized. Upon answering 
the summons to appear on or prior to the last reporting date specified 
in the summons, the

[[Page 187]]

owner of the vessel may file a petition for expedited release pursuant 
to paragraph (a) of this section and the provisions of paragraph (a) of 
this section and other provishons in this subpart pertaining to a 
petition for expedited release shall apply as if the vessel had been 
physically seized.
    (c) The owner filing the petition for expedited release shall 
establish the following:
    (1) The owner has a valid, good faith interest in the seized 
property as owner or otherwise;
    (2) The owner reasonably attempted to ascertain the use of the 
property in a normal and customary manner; and
    (3) The owner did not know or consent to the illegal use of the 
property, or in the event that the owner knew or should have known of 
the illegal use, the owner did what reasonably could be expected to 
prevent the violation.
    (d) In addition to those factors listed in paragraph (c) of this 
section, if an owner can demonstrate that the owner has other statutory 
rights or defenses that would cause the owner to prevail on the issue of 
forfeiture, such factors shall also be considered in ruling on the 
petition for expedited release.
    (e) A petition for expedited release must be filed in a timely 
manner to be considered by the seizing agency. In order to be filed in a 
timely manner, the petition must be received by the appropriate seizing 
agency within 20 days from the date of the first publication of the 
notice of seizure. The petition must be executed and sworn to by the 
owner and both the envelope and the request must be clearly marked 
``PETITION FOR EXPEDITED RELEASE.'' Such petition shall be filed in 
triplicate with the Special Agent in Charge of the Drug Enforcement 
Administration (DEA) or Federal Bureau of Investigation (FBI) field 
office in the judicial district in which the property was seized, 
depending upon which agency seized the property. The petition shall be 
addressed to the Director of the FBI or to the Administrator of the DEA, 
depending upon which agency seized the property.
    (f) The petition shall include the following:
    (1) A complete description of the property, including identification 
numbers, if any, and the date and place of seizure;
    (2) The petitioner's interest in the property, which shall be 
supported by title documentation, bills of sale, contracts, mortgages, 
or other satisfactory documentary evidence; and
    (3) A statement of the facts and circumstances, to be established by 
satisfactory proof, relied upon by the petitioner to justify expedited 
release of the seized property.



Sec. 1316.93  Ruling on petition for expedited release in an administrative 
forfeiture action.

    (a) Upon receipt of a petition for expedited release filed pursuant 
to Sec. 1316.92(a), the seizing agency shall determine first whether a 
final administrative determination of the case, without regard to the 
provisions of this subpart, can be made within 21 days of the seizure. 
If such a final administrative determination is made within 21 days, no 
further action need be taken under this subpart.
    (b) If no such final administrative determination is made within 21 
days of the seizure, the following procedure shall apply. The seizing 
agency shall, within 20 days after the receipt of the petition for 
expedited release, determine whether the petition filed by the owner has 
established the factors listed in Sec. 1316.92(c) and:
    (1) If the seizing agency determines that those factors have been 
established, it shall terminate the administrative proceedings and 
return the property to the owner (or in the case of a commercial fishing 
industry vessel for which a summons has been issued shall dismiss the 
summons), except where it is evidence of a violation of law; or
    (2) If the seizing agency determines that those factors have not 
been established, the agency shall proceed with the administrative 
forfeiture.



Sec. 1316.94  Posting of substitute res in an administrative forfeiture 
action.

    (a) Where property is seized for administrative forfeiture involving 
controlled substances in personal use quantities, the owner may obtain 
release of the property by posting a substitute res with the seizing 
agency. The

[[Page 188]]

property will be released to the owner upon the payment of an amount 
equal to the appraised value of the property if it is not evidence of a 
violation of law or has design or other characteristics that 
particularly suit it for use in illegal activities. This payment must be 
in the form of a traveler's check, a money order, a cashier's check or 
an irrevocable letter of credit made payable to the seizing agency. A 
bond in the form of a cashier's check will be considered as paid once 
the check has been accepted for payment by the financial institution 
which issued the check.
    (b) If a substitute res is posted and the property is 
administratively forfeited, the seizing agency will forfeit the 
substitute res in lieu of the property.



Sec. 1316.95  Petition for expedited release of a conveyance in a judicial 
forfeiture action.

    (a) Where a conveyance has been seized and is being forfeited in a 
judicial proceeding for a drug-related offense, the owner may petition 
the United States Attorney for an expedited release of the conveyance.
    (b) The owner filing the petition for expedited release shall 
establish the following:
    (1) The owner has a valid, good faith interest in the seized 
conveyance as owner or otherwise;
    (2) The owner has statutory rights or defenses that would show to a 
substantial probability that the owner would prevail on the issue of 
forfeiture;
    (3) The owner reasonably attempted to ascertain the use of the 
conveyance in a normal and customary manner; and
    (4) The owner did not know or consent to the illegal use of the 
conveyance; or in the event that the owner knew or should have known of 
the illegal use, the owner did what reasonably could be expected to 
prevent the violation.
    (c) A petition for expedited release must be filed in a timely 
manner in order to be considered by the United States Attorney. To be 
considered as filed in a timely manner, the petition must be received by 
the appropriate United States Attorney within 20 days from the date of 
the first publication of the notice of the action and arrest of the 
property, or within 30 days after filing of the claim, whichever occurs 
later. The petition must be executed and sworn to by the owner, and both 
the envelope and the request must be clearly marked ``PETITION FOR 
EXPEDITED RELEASE.'' Such petition shall be filed in triplicate and 
addressed to and filed with the United States Attorney prosecuting the 
conveyance for forfeiture with a copy to the seizing agency.
    (d) The petition shall include the following:
    (1) A complete description of the conveyance, including the 
identification number, and the date and place of seizure;
    (2) The petitioner's interest in the conveyance, which shall be 
supported by bills of sale, contracts, mortgages, or other satisfactory 
documentary evidence; and,
    (3) The facts and circumstances, to be established by satisfactory 
proof, relied upon by the petitioner to justify expedited release of the 
seized conveyance.



Sec. 1316.96  Ruling on a petition for expedited release of a conveyance 
in a judicial forfeiture action.

    (a) Upon receipt of a petition for expedited release filed pursuant 
to Sec. 1316.95, the United States Attorney shall rule on the petition 
within 20 days of receipt. A petition shall be deemed filed on the date 
it is received by the United States Attorney.
    (b) If the United States Attorney does not rule on the petition for 
expedited release within 20 days after the date on which it is filed, 
the conveyance shall be returned to the owner or interested party 
pending further forfeiture proceedings, except where it is evidence of a 
violation of law. Release of conveyance under provisions of this 
paragraph shall not affect the forfeiture action with respect to that 
conveyance.
    (c) Upon a favorable ruling on the petition for expedited release, 
the United States Attorney shall, where necessary, move to terminate the 
judicial proceedings against the conveyance and immediately direct the 
return of the conveyance except where it is evidence of a violation of 
law.

[[Page 189]]

    (d) If, within 20 days, the United States Attorney denies the 
petition for expedited release, the government shall retain possession 
of the conveyance until the owner provides a substitute res bond 
pursuant to Sec. 1316.98 or the forfeiture is finalized.



Sec. 1316.97  Initiating judicial forfeiture proceeding against a conveyance 
within 60 days of the filing of a claim and cost bond.

    (a) The United States Attorney shall file a complaint for forfeiture 
of the conveyance within 60 days of the filing of the claim and cost 
bond.
    (b) Upon the failure of the United States Attorney to file a 
complaint for forfeiture of a conveyance within 60 days unless the court 
extends the 60-day period following a showing of good cause, or unless 
the owner and the United States Attorney agree to such an extension, the 
court shall order the return of the conveyance and the return of any 
bond.



Sec. 1316.98  Substitute res bond in a judicial forfeiture action against 
a conveyance.

    (a) Where a conveyance is being forfeited in a judicial proceeding 
for a drug-related offense, the owner may obtain release of the property 
by filing a substitute res bond with the seizing agency. The conveyance 
will be released to the owner upon the payment of a bond in the amount 
of the appraised value of the conveyance if it is not evidence of a 
violation of law or has design or other characteristics that 
particularly suit it for use in illegal activities. This bond must be in 
the form of a traveler's check, a money order, a cashier's check or an 
irrevocable letter of credit made payable to the Department of Justice 
or to the United States Customs Service depending on which agency seized 
the conveyance. A bond in the form of a cashier's check will be 
considered as paid once the check has been accepted for payment by the 
financial institution which issued the check.
    (b) If a substitute res bond is filed and the conveyance is 
judicially forfeited, the court will forfeit the bond in lieu of the 
property.



Sec. 1316.99  Notice provisions.

    (a) Special notice provision. At the time of seizure of property 
defined in Sec. 1316.91 for violations involving the possession of 
personal use quantities of a controlled substance and conveyances seized 
pursuant to Sec. 1316.95, written notice must be provided to the 
possessor of the property regarding applicable statutes and Federal 
regulations including the procedures established for the filing of a 
petition for expedited release and for the posting of a substitute res 
bond as set forth in sections 6079 and 6080 of the Anti-Drug Abuse Act 
of 1988 and implementing regulations.
    (b) Standard notice provision. The standard notice to the owner as 
required by title 19, U.S.C., section 1607 and applicable regulations, 
shall be made at the earliest practicable opportunity after determining 
ownership of the seized property or conveyance and shall include the 
legal and factual basis of the seizure.

[[Page 191]]



           CHAPTER III--OFFICE OF NATIONAL DRUG CONTROL POLICY




  --------------------------------------------------------------------
Part                                                                Page
1400            [Reserved]
1401            Public availability of information..........         193
1402            Mandatory declassification review...........         196
1403            Uniform administrative requirements for 
                    grants and cooperative agreements to 
                    State and local governments.............         197
1404            Governmentwide debarment and suspension 
                    (nonprocurement)........................         230
1405            Governmentwide requirements for drug-free 
                    workplace (financial assistance)........         253
1406-1499       [Reserved]

[[Page 193]]

                          PART 1400 [RESERVED]



PART 1401_PUBLIC AVAILABILITY OF INFORMATION--Table of Contents

Sec.
1401.1 Purpose.
1401.2 The Office of National Drug Control Policy--organization and 
          functions.
1401.3 Definitions.
1401.4 Access to information.
1401.5 How to request records.
1401.6 Expedited process.
1401.7 Prompt response.
1401.8 Extension of time.
1401.9 Appeals.
1401.10 Fees to be charged--general.
1401.11 Fees to be charged--miscellaneous provisions.
1401.12 Fees to be charged--categories of requesters.
1401.13 Waiver or reduction of fees.

    Authority: 5 U.S.C. 552, as amended.

    Source: 64 FR 69901, Dec. 15, 1999, unless otherwise noted.



Sec. 1401.1  Purpose.

    The purpose of this part is to prescribe rules, guidelines and 
procedures to implement the Freedom of Information Act (FOIA), as 
amended, 5 U.S.C. 552.



Sec. 1401.2  The Office of National Drug Control Policy--organization 
and functions.

    (a) The Office of National Drug Control Policy (ONDCP) was created 
by the Anti-Drug Abuse Act of 1988, 21 U.S.C. 1501 et seq., and 
reestablished under 21 U.S.C. 1701 et seq. The mission of ONDCP is to 
coordinate the anti-drug efforts of the various agencies and departments 
of the Federal government, to consult with States and localities and 
assist their anti-drug efforts, to conduct a national media campaign, 
and to annually promulgate the National Drug Control Strategy.
    (b) ONDCP is headed by the Director of National Drug Control Policy. 
The Director is assisted by a Deputy Director of National Drug Control 
Policy, a Deputy Director for Supply Reduction, a Deputy Director for 
Demand Reduction, and a Deputy Director for State and Local Affairs.
    (c) Offices within ONDCP include Chief of Staff, and the Offices of 
Legal Counsel, Strategic Planning, Legislative Affairs, Programs Budget 
and Evaluation, Supply Reduction, Demand Reduction, Public Affairs, 
State and Local Affairs, and the Financial Management Office.
    (d) The Office of Public Affairs is responsible for providing 
information to the press and to the general public. If members of the 
public have general questions about ONDCP that can be answered by 
telephone, they may call the Office of Public Affairs at (202) 395-6618. 
This number should not be used to make FOIA requests. All oral requests 
for information under FOIA will be rejected.



Sec. 1401.3  Definitions.

    For the purpose of this part:
    (a) All the terms defined in the Freedom of Information Act apply.
    (b) Commercial-use request means a request from or on behalf of one 
who seeks information for a cause or purpose that furthers the 
commercial, trade or profit interests of the requester or the person or 
institution on whose behalf the request is made. In determining whether 
a requester properly belongs in this category, ONDCP will consider the 
intended use of the information.
    (c) Direct costs means the expense actually expended to search, 
review, or duplicate in response to a FOIA request. For example, direct 
costs include 116% of the salary of the employee performing work and the 
actual costs incurred while operating equipment.
    (d) Duplicate means the process of making a copy of a document. Such 
copies may take the form of paper, microform, audio-visual materials, or 
machine-readable documentation. ONDCP will provide a copy of the 
material in a form that is usable by the requester.
    (e) Educational institution means preschool, a public or private 
elementary or secondary school, an institution of undergraduate higher 
education, an institution of graduate higher education, an institution 
of professional education, or an institution of vocational education 
that operates a program or programs of scholarly research.

[[Page 194]]

    (f) Noncommercial scientific institution means an institution that 
is not operated on a commercial basis as that term is defined in this 
section, and that is operated solely for the purpose of conducting 
scientific research not intended to promote any particular product or 
industry.
    (g) Records and any other terms used in this part in reference to 
information includes any information that would be an agency record 
subject to the requirements of this part when maintained in any format, 
including electronic format.
    (h) Representative of the news media means any person actively 
gathering news for an entity that is organized and operated to publish 
or broadcast news to the public. News is information about current 
events or information that would be of interest to the public. Examples 
of the news media include television or radio stations that broadcast to 
the public at large and publishers of news periodicals that make their 
products available to the general public for purchase or subscription. 
Freelance journalists may be regarded as working for the news media 
where they demonstrate a reasonable basis for expecting publication 
through that organization, even though not actually employed by it.
    (i) Request means a letter or other written communication seeking 
records or information under FOIA.
    (j) Review means the process of examining documents that are located 
during a search to determine if any portion should lawfully be withheld. 
It is the processing of determining disclosability.
    (k) Search means to review, manually or by automated means, agency 
records for the purpose of locating those records responsive to a 
request.



Sec. 1401.4  Access to information.

    The Office of National Drug Control Policy makes available 
information pertaining to matters issued, adopted, or promulgated by 
ONDCP, that are within the scope of 5 U.S.C. 552(a)(2). A public reading 
area and the ONDCP FOIA Handbook are located at http://
www.whitehousedrugpolicy.gov/about/about.html.



Sec. 1401.5  How to request records.

    (a) Each request must reasonably describe the record(s) sought 
including the type of document, specific event or action, originator of 
the record, date or time period, subject matter, location, and all other 
pertinent data.
    (b) Requests must be received by ONDCP through the mail or by 
electronic facsimile transmission. Mailed requests must be addressed to 
Executive Office of the President, Office of National Drug Control 
Policy, Office of Legal Counsel, Washington, DC 20503. The applicable 
fax number is (202) 395-5543.
    (c) The words ``FOIA REQUEST'' or ``REQUEST FOR RECORDS'' must be 
clearly marked on the cover-letter, letter and envelope. The time 
limitations imposed by Sec. 1401.7 will not begin until the Office of 
the General Counsel identifies a letter or fax as a FOIA request.



Sec. 1401.6  Expedited process.

    (a) Requests and appeals will be given expedited treatment whenever 
ONDCP determines either:
    (1) The lack of expedited treatment could reasonably be expected to 
pose an imminent threat to the life or physical safety of an individual; 
or
    (2) An urgency to inform the public about an actual or alleged 
federal government activity occurs and the request is made by a person 
primarily engaged in disseminating information.
    (b) A request for expedited processing may be made at the time of 
the initial request for records or at a later time.
    (c) A requester who seeks expedited processing must submit a 
statement, certified to be true and correct to the best of that person's 
knowledge and belief, explaining in detail the basis for requesting 
expedited processing. A requester within the category in paragraph 
(a)(2) of this section also must establish a particular urgency to 
inform the public about the government activity involved in the request, 
beyond the public's right to know about government activity generally. 
The formality of certification may be waived as a matter of 
administrative discretion.
    (d) Within ten days of receipt of a request for expedited 
processing, ONDCP will decide whether to grant it and will

[[Page 195]]

notify the requester of the decision. If a request for expedited 
treatment is granted, the request will be given priority and will be 
processed as soon as practicable. If a request for expedited processing 
is denied, any appeal of that decision will be acted on expeditiously.



Sec. 1401.7  Prompt response.

    The General Counsel, or designee, will determine within 20 days 
(excepting Saturdays, Sundays and legal public holidays) after the 
receipt of a FOIA request whether it is appropriate to grant the request 
and will provide written notification to the person making the request. 
If the request is denied, the written notification will include the 
names of the individuals who participated in the determination, the 
reasons for the denial, and that an appeal may be lodged within the 
Office of National Drug Control Policy.



Sec. 1401.8  Extension of time.

    (a) In unusual circumstances, the Office of General Counsel may 
extend the time limit prescribed in Sec. 1401.7 or Sec. 1401.9 by 
written notice to the FOIA requester. The notice will state the reasons 
for the extension and the date a determination is expected. The 
extension period may be divided among the initial request and an appeal 
but will not exceed a total of 10 working days (excepting Saturdays, 
Sundays, or legal public holidays).
    (b) The phrase ``unusual circumstances'' means:
    (1) The requested records are located in establishments that are 
separated from the office processing the request;
    (2) A voluminous amount of separate and distinct records are 
demanded in a single request; or
    (3) Another agency or two or more components in the same agency have 
substantial interest in the determination of the request.
    (c) Where unusual circumstance exist, ONDCP may provide an 
opportunity for amendment of the initial request so that the request may 
be timely processed. Refusal by the person to reasonably modify the 
request or arrange an alternative time frame shall be considered as a 
factor for purposes of 5 U.S.C. 552 (a)(6)(C).
    (d) ONDCP may aggregate requests by a requester or a group of 
requestors where multiple requests reasonably appear to be a single 
request.



Sec. 1401.9  Appeals.

    An appeal to the ONDCP must explain in writing the legal and factual 
basis for the appeal. It must be received by mail at the address 
specified in Sec. 1401.5 within 30 days of receipt of a denial. The 
Director or designee will decide the appeal within 20 days (excepting 
Saturdays, Sundays, and legal public holidays). If the Director or 
designee deny an appeal in whole or in part, the written determination 
will contain the reason for the denial, the names of the individuals who 
participated in the determination, and the provisions for judicial 
review.



Sec. 1401.10  Fees to be charged--general.

    ONDCP will recoup the full allowable costs it incurs in response to 
a FOIA request.
    (a) Manual search for records. ONDCP will charge 116% of the salary 
of the individual(s) making a search.
    (b) Computerized search for records. ONDCP will charge 116% of the 
salary of the programmer/operator and the apportionable time of the 
central processing unit directly attributed to the search.
    (c) Review of records. ONDCP will charge 116% of the salary of the 
individual(s) conducting a review. Records or portions of records 
withheld under an exemption subsequently determined not to apply may be 
reviewed to determine the applicability of exemptions not considered. 
The cost for a subsequent review is assessable.
    (d) Duplication of records. Request for copies prepared by computer 
will cost 116% of the apportionable operator time and the cost of the 
tape or disk. Other methods of duplication will cost 116% of the salary 
of the individual copying the data plus 15 cents per copy of 8\1/2\x11 
inch original.
    (e) Other charges. ONDCP will recover the costs of providing other 
services such as certifying records or sending records by special 
methods.

[[Page 196]]



Sec. 1401.11  Fees to be charged--miscellaneous provisions.

    (a) Remittance shall be mailed to the Office of Legal Counsel, 
ONDCP, Washington DC 20503, and made payable to the order of the 
Treasury of the United States on a postal money order or personal check 
or bank draft drawn on a bank in the United States.
    (b) ONDCP may require advance payment where the estimated fee 
exceeds $250, or a requester previously failed to pay within 30 days of 
the billing date.
    (c) ONDCP may assess interest charges beginning the 31st day of 
billing. Interest will be at the rate prescribed in section 3717 of 
title 31 of the United States Code and will accrue from the date of the 
billing.
    (d) ONDCP may assess search charges where records are not located or 
where records are exempt from disclosure.
    (e) ONDCP may aggregate individual requests and charge accordingly 
for requests seeking portions of a document or documents.



Sec. 1401.12  Fees to be charged--categories of requesters.

    (a) There are four categories of FOIA requesters: commercial use 
requesters; educational and non-commercial scientific institutions; 
representatives of the news media; and all other requesters.
    (b) The specific levels of fees for each of these categories are:
    (1) Commercial use requesters. ONDCP will recover the full direct 
cost of providing search, review and duplication services. Commercial 
use requesters will not receive free search-time or free reproduction of 
documents.
    (2) Educational and non-commercial scientific institution 
requesters. ONDCP will charge the cost of reproduction, excluding 
charges for the first 100 pages. Requesters must demonstrate the request 
is authorized by and under the auspices of a qualifying institution and 
that the records are sought for scholarly or scientific research not a 
commercial use.
    (3) Requesters who are representatives of the news media. ONDCP will 
charge the cost of reproduction, excluding charges for the first 100 
pages. Requesters must meet the criteria in Sec. 1401.3(h), and the 
request must not be made for a commercial use. A request that supports 
the news dissemination function of the requester shall not be considered 
a commercial use.
    (4) All other requesters. ONDCP will recover the full direct cost of 
the search and the reproduction of records, excluding the first 100 
pages of reproduction and the first two hours of search time. Requests 
for records concerning the requester will be treated under the fee 
provisions of the Privacy Act of 1974, 5 U.S.C. 552a, which permits fees 
only for reproduction.



Sec. 1401.13  Waiver or reduction of fees.

    Fees chargeable in connection with a request may be waived or 
reduced where ONDCP determines that disclosure is in the public interest 
because it is likely to contribute significantly to public understanding 
of the operations or activities of the Government and is not primarily 
in the commercial interest of the requester.



PART 1402_MANDATORY DECLASSIFICATION REVIEW--Table of Contents

Sec.
1402.1 Purpose.
1402.2 Responsibility.
1402.3 Information in the custody of ONDCP.
1402.4 Information classified by another agency.
1402.5 Appeal procedure.
1402.6 Fees.
1402.7 Suggestions and complaints.

    Authority: Section 3.4, E.O. 12356 (3 CFR, 1982 Comp., p. 166), and 
Information Security Oversight Office Directive No. 1 (32 CFR 2001.32).

    Source: 57 FR 55089, Nov. 24, 1992, unless otherwise noted.



Sec. 1402.1  Purpose.

    Other government agencies, U.S. citizens or permanent resident 
aliens may request that classified information in files of the Office of 
National Drug Control Policy (ONDCP) be reviewed for possible 
declassification and release. This part prescribes the procedures for 
such review and subsequent release or denial.

[[Page 197]]



Sec. 1402.2  Responsibility.

    All requests for the mandatory declassification review of classified 
information in ONDCP files should be addressed to the Security Officer, 
Office of National Drug Control Policy, Executive Office of the 
President, Washington, DC 20500, who will acknowledge receipt of the 
request. When a request does not reasonably describe the information 
sought, the requester shall be notified that unless additional 
information is provided, or the scope of the request is narrowed, no 
further action will be taken.



Sec. 1402.3  Information in the custody of ONDCP.

    Information contained in ONDCP files and under the exclusive 
declassification jurisdiction of ONDCP will be reviewed by the Director 
of the Office of Planning, Budget, and Administration of ONDCP and/or 
the office of primary interest to determine whether, under the 
declassification provisions of section 3.1 of Executive Order 12356 (3 
CFR, 1982 Comp., p. 166), the requested information may be declassified. 
If the information may not be released, in whole or in part, the 
requester shall be given a brief statement as to the reasons for denial, 
a notice of the right to appeal the determination to the Director of 
ONDCP, and a notice that such an appeal must be filed within 60 days in 
order to be considered.



Sec. 1402.4  Information classified by another agency.

    When a request is received for information that was classified by 
another agency, the Director of the Office of Planning, Budget, and 
Administration of ONDCP will forward the request and a copy of the 
document(s) along with any other related materials, to the appropriate 
agency for review and determination as to release. Recommendations as to 
release or denial may be made if appropriate. The requester will be 
notified of the referral, unless the receiving agency objects on the 
grounds that its association with the information requires protection.



Sec. 1402.5  Appeal procedure.

    Appeals reviewed as a result of a denial will be routed to the 
Director of ONDCP, who will take action as necessary to determine 
whether any part of the information may be declassified. If so, the 
Director shall notify the requester of this determination and shall make 
any information available that is declassified and is otherwise 
releasable. If continued classification is required, the requester shall 
be notified by the Director of ONDCP of the reasons therefore.



Sec. 1402.6  Fees.

    There will normally be no fees charged for the mandatory review of 
classified material for declassification under this part.



Sec. 1402.7  Suggestions and complaints.

    Suggestions and complaints regarding the information security 
program of ONDCP should be submitted, in writing, to the Security 
Officer, Office of National Drug Control Policy, Washington, DC 20500.



PART 1403_UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE 
AGREEMENTS TO STATE AND LOCAL GOVERNMENTS--Table of Contents

                            Subpart A_General

Sec.
1403.1 Purpose and scope of this part.
1403.2 Scope of subpart.
1403.3 Definitions.
1403.4 Applicability.
1403.5 Effect on other issuances.
1403.6 Additions and exceptions.

                    Subpart B_Pre-Award Requirements

1403.10 Forms for applying for grants.
1403.11 State plans.
1403.12 Special grant or subgrant conditions for ``high-risk'' grantees.

                    Subpart C_Post-Award Requirements

                        Financial Administration

1403.20 Standards for financial management systems.
1403.21 Payment.
1403.22 Allowable costs.
1403.23 Period of availability of funds.
1403.24 Matching or cost sharing.
1403.25 Program income.
1403.26 Non-Federal audit.

[[Page 198]]

                    Changes, Property, and Subawards

1403.30 Changes.
1403.31 Real property.
1403.32 Equipment.
1403.33 Supplies.
1403.34 Copyrights.
1403.35 Subawards to debarred and suspended parties.
1403.36 Procurement.
1403.37 Subgrants.

              Reports, Records, Retention, and Enforcement

1403.40 Monitoring and reporting program performance.
1403.41 Financial reporting.
1403.42 Retention and access requirements for records.
1403.43 Enforcement.
1403.44 Termination for convenience.

                 Subpart D_After-The-Grant Requirements

1403.50 Closeout.
1403.51 Later disallowances and adjustments.
1403.52 Collection of amounts due.

Subpart E--Entitlement [Reserved]

Appendix A to Part 1403--OMB Circular A-128, ``Audits of State and Local 
          Governments''

    Authority: 5 U.S.C. 301.

    Source: 57 FR 55092, Nov. 24, 1992, unless otherwise noted.



                            Subpart A_General



Sec. 1403.1  Purpose and scope of this part.

    This part establishes uniform administrative rules for Federal 
grants and cooperative agreements and subawards to State, local and 
Indian tribal governments.



Sec. 1403.2  Scope of subpart.

    This subpart contains general rules pertaining to this part and 
procedures for control of exceptions from this part.



Sec. 1403.3  Definitions.

    As used in this part:
    Accrued expenditures mean the charges incurred by the grantee during 
a given period requiring the provision of funds for:
    (1) Goods and other tangible property received;
    (2) Services performed by employees, contractors, subgrantees, 
subcontractors, and other payees; and
    (3) Other amounts becoming owed under programs for which no current 
services or performance is required, such as annuities, insurance 
claims, and other benefit payments.
    Accrued income means the sum of:
    (1) Earnings during a given period from services performed by the 
grantee and goods and other tangible property delivered to purchasers, 
and
    (2) Amounts becoming owed to the grantee for which no current 
services or performance is required by the grantee.
    Acquisition cost of an item of purchased equipment means the net 
invoice unit price of the property including the cost of modifications, 
attachments, accessories, or auxiliary apparatus necessary to make the 
property usable for the purpose for which it was acquired. Other charges 
such as the cost of installation, transportation, taxes, duty or 
protective in-transit insurance, shall be included or excluded from the 
unit acquisition cost in accordance with the grantee's regular 
accounting practices.
    Administrative requirements mean those matters common to grants in 
general, such as financial management, kinds and frequency of reports, 
and retention of records. These are distinguished from ``programmatic'' 
requirements, which concern matters that can be treated only on a 
program-by-program or grant-by-grant basis, such as kinds of activities 
that can be supported by grants under a particular program.
    Awarding agency means:
    (1) With respect to a grant, the Federal agency, and
    (2) With respect to a subgrant, the party that awarded the subgrant.
    Cash contributions means the grantee's cash outlay, including the 
outlay of money contributed to the grantee or subgrantee by other public 
agencies and institutions, and private organizations and individuals. 
When authorized by Federal legislation, Federal funds received from 
other assistance agreements may be considered as grantee or subgrantee 
cash contributions.

[[Page 199]]

    Contract means (except as used in the definitions for ``grant'' and 
``subgrant'' in this section and except where qualified by ``Federal'') 
a procurement contract under a grant or subgrant, and means a 
procurement subcontract under a contract.
    Cost sharing or matching means the value of the third party in-kind 
contributions and the portion of the costs of a federally assisted 
project or program not borne by the Federal Government.
    Cost-type contract means a contract or subcontract under a grant in 
which the contractor or subcontractor is paid on the basis of the costs 
it incurs, with or without a fee.
    Equipment means tangible, nonexpendable, personal property having a 
useful life of more than one year and an acquisition cost of $5,000 or 
more per unit. A grantee may use its own definition of equipment 
provided that such definition would at least include all equipment 
defined above.
    Expenditure report means:
    (1) For nonconstruction grants, the SF-269 ``Financial Status 
Report'' (or other equivalent report);
    (2) For construction grants, the SF-271 ``Outlay Report and Request 
for Reimbursement'' (or other equivalent report).
    Federally recognized Indian tribal government means the governing 
body or a governmental agency of any Indian tribe, band, nation, or 
other organized group or community (including any Native village as 
defined in section 3 of the Alaska Native Claims Settlement Act, 85 
Stat. 688) certified by the Secretary of the Interior as eligible for 
the special programs and services provided by him through the Bureau of 
Indian Affairs.
    Government means a State or local government or a federally 
recognized Indian tribal government.
    Grant means an award of financial assistance, including cooperative 
agreements, in the form of money, or property in lieu of money, by the 
Federal Government to an eligible grantee. The term does not include 
technical assistance which provides services instead of money, or other 
assistance in the form of revenue sharing, loans, loan guarantees, 
interest subsidies, insurance, or direct appropriations. Also, the term 
does not include assistance, such as a fellowship or other lump sum 
award, which the grantee is not required to account for.
    Grantee means the government to which a grant is awarded and which 
is accountable for the use of the funds provided. The grantee is the 
entire legal entity even if only a particular component of the entity is 
designated in the grant award document.
    Local government means a county, municipality, city, town, township, 
local public authority (including any public and Indian housing agency 
under the United States Housing Act of 1937) school district, special 
district, intrastate district, council of governments (whether or not 
incorporated as a nonprofit corporation under state law), any other 
regional or interstate government entity, or any agency or 
instrumentality of a local government.
    Obligations means the amounts of orders placed, contracts and 
subgrants awarded, goods and services received, and similar transactions 
during a given period that will require payment by the grantee during 
the same or a future period.
    OMB means the United States Office of Management and Budget.
    Outlays (expenditures) means charges made to the project or program. 
They may be reported on a cash or accrual basis. For reports prepared on 
a cash basis, outlays are the sum of actual cash disbursement for direct 
charges for goods and service, the amount of indirect expense incurred, 
the value of in-kind contributions applied, and the amount of cash 
advances and payments made to contractors and subgrantees. For reports 
prepared on an accrued expenditure basis, outlays are the sum of actual 
cash disbursements, the amount of indirect expense incurred, the value 
of in-kind contributions applied, and the new increase (or decrease) in 
the amounts owed by the grantee for goods and other property received, 
for services performed by employees, contractors, subgrantees, 
subcontractors, and other payees, and other amounts becoming owed under 
programs for which no current services or performance are required, such 
as annuities, insurance claims, and other benefit payments.

[[Page 200]]

    Percentage of completion method refers to a system under which 
payments are made for construction work according to the percentage of 
completion of the work, rather than to the grantee's cost incurred.
    Prior approval means documentation evidencing consent prior to 
incurring specific cost.
    Real property means land, including land improvements, structures 
and appurtenances thereto, excluding movable machinery and equipment.
    Share, when referring to the awarding agency's portion of real 
property, equipment or supplies, means the same percentage as the 
awarding agency's portion of the acquiring party's total costs under the 
grant to which the acquisition costs under the grant to which the 
acquisition cost of the property was charged. Only costs are to be 
counted--not the value of third-party in-kind contributions.
    State means any of the several States of the United States, the 
District of Columbia, the Commonwealth of Puerto Rico, any territory or 
possession of the United States, or any agency or instrumentality of a 
State exclusive of local governments. The term does not include any 
public and Indian housing agency under United States Housing Act of 
1937.
    Subgrant means an award of financial assistance in the form of 
money, or property in lieu of money, made under a grant by a grantee to 
an eligible subgrantee. The term includes financial assistance when 
provided by contractual legal agreement, but does not include 
procurement purchases, nor does it include any form of assistance which 
is excluded from the definition of ``grant'' in this part.
    Subgrantee means the government or other legal entity to which a 
subgrant is awarded and which is accountable to the grantee for the use 
of the funds provided.
    Supplies means all tangible personal property other than 
``equipment'' as defined in this part.
    Suspension means depending on the context, either
    (1) Temporary withdrawal of the authority to obligate grant funds 
pending corrective action by the grantee or subgrantee or a decision to 
terminate the grant, or
    (2) In action taken by a suspending official in accordance with 
agency regulations implementing E.O. 12549 to immediately exclude a 
person from participating in grant transactions for a period, pending 
completion of an investigation and such legal or debarment proceedings 
as may ensue.
    Termination means permanent withdrawal of the authority to obligate 
previously-awarded grant funds before that authority would otherwise 
expire. It also means the voluntary relinquishment of that authority by 
the grantee or subgrantee. ``Termination'' does not include:
    (1) Withdrawal of funds awarded on the basis of the grantee's 
underestimate of the unobligated balance in a prior period;
    (2) Withdrawal of the unobligated balance as of the expiration of a 
grant;
    (3) Refusal to extend a grant or award additional funds, to make a 
competing or noncompeting continuation, renewal, extension, or 
supplemental award; or
    (4) Voiding of a grant upon determination that the award was 
obtained fraudulently, or was otherwise illegal or invalid from 
inception.
    Terms of a grant or subgrant mean all requirements of the grant or 
subgrant, whether in statute, regulations, or the award document.
    Third party in-kind contributions mean property or services which 
benefit a federally assisted project or program and which are 
contributed by non-Federal third parties without charge to the grantee, 
or a cost-type contractor under the grant agreement.
    Unliquidated obligations for reports prepared on a cash basis mean 
the amount of obligations incurred by the grantee that has not been 
paid. For reports prepared on an accrued expenditure basis, they 
represent the amount of obligations incurred by the grantee for which an 
outlay has not been recorded.
    Unobligated balance means the portion of the funds authorized by the 
Federal agency that has not been obligated by the grantee and is 
determined

[[Page 201]]

by deducting the cumulative obligations from the cumulative funds 
authorized.



Sec. 1403.4  Applicability.

    (a) General. Subparts A-D of this part apply to all grants and 
subgrants to governments, except where inconsistent with Federal 
statutes or with regulations authorized in accordance with the exception 
provision of Sec. 1403.6, or:
    (1) Grants and subgrants to State and local institutions of higher 
education or State and local hospitals;
    (2) The block grants authorized by the Omnibus Budget Reconciliation 
Act of 1981 (Community Services; Preventive Health and Health Services; 
Alcohol, Drug Abuse, and Mental Health Services; Maternal and Child 
Health Services; Social Services; Low-Income Home Energy Assistance; 
States' Program of Community Development Block Grants for Small Cities; 
and Elementary and Secondary Education other than programs administered 
by the Secretary of Education under title V, subtitle D, chapter 2, 
section 583--the Secretary's discretionary grant program) and titles I-
III of the Job Training Partnership Act of 1982 and under the Public 
Health Services Act (Section 1921), Alcohol and Drug Abuse Treatment and 
Rehabilitation Block Grant and part C of title V, Mental Health Service 
for the Homeless Block Grant);
    (3) Entitlement grants to carry out the following programs of the 
Social Security Act:
    (i) Aid to Needy Families with Dependent Children (title IV-A of the 
Act, not including the Work Incentive Program (WIN) authorized by 
section 402(a)19(G); HHS grants for WIN are subject to this part);
    (ii) Child Support Enforcement and Establishment of Paternity (title 
IV-D of the Act);
    (iii) Foster Care and Adoption Assistance (title IV-E of the Act);
    (iv) Aid to the Aged, Blind, and Disabled (titles I, X, XIV, and 
XVI-AABD of the Act); and
    (v) Medical Assistance (Medicaid) (title XIX of the Act) not 
including the State Medicaid Fraud Control program authorized by section 
1903(a)(6)(B);
    (4) Entitlement grants under the following programs of The National 
School Lunch Act:
    (i) School Lunch (section 4 of the Act),
    (ii) Commodity Assistance (section 6 of the Act),
    (iii) Special Meal Assistance (section 11 of the Act),
    (iv) Summer Food Service for Children (section 13 of the Act), and
    (v) Child Care Food Program (section 17 of the Act);
    (5) Entitlement grants under the following programs of The Child 
Nutrition Act of 1966:
    (i) Special Milk (section 3 of the Act), and
    (ii) School Breakfast (section 4 of the Act);
    (6) Entitlement grants for State Administrative expenses under The 
Food Stamp Act of 1977 (section 16 of the Act);
    (7) A grant for an experimental, pilot, or demonstration project 
that is also supported by a grant listed in paragraph (a)(3) of this 
section;
    (8) Grant funds awarded under subsection 412(e) of the Immigration 
and Nationality Act (8 U.S.C. 1522(e)) and subsection 501(a) of the 
Refugee Education Assistance Act of 1980 (Pub. L. 96-422, 94 Stat. 
1809), for cash assistance, medical assistance, and supplemental 
security income benefits to refugees and entrants and the administrative 
costs of providing the assistance and benefits;
    (9) Grants to local education agencies under 20 U.S.C. 236 through 
241-1(a), and 242 through 244 (portions of the Impact Aid program), 
except for 20 U.S.C. 238(d)(2)(c) and 240(f) (Entitlement Increase for 
Handicapped Children); and
    (10) Payments under the Veterans Administration's State Home Per 
Diem Program (38 U.S.C. 641(a)).
    (b) Entitlement programs. Entitlement programs enumerated above in 
Sec. 1403.4(a) (3) through (8) are subject to subpart E.



Sec. 1403.5  Effect on other issuances.

    All other grants administration provisions of codified program 
regulations, program manuals, handbooks and other nonregulatory 
materials which are inconsistent with this part

[[Page 202]]

are superseded, except to the extent they are required by statute, or 
authorized in accordance with the exception provision in Sec. 1403.6.



Sec. 1403.6  Additions and exceptions.

    (a) For classes of grants and grantees subject to this part, Federal 
agencies may not impose additional administrative requirements except in 
codified regulations published in the Federal Register.
    (b) Exceptions for classes of grants or grantees may be authorized 
only by OMB.
    (c) Exceptions on a case-by-case basis and for subgrantees may be 
authorized by the affected Federal agencies.



                    Subpart B_Pre-Award Requirements



Sec. 1403.10  Forms for applying for grants.

    (a) Scope. (1) This section prescribes forms and instructions to be 
used by governmental organizations (except hospitals and institutions of 
higher education operated by a government) in applying for grants. This 
section is not applicable, however, to formula grant programs which do 
not require applicants to apply for funds on a project basis.
    (2) This section applies only to applications to Federal agencies 
for grants, and is not required to be applied by grantees in dealing 
with applicants for subgrants. However, grantees are encouraged to avoid 
more detailed or burdensome application requirements for subgrants.
    (b) Authorized forms and instructions for governmental 
organizations. (1) In applying for grants, applicants shall only use 
standard application forms or those prescribed by the granting agency 
with the approval of OMB under the Paperwork Reduction Act of 1980.
    (2) Applicants are not required to submit more than the original and 
two copies of preapplications or applications.
    (3) Applicants must follow all applicable instructions that bear OMB 
clearance numbers. Federal agencies may specify and describe the 
programs, functions, or activities that will be used to plan, budget, 
and evaluate the work under a grant. Other supplementary instructions 
may be issued only with the approval of OMB to the extent required under 
the Paperwork Reduction Act of 1980. For any standard form, except the 
SF-424 facesheet, Federal agencies may shade out or instruct the 
applicant to disregard any line item that is not needed.
    (4) When a grantee applies for additional funding (such as a 
continuation or supplemental award) or amends a previously submitted 
application, only the affected pages need be submitted. Previously 
submitted pages with information that is still current need not be 
resubmitted.



Sec. 1403.11  State plans.

    (a) Scope. The statutes for some programs require States to submit 
plans before receiving grants. Under regulations implementing Executive 
Order 12372, ``Intergovernmental Review of Federal Programs,'' States 
are allowed to simplify, consolidate and substitute plans. This section 
contains additional provisions for plans that are subject to regulations 
implementing the Executive Order.
    (b) Requirements. A State need meet only Federal administrative or 
programmatic requirements for a plan that are in statutes or codified 
regulations.
    (c) Assurances. In each plan the States will include an assurance 
that the State shall comply with all applicable Federal statutes and 
regulations in effect with respect to the periods for which it receives 
grant funding. For this assurance and other assurances required in the 
plan, the State may:
    (1) Cite by number the statutory or regulatory provisions requiring 
the assurances and affirm that it gives the assurances required by those 
provisions,
    (2) Repeat the assurance language in the statutes or regulations, or
    (3) Develop its own language to the extent permitted by law.
    (d) Amendments. A State will amend a plan whenever necessary to 
reflect: (1) New or revised Federal statutes or regulations or (2) a 
material change in any State law, organization, policy, or State agency 
operation. The State will obtain approval for the amendment and

[[Page 203]]

its effective date but need submit for approval only the amended 
portions of the plan.



Sec. 1403.12  Special grant or subgrant conditions for ``high-risk'' grantees.

    (a) A grantee or subgrantee may be considered ``high risk'' if an 
awarding agency determines that a grantee or subgrantee:
    (1) Has a history of unsatisfactory performance, or
    (2) Is not financially stable, or
    (3) Has a management system which does not meet the management 
standards set forth in this part, or
    (4) Has not conformed to terms and conditions of previous awards, or
    (5) Is otherwise not responsible; and if the awarding agency 
determines that an award will be made, special conditions and/or 
restrictions shall correspond to the high risk condition and shall be 
included in the award.
    (b) Special conditions or restrictions may include:
    (1) Payment on a reimbursement basis;
    (2) Withholding authority to proceed to the next phase until receipt 
of evidence of acceptable performance within a given funding period;
    (3) Requiring additional, more detailed financial reports;
    (4) Additional project monitoring;
    (5) Requiring the grantee or subgrantee to obtain technical or 
management assistance; or
    (6) Establishing additional prior approvals;
    (c) If an awarding agency decides to impose such conditions, the 
awarding official will notify the grantee or subgrantee as early as 
possible, in writing, of:
    (1) The nature of the special conditions/restrictions;
    (2) The reason(s) for imposing them;
    (3) The corrective actions which must be taken before they will be 
removed and the time allowed for completing the corrective actions; and
    (4) The method of requesting reconsideration of the conditions/
restrictions imposed.



                    Subpart C_Post-Award Requirements

                        Financial Administration



Sec. 1403.20  Standards for financial management systems.

    (a) A State must expend and account for grant funds in accordance 
with State laws and procedures for expending and accounting for its own 
funds. Fiscal control and accounting procedures of the State, as well as 
its subgrantees and cost-type contractors, must be sufficient to--
    (1) Permit preparation of reports required by this part and the 
statutes authorizing the grant, and
    (2) Permit the tracing of funds to a level of expenditures adequate 
to establish that such funds have not been used in violation of the 
restrictions and prohibitions of applicable statutes.
    (b) The financial management systems of other grantees and 
subgrantees must meet the following standards:
    (1) Financial reporting. Accurate, current, and complete disclosure 
of the financial results of financially assisted activities must be made 
in accordance with the financial reporting requirements of the grant or 
subgrant.
    (2) Accounting records. Grantees and subgrantees must maintain 
records which adequately identify the source and application of funds 
provided for financially-assisted activities. These records must contain 
information pertaining to grant or subgrant awards and authorizations, 
obligations, unobligated balances, assets, liabilities, outlays or 
expenditures, and income.
    (3) Internal control. Effective control and accountability must be 
maintained for all grant and subgrant cash, real and personal property, 
and other assets. Grantees and subgrantees must adequately safeguard all 
such property and must assure that it is used solely for authorized 
purposes.
    (4) Budget control. Actual expenditures or outlays must be compared 
with budgeted amounts for each grant or subgrant. Financial information

[[Page 204]]

must be related to performance or productivity data, including the 
development of unit cost information whenever appropriate or 
specifically required in the grant or subgrant agreement. If unit cost 
data are required, estimates based on available documentation will be 
accepted whenever possible.
    (5) Allowable cost. Applicable OMB cost principles, agency program 
regulations, and the terms of grant and subgrant agreements will be 
followed in determining the reasonableness, allowability, and 
allocability of costs.
    (6) Source documentation. Accounting records must be supported by 
such source documentation as canceled checks, paid bills, payrolls, time 
and attendance records, contract and subgrant award documents, etc.
    (7) Cash management. Procedures for minimizing the time elapsing 
between the transfer of funds from the U.S. Treasury and disbursement by 
grantees and subgrantees must be followed whenever advance payment 
procedures are used. Grantees must establish reasonable procedures to 
ensure the receipt of reports on subgrantees' cash balances and cash 
disbursements in sufficient time to enable them to prepare complete and 
accurate cash transactions reports to the awarding agency. When advances 
are made by letter-of-credit or electronic transfer of funds methods, 
the grantee must make drawdowns as close as possible to the time of 
making disbursements. Grantees must monitor cash drawdowns by their 
subgrantees to assure that they conform substantially to the same 
standards of timing and amount as apply to advances to the grantees.
    (c) An awarding agency may review the adequacy of the financial 
management system of any applicant for financial assistance as part of a 
preaward review or at any time subsequent to award.



Sec. 1403.21  Payment.

    (a) Scope. This section prescribes the basic standard and the 
methods under which a Federal agency will make payments to grantees, and 
grantees will make payments to subgrantees and contractors.
    (b) Basic standard. Methods and procedures for payment shall 
minimize the time elapsing between the transfer of funds and 
disbursement by the grantee or subgrantee, in accordance with Treasury 
regulations at 31 CFR part 205.
    (c) Advances. Grantees and subgrantees shall be paid in advance, 
provided they maintain or demonstrate the willingness and ability to 
maintain procedures to minimize the time elapsing between the transfer 
of the funds and their disbursement by the grantee or subgrantee.
    (d) Reimbursement. Reimbursement shall be the preferred method when 
the requirements in paragraph (c) of this section are not met. Grantees 
and subgrantees may also be paid by reimbursement for any construction 
grant. Except as otherwise specified in regulation, Federal agencies 
shall not use the percentage of completion method to pay construction 
grants. The grantee or subgrantee may use that method to pay its 
construction contractor, and if it does, the awarding agency's payments 
to the grantee or subgrantee will be based on the grantee's or 
subgrantee's actual rate of disbursement.
    (e) Working capital advances. If a grantee cannot meet the criteria 
for advance payments described in paragraph (c) of this section, and the 
Federal agency has determined that reimbursement is not feasible the 
grantee lacks sufficient working capital, the awarding agency may 
provide cash or a working capital advance basis. Under this procedure 
the awarding agency shall advance cash to the grantee to cover its 
estimated disbursement needs for an initial period generally geared to 
the grantee's disbursing cycle. Thereafter, the awarding agency shall 
reimburse the grantee for its actual cash disbursements. The working 
capital advance method of payment shall not be used by grantees or 
subgrantees if the reason for using such method is the unwillingness or 
inability of the grantee to provide timely advances to the subgrantee to 
meet the subgrantee's actual cash disbursements.
    (f) Effect of program income, refunds, and audit recoveries on 
payment. (1) Grantees and subgrantees shall disburse repayments to and 
interest

[[Page 205]]

earned on a revolving fund before requesting additional cash payments 
for the same activity.
    (2) Except as provided in paragraph (f)(1) of this section, grantees 
and subgrantees shall disburse program income, rebates, refunds, 
contract settlements, audit recoveries and interest earned on such funds 
before requesting additional cash payments.
    (g) Withholding payments. (1) Unless otherwise required by Federal 
statute, awarding agencies shall not withhold payments for proper 
charges incurred by grantees or subgrantees unless--
    (i) The grantee or subgrantee has failed to comply with grant award 
conditions or
    (ii) The grantee or subgrantee is indebted to the United States.
    (2) Cash withheld for failure to comply with grant award condition, 
but without suspension of the grant, shall be released to the grantee 
upon subsequent compliance. When a grant is suspended, payment 
adjustments will be made in accordance with Sec. 1403.43(c).
    (3) A Federal agency shall not make payment to grantees for amounts 
that are withheld by grantees or subgrantees from payment to contractors 
to assure satisfactory completion of work. Payments shall be made by the 
Federal agency when the grantees or subgrantees actually disburse the 
withheld funds to the contractors or to escrow accounts established to 
assure satisfactory completion of work.
    (h) Cash depositories. (1) Consistent with the national goal of 
expanding the opportunities for minority business enterprises, grantees 
and subgrantees are encouraged to use minority banks (a bank which is 
owned at least 50 percent by minority group members). A list of minority 
owned banks can be obtained from the Minority Business Development 
Agency, Department of Commerce, Washington, DC 20230.
    (2) A grantee or subgrantee shall maintain a separate bank account 
only when required by Federal-State agreement.
    (i) Interest earned on advances. Except for interest earned on 
advances of funds exempt under the Intergovernmental Cooperation Act (31 
U.S.C. 6501 et seq.) and the Indian Self-Determination Act (23 U.S.C. 
450), grantees and subgrantees shall promptly, but at least quarterly, 
remit interest earned on advances to the Federal agency. The grantee or 
subgrantee may keep interest amounts up to $100 per year for 
administrative expenses.



Sec. 1403.22  Allowable costs.

    (a) Limitation on use of funds. Grant funds may be used only for:
    (1) The allowable costs of the grantees, subgrantees and cost-type 
contractors, including allowable costs in the form of payments to fixed-
price contractors; and
    (2) Reasonable fees or profit to cost-type contractors but not any 
fee or profit (or other increment above allowable costs) to the grantee 
or subgrantee.
    (b) Applicable cost principles. For each kind of organization, there 
is a set of Federal principles for determining allowable costs. 
Allowable costs will be determined in accordance with the cost 
principles applicable to the organization incurring the costs. The 
following chart lists the kinds of organizations and the applicable cost 
principles.

------------------------------------------------------------------------
           For the costs of a--                Use the principles in--
------------------------------------------------------------------------
State, local or Indian tribal government..  OMB Circular A-87.
Private nonprofit organization other than   OMB Circular A-122.
 (1) institution of higher education, (2)
 hospital, or (3) organization named in
 OMB Circular A-122 as not subject to that
 circular.
Educational institutions..................  OMB Circular A-21.
For-profit organizations other than a       48 CFR part 31. Contract
 hospital and an organization named in OMB   Cost Principles and
 Circular A-122 as not subject to that       Procedures, or uniform cost
 circular.                                   accounting standards that
                                             comply with cost principles
                                             acceptable to the Federal
                                             agency.
------------------------------------------------------------------------



Sec. 1403.23  Period of availability of funds.

    (a) General. Where a funding period is specified, a grantee may 
charge to the award only costs resulting from obligations of the funding 
period unless carryover of unobligated balances is permitted, in which 
case the carryover balances may be charged for costs resulting from 
obligations of the subsequent funding period.

[[Page 206]]

    (b) Liquidation of obligations. A grantee must liquidate all 
obligations incurred under the award not later than 90 days after the 
end of the funding period (or as specified in a program regulation) to 
coincide with the submission of the annual Financial Status Report (SF-
269). The Federal agency may extend this deadline at the request of the 
grantee.



Sec. 1403.24  Matching or cost sharing.

    (a) Basic rule: Costs and contributions acceptable. With the 
qualifications and exceptions listed in paragraph (b) of this section, a 
matching or cost sharing requirement may be satisfied by either or both 
of the following:
    (1) Allowable costs incurred by the grantee, subgrantee or a cost-
type contractor under the assistance agreement. This includes allowable 
costs borne by non-Federal grants or by others cash donations from non-
Federal third parties.
    (2) The value of third party in-kind contributions applicable to the 
period to which the cost sharing or matching requirements applies.
    (b) Qualifications and exceptions--(1) Costs borne by other Federal 
grant agreements. Except as provided by Federal statute, a cost sharing 
or matching requirement may not be met by costs borne by another Federal 
grant. This prohibition does not apply to income earned by a grantee or 
subgrantee from a contract awarded under another Federal grant.
    (2) General revenue sharing. For the purpose of this section, 
general revenue sharing funds distributed under 31 U.S.C. 6702 are not 
considered Federal grant funds.
    (3) Cost or contributions counted towards other Federal cost-sharing 
requirements. Neither costs nor the values of third party in-kind 
contributions may count towards satisfying a cost sharing or matching 
requirement of a grant agreement if they have been or will be counted 
towards satisfying a cost sharing or matching requirement of another 
Federal grant agreement, a Federal procurement contract, or any other 
award of Federal funds.
    (4) Costs financed by program income. Costs financed by program 
income, as defined in Sec. 1403.25, shall not count towards satisfying 
a cost sharing or matching requirement unless they are expressly 
permitted in the terms of the assistant agreement. (This use of general 
program income is described in Sec. 1403.25(g).)
    (5) Services or property financed by income earned by contractors. 
Contractors under a grant may earn income from the activities carried 
out under the contract in addition to the amounts earned from the party 
awarding the contract. No costs of services or property supported by 
this income may count toward satisfying cost sharing or matching 
requirement unless other provisions of the grant agreement expressly 
permit this kind of income to be used to meet the requirement.
    (6) Records. Costs and third party in-kind contributions counting 
towards satisfying a cost sharing or matching requirement must be 
verifiable from the records of grantees and subgrantee or cost-type 
contractors. These records must show how the value placed on third party 
in-kind contributions was derived. To the extent feasible, volunteer 
services will be supported by the same methods that the organization 
uses to support the allocability of regular personnel costs.
    (7) Special standards for third party in-kind contributions. (i) 
Third party in-kind contributions count towards satisfying a cost 
sharing or matching requirement only where, if the party receiving the 
contributions were to pay for them, the payments would be allowable 
costs.
    (ii) Some third party in-kind contributions are goods and services 
that, if the grantee, subgrantee, or contractor receiving the 
contribution had to pay for them, the payments would have been an 
indirect costs. Costs sharing or matching credit for such contributions 
shall be given only if the grantee, subgrantee, or contractor has 
established, along with its regular indirect cost rate, a special rate 
for allocating to individual projects or programs the value of the 
contributions.
    (iii) A third party in-kind contribution to a fixed-price contract 
may count towards satisfying a cost sharing or matching requirement only 
if it results in:

[[Page 207]]

    (A) An increase in the services or property provided under the 
contract (without additional cost to the grantee or subgrantee) or
    (B) A cost savings to the grantee or subgrantee.
    (iv) The values placed on third party in-kind contributions for cost 
sharing or matching purposes will conform to the rules in the succeeding 
sections of this part. If a third party in-kind contribution is a type 
not treated in those sections, the value placed upon it shall be fair 
and reasonable.
    (c) Valuation of donated services--(1) Volunteer services. Unpaid 
services provided to a grantee or subgrantee by individuals will be 
valued at rates consistent with those ordinarily paid for similar work 
in the grantee's or subgrantee's organization. If the grantee or 
subgrantee does not have employees performing similar work, the rates 
will be consistent with those ordinarily paid by other employers for 
similar work in the same labor market. In either case, a reasonable 
amount for fringe benefits may be included in the valuation.
    (2) Employees of other organizations. When an employer other than a 
grantee, subgrantee, or cost-type contractor furnishes free of charge 
the services of an employee in the employee's normal line of work, the 
services will be valued at the employee's regular rate of pay exclusive 
of the employee's fringe benefits and overhead costs. If the services 
are in a different line of work, paragraph (c)(1) of this section 
applies.
    (d) Valuation of third party donated supplies and loaned equipment 
or space. (1) If a third party donates supplies, the contribution will 
be valued at the market value of the supplies at the time of donation.
    (2) If a third party donates the use of equipment or space in a 
building but retains title, the contribution will be valued at the fair 
rental rate of the equipment or space.
    (e) Valuation of third party donated equipment, buildings, and land. 
If a third party donates equipment, buildings, or land, and title passes 
to a grantee or subgrantee, the treatment of the donated property will 
depend upon the purpose of the grant or subgrant, as follows:
    (1) Awards for capital expenditures. If the purpose of the grant or 
subgrant is to assist the grantee or subgrantee in the acquisition of 
property, the market value of that property at the time of donation may 
be counted as cost sharing or matching.
    (2) Other awards. If assisting in the acquisition of property is not 
the purpose of the grant or subgrant, paragraphs (e)(2) (i) and (ii) of 
this section apply:
    (i) If approval is obtained from the awarding agency, the market 
value at the time of donation of the donated equipment or buildings and 
the fair rental rate of the donated land may be counted as cost sharing 
or matching. In the case of a subgrant, the terms of the grant agreement 
may require that the approval be obtained from the Federal agency as 
well as the grantee. In all cases, the approval may be given only if a 
purchase of the equipment or rental of the land would be approved as an 
allowable direct cost. If any part of the donated property was acquired 
with Federal funds, only the non-federal share of the property may be 
counted as cost-sharing or matching.
    (ii) If approval is not obtained under paragraph (e)(2)(i) of this 
section, no amount may be counted for donated land, and only 
depreciation or use allowances may be counted for donated equipment and 
buildings. The depreciation or use allowances for this property are not 
treated as third party in-kind contributions. Instead, they are treated 
as costs incurred by the grantee or subgrantee. They are computed and 
allocated (usually as indirect costs) in accordance with the cost 
principles specified in Sec. 1403.22, in the same way as depreciation 
or use allowances for purchased equipment and buildings. The amount of 
depreciation or use allowances for donated equipment and buildings is 
based on the property's market value at the time it was donated.
    (f) Valuation of grantee or subgrantee donates real property for 
construction/acquisition. If a grantee or subgrantee donates real 
property for a construction or facilities acquisition project, the 
current market value of that property may be counted as cost sharing or 
matching. If any part of the donated property was acquired with Federal

[[Page 208]]

funds, only the non-federal share of the property may be counted as cost 
sharing or matching.
    (g) Appraisal of real property. In some cases under paragraphs (d), 
(e) and (f) of this section, it will be necessary to establish the 
market value of land or a building or the fair rental rate of land or of 
space in a building. In these cases, the Federal agency may require the 
market value or fair rental value be set by an independent appraiser, 
and that the value or rate be certified by the grantee. This requirement 
will also be imposed by the grantee on subgrantees.



Sec. 1403.25  Program income.

    (a) General. Grantees are encouraged to earn income to defray 
program costs. Program income includes income from fees for services 
performed, from the use of rental of real or personal property acquired 
with grant funds, from the sale of commodities or items fabricated under 
a grant agreement, and from payments of principal and interest on loans 
made with grant funds. Except as otherwise provided in regulations of 
the Federal agency, program income does not include interest on grant 
funds, rebates, credits, discounts, refunds, etc., and interest earned 
on any of them.
    (b) Definition of program income. Program income means gross income 
received by the grantee or subgrantee directly generated by a grant 
supported activity, or earned only as a result of the grant agreement 
during the grant period. ``During the grant period'' is the time between 
the effective date of the award and the ending date of the award 
reflected in the final financial report.
    (c) Cost of generating program income. If authorized by Federal 
regulations or the grant agreement, costs incident to the generation of 
program income may be deducted from gross income to determine program 
income.
    (d) Governmental revenues. Taxes, special assessments levies, fines, 
and other such revenues raised by a grantee or subgrantee are not 
program income unless the revenues are specifically identified in the 
grant agreement or Federal agency regulations as program income.
    (e) Royalties. Income from royalties and license fees for 
copyrighted material, patents, and inventions developed by a grantee or 
subgrantee is program income only if the revenues are specifically 
identified in the grant agreement or Federal agency regulations as 
program income. (See Sec. 1403.34.)
    (f) Property. Proceeds from the sale of real property or equipment 
will be handled in accordance with the requirements of Sec. 1403.31 and 
Sec. 1403.32.
    (g) Use of program income. Program income shall be deducted from 
outlays which may be both Federal and non-Federal as described below, 
unless the Federal agency regulations or the grant agreement specify 
another alternative (or a combination of the alternatives). In 
specifying alternatives, the Federal agency may distinguish between 
income earned by the grantee and income earned by subgrantees and 
between the sources, kinds, or amounts of income. When Federal agencies 
authorize the alternatives in paragraphs (g) (2) and (3) of this 
section, program income in excess of any limits stipulated shall also be 
deducted from outlays.
    (1) Deduction. Ordinarily program income shall be deducted from 
total allowable costs to determine the net allowable costs. Program 
income shall be used for current costs unless the Federal agency 
authorizes otherwise. Program income which the grantee did not 
anticipate at the time of the award shall be used to reduce the Federal 
agency and grantee contributions rather than to increase the funds 
committed to the project.
    (2) Addition. When authorized, program income may be added to the 
funds committed to the grant agreement by the Federal agency and the 
grantee. The program income shall be used for the purposes and under the 
conditions of the grant agreement.
    (3) Cost sharing or matching. When authorized, program income may be 
used to meet the cost sharing or matching requirement of the grant 
agreement. The amount of the Federal grant award remains the same.
    (h) Income after the award period. There are no Federal requirements 
governing the disposition of program income earned after the end of the 
award

[[Page 209]]

period (i.e., until the ending date of the final financial report, see 
paragraph (a) of this section), unless the terms of the agreement or the 
Federal agency regulations provide otherwise.



Sec. 1403.26  Non-Federal audit.

    (a) Basic rule. Grantees and subgrantees are responsible for 
obtaining audits in accordance with the Single Audit Act Amendments of 
1996 (31 U.S.C. 7501-7507) and revised OMB Circular A-133, ``Audits of 
States, Local Governments, and Non-Profit Organizations.'' The audits 
shall be made by an independent auditor in accordance with generally 
accepted government auditing standards covering financial audits.
    (b) Subgrantees. State or local governments, as those terms are 
defined for purposes of the Single Audit Act Amendments of 1996, that 
provide Federal awards to a subgrantee, which expends $300,000 or more 
(or other amount as specified by OMB) in Federal awards in a fiscal 
year, shall:
    (1) Determine whether State or local subgrantees have met the audit 
requirements of the Act and whether subgrantees covered by OMB Circular 
A-110, ``Uniform Administrative Requirements for Grants and Agreements 
with Institutions of Higher Education, Hospitals, and Other Non-Profit 
Organizations,'' have met the audit requirements of the Act. Commercial 
contractors (private for-profit and private and governmental 
organizations) providing goods and services to State and local 
governments are not required to have a single audit performed. State and 
local governments should use their own procedures to ensure that the 
contractor has complied with laws and regulations affecting the 
expenditure of Federal funds;
    (2) Determine whether the subgrantee spent Federal assistance funds 
provided in accordance with applicable laws and regulations. This may be 
accomplished by reviewing an audit of the subgrantee made in accordance 
with the Act, Circular A-110, or through other means (e.g., program 
reviews) if the subgrantee has not had such an audit;
    (3) Ensure that appropriate corrective action is taken within six 
months after receipt of the audit report in instance of noncompliance 
with Federal laws and regulations;
    (4) Consider whether subgrantee audits necessitate adjustment of the 
grantee's own records; and
    (5) Require each subgrantee to permit independent auditors to have 
access to the records and financial statements.
    (c) Auditor selection. In arranging for audit services, Sec. 
1403.36 shall be followed.

[57 FR 55092, Nov. 24, 1992, as amended at 62 FR 45939, 45941, Aug. 29, 
1997]

                    Changes, Property, and Subawards



Sec. 1403.30  Changes.

    (a) General. Grantees and subgrantees are permitted to rebudget 
within the approved direct cost budget to meet unanticipated 
requirements and may make limited program changes to the approved 
project. However, unless waived by the awarding agency, certain types of 
post-award changes in budgets and projects shall require the prior 
written approval of the awarding agency.
    (b) Relation to cost principles. The applicable cost principles (see 
Sec. 1403.22) contain requirements for prior approval of certain types 
of costs. Except where waived, those requirements apply to all grants 
and subgrants even if paragraphs (c) through (f) of this section do not.
    (c) Budget changes--(1) Nonconstruction projects. Except as stated 
in other regulations or an award document, grantees or subgrantees shall 
obtain the prior approval of the awarding agency whenever any of the 
following changes is anticipated under a nonconstruction award:
    (i) Any revision which would result in the need for additional 
funding.
    (ii) Unless waived by the awarding agency, cumulative transfers 
among direct cost categories, or, if applicable, among separately 
budgeted programs, projects, functions, or activities which exceed or 
are expected to exceed ten percent of the current total approved budget, 
whenever the awarding agency's share exceeds $100,000.
    (iii) Transfer of funds allotted for training allowances (i.e., from 
direct

[[Page 210]]

payments to trainees to other expense categories).
    (2) Construction projects. Grantees and subgrantees shall obtain 
prior written approval for any budget revision which would result in the 
need for additional funds.
    (3) Combined construction and nonconstruction projects. When a grant 
or subgrant provides funding for both construction and nonconstruction 
activities, the grantee or subgrantee must obtain prior written approval 
from the awarding agency before making any fund or budget transfer from 
nonconstruction to construction or vice versa.
    (d) Programmatic changes. Grantees or subgrantees must obtain the 
prior approval of the awarding agency whenever any of the following 
actions is anticipated:
    (1) Any revision of the scope or objectives of the project 
(regardless of whether there is an associated budget revision requiring 
prior approval).
    (2) Need to extend the period of availability of funds.
    (3) Changes in key persons in cases where specified in an 
application or a grant award. In research projects, a change in the 
project director or principal investigator shall always require approval 
unless waived by the awarding agency.
    (4) Under nonconstruction projects, contracting out, subgranting (if 
authorized by law) or otherwise obtaining the services of a third party 
to perform activities which are central to the purposes of the award. 
This approval requirement is in addition to the approval requirements of 
Sec. 1403.36 but does not apply to the procurement of equipment, 
supplies, and general support services.
    (e) Additional prior approval requirements. The awarding agency may 
not require prior approval for any budget revision which is not 
described in paragraph (c) of this section.
    (f) Requesting prior approval. (1) A request for prior approval of 
any budget revision will be in the same budget format the grantee used 
in its application and shall be accompanied by a narrative justification 
for the proposed revision.
    (2) A request for a prior approval under the applicable Federal cost 
principles (see Sec. 1403.22) may be made by letter.
    (3) A request by a subgrantee for prior approval will be addressed 
in writing to the grantee. The grantee will promptly review such request 
and shall approve or disapprove the request in writing. A grantee will 
not approve any budget or project revision which is inconsistent with 
the purpose or terms and conditions of the Federal grant to the grantee. 
If the revision requested by the subgrantee would result in a change to 
the grantee's approved project which requires Federal prior approval, 
the grantee will obtain the Federal agency's approval before approving 
the subgrantee's request.



Sec. 1403.31  Real property.

    (a) Title. Subject to the obligations and conditions set forth in 
this section, title to real property acquired under a grant or subgrant 
will vest upon acquisition in the grantee or subgrantee respectively.
    (b) Use. Except as otherwise provided by Federal statutes, real 
property will be used for the originally authorized purposes as long as 
needed for those purposes, and the grantee or subgrantee shall not 
dispose of or encumber its title or other interests.
    (c) Disposition. When real property is no longer needed for the 
originally authorized purpose, the grantee or subgrantee will request 
disposition instructions from the awarding agency. The instructions will 
provide for one of the following alternatives:
    (1) Retention of title. Retain title after compensating the awarding 
agency. The amount paid to the awarding agency will be computed by 
applying the awarding agency's percentage of participation in the cost 
of the original purchase to the fair market value of the property. 
However, in those situations were a grantee or subgrantee is disposing 
of real property acquired with grant funds and acquiring replacement 
real property under the same program, the net proceeds from the 
disposition may be used as an offset to the cost of the replacement 
property.
    (2) Sale of property. Sell the property and compensate the awarding 
agency.

[[Page 211]]

The amount due to the awarding agency will be calculated by applying the 
awarding agency's percentage of participation in the cost of the 
original purchase to the proceeds of the sale after deduction of any 
actual and reasonable selling and fixing-up expenses. If the grant is 
still active, the net proceeds from sale may be offset against the 
original cost of the property. When a grantee or subgrantee is directed 
to sell property, sales procedures shall be followed that provide for 
competition to the extent practicable and result in the highest possible 
return.
    (3) Transfer of title. Transfer title to the awarding agency or to a 
third-party designated/approved by the awarding agency. The grantee or 
subgrantee shall be paid an amount calculated by applying the grantee or 
subgrantee's percentage of participation in the purchase of the real 
property to the current fair market value of the property.



Sec. 1403.32  Equipment.

    (a) Title. Subject to the obligations and conditions set forth in 
this section, title to equipment acquired under a grant or subgrant will 
vest upon acquisition in the grantee or subgrantee respectively.
    (b) States. A State will use, manage, and dispose of equipment 
acquired under a grant by the State in accordance with State laws and 
procedures. Other grantees and subgrantees will follow paragraphs (c) 
through (e) of this section.
    (c) Use. (1) Equipment shall be used by the grantee or subgrantee in 
the program or project for which it was acquired as long as needed, 
whether or not the project or program continues to be supported by 
Federal funds. When no longer needed for the original program or 
project, the equipment may be used in other activities currently or 
previously supported by a Federal agency.
    (2) The grantee or subgrantee shall also make equipment available 
for use on other projects or programs currently or previously supported 
by the Federal Government, providing such use will not interfere with 
the work on the projects or program for which it was originally 
acquired. First preference for other use shall be given to other 
programs or projects supported by the awarding agency. User fees should 
be considered if appropriate.
    (3) Notwithstanding the encouragement in Sec. 1403.25(a) to earn 
program income, the grantee or subgrantee must not use equipment 
acquired with grant funds to provide services for a fee to compete 
unfairly with private companies that provide equivalent services, unless 
specifically permitted or contemplated by Federal statute.
    (4) When acquiring replacement equipment, the grantee or subgrantee 
may use the equipment to be replaced as a trade-in or sell the property 
and use the proceeds to offset the cost of the replacement property, 
subject to the approval of the awarding agency.
    (d) Management requirements. Procedures for managing equipment 
(including replacement equipment), whether acquired in whole or in part 
with grant funds, until disposition takes place will, as a minimum, meet 
the following requirements:
    (1) Property records must be maintained that include a description 
of the property, a serial number or other identification number, the 
source of property, who holds title, the acquisition date, and cost of 
the property, percentage of Federal participation in the cost of the 
property, the location, use and condition of the property, and any 
ultimate disposition data including the date of disposal and sale price 
of the property.
    (2) A physical inventory of the property must be taken and the 
results reconciled with the property records at least once every two 
years.
    (3) A control system must be developed to ensure adequate safeguards 
to prevent loss, damage, or theft of the property. Any loss, damage, or 
theft shall be investigated.
    (4) Adequate maintenance procedures must be developed to keep the 
property in good condition.
    (5) If the grantee or subgrantee is authorized or required to sell 
the property, proper sales procedures must be established to ensure the 
highest possible return.
    (e) Disposition. When original or replacement equipment acquired 
under a grant or subgrant is no longer needed

[[Page 212]]

for the original project or program or for other activities currently or 
previously supported by a Federal agency, disposition of the equipment 
will be made as follows:
    (1) Items of equipment with a current per-unit fair market value of 
less than $5,000 may be retained, sold or otherwise disposed of with no 
further obligation to the awarding agency.
    (2) Items of equipment with a current per unit fair market value in 
excess of $5,000 may be retained or sold and the awarding agency shall 
have a right to an amount calculated by multiplying the current market 
value or proceeds from sale by the awarding agency's share of the 
equipment.
    (3) In cases where a grantee or subgrantee fails to take appropriate 
disposition actions, the awarding agency may direct the grantee or 
subgrantee to take excess and disposition actions.
    (f) Federal equipment. In the event a grantee or subgrantee is 
provided federally-owned equipment:
    (1) Title will remain vested in the Federal Government.
    (2) Grantees or subgrantees will manage the equipment in accordance 
with Federal agency rules and procedures, and submit an annual inventory 
listing.
    (3) When the equipment is no longer needed, the grantee or 
subgrantee will request disposition instructions from the Federal 
agency.
    (g) Right to transfer title. The Federal awarding agency may reserve 
the right to transfer title to the Federal Government or a third party 
named by the awarding agency when such a third party is otherwise 
eligible under existing statutes. Such transfers shall be subject to the 
following standards:
    (1) The property shall be identified in the grant or otherwise made 
known to the grantee in writing.
    (2) The Federal awarding agency shall issue disposition instruction 
within 120 calendar days after the end of the Federal support of the 
project for which it was acquired. If the federal awarding agency fails 
to issue disposition instructions within the 120 calendar-day period the 
grantee shall follow Sec. 1403.32(e).
    (3) When title to equipment is transferred, the grantee shall be 
paid an amount calculated by applying the percentage of participation in 
the purchase to the current fair market value of the property.



Sec. 1403.33  Supplies.

    (a) Title. Title to supplies acquired under a grant or subgrant will 
vest, upon acquisition, in the grantee or subgrantee respectively.
    (b) Disposition. If there is a residual inventory of unused supplies 
exceeding $5,000 in total aggregate fair market value upon termination 
or completion of the award, and if the supplies are not needed for any 
other federally sponsored programs or projects, the grantee or 
subgrantee shall compensate the awarding agency for its share.



Sec. 1403.34  Copyrights.

    The Federal awarding agency reserves a royalty-free, nonexclusive, 
and irrevocable license to reproduce, publish or otherwise use, and to 
authorize others to use, for Federal Government purposes:
    (a) The copyright in any work developed under a grant, subgrant, or 
contract under a grant or subgrant; and
    (b) Any rights of copyright to which a grantee, subgrantee or a 
contractor purchases ownership with grant support.



Sec. 1403.35  Subawards to debarred and suspended parties.

    Grantees and subgrantees must not make any award or permit any award 
(subgrant or contract) at any tier to any party which is debarred or 
suspended or is otherwise excluded from or ineligible for participation 
in Federal assistance programs under Executive Order 12549, ``Debarment 
and Suspension.''



Sec. 1403.36  Procurement.

    (a) States. When procuring property and services under a grant, a 
State will follow the same policies and procedures it uses for 
procurements from its non-Federal funds. The State will ensure that 
every purchase order or other contract includes any clauses required by 
Federal statutes and executive orders and their implementing 
regulations. Other grantees and subgrantees will

[[Page 213]]

follow paragraphs (b) through (i) of this section.
    (b) Procurement standards. (1) Grantees and subgrantees will use 
their own procurement procedures which reflect applicable State and 
local laws and regulations, provided that the procurements conform to 
applicable Federal law and the standards identified in this section.
    (2) Grantees and subgrantees will maintain a contract administration 
system which ensures that contractors perform in accordance with the 
terms, conditions, and specifications of their contracts or purchase 
orders.
    (3) Grantees and subgrantees will maintain a written code of 
standards of conduct governing the performance of their employees 
engaged in the award and administration of contracts. No employee, 
officer or agent of the grantee or subgrantee shall participate in 
selection, or in the award or administration of a contract supported by 
Federal funds if a conflict of interest, real or apparent, would be 
involved. Such a conflict would arise when:
    (i) The employee, officer or agent,
    (ii) Any member of his immediate family,
    (iii) His or her partner, or
    (iv) An organization which employs, or is about to employ, any of 
the above, has a financial or other interest in the firm selected for 
award. The grantee's or subgrantee's officers, employees or agents will 
neither solicit nor accept gratuities, favors or anything of monetary 
value from contractors, potential contractors, or parties to 
subagreements. Grantee and subgrantees may set minimum rules where the 
financial interest is not substantial or the gift is an unsolicited item 
of nominal intrinsic value. To the extent permitted by State or local 
law or regulations, such standards or conduct will provide for 
penalties, sanctions, or other disciplinary actions for violations of 
such standards by the grantee's and subgrantee's officers, employees, or 
agents, or by contractors or their agents. The awarding agency may in 
regulation provide additional prohibitions relative to real, apparent, 
or potential conflicts of interest.
    (4) Grantee and subgrantee procedures will provide for a review of 
proposed procurements to avoid purchase of unnecessary or duplicative 
items. Consideration should be given to consolidating or breaking out 
procurements to obtain a more economical purchase. Where appropriate, an 
analysis will be made of lease versus purchase alternatives, and any 
other appropriate analysis to determine the most economical approach.
    (5) To foster greater economy and efficiency, grantees and 
subgrantees are encouraged to enter into State and local 
intergovernmental agreements for procurement or use of common goods and 
services.
    (6) Grantees and subgrantees are encouraged to use Federal excess 
and surplus property in lieu of purchasing new equipment and property 
whenever such use is feasible and reduces project costs.
    (7) Grantees and subgrantees are encouraged to use value engineering 
clauses in contracts for construction projects of sufficient size to 
offer reasonable opportunities for cost reductions. Value engineering is 
a systematic and creative analysis of each contract item or task to 
ensure that its essential function is provided at the overall lower 
cost.
    (8) Grantees and subgrantees will make awards only to responsible 
contractors possessing the ability to perform successfully under the 
terms and conditions of a proposed procurement. Consideration will be 
given to such matters as contractor integrity, compliance with public 
policy, record of past performance, and financial and technical 
resources.
    (9) Grantees and subgrantees will maintain records sufficient to 
detail the significant history of a procurement. These records will 
include, but are not necessarily limited to the following: rationale for 
the method of procurement, selection of contract type, contractor 
selection or rejection, and the basis for the contract price.
    (10) Grantees and subgrantees will use time and material type 
contracts only--
    (i) After a determination that no other contract is suitable, and
    (ii) If the contract includes a ceiling price that the contractor 
exceeds at its own risk.

[[Page 214]]

    (11) Grantees and subgrantees alone will be responsible, in 
accordance with good administrative practice and sound business 
judgment, for the settlement of all contractual and administrative 
issues arising out of procurements. These issues include, but are not 
limited to source evaluation, protests, disputes, and claims. These 
standards do not relieve the grantee or subgrantee of any contractual 
responsibilities under its contracts. Federal agencies will not 
substitute their judgment for that of the grantee or subgrantee unless 
the matter is primarily a Federal concern. Violations of law will be 
referred to the local, State, or Federal authority having proper 
jurisdiction.
    (12) Grantees and subgrantees will have protest procedures to handle 
and resolve disputes relating to their procurements and shall in all 
instances disclose information regarding the protest to the awarding 
agency. A protestor must exhaust all administrative remedies with the 
grantee and subgrantee before pursuing a protest with the Federal 
agency. Reviews of protests by the Federal agency will be limited to:
    (i) Violations of Federal law or regulations and the standards of 
this section (violations of State or local law will be under the 
jurisdiction of State or local authorities) and
    (ii) Violations of the grantee's or subgrantee's protest procedures 
for failure to review a complaint or protest. Protests received by the 
Federal agency other than those specified above will be referred to the 
grantee or subgrantee.
    (c) Competition. (1) All procurement transactions will be conducted 
in a manner providing full and open competition consistent with the 
standards of Sec. 1403.36. Some of the situations considered to be 
restrictive of competition include but are not limited to:
    (i) Placing unreasonable requirements on firms in order for them to 
qualify to do business,
    (ii) Requiring unnecessary experience and excessive bonding,
    (iii) Noncompetitive pricing practices between firms or between 
affiliated companies,
    (iv) Noncompetitive awards to consultants that are on retainer 
contracts,
    (v) Organizational conflicts of interest,
    (vi) Specifying only a ``brand name'' product instead of allowing 
``an equal'' product to be offered and describing the performance of 
other relevant requirements of the procurement, and
    (vii) Any arbitrary action in the procurement process.
    (2) Grantees and subgrantees will conduct procurements in a manner 
that prohibits the use of statutorily or administratively imposed in-
State or local geographical preferences in the evaluation of bids or 
proposals, except in those cases where applicable Federal statutes 
expressly mandate or encourage geographic preference. Nothing in this 
section preempts State licensing laws. When contracting for 
architectural and engineering (A/E) services, geographic location may be 
a selection criteria provided its application leaves an appropriate 
number of qualified firms, given the nature and size of the project, to 
compete for the contract.
    (3) Grantees will have written selection procedures for procurement 
transactions. These procedures will ensure that all solicitations:
    (i) Incorporate a clear and accurate description of the technical 
requirements for the material, product, or service to be procured. Such 
description shall not, in competitive procurements, contain features 
which unduly restrict competition. The description may include a 
statement of the qualitative nature of the material, product or service 
to be procured, and when necessary, shall set forth those minimum 
essential characteristics and standards to which it must conform if it 
is to satisfy its intended use. Detailed product specifications should 
be avoided if at all possible. When it is impractical or uneconomical to 
make a clear and accurate description of the technical requirements, a 
``brand name or equal'' description may be used as a means to define the 
performance or other salient requirements of a procurement. The specific 
features of the named brand which must be met by offerors shall be 
clearly stated; and
    (ii) Identify all requirements which the offerors must fulfill and 
all other factors to be used in evaluating bids or proposals.

[[Page 215]]

    (4) Grantees and subgrantees will ensure that all prequalified lists 
of persons, firms, or products which are used in acquiring goods and 
services are current and include enough qualified sources to ensure 
maximum open and free competition. Also, grantees and subgrantees will 
not preclude potential bidders from qualifying during the solicitation 
period.
    (d) Methods of procurement to be followed. (1) Procurement by small 
purchase procedures. Small purchase procedures are those relatively 
simple and informal procurement methods for securing services, supplies, 
or other property that do not cost more than the simplified acquisition 
threshold fixed at 41 U.S.C. 403(11) (currently set at $100,000). If 
small purchase procedures are used, price or rate quotations shall be 
obtained from an adequate number of qualified sources.
    (2) Procurement by sealed bids (formal advertising). Bids are 
publicly solicited and a firm-fixed-price contract (lump sum or unit 
price) is awarded to the responsible bidder whose bid, conforming with 
all the material terms and conditions of the invitation for bids, is the 
lowest in price. The sealed bid method is the preferred method for 
procuring construction, if the conditions in Sec. 1403.36(d)(2)(i) 
apply.
    (i) In order for sealed bidding to be feasible, the following 
conditions should be present:
    (A) A complete, adequate, and realistic specification or purchase 
description is available;
    (B) Two or more responsible bidders are willing and able to compete 
effectively and for the business; and
    (C) The procurement lends itself to a firm fixed price contract and 
the selection of the successful bidder can be made principally on the 
basis of price.
    (ii) If sealed bids are used, the following requirements apply:
    (A) The invitation for bids will be publicly advertised and bids 
shall be solicited from an adequate number of known suppliers, providing 
them sufficient time prior to the date set for opening the bids;
    (B) The invitation for bids, which will include any specifications 
and pertinent attachments, shall define the items or services in order 
for the bidder to properly respond;
    (C) All bids will be publicly opened at the time and place 
prescribed in the invitation for bids;
    (D) A firm fixed-price contract award will be made in writing to the 
lowest responsive and responsible bidder. Where specified in bidding 
documents, factors such as discounts, transportation cost, and life 
cycle costs shall be considered in determining which bid is lowest. 
Payment discounts will only be used to determine the low bid when prior 
experience indicates that such discounts are usually taken advantage of; 
and
    (E) Any or all bids may be rejected if there is a sound documented 
reason.
    (3) Procurement by competitive proposals. The technique of 
competitive proposals is normally conducted with more than one source 
submitting an offer, and either a fixed-price or cost-reimbursement type 
contract is awarded. It is generally used when conditions are not 
appropriate for the use of sealed bids. If this method is used, the 
following requirements apply:
    (i) Requests for proposals will be publicized and identify all 
evaluation factors and their relative importance. Any response to 
publicized requests for proposals shall be honored to the maximum extent 
practical;
    (ii) Proposals will be solicited from an adequate number of 
qualified sources;
    (iii) Grantees and subgrantees will have a method for conducting 
technical evaluations of the proposals received and for selecting 
awardees;
    (iv) Awards will be made to the responsible firm whose proposal is 
most advantageous to the program, with price and other factors 
considered; and
    (v) Grantees and subgrantees may use competitive proposal procedures 
for qualifications-based procurement of architectural/engineering (A/E) 
professional services whereby competitors' qualifications are evaluated 
and the most qualified competitor is selected, subject to negotiation of 
fair and reasonable compensation. The method, where price is not used as 
a selection factor, can only be used in procurement of A/E professional 
services. It cannot be used to purchase other types

[[Page 216]]

of services though A/E firms are a potential source to perform the 
proposed effort.
    (4) Procurement by noncompetitive proposals is procurement through 
solicitation of a proposal from only one source, or after solicitation 
of a number of sources, competition is determined inadequate.
    (i) Procurement by noncompetitive proposals may be used only when 
the award of a contract is infeasible under small purchase procedures, 
sealed bids or competitive proposals and one of the following 
circumstances applies:
    (A) The item is available only from a single source;
    (B) The public exigency or emergency for the requirement will not 
permit a delay resulting from competitive solicitation;
    (C) The awarding agency authorizes noncompetitive proposals; or
    (D) After solicitation of a number of sources, competition is 
determined inadequate.
    (ii) Cost analysis, i.e., verifying the proposed cost data, the 
projections of the data, and the evaluation of the specific elements of 
costs and profits, is required.
    (iii) Grantees and subgrantees may be required to submit the 
proposed procurement to the awarding agency for pre-award review in 
accordance with paragraph (g) of this section.
    (e) Contracting with small and minority firms, women's business 
enterprise and labor surplus area firms. (1) The grantee and subgrantee 
will take all necessary affirmative steps to assure that minority firms, 
women's business enterprises, and labor surplus area firms are used when 
possible.
    (2) Affirmative steps shall include:
    (i) Placing qualified small and minority businesses and women's 
business enterprises on solicitation lists;
    (ii) Assuring that small and minority businesses, and women's 
business enterprises are solicited whenever they are potential sources;
    (iii) Dividing total requirements, when economically feasible, into 
smaller tasks or quantities to permit maximum participation by small and 
minority business, and women's business enterprises;
    (iv) Establishing delivery schedules, where the requirement permits, 
which encourage participation by small and minority business, and 
women's business enterprises;
    (v) Using the services and assistance of the Small Business 
Administration, and the Minority Business Development Agency of the 
Department of Commerce; and
    (vi) Requiring the prime contractor, if subcontracts are to be let, 
to take the affirmative steps listed in paragraphs (e)(2) (i) through 
(v) of this section.
    (f) Contract cost and price. (1) Grantees and subgrantees must 
perform a cost or price analysis in connection with every procurement 
action including contract modifications. The method and degree of 
analysis is dependent on the facts surrounding the particular 
procurement situation, but as a starting point, grantees must make 
independent estimates before receiving bids or proposals. A cost 
analysis must be performed when the offeror is required to submit the 
elements of his estimated cost, e.g., under professional, consulting, 
and architectural engineering services contracts. A cost analysis will 
be necessary when adequate price competition is lacking, and for sole 
source procurements, including contract modifications or change orders, 
unless price reasonableness can be established on the basis of a catalog 
or market price of a commercial product sold in substantial quantities 
to the general public or based on prices set by law or regulation. A 
price analysis will be used in all other instances to determine the 
reasonableness of the proposed contract price.
    (2) Grantees and subgrantees will negotiate profit as a separate 
element of the price for each contract in which there is no price 
competition and in all cases where cost analysis is performed. To 
establish a fair and reasonable profit, consideration will be given to 
the complexity of the work to be performed, the risk borne by the 
contractor, the contractor's investment, the amount of subcontracting, 
the quality of its record of past performance, and industry profit rates 
in the surrounding geographical area for similar work.

[[Page 217]]

    (3) Costs or prices based on estimated costs for contracts under 
grants will be allowable only to the extent that costs incurred or cost 
estimates included in negotiated prices are consistent with Federal cost 
principles (see Sec. 1403.22). Grantees may reference their own cost 
principles that comply with the applicable Federal cost principles.
    (4) The cost plus a percentage of cost and percentage of 
constructing cost methods of contracting shall not be used.
    (g) Awarding agency review. (1) Grantees and subgrantees must make 
available, upon request of the awarding agency, technical specifications 
on proposed procurements where the awarding agency believes such review 
is needed to ensure that the item and/or service specified is the one 
being proposed for purchase. This review generally will take place prior 
to the time the specification is incorporated into a solicitation 
document. However, if the grantee or subgrantee desires to have the 
review accomplished after a solicitation has been developed, the 
awarding agency may still review the specifications, with such review 
usually limited to the technical aspects of the proposed purchase.
    (2) Grantees and subgrantees must on request make available for 
awarding agency pre-award review procurement documents, such as requests 
for proposals or invitations for bids, independent cost estimates, etc. 
when:
    (i) A grantee's or subgrantee's procurement procedures or operation 
fails to comply with the procurement standards in this section; or
    (ii) The procurement is expected to exceed the simplified 
acquisition threshold and is to be awarded without competition or only 
one bid or offer is received in response to a solicitation; or
    (iii) The procurement, which is expected to exceed the simplified 
acquisition threshold, specifies a ``brand name'' product; or
    (iv) The proposed award is more than the simplified acquisition 
threshold and is to be awarded to other than the apparent low bidder 
under a sealed bid procurement; or
    (v) A proposed contract modification changes the scope of a contract 
or increases the contract amount by more than the simplified acquisition 
threshold.
    (3) A grantee or subgrantee will be exempt from the pre-award review 
in paragraph (g)(2) of this section if the awarding agency determines 
that its procurement systems comply with the standards of this section.
    (i) A grantee or subgrantee may request that its procurement system 
be reviewed by the awarding agency to determine whether its system meets 
these standards in order for its system to be certified. Generally, 
these reviews shall occur where there is a continuous high-dollar 
funding, and third-party contracts are awarded on a regular basis.
    (ii) A grantee or subgrantee may self-certify its procurement 
system. Such self-certification shall not limit the awarding agency's 
right to survey the system. Under a self-certification procedure, 
awarding agencies may wish to rely on written assurances from the 
grantee or subgrantee that it is complying with these standards. A 
grantee or subgrantee will cite specific procedures, regulations, 
standards, etc., as being in compliance with these requirements and have 
its system available for review.
    (h) Bonding requirements. For construction or facility improvement 
contracts or subcontracts exceeding the simplified acquisition 
threshold, the awarding agency may accept the bonding policy and 
requirements of the grantee or subgrantee provided the awarding agency 
has made a determination that the awarding agency's interest is 
adequately protected. If such a determination has not been made, the 
minimum requirements shall be as follows:
    (1) A bid guarantee from each bidder equivalent to five percent of 
the bid price. The ``bid guarantee'' shall consist of a firm commitment 
such as a bid bond, certified check, or other negotiable instrument 
accompanying a bid as assurance that the bidder will, upon acceptance of 
his bid, execute such contractual documents as may be required within 
the time specified.
    (2) A performance bond on the part of the contractor for 100 percent 
of the contract price. A ``performance bond'' is

[[Page 218]]

one executed in connection with a contract to secure fulfillment of all 
the contractor's obligations under such contract.
    (3) A payment bond on the part of the contractor for 100 percent of 
the contract price. A ``payment bond'' is one executed in connection 
with a contract to assure payment as required by law of all persons 
supplying labor and material in the execution of the work provided for 
in the contract.
    (i) Contract provisions. A grantee's and subgrantee's contracts must 
contain provisions in paragraph (i) of this section. Federal agencies 
are permitted to require changes, remedies, changed conditions, access 
and records retention, suspension of work, and other clauses approved by 
the Office of Federal Procurement Policy.
    (1) Administrative, contractual, or legal remedies in instances 
where contractors violate or breach contract terms, and provide for such 
sanctions and penalties as may be appropriate. (Contracts more than the 
simplified acquisition threshold)
    (2) Termination for cause and for convenience by the grantee or 
subgrantee including the manner by which it will be effected and the 
basis for settlement. (All contracts in excess of $10,000)
    (3) Compliance with Executive Order 11246 of September 24, 1965, 
entitled ``Equal Employment Opportunity,'' as amended by Executive Order 
11375 of October 13, 1967, and as supplemented in Department of Labor 
regulations (41 CFR chapter 60). (All construction contracts awarded in 
excess of $10,000 by grantees and their contractors or subgrantees)
    (4) Compliance with the Copeland ``Anti-Kickback'' Act (18 U.S.C. 
874) as supplemented in Department of Labor regulations (29 CFR Part 3). 
(All contracts and subgrants for construction or repair)
    (5) Compliance with the Davis-Bacon Act (40 U.S.C. 276a to 276a-7) 
as supplemented by Department of Labor regulations (29 CFR Part 5). 
(Construction contracts in excess of $2000 awarded by grantees and 
subgrantees when required by Federal grant program legislation)
    (6) Compliance with Sections 103 and 107 of the Contract Work Hours 
and Safety Standards Act (40 U.S.C. 327-330) as supplemented by 
Department of Labor regulations (29 CFR Part 5). (Construction contracts 
awarded by grantees and subgrantees in excess of $2000, and in excess of 
$2500 for other contracts which involve the employment of mechanics or 
laborers)
    (7) Notice of awarding agency requirements and regulations 
pertaining to reporting.
    (8) Notice of awarding agency requirements and regulations 
pertaining to patent rights with respect to any discovery or invention 
which arises or is developed in the course of or under such contract.
    (9) Awarding agency requirements and regulations pertaining to 
copyrights and rights in data.
    (10) Access by the grantee, the subgrantee, the Federal grantor 
agency, the Comptroller General of the United States, or any of their 
duly authorized representatives to any books, documents, papers, and 
records of the contractor which are directly pertinent to that specific 
contract for the purpose of making audit, examination, excerpts, and 
transcriptions.
    (11) Retention of all required records for three years after 
grantees or subgrantees make final payments and all other pending 
matters are closed.
    (12) Compliance with all applicable standards, orders, or 
requirements issued under section 306 of the Clean Air Act (42 U.S.C. 
1857(h)), section 508 of the Clean Water Act (33 U.S.C. 1368), Executive 
Order 11738, and Environmental Protection Agency regulations (40 CFR 
part 15). (Contracts, subcontracts, and subgrants of amounts in excess 
of $100,000).
    (13) Mandatory standards and policies relating to energy efficiency 
which are contained in the state energy conservation plan issued in 
compliance with the Energy Policy and Conservation Act (Pub. L. 94-163, 
89 Stat. 871).

[57 FR 55092, Nov. 24, 1992, as amended at 60 FR 19639, 19642, Apr. 19, 
1995]



Sec. 1403.37  Subgrants.

    (a) States. States shall follow state law and procedures when 
awarding and administering subgrants (whether on a

[[Page 219]]

cost reimbursement or fixed amount basis) of financial assistance to 
local and Indian tribal governments. States shall:
    (1) Ensure that every subgrant includes any clauses required by 
Federal statute and executive orders and their implementing regulations;
    (2) Ensure that subgrantees are aware of requirements imposed upon 
them by Federal statute and regulation;
    (3) Ensure that a provision for compliance with Sec. 1403.42 is 
placed in every cost reimbursement subgrant; and
    (4) Conform any advances of grant funds to subgrantees substantially 
to the same standards of timing and amount that apply to cash advances 
by Federal agencies.
    (b) All other grantees. All other grantees shall follow the 
provisions of this part which are applicable to awarding agencies when 
awarding and administering subgrants (whether on a cost reimbursement or 
fixed amount basis) of financial assistance to local and Indian tribal 
governments. Grantees shall:
    (1) Ensure that every subgrant includes a provision for compliance 
with this part;
    (2) Ensure that every subgrant includes any clauses required by 
Federal statute and executive orders and their implementing regulations; 
and
    (3) Ensure that subgrantees are aware of requirements imposed upon 
them by Federal statutes and regulations.
    (c) Exceptions. By their own terms, certain provisions of this part 
do not apply to the award and administration of subgrants:
    (1) Section 1403.10;
    (2) Section 1403.11;
    (3) The letter-of-credit procedures specified in Treasury 
Regulations at 31 CFR part 205, cited in Sec. 1403.21; and
    (4) Section 1403.50.

              Reports, Records, Retention, and Enforcement



Sec. 1403.40  Monitoring and reporting program performance.

    (a) Monitoring by grantees. Grantees are responsible for managing 
the day-to-day operations of grant and subgrant supported activities. 
Grantees must monitor grant and subgrant supported activities to assure 
compliance with applicable Federal requirements and that performance 
goals are being achieved. Grantee monitoring must cover each program, 
function or activity.
    (b) Nonconstruction performance reports. The Federal agency may, if 
it decides that performance information available from subsequent 
applications contains sufficient information to meet its programmatic 
needs, require the grantee to submit a performance report only upon 
expiration or termination of grant support. Unless waived by the Federal 
agency this report will be due on the same date as the final Financial 
Status Report.
    (1) Grantees shall submit annual performance reports unless the 
awarding agency requires quarterly or semi-annual reports. However, 
performance reports will not be required more frequently than quarterly. 
Annual reports shall be due 90 days after the grant year, quarterly or 
semi-annual reports shall be due 30 days after the reporting period. The 
final performance report will be due 90 days after the expiration or 
termination of grant support. If a justified request is submitted by a 
grantee, the Federal agency may extend the due date for any performance 
report. Additionally, requirements for unnecessary performance reports 
may be waived by the Federal agency.
    (2) Performance reports will contain, for each grant, brief 
information on the following:
    (i) A comparison of actual accomplishments to the objectives 
established for the period. Where the output of the project can be 
quantified, a computation of the cost per unit of output may be required 
if that information will be useful.
    (ii) The reasons for slippage if established objectives were not 
met.
    (iii) Additional pertinent information including, when appropriate, 
analysis and explanation of cost overruns or high unit costs.
    (3) Grantees will not be required to submit more than the original 
and two copies of performance reports.

[[Page 220]]

    (4) Grantees will adhere to the standards in this section in 
prescribing performance reporting requirements for subgrantees.
    (c) Construction performance reports. For the most part, on-site 
technical inspections and certified percentage-of-completion data are 
relied on heavily by Federal agencies to monitor progress under 
construction grants and subgrants. The Federal agency will require 
additional formal performance reports only when considered necessary, 
and never more frequently than quarterly.
    (d) Significant developments. Events may occur between the scheduled 
performance reporting dates which have significant impact upon the grant 
or subgrant supported activity. In such cases, the grantee must inform 
the Federal agency as soon as the following types of conditions become 
known:
    (1) Problems, delays, or adverse conditions which will materially 
impair the ability to meet the objective of the award. This disclosure 
must include a statement of the action taken, or contemplated, and any 
assistance needed to resolve the situation.
    (2) Favorable developments which enable meeting time schedules and 
objectives sooner or at less cost than anticipated or producing more 
beneficial results than originally planned.
    (e) Federal agencies may make site visits as warranted by program 
needs.
    (f) Waivers, extensions. (1) Federal agencies may waive any 
performance report required by this part if not needed.
    (2) The grantee may waive any performance report from a subgrantee 
when not needed. The grantee may extend the due date for any performance 
report from a subgrantee if the grantee will still be able to meet its 
performance reporting obligations to the Federal agency.



Sec. 1403.41  Financial reporting.

    (a) General. (1) Except as provided in paragraphs (a) (2) and (5) of 
this section, grantees will use only the forms specified in paragraphs 
(a) through (e) of this section, and such supplementary or other forms 
as may from time to time be authorized by OMB, for:
    (i) Submitting financial reports to Federal agencies, or
    (ii) Requesting advances or reimbursements when letters of credit 
are not used.
    (2) Grantees need not apply the forms prescribed in this section in 
dealing with their subgrantees. However, grantees shall not impose more 
burdensome requirements on subgrantees.
    (3) Grantees shall follow all applicable standard and supplemental 
Federal agency instructions approved by OMB to the extent required under 
the Paperwork Reduction Act of 1980 for use in connection with forms 
specified in paragraphs (b) through (e) of this section. Federal 
agencies may issue substantive supplementary instructions only with the 
approval of OMB. Federal agencies may shade out or instruct the grantee 
to disregard any line item that the Federal agency finds unnecessary for 
its decision making purposes.
    (4) Grantees will not be required to submit more than the original 
and two copies of forms required under this part.
    (5) Federal agencies may provide computer outputs to grantees to 
expedite or contribute to the accuracy of reporting. Federal agencies 
may accept the required information from grantees in machine usable 
format or computer printouts instead of prescribed forms.
    (6) Federal agencies may waive any report required by this section 
if not needed.
    (7) Federal agencies may extend the due date of any financial report 
upon receiving a justified request from a grantee.
    (b) Financial Status Report--(1) Form. Grantees will use Standard 
Form 269 or 269A, Financial Status Report, to report the status of funds 
for all nonconstruction grants and for construction grants when required 
in accordance with paragraph Sec. 1403.41(e)(2)(iii) of this section.
    (2) Accounting basis. Each grantee will report program outlays and 
program income on a cash or accrual basis as prescribed by the awarding 
agency. If the Federal agency requires accrual information and the 
grantee's accounting records are not normally kept on the accrual basis, 
the grantee shall not be

[[Page 221]]

required to convert its accounting system but shall develop such accrual 
information through an analysis of the documentation on hand.
    (3) Frequency. The Federal agency may prescribe the frequency of the 
report for each project or program. However, the report will not be 
required more frequently than quarterly. If the Federal agency does not 
specify the frequency of the report, it will be submitted annually. A 
final report will be required upon expiration or termination of grant 
support.
    (4) Due date. When reports are required on a quarterly or semiannual 
basis, they will be due 30 days after the reporting period. When 
required on an annual basis, they will be due 90 days after the grant 
year. Final reports will be due 90 days after the expiration or 
termination of grant support.
    (c) Federal Cash Transactions Report--(1) Form. (i) For grants paid 
by letter of credit, Treasury check advances or electronic transfer of 
funds, the grantee will submit the Standard Form 272, Federal Cash 
Transactions Report, and when necessary, its continuation sheet, 
Standard Form 272a, unless the terms of the award exempt the grantee 
from this requirement.
    (ii) These reports will be used by the Federal agency to monitor 
cash advanced to grantees and to obtain disbursement or outlay 
information for each grant from grantees. The format of the report may 
be adapted as appropriate when reporting is to be accomplished with the 
assistance of automatic data processing equipment provided that the 
information to be submitted is not changed in substance.
    (2) Forecasts of Federal cash requirements. Forecasts of Federal 
cash requirements may be required in the ``Remarks'' section of the 
report.
    (3) Cash in hands of subgrantees. When considered necessary and 
feasible by the Federal agency, grantees may be required to report the 
amount of cash advances in excess of three days' needs in the hands of 
their subgrantees or contractors and to provide short narrative 
explanations of actions taken by the grantee to reduce the excess 
balances.
    (4) Frequency and due date. Grantees must submit the report no later 
than 15 working days following the end of each quarter. However, where 
an advance either by letter of credit or electronic transfer of funds is 
authorized at an annualized rate of one million dollars or more, the 
Federal agency may require the report to be submitted within 15 working 
days following the end of each month.
    (d) Request for advance or reimbursement--(1) Advance payments. 
Requests for Treasury check advance payments will be submitted on 
Standard Form 270, Request for Advance or Reimbursement. (This form will 
not be used for drawdowns under a letter of credit, electronic funds 
transfer or when Treasury check advance payments are made to the grantee 
automatically on a predetermined basis.)
    (2) Reimbursements. Requests for reimbursement under nonconstruction 
grants will also be submitted on Standard Form 270. (For reimbursement 
requests under construction grants, see paragraph (e)(1) of this 
section.)
    (3) The frequency for submitting payment requests is treated in 
Sec. 1403.41(b)(3).
    (e) Outlay report and request for reimbursement for construction 
programs--(1) Grants that support construction activities paid by 
reimbursement method. (i) Requests for reimbursement under construction 
grants will be submitted on Standard Form 271, Outlay Report and Request 
for Reimbursement for Construction Programs. Federal agencies may, 
however, prescribe the Request for Advance or Reimbursement form, 
specified in Sec. 1403.41(d), instead of this form.
    (ii) The frequency for submitting reimbursement requests is treated 
in Sec. 1403.41(b)(3).
    (2) Grants that support construction activities paid by letter of 
credit, electronic funds transfer or Treasury check advance. (i) When a 
construction grant is paid by letter of credit, electronic funds 
transfer or Treasury check advances, the grantee will report its outlays 
to the Federal agency using Standard Form 271, Outlay Report and Request 
for Reimbursement for Construction Programs. The Federal agency will 
provide any necessary special instruction. However, frequency and

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due date shall be governed by Sec. 1403.41(b) (3) and (4).
    (ii) When a construction grant is paid by Treasury check advances 
based on periodic requests from the grantee, the advances will be 
requested on the form specified in Sec. 1403.41(d).
    (iii) The Federal agency may substitute the Financial Status Report 
specified in Sec. 1403.41(b) for the Outlay Report and Request for 
Reimbursement for Construction Programs.
    (3) Accounting basis. The accounting basis for the Outlay Report and 
Request for Reimbursement for Construction Programs shall be governed by 
Sec. 1403.41(b)(2).



Sec. 1403.42  Retention and access requirements for records.

    (a) Applicability. (1) This section applies to all financial and 
programmatic records, supporting documents, statistical records, and 
other records of grantees or subgrantees which are:
    (i) Required to be maintained by the terms of this Part, program 
regulations or the grant agreement, or
    (ii) Otherwise reasonably considered as pertinent to program 
regulations or the grant agreement.
    (2) This section does not apply to records maintained by contractors 
or subcontractors. For a requirement to place a provision concerning 
records in certain kinds of contracts, see Sec. 1403.36(i)(10).
    (b) Length of retention period. (1) Except as otherwise provided, 
records must be retained for three years from the starting date 
specified in paragraph (c) of this section.
    (2) If any litigation, claim, negotiation, audit or other action 
involving the records has been started before the expiration of the 3-
year period, the records must be retained until completion of the action 
and resolution of all issues which arise from it, or until the end of 
the regular 3-year period, whichever is later.
    (3) To avoid duplicate recordkeeping, awarding agencies may make 
special arrangements with grantees and subgrantees to retain any records 
which are continuously needed for joint use. The awarding agency will 
request transfer of records to its custody when it determines that the 
records possess long-term retention value. When the records are 
transferred to or maintained by the Federal agency, the 3-year retention 
requirement is not applicable to the grantee or subgrantees.
    (c) Starting date of retention period--(1) General. When grant 
support is continued or renewed at annual or other intervals, the 
retention period for the records of each funding period starts on the 
day the grantee or subgrantee submits to the awarding agency its single 
or last expenditure report for that period. However, if grant support is 
continued or renewed quarterly, the retention period for each year's 
records starts on the day the grantee submits its expenditure report for 
the last quarter of the Federal fiscal year. In all other cases, the 
retention period starts on the day the grantee submits its final 
expenditure report. If an expenditure report has been waived, the 
retention period starts on the day the report would have been due.
    (2) Real property and equipment records. The retention period for 
real property and equipment records starts from the date of the 
disposition or replacement or transfer at the direction of the awarding 
agency.
    (3) Records for income transactions after grant or subgrant support. 
In some cases grantees must report income after the period of grant 
support. Where there is such a requirement, the retention period for the 
records pertaining to the earning of the income starts from the end of 
the grantee's fiscal year in which the income is earned.
    (4) Indirect cost rate proposals, cost allocations plans, etc. This 
paragraph applies to the following types of documents, and their 
supporting records: indirect cost rate computations or proposals, cost 
allocation plans, and any similar accounting computations of the rate at 
which a particular group of costs is chargeable (such as computer usage 
chargeback rates or composite fringe benefit rates).
    (i) If submitted for negotiation. If the proposal, plan, or other 
computation is required to be submitted to the Federal Government (or to 
the grantee) to form the basis for negotiation of the rate, then the 3-
year retention period for its supporting records starts from the date of 
such submission.

[[Page 223]]

    (ii) If not submitted for negotiation. If the proposal, plan, or 
other computation is not required to be submitted to the Federal 
Government (or to the grantee) for negotiation purposes, then the 3-year 
retention period for the proposal plan, or computation and its 
supporting records starts from end of the fiscal year (or other 
accounting period) covered by the proposal, plan, or other computation.
    (d) Substitution of microfilm. Copies made by microfilming, 
photocopying, or similar methods may be substituted for the original 
records.
    (e) Access to records--(1) Records of grantees and subgrantees. The 
awarding agency and the Comptroller General of the United States, or any 
of their authorized representatives, shall have the right of access to 
any pertinent books, documents, papers, or other records of grantees and 
subgrantees which are pertinent to the grant, in order to make audits, 
examinations, excerpts, and transcripts.
    (2) Expiration of right of access. The rights of access in this 
section must not be limited to the required retention period but shall 
last as long as the records are retained.
    (f) Restrictions on public access. The Federal Freedom of 
Information Act (5 U.S.C. 552) does not apply to records. Unless 
required by Federal, State, or local law, grantees and subgrantees are 
not required to permit public access to their records.



Sec. 1403.43  Enforcement.

    (a) Remedies for noncompliance. If a grantee or subgrantee 
materially fails to comply with any term of an award, whether stated in 
a Federal statute or regulation, an assurance, in a State plan or 
application, a notice of award, or elsewhere, the awarding agency may 
take one or more of the following actions, as appropriate in the 
circumstances:
    (1) Temporarily withhold cash payments pending correction of the 
deficiency by the grantee or subgrantee or more severe enforcement 
action by the awarding agency,
    (2) Disallow (that is, deny both use of funds and matching credit 
for) all or part of the cost of the activity or action not in 
compliance,
    (3) Wholly or partly suspend or terminate the current award for the 
grantee's or subgrantee's program,
    (4) Withhold further awards for the program, or
    (5) Take other remedies that may be legally available.
    (b) Hearings, appeals. In taking an enforcement action, the awarding 
agency will provide the grantee or subgrantee an opportunity for such 
hearing, appeal, or other administrative proceeding to which the grantee 
or subgrantee is entitled under any statute or regulation applicable to 
the action involved.
    (c) Effects of suspension and termination. Costs of grantee or 
subgrantee resulting from obligations incurred by the grantee or 
subgrantee during a suspension or after termination of an award are not 
allowable unless the awarding agency expressly authorizes them in the 
notice of suspension or termination or subsequently. Other grantee or 
subgrantee costs during suspension or after termination which are 
necessary and not reasonably avoidable are allowable if:
    (1) The costs result from obligations which were properly incurred 
by the grantee or subgrantee before the effective date of suspension or 
termination, are not in anticipation of it, and, in the case of a 
termination, are noncancellable, and,
    (2) The costs would be allowable if the award were not suspended or 
expired normally at the end of the funding period in which the 
termination takes effect.
    (d) Relationship to Debarment and Suspension. The enforcement 
remedies identified in this section, including suspension and 
termination, do not preclude grantee or subgrantee from being subject to 
``Debarment and Suspension'' under E.O. 12549 (see Sec. 1403.35).



Sec. 1403.44  Termination for convenience.

    Except as provided in Sec. 1403.43 awards may be terminated in 
whole or in part only as follows:
    (a) By the awarding agency with the consent of the grantee or 
subgrantee in which case the two parties shall agree upon the 
termination conditions, including the effective date and in the

[[Page 224]]

case of partial termination, the portion to be terminated, or
    (b) By the grantee or subgrantee upon written notification to the 
awarding agency, setting forth the reasons for such termination, the 
effective date, and in the case of partial termination, the portion to 
be terminated. However, if, in the case of a partial termination, the 
awarding agency determines that the remaining portion of the award will 
not accomplish the purposes for which the award was made, the awarding 
agency may terminate the award in its entirety under either Sec. 
1403.43 or paragraph (a) of this section.



                 Subpart D_After-The-Grant Requirements



Sec. 1403.50  Closeout.

    (a) General. The Federal agency will close out the award when it 
determines that all applicable administrative actions and all required 
work of the grant has been completed.
    (b) Reports. Within 90 days after the expiration or termination of 
the grant, the grantee must submit all financial, performance, and other 
reports required as a condition of the grant. Upon request by the 
grantee, Federal agencies may extend this time frame. These may include 
but are not limited to:
    (1) Final performance or progress report.
    (2) Financial Status Report (SF 269) or Outlay Report and Request 
for Reimbursement for Construction Programs (SF-271) (as applicable).
    (3) Final request for payment (SF-270) (if applicable).
    (4) Invention disclosure (if applicable).
    (5) Federally-owned property report: In accordance with Sec. 
1403.32(f), a grantee must submit an inventory of all federally owned 
property (as distinct from property acquired with grant funds) for which 
it is accountable and request disposition instructions from the Federal 
agency of property no longer needed.
    (c) Cost adjustment. The Federal agency will, within 90 days after 
receipt of reports in paragraph (b) of this section, make upward or 
downward adjustments to the allowable costs.
    (d) Cash adjustments. (1) The Federal agency will make prompt 
payment to the grantee for allowable reimbursable costs.
    (2) The grantee must immediately refund to the Federal agency any 
balance of unobligated (unencumbered) cash advanced that is not 
authorized to be retained for use on other grants.



Sec. 1403.51  Later disallowances and adjustments.

    The closeout of a grant does not affect:
    (a) The Federal agency's right to disallow costs and recover funds 
on the basis of a later audit or other review;
    (b) The grantee's obligation to return any funds due as a result of 
later refunds, corrections, or other transactions;
    (c) Records retention as required in Sec. 1403.42;
    (d) Property management requirements in Sec. 1403.31 and Sec. 
1403.32; and
    (e) Audit requirements in Sec. 1403.26.



Sec. 1403.52  Collection of amounts due.

    (a) Any funds paid to a grantee in excess of the amount to which the 
grantee is finally determined to be entitled under the terms of the 
award constitute a debt to the Federal Government. If not paid within a 
reasonable period after demand, the Federal agency may reduce the debt 
by:
    (1) Making an administrative offset against other requests for 
reimbursement,
    (2) Withholding advance payments otherwise due to the grantee, or
    (3) Other action permitted by law.
    (b) Except where otherwise provided by statutes or regulations, the 
Federal agency will charge interest on an overdue debt in accordance 
with the Federal Claims Collection Standards (4 CFR ch. II). The date 
from which interest is computed is not extended by litigation or the 
filing of any form of appeal.

Subpart E--Entitlement [Reserved]

Appendix A to Part 1403--OMB Circular A-128, ``Audits of State and Local 
                              Governments''

Circular No. A-128
April 12, 1985.

[[Page 225]]

To the Heads of Executive Departments and Establishments
Subject: Audits of State and Local Governments.
    1. Purpose. This Circular is issued pursuant to the Single Audit Act 
of 1984, Pub. L. 98-502. It establishes audit requirements for State and 
local governments that receive Federal aid, and defines Federal 
responsibilities for implementing and monitoring those requirements.
    2. Supersession. The Circular supersedes Attachment P, ``Audit 
Requirements,'' of Circular A-102, ``Uniform requirements for grants to 
State and local governments.''
    3. Background. The Single Audit Act builds upon earlier efforts to 
improve audits of Federal aid programs. The Act requires State or local 
governments that receive $100,000 or more a year in Federal funds to 
have an audit made for that year. Section 7505 of the Act requires the 
Director of the Office of Management and Budget to prescribe policies, 
procedures and guidelines to implement the Act. It specifies that the 
Director shall designate ``cognizant'' Federal agencies, determine 
criteria for making appropriate charges to federal programs for the cost 
of audits, and provide procedures to assure that small firms or firms 
owned and controlled by disadvantaged individuals have the opportunity 
to participate in contracts for single audits.
    4. Policy. The Single Audit Act requires the following:
    a. State or local governments that receive $100,000 or more a year 
in Federal financial assistance shall have an audit made in accordance 
with this Circular.
    b. State or local governments that receive between $25,000 and 
$100,000 a year shall have an audit made in accordance with this 
Circular, or in accordance with Federal laws and regulations governing 
the programs they participate in.
    c. State or local governments that receive less than $25,000 a year 
shall be exempt from compliance with the Act and other Federal audit 
requirements. These State and local governments shall be governed by 
audit requirements prescribed by State or local law or regulation.
    d. Nothing in this paragraph exempts State or local governments from 
maintaining records of Federal financial assistance or from providing 
access to such records to Federal agencies, as provided for in Federal 
law or in Circular A-102, ``Uniform requirements for grants to state or 
local governments.''
    5. Definitions. For the purposes of this Circular the following 
definitions from the Single Audit Act apply:
    a. Cognizant agency means the Federal agency assigned by the Office 
of Management and Budget to carry out the responsibilities described in 
paragraph 11 of this Circular.
    b. Federal financial assistance means assistance provided by a 
Federal agency in the form of grants, contracts, cooperative agreements, 
loans, loan guarantees, property, interest subsidies, insurance, or 
direct appropriations, but does not include direct Federal cash 
assistance to individuals. It includes awards received directly from 
Federal agencies, or indirectly through other units of States and local 
governments.
    c. Federal agency has the same meaning as the term ``agency'' in 
section 551(1) of Title 5, United States Code.
    d. Generally accepted accounting principles has the meaning 
specified in the generally accepted government auditing standards.
    e. Generally accepted government auditing standards means the 
Standards For Audit of Government Organizations, Programs, Activities, 
and Functions, developed by the Comptroller General, dated February 27, 
1981.
    f. Independent auditor means:
    (1) A State or local government auditor who meets the independence 
standards specified in generally accepted government auditing standards; 
or
    (2) A public accountant who meets such independence standards.
    g. Internal controls means the plan of organization and methods and 
procedures adopted by management to ensure that:
    (1) Resource use is consistent with laws, regulations, and policies;
    (2) Resources are safeguarded against waste, loss, and misuse; and
    (3) Reliable data are obtained, maintained, and fairly disclosed in 
reports.
    h. Indian tribe means any Indian tribe, band, nations, or other 
organized group or community, including any Alaskan Native village or 
regional or village corporations (as defined in, or established under, 
the Alaskan Native Claims Settlement Act) that is recognized by the 
United States as eligible for the special programs and services provided 
by the United States to Indians because of their status as Indians.
    i. Local government means any unit of local government within a 
State, including a county, a borough, municipality, city, town, 
township, parish, local public authority, special district, school 
district, intrastate district, council of government, and any other 
instrumentality of local government.
    j. Major Federal Assistance Program, as defined by Pub. L. 98-502, 
is described in the Attachment to this Circular.
    k. Public accountants means those individuals who meet the 
qualification standards included in generally accepted government 
auditing standards for personnel performing government audits.

[[Page 226]]

    l. State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
American Samoa, the Commonwealth of the Northern Mariana Islands, and 
the Trust Territory of the Pacific Islands, any instrumentality thereof, 
and any multi-State, regional, or interstate entity that has 
governmental functions and any Indian tribe.
    m. Subrecipient means any person or government department, agency, 
or establishment that receives Federal financial assistance to carry out 
a program through a State or local government, but does not include an 
individual that is a beneficiary of such a program. A subrecipient may 
also be a direct recipient of Federal financial assistance.
    6. Scope of audit. The Single Act provides that:
    a. The audit shall be made by an independent auditor in accordance 
with generally accepted government auditing standards covering financial 
and compliance audits.
    b. The audit shall cover the entire operations of a State or local 
government or, at the option of that government, it may cover 
departments, agencies or establishments that received, expended, or 
otherwise administered Federal financial assistance during the year. 
However, if a State or local government receives $25,000 or more in 
General Revenue Sharing Funds in a fiscal year, it shall have an audit 
of its entire operations. A series of audits of individual departments, 
agencies, and establishments for the same fiscal year may be considered 
a single audit.
    c. Public hospitals and public colleges and universities may be 
excluded from State and local audits and the requirements of this 
Circular. However, if such entities are excluded, audits of these 
entities shall be made in accordance with statutory requirements and the 
provisions of Circular A-110, ``Uniform requirements for grants to 
universities, hospitals, and other nonprofit organizations.''
    d. The auditor shall determine whether:
    (1) The financial statements of the government, department, agency 
or establishment present fairly its financial position and the results 
of its financial operations in accordance with generally accepted 
accounting principles;
    (2) The organization has internal accounting and other control 
systems to provide reasonable assurance that it is managing Federal 
financial assistance programs in compliance with applicable laws and 
regulations; and
    (3) The organization has complied with laws and regulations that may 
have material effect on its financial statements and on each major 
Federal assistance program.
    7. Frequency of audit. Audits shall be made annually unless the 
State or local government has, by January 1, 1987, a constitutional or 
statutory requirement for less frequent audits. For those governments, 
the cognizant agency shall permit biennial audits, covering both years, 
if the government so requests. It shall also honor requests for biennial 
audits by governments that have an administrative policy calling for 
audits less frequent than annual, but only for fiscal years beginning 
before January 1, 1987.
    8. Internal control and compliance reviews. The Single Audit Act 
requires that the independent auditor determine and report on whether 
the organization has internal control systems to provide reasonable 
assurance that it is managing Federal assistance programs in compliance 
with applicable laws and regulations.
    a. Internal control review. In order to provide this assurance the 
auditor must make a study and evaluation of internal control systems 
used in administering Federal assistance programs. The study and 
evaluation must be made whether or not the auditor intends to place 
reliance on such systems. As part of this review, the auditor shall:
    (1) Test whether these internal control systems are functioning in 
accordance with prescribed procedures.
    (2) Examine the recipient's system for monitoring subrecipients and 
obtaining and acting on subrecipient audit reports.
    b. Compliance review. The law also requires the auditor to determine 
whether the organization has complied with laws and regulations that may 
have a material effect on each major Federal assistance program.
    (1) In order to determine which major programs are to be tested for 
compliance, State and local governments shall identify in their accounts 
all Federal funds received and expended and the programs under which 
they were received. This shall include funds received directly from 
Federal agencies and through other State and local governments.
    (2) The review must include the selection and testing of a 
representative number of charges from each major Federal assistance 
program. The selection and testing of transactions shall be based on the 
auditor's professional judgment considering such factors as the amount 
of expenditures for the program and the individual awards; the newness 
of the program or changes in its conditions; prior experience with the 
program, particularly as revealed in audits and other evaluations (e.g., 
inspections program reviews); the extent to which the program is carried 
out through subrecipients; the extent to which the program contracts for 
goods or services; the level to which the program is already subject to 
program reviews or other forms of independent oversight; the adequacy of 
the controls for ensuring compliance; the exception of adherence or lack 
of adherence to the applicable laws and regulations; and the potential 
impact of adverse findings.

[[Page 227]]

    (a) In making the test of transactions, the auditor shall determine 
whether:
--The amounts reported as expenditures were for allowable services, and
--The records show that those who received services or benefits were 
eligible to receive them.
    (b) In addition to transaction testing, the auditor shall determine 
whether:
--Matching requirements, levels of effort and earmarking limitations 
were met,
--Federal financial reports and claims for advances and reimbursements 
contain information that is supported by the books and records from 
which the basic financial statements have been prepared, and
--Amounts claimed or used for matching were determined in accordance 
with OMB Circular A-87, ``Cost principles for State and local 
governments,'' and Attachment F of Circular A-102, ``Uniform 
requirements for grants to State and local governments.''
    (c) The principal compliance requirements of the largest Federal aid 
programs may be ascertained by referring to the Compliance Supplement 
for Single Audits of State and Local Governments, issued by OMB and 
available from the Government Printing Office. For those programs not 
covered in the Compliance Supplement, the auditor may ascertain 
compliance requirements by researching the statutes, regulations, and 
agreements governing individual programs.
    (3) Transactions related to other Federal assistance programs that 
are selected in connection with examinations of financial statements and 
evaluations of internal controls shall be tested for compliance with 
Federal laws and regulations that apply to such transactions.
    9. Subrecipients. State or local governments that receive Federal 
financial assistance and provide $25,000 or more of it in a fiscal year 
to a subrecipient shall:
    a. Determine whether State or local subrecipients have met the audit 
requirements of this Circular and whether subrecipients covered by 
Circular A-110, ``Uniform requirements for grants to universities, 
hospitals, and other nonprofit organizations,'' have met that 
requirement;
    b. Determine whether the subrecipient spent Federal assistance funds 
provided in accordance with applicable laws and regulations. This may be 
accomplished by reviewing an audit of the subrecipient made in 
accordance with this Circular, Circular A-110, or through other means 
(e.g., program reviews) if the subrecipient has not yet had such an 
audit;
    c. Ensure that appropriate corrective action is taken within six 
months after receipt of the audit report in instances of noncompliance 
with Federal laws and regulations;
    d. Consider whether subrecipient audits necessitate adjustment of 
the recipient's own records; and
    e. Require each subrecipient to permit independent auditors to have 
access to the records and financial statements as necessary to comply 
with this Circular.
    10. Relation to other audit requirements. The Single Audit Act 
provides that an audit made in accordance with this Circular shall be in 
lieu of any financial or financial compliance audit required under 
individual Federal assistance programs. To the extent that a single 
audit provides Federal agencies with information and assurances they 
need to carry out their overall responsibilities, they shall rely upon 
and use such information. However, a Federal agency shall make any 
additional audits which are necessary to carry out its responsibilities 
under Federal law and regulation. Any additional Federal audit effort 
shall be planned and carried out in such a way as to avoid duplication.
    a. The provisions of this Circular do not limit the authority of 
Federal agencies to make, or contract for audits and evaluations of 
Federal financial assistance programs, nor do they limit the authority 
of any Federal agency Inspector General or other Federal audit official.
    b. The provisions of this Circular do not authorize any State or 
local government or subrecipient thereof to constrain Federal agencies, 
in any manner, from carrying out additional audits.
    c. A Federal agency that makes or contracts for audits in addition 
to the audits made by recipients pursuant to this Circular shall, 
consistent with other applicable laws and regulations, arrange for 
funding the cost of such additional audits. Such additional audits 
include economy and efficiency audits, program results audits, and 
program evaluations.
    11. Cognizant agency responsibilities. The Single Audit Act provides 
for cognizant Federal agencies to oversee the implementation of this 
Circular.
    a. The Office of Management and Budget will assign cognizant 
agencies for States and their subdivisions and larger local governments 
and their subdivisions. Other Federal agencies may participate with an 
assigned cognizant agency, in order to fulfill the cognizance 
responsibilities. Smaller governments not assigned a cognizant agency 
will be under the general oversight of the Federal agency that provides 
them the most funds whether directly or indirectly.
    b. A cognizant agency shall have the following responsibilities:
    (1) Ensure that audits are made and reports are received in a timely 
manner and in accordance with the requirements of this Circular.

[[Page 228]]

    (2) Provide technical advice and liaison to State and local 
governments and independent auditors.
    (3) Obtain or make quality control reviews of selected audits made 
by non-Federal audit organizations, and provide the results, when 
appropriate, to other interested organizations.
    (4) Promptly inform other affected Federal agencies and appropriate 
Federal law enforcement officials of any reported illegal acts or 
irregularities. They should also inform State or local law enforcement 
and prosecuting authorities, if not advised by the recipient, of any 
violation of law within their jurisdiction.
    (5) Advise the recipient of audits that have been found not to have 
met the requirements set forth in this Circular. In such instances, the 
recipient will be expected to work with the auditor to take corrective 
action. If corrective action is not taken, the cognizant agency shall 
notify the recipient and Federal awarding agencies of the facts and make 
recommendations for followup action. Major inadequacies or repetitive 
substandard performance of independent auditors shall be referred to 
appropriate professional bodies for disciplinary action.
    (6) Coordinate, to the extent practicable, audits made by or for 
Federal agencies that are in addition to the audits made pursuant to 
this Circular; so that the additional audits build upon such audits.
    (7) Oversee the resolution of audit findings that affect the 
programs of more than one agency.
    12. Illegal acts or irregularities. If the auditor becomes aware of 
illegal acts or other irregularities, prompt notice shall be given to 
recipient management officials above the level of involvement. (See also 
paragraph 13(a)(3) below for the auditor's reporting responsibilities.) 
The recipient, in turn, shall promptly notify the cognizant agency of 
the illegal acts or irregularities and of proposed and actual actions, 
if any. Illegal acts and irregularities include such matters as 
conflicts of interest, falsification of records or reports, and 
misappropriations of funds or other assets.
    13. Audit reports. Audit reports must be prepared at the completion 
of the audit. Reports serve many needs of State and local governments as 
well as meeting the requirements of the Single Audit Act.
    a. The audit report shall state that the audit was made in 
accordance with the provisions of this Circular. The report shall be 
made up of at least:
    (1) The auditor's report on financial statements and on a schedule 
of Federal assistance; the financial statements; and a schedule of 
Federal assistance, showing the total expenditures for each Federal 
assistance program as identified in the Catalog of Federal Domestic 
Assistance. Federal programs or grants that have not been assigned a 
catalog number shall be identified under the caption ``other Federal 
assistance.''
    (2) The auditor's report on the study and evaluation of internal 
control systems must identify the organization's significant internal 
accounting controls, and those controls designed to provide reasonable 
assurance that Federal programs are being managed in compliance with 
laws and regulations. It must also identify the controls that were 
evaluated, the controls that were not evaluated, and the material 
weaknesses identified as a result of the evaluation.
    (3) The auditor's report on compliance containing:
--A statement of positive assurance with respect to those items tested 
for compliance, including compliance with law and regulations pertaining 
to financial reports and claims for advances and reimbursements;
--Negative assurance on those items not tested;
--A summary of all instances of noncompliance; and
--An identification of total amounts questioned, if any, for each 
Federal assistance award, as a result of noncompliance.
    b. The three parts of the audit report may be bound into a single 
report, or presented at the same time as separate documents.
    c. All fraud abuse, or illegal acts or indications of such acts, 
including all questioned costs found as the result of these acts that 
auditors become aware of, should normally be covered in a separate 
written report submitted in accordance with paragraph 13f.
    d. In addition to the audit report, the recipient shall provide 
comments on the findings and recommendations in the report, including a 
plan for corrective action taken or planned and comments on the status 
of corrective action taken on prior findings. If corrective action is 
not necessary, a statement describing the reason it is not should 
accompany the audit report.
    e. The reports shall be made available by the State or local 
government for public inspection within 30 days after the completion of 
the audit.
    f. In accordance with generally accepted government audit standards, 
reports shall be submitted by the auditor to the organization audited 
and to those requiring or arranging for the audit. In addition, the 
recipient shall submit copies of the reports to each Federal department 
or agency that provided Federal assistance funds to the recipient. 
Subrecipients shall submit copies to recipients that provided them 
Federal assistance funds. The reports shall be sent within 30 days after 
the completion of the audit, but no later than one year after the end of 
the audit period unless a longer period is agreed to with the cognizant 
agency.
    g. Recipients of more than $100,000 in Federal funds shall submit 
one copy of the audit

[[Page 229]]

report within 30 days after issuance to a central clearinghouse to be 
designated by the Office of Management and Budget. The clearinghouse 
will keep completed audits on file and follow up with State and local 
governments that have not submitted required audit reports.
    h. Recipients shall keep audit reports on file for three years from 
their issuance.
    14. Audit Resolution. As provided in paragraph 11, the cognizant 
agency shall be responsible for monitoring the resolution of audit 
findings that affect the programs of more than one Federal agency. 
Resolution of findings that relate to the programs of a single Federal 
agency will be the responsibility of the recipient and that agency. 
Alternate arrangements may be made on a case-by-case basis by agreement 
among the agencies concerned.
    Resolution shall be made within six months after receipt of the 
report by the Federal departments and agencies. Corrective action should 
proceed as rapidly as possible.
    15. Audit workpapers and reports. Workpapers and reports shall be 
retained for a minimum of three years from the date of the audit report, 
unless the auditor is notified in writing by the cognizant agency to 
extend the retention period. Audit workpapers shall be made available 
upon request to the cognizant agency or its designee or the General 
Accounting Office, at the completion of the audit.
    16. Audit Costs. The cost of audits made in accordance with the 
provisions of this Circular are allowable charges to Federal assistance 
programs.
    a. The charges may be considered a direct cost or an allocated 
indirect cost, determined in accordance with the provision of Circular 
A-87, ``Cost principles for State and local governments.''
    b. Generally, the percentage of costs charged to Federal assistance 
programs for a single audit shall not exceed the percentage that Federal 
funds expended represent of total funds expended by the recipient during 
the fiscal year. The percentage may be exceeded, however, if appropriate 
documentation demonstrates higher actual cost.
    17. Sanctions. The Single Audit Act provides that no cost may be 
charged to Federal assistance programs for audits required by the Act 
that are not made in accordance with this Circular. In cases of 
continued inability or unwillingness to have a proper audit, Federal 
agencies must consider other appropriate sanctions including:
--Withhodling a percentage of assistance payments until the audit is 
completed satisfactorily,
--Withholding or disallowing overhead costs, and
--Suspending the Federal assistance agreement until the audit is made.
    18. Auditor Selection. In arranging for audit services State and 
local governments shall follow the procurement standards prescribed by 
Attachment O of Circular A-102, ``Uniform requirements for grants to 
State and local governments.'' The standards provide that while 
recipients are encouraged to enter into intergovernmental agreements for 
audit and other services, analysis should be made to determine whether 
it would be more economical to purchase the services from private firms. 
In instances where use of such intergovernmental agreements are required 
by State statutes (e.g., audit services) these statutes will take 
precedence.
    19. Small and Minority Audit Firms. Small audit firms and audit 
firms owned and controlled by socially and economically disadvantaged 
individuals shall have the maximum practicable opportunity to 
participate in contracts awarded to fulfill the requirements of this 
Circular. Recipients of Federal assistance shall take the following 
steps to further this goal:
    a. Assure that small audit firms and audit firms owned and 
controlled by socially and economically disadvantaged individuals are 
used to the fullest extent practicable.
    b. Make information on forthcoming opportunities available and 
arrange time frames for the audit so as to encourage and facilitate 
participation by small audit firms and audit firms owned and controlled 
by socially and economically disadvantaged individuals.
    c. Consider in the contract process whether firms competing for 
larger audits intend to subcontract with small audit firms and audit 
firms owned and controlled by socially and economically disadvantaged 
individuals.
    d. Encourage contracting with small audit firms or audit firms owned 
and controlled by socially and economically disadvantaged individuals 
which have traditionally audited government programs and, in such cases 
where this is not possible, assure that these firms are given 
consideration for audit subcontracting opportunities.
    e. Encourage contracting with consortiums of small audit firms as 
described in paragraph (a) above when a contract is too large for an 
individual small audit firm or audit firm owned and controlled by 
socially and economically disadvantaged individuals.
    f. Use the services and assistance, as appropriate, of such 
organizations as the Small Business Administration in the solicitation 
and utilization of small audit firms or audit firms owned and controlled 
by socially and economically disadvantaged individuals.
    20. Reporting. Each Federal agency will report to the Director of 
OMB on or before March 1, 1987, and annually thereafter on the 
effectiveness of State and local governments in carrying out the 
provisions of this Circular. The report must identify each State or 
local government or Indian tribe that, in the

[[Page 230]]

opinion of the agency, is failing to comply with Circular.
    21. Regulations. Each Federal agency shall include the provisions of 
this Circular in its regulations implementing the Single Audit Act.
    22. Effective date. This Circular is effective upon publication and 
shall apply to fiscal years of State and local governments that begin 
after December 31, 1984. Earlier implementation is encouraged. However, 
until it is implemented, the audit provisions of Attachment P to 
Circular A-102 shall continue to be observed.
    23. Inquiries. All questions or inquiries should be addressed to 
Financial Management Division, Office of Management and Budget, 
telephone number (202) 395-3993.
    24. Sunset review date. This Circular shall have an independent 
policy review to ascertain its effectiveness three years from the date 
of issuance.

David A. Stockman,
    Director.

                        Circular A-128 Attachment

        Definition of Major Program as Provided in Pub. L. 98-502

    ``Major Federal Assistance Program,'' for State and local 
governments having Federal assistance expenditures between $100,000 and 
$100,000,000. means any program for which Federal expenditures during 
the applicable year exceed the larger of $300,000, or 3 percent of such 
total expenditures.
    Where total expenditures of Federal assistance exceed $100,000,000, 
the following criteria apply:

------------------------------------------------------------------------
     Total expenditures of Federal financial           Major Federal
           assistance for all programs              assistance program
------------------------------------------------- means any program that
       More than              But less than               exceeds
------------------------------------------------------------------------
$100 million             1 billion                $3 million
    1 billion            2 billion                4 million
    2 billion            3 billion                7 million
    3 billion            4 billion                10 million
    4 billion            5 billion                13 million
    5 billion            6 billion                16 million
    6 billion            7 billion                19 million
Over 7 billion           .......................  20 million
------------------------------------------------------------------------


[57 FR 55092, Nov. 24, 1992; 58 FR 26185, Apr. 30, 1993]



PART 1404_GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)--Table 
of Contents

Sec.
1404.25 How is this part organized?
1404.50 How is this part written?
1404.75 Do terms in this part have special meanings?

                            Subpart A_General

1404.100 What does this part do?
1404.105 Does this part apply to me?
1404.110 What is the purpose of the nonprocurement debarment and 
          suspension system?
1404.115 How does an exclusion restrict a person's involvement in 
          covered transactions?
1404.120 May we grant an exception to let an excluded person participate 
          in a covered transaction?
1404.125 Does an exclusion under the nonprocurement system affect a 
          person's eligibility for Federal procurement contracts?
1404.130 Does exclusion under the Federal procurement system affect a 
          person's eligibility to participate in nonprocurement 
          transactions?
1404.135 May the Office of National Drug Control Policy exclude a person 
          who is not currently participating in a nonprocurement 
          transaction?
1404.140 How do I know if a person is excluded?
1404.145 Does this part address persons who are disqualified, as well as 
          those who are excluded from nonprocurement transactions?

                     Subpart B_Covered Transactions

1404.200 What is a covered transaction?
1404.205 Why is it important to know if a particular transaction is a 
          covered transaction?
1404.210 Which nonprocurement transactions are covered transactions?
1404.215 Which nonprocurement transactions are not covered transactions?
1404.220 Are any procurement contracts included as covered transactions?
1404.225 How do I know if a transaction in which I may participate is a 
          covered transaction?

    Subpart C_Responsibilities of Participants Regarding Transactions

                    Doing Business With Other Persons

1404.300 What must I do before I enter into a covered transaction with 
          another person at the next lower tier?
1404.305 May I enter into a covered transaction with an excluded or 
          disqualified person?
1404.310 What must I do if a Federal agency excludes a person with whom 
          I am already doing business in a covered transaction?
1404.315 May I use the services of an excluded person as a principal 
          under a covered transaction?

[[Page 231]]

1404.320 Must I verify that principals of my covered transactions are 
          eligible to participate?
1404.325 What happens if I do business with an excluded person in a 
          covered transaction?
1404.330 What requirements must I pass down to persons at lower tiers 
          with whom I intend to do business?

            Disclosing Information--Primary Tier Participants

1404.335 What information must I provide before entering into a covered 
          transaction with the Office of National Drug Control Policy?
1404.340 If I disclose unfavorable information required under Sec. 
          1404.335, will I be prevented from participating in the 
          transaction?
1404.345 What happens if I fail to disclose the information required 
          under Sec. 1404.335?
1404.350 What must I do if I learn of the information required under 
          Sec. 1404.335 after entering into a covered transaction with 
          the Office of National Drug Control Policy?

             Disclosing Information--Lower Tier Participants

1404.355 What information must I provide to a higher tier participant 
          before entering into a covered transaction with that 
          participant?
1404.360 What happens if I fail to disclose the information required 
          under Sec. 1404.355?
1404.365 What must I do if I learn of information required under Sec. 
          1404.355 after entering into a covered transaction with a 
          higher tier participant?

  Subpart D_Responsibilities of Office of National Drug Control Policy 
                    Officials Regarding Transactions

1404.400 May I enter into a transaction with an excluded or disqualified 
          person?
1404.405 May I enter into a covered transaction with a participant if a 
          principal of the transaction is excluded?
1404.410 May I approve a participant's use of the services of an 
          excluded person?
1404.415 What must I do if a Federal agency excludes the participant or 
          a principal after I enter into a covered transaction?
1404.420 May I approve a transaction with an excluded or disqualified 
          person at a lower tier?
1404.425 When do I check to see if a person is excluded or disqualified?
1404.430 How do I check to see if a person is excluded or disqualified?
1404.435 What must I require of a primary tier participant?
1404.440 What method do I use to communicate those requirements to 
          participants?
1404.445 What action may I take if a primary tier participant knowingly 
          does business with an excluded or disqualified person?
1404.450 What action may I take if a primary tier participant fails to 
          disclose the information required under Sec. 1404.335?
1404.455 What may I do if a lower tier participant fails to disclose the 
          information required under Sec. 1404.355 to the next higher 
          tier?

                 Subpart E_Excluded Parties List System

1404.500 What is the purpose of the Excluded Parties List System (EPLS)?
1404.505 Who uses the EPLS?
1404.510 Who maintains the EPLS?
1404.515 What specific information is in the EPLS?
1404.520 Who places the information into the EPLS?
1404.525 Whom do I ask if I have questions about a person in the EPLS?
1404.530 Where can I find the EPLS?

   Subpart F_General Principles Relating to Suspension and Debarment 
                                 Actions

1404.600 How do suspension and debarment actions start?
1404.605 How does suspension differ from debarment?
1404.610 What procedures does the Office of National Drug Control Policy 
          use in suspension and debarment actions?
1404.615 How does the Office of National Drug Control Policy notify a 
          person of a suspension and debarment action?
1404.620 Do Federal agencies coordinate suspension and debarment 
          actions?
1404.625 What is the scope of a suspension or debarment action?
1404.630 May the Office of National Drug Control Policy impute the 
          conduct of one person to another?
1404.635 May the Office of National Drug Control Policy settle a 
          debarment or suspension action?
1404.640 May a settlement include a voluntary exclusion?
1404.645 Do other Federal agencies know if the Office of National Drug 
          Control Policy agrees to a voluntary exclusion?

                          Subpart G_Suspension

1404.700 When may the suspending official issue a suspension?
1404.705 What does the suspending official consider in issuing a 
          suspension?
1404.710 When does a suspension take effect?
1404.715 What notice does the suspending official give me if I am 
          suspended?

[[Page 232]]

1404.720 How may I contest a suspension?
1404.725 How much time do I have to contest a suspension?
1404.730 What information must I provide to the suspending official if I 
          contest a suspension?
1404.735 Under what conditions do I get an additional opportunity to 
          challenge the facts on which the suspension is based?
1404.740 Are suspension proceedings formal?
1404.745 How is fact-finding conducted?
1404.750 What does the suspending official consider in deciding whether 
          to continue or terminate my suspension?
1404.755 When will I know whether the suspension is continued or 
          terminated?
1404.760 How long may my suspension last?

                           Subpart H_Debarment

1404.800 What are the causes for debarment?
1404.805 What notice does the debarring official give me if I am 
          proposed for debarment?
1404.810 When does a debarment take effect?
1404.815 How may I contest a proposed debarment?
1404.820 How much time do I have to contest a proposed debarment?
1404.825 What information must I provide to the debarring official if I 
          contest a proposed debarment?
1404.830 Under what conditions do I get an additional opportunity to 
          challenge the facts on which the proposed debarment is based?
1404.835 Are debarment proceedings formal?
1404.840 How is fact-finding conducted?
1404.845 What does the debarring official consider in deciding whether 
          to debar me?
1404.850 What is the standard of proof in a debarment action?
1404.855 Who has the burden of proof in a debarment action?
1404.860 What factors may influence the debarring official's decision?
1404.865 How long may my debarment last?
1404.870 When do I know if the debarring official debars me?
1404.875 May I ask the debarring official to reconsider a decision to 
          debar me?
1404.880 What factors may influence the debarring official during 
          reconsideration?
1404.885 May the debarring official extend a debarment?

                          Subpart I_Definitions

1404.900 Adequate evidence.
1404.905 Affiliate.
1404.910 Agency.
1404.915 Agent or representative.
1404.920 Civil judgment.
1404.925 Conviction.
1404.930 Debarment.
1404.935 Debarring official.
1404.940 Disqualified.
1404.945 Excluded or exclusion.
1404.950 Excluded Parties List System.
1404.955 Indictment.
1404.960 Ineligible or ineligibility.
1404.965 Legal proceedings.
1404.970 Nonprocurement transaction.
1404.975 Notice.
1404.980 Participant.
1404.985 Person.
1404.990 Preponderance of the evidence.
1404.995 Principal.
1404.1000 Respondent.
1404.1005 State.
1404.1010 Suspending official.
1404.1015 Suspension.
1404.1020 Voluntary exclusion or voluntarily excluded.

Subpart J [Reserved]

Appendix to Part 1404--Covered Transactions

    Authority: E.O. 12549 3 CFR 1986 Comp., p. 189; E.O. 12689 3 CFR 
1989 Comp., p. 235; sec. 2455, Pub. L. 103-355, 108 Stat. 3327 (31 
U.S.C. 6101 note); 21 U.S.C. 1701.

    Source:  68 FR 66544, 66580, 66581, Nov. 26, 2003, unless otherwise 
noted.



Sec. 1404.25  How is this part organized?

    (a) This part is subdivided into ten subparts. Each subpart contains 
information related to a broad topic or specific audience with special 
responsibilities, as shown in the following table:

------------------------------------------------------------------------
       In subpart . . .        You will find provisions related to . . .
------------------------------------------------------------------------
A............................  general information about this rule.
B............................  the types of Office of National Drug
                                Control Policy transactions that are
                                covered by the Governmentwide
                                nonprocurement suspension and debarment
                                system.
C............................  the responsibilities of persons who
                                participate in covered transactions.
D............................  the responsibilities of Office of
                                National Drug Control Policy officials
                                who are authorized to enter into covered
                                transactions.
E............................  the responsibilities of Federal agencies
                                for the Excluded Parties List System
                                (Disseminated by the General Services
                                Administration).
F............................  the general principles governing
                                suspension, debarment, voluntary
                                exclusion and settlement.
G............................  suspension actions.
H............................  debarment actions.
I............................  definitions of terms used in this part.

[[Page 233]]

 
J............................  [Reserved]
------------------------------------------------------------------------

    (b) The following table shows which subparts may be of special 
interest to you, depending on who you are:

------------------------------------------------------------------------
             If you are . . .                   See subpart(s) . . .
------------------------------------------------------------------------
(1) a participant or principal in a         A, B, C, and I.
 nonprocurement transaction.
(2) a respondent in a suspension action...  A, B, F, G and I.
(3) a respondent in a debarment action....  A, B, F, H and I.
(4) a suspending official.................  A, B, D, E, F, G and I.
(5) a debarring official..................  A, B, D, E, F, H and I.
(6) a (n) Office of National Drug Control   A, B, D, E and I.
 Policy official authorized to enter into
 a covered transaction.
(7) Reserved..............................  J.
------------------------------------------------------------------------



Sec. 1404.50  How is this part written?

    (a) This part uses a ``plain language'' format to make it easier for 
the general public and business community to use. The section headings 
and text, often in the form of questions and answers, must be read 
together.
    (b) Pronouns used within this part, such as ``I'' and ``you,'' 
change from subpart to subpart depending on the audience being 
addressed. The pronoun ``we'' always is the Office of National Drug 
Control Policy.
    (c) The ``Covered Transactions'' diagram in the appendix to this 
part shows the levels or ``tiers'' at which the Office of National Drug 
Control Policy enforces an exclusion under this part.



Sec. 1404.75  Do terms in this part have special meanings?

    This part uses terms throughout the text that have special meaning. 
Those terms are defined in Subpart I of this part. For example, three 
important terms are--
    (a) Exclusion or excluded, which refers only to discretionary 
actions taken by a suspending or debarring official under this part or 
the Federal Acquisition Regulation (48 CFR part 9, subpart 9.4);
    (b) Disqualification or disqualified, which refers to prohibitions 
under specific statutes, executive orders (other than Executive Order 
12549 and Executive Order 12689), or other authorities. 
Disqualifications frequently are not subject to the discretion of an 
agency official, may have a different scope than exclusions, or have 
special conditions that apply to the disqualification; and
    (c) Ineligibility or ineligible, which generally refers to a person 
who is either excluded or disqualified.



                            Subpart A_General



Sec. 1404.100  What does this part do?

    This part adopts a governmentwide system of debarment and suspension 
for Office of National Drug Control Policy nonprocurement activities. It 
also provides for reciprocal exclusion of persons who have been excluded 
under the Federal Acquisition Regulation, and provides for the 
consolidated listing of all persons who are excluded, or disqualified by 
statute, executive order, or other legal authority. This part satisfies 
the requirements in section 3 of Executive Order 12549, ``Debarment and 
Suspension'' (3 CFR 1986 Comp., p. 189), Executive Order 12689, 
``Debarment and Suspension'' (3 CFR 1989 Comp., p. 235) and 31 U.S.C. 
6101 note (Section 2455, Public Law 103-355, 108 Stat. 3327).



Sec. 1404.105  Does this part apply to me?

    Portions of this part (see table at Sec. 1404.25(b)) apply to you 
if you are a(n)--
    (a) Person who has been, is, or may reasonably be expected to be, a 
participant or principal in a covered transaction;
    (b) Respondent (a person against whom the Office of National Drug 
Control Policy has initiated a debarment or suspension action);
    (c) Office of National Drug Control Policy debarring or suspending 
official; or
    (d) Office of National Drug Control Policy official who is 
authorized to enter into covered transactions with non-Federal parties.

[[Page 234]]



Sec. 1404.110  What is the purpose of the nonprocurement debarment and 
suspension system?

    (a) To protect the public interest, the Federal Government ensures 
the integrity of Federal programs by conducting business only with 
responsible persons.
    (b) A Federal agency uses the nonprocurement debarment and 
suspension system to exclude from Federal programs persons who are not 
presently responsible.
    (c) An exclusion is a serious action that a Federal agency may take 
only to protect the public interest. A Federal agency may not exclude a 
person or commodity for the purposes of punishment.



Sec. 1404.115  How does an exclusion restrict a person's involvement in 
covered transactions?

    With the exceptions stated in Sec. Sec. 1404.120, 1404.315, and 
1404.420, a person who is excluded by the Office of National Drug 
Control Policy or any other Federal agency may not:
    (a) Be a participant in a(n) Office of National Drug Control Policy 
transaction that is a covered transaction under subpart B of this part;
    (b) Be a participant in a transaction of any other Federal agency 
that is a covered transaction under that agency's regulation for 
debarment and suspension; or
    (c) Act as a principal of a person participating in one of those 
covered transactions.



Sec. 1404.120  May we grant an exception to let an excluded person 
participate in a covered transaction?

    (a) The Director of National Drug Control Policy may grant an 
exception permitting an excluded person to participate in a particular 
covered transaction. If the Director of National Drug Control Policy 
grants an exception, the exception must be in writing and state the 
reason(s) for deviating from the governmentwide policy in Executive 
Order 12549.
    (b) An exception granted by one agency for an excluded person does 
not extend to the covered transactions of another agency.



Sec. 1404.125  Does an exclusion under the nonprocurement system 
affect a person's eligibility for Federal procurement contracts?

    If any Federal agency excludes a person under its nonprocurement 
common rule on or after August 25, 1995, the excluded person is also 
ineligible to participate in Federal procurement transactions under the 
FAR. Therefore, an exclusion under this part has reciprocal effect in 
Federal procurement transactions.



Sec. 1404.130  Does exclusion under the Federal procurement system 
affect a person's eligibility to participate in nonprocurement transactions?

    If any Federal agency excludes a person under the FAR on or after 
August 25, 1995, the excluded person is also ineligible to participate 
in nonprocurement covered transactions under this part. Therefore, an 
exclusion under the FAR has reciprocal effect in Federal nonprocurement 
transactions.



Sec. 1404.135  May the Office of National Drug Control Policy exclude 
a person who is not currently participating in a nonprocurement transaction?

    Given a cause that justifies an exclusion under this part, we may 
exclude any person who has been involved, is currently involved, or may 
reasonably be expected to be involved in a covered transaction.



Sec. 1404.140  How do I know if a person is excluded?

    Check the Excluded Parties List System (EPLS) to determine whether a 
person is excluded. The General Services Administration (GSA) maintains 
the EPLS and makes it available, as detailed in subpart E of this part. 
When a Federal agency takes an action to exclude a person under the 
nonprocurement or procurement debarment and suspension system, the 
agency enters the information about the excluded person into the EPLS.



Sec. 1404.145  Does this part address persons who are disqualified, as 
well as those who are excluded from nonprocurement transactions?

    Except if provided for in Subpart J of this part, this part--

[[Page 235]]

    (a) Addresses disqualified persons only to--
    (1) Provide for their inclusion in the EPLS; and
    (2) State responsibilities of Federal agencies and participants to 
check for disqualified persons before entering into covered 
transactions.
    (b) Does not specify the--
    (1) Office of National Drug Control Policy transactions for which a 
disqualified person is ineligible. Those transactions vary on a case-by-
case basis, because they depend on the language of the specific statute, 
Executive order, or regulation that caused the disqualification;
    (2) Entities to which the disqualification applies; or
    (3) Process that the agency uses to disqualify a person. Unlike 
exclusion, disqualification is frequently not a discretionary action 
that a Federal agency takes.



                     Subpart B_Covered Transactions



Sec. 1404.200  What is a covered transaction?

    A covered transaction is a nonprocurement or procurement transaction 
that is subject to the prohibitions of this part. It may be a 
transaction at--
    (a) The primary tier, between a Federal agency and a person (see 
appendix to this part); or
    (b) A lower tier, between a participant in a covered transaction and 
another person.



Sec. 1404.205  Why is it important if a particular transaction is a 
covered transaction?

    The importance of a covered transaction depends upon who you are.
    (a) As a participant in the transaction, you have the 
responsibilities laid out in Subpart C of this part. Those include 
responsibilities to the person or Federal agency at the next higher tier 
from whom you received the transaction, if any. They also include 
responsibilities if you subsequently enter into other covered 
transactions with persons at the next lower tier.
    (b) As a Federal official who enters into a primary tier 
transaction, you have the responsibilities laid out in subpart D of this 
part.
    (c) As an excluded person, you may not be a participant or principal 
in the transaction unless--
    (1) The person who entered into the transaction with you allows you 
to continue your involvement in a transaction that predates your 
exclusion, as permitted under Sec. 1404.310 or Sec. 1404.415; or
    (2) A(n) Office of National Drug Control Policy official obtains an 
exception from the Director of National Drug Control Policy to allow you 
to be involved in the transaction, as permitted under Sec. 1404.120.



Sec. 1404.210  Which nonprocurement transactions are covered transactions?

    All nonprocurement transactions, as defined in Sec. 1404.970, are 
covered transactions unless listed in Sec. 1404.215. (See appendix to 
this part.)



Sec. 1404.215  Which nonprocurement transactions are not covered 
transactions?

    The following types of nonprocurement transactions are not covered 
transactions:
    (a) A direct award to--
    (1) A foreign government or foreign governmental entity;
    (2) A public international organization;
    (3) An entity owned (in whole or in part) or controlled by a foreign 
government; or
    (4) Any other entity consisting wholly or partially of one or more 
foreign governments or foreign governmental entities.
    (b) A benefit to an individual as a personal entitlement without 
regard to the individual's present responsibility (but benefits received 
in an individual's business capacity are not excepted). For example, if 
a person receives social security benefits under the Supplemental 
Security Income provisions of the Social Security Act, 42 U.S.C. 1301 et 
seq., those benefits are not covered transactions and, therefore, are 
not affected if the person is excluded.
    (c) Federal employment.
    (d) A transaction that the Office of National Drug Control Policy 
needs to

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respond to a national or agency-recognized emergency or disaster.
    (e) A permit, license, certificate, or similar instrument issued as 
a means to regulate public health, safety, or the environment, unless 
the Office of National Drug Control Policy specifically designates it to 
be a covered transaction.
    (f) An incidental benefit that results from ordinary governmental 
operations.
    (g) Any other transaction if the application of an exclusion to the 
transaction is prohibited by law.



Sec. 1404.220  Are any procurement contracts included as covered 
transactions?

    (a) Covered transactions under this part--
    (1) Do not include any procurement contracts awarded directly by a 
Federal agency; but
    (2) Do include some procurement contracts awarded by non-Federal 
participants in nonprocurement covered transactions (see appendix to 
this part).
    (b) Specifically, a contract for goods or services is a covered 
transaction if any of the following applies:
    (1) The contract is awarded by a participant in a nonprocurement 
transaction that is covered under Sec. 1404.210, and the amount of the 
contract is expected to equal or exceed $25,000.
    (2) The contract requires the consent of a(n) Office of National 
Drug Control Policy official. In that case, the contract, regardless of 
the amount, always is a covered transaction, and it does not matter who 
awarded it. For example, it could be a subcontract awarded by a 
contractor at a tier below a nonprocurement transaction, as shown in the 
appendix to this part.
    (3) The contract is for federally-required audit services.



Sec. 1404.225  How do I know if a transaction in which I may participate 
is a covered transaction?

    As a participant in a transaction, you will know that it is a 
covered transaction because the agency regulations governing the 
transaction, the appropriate agency official, or participant at the next 
higher tier who enters into the transaction with you, will tell you that 
you must comply with applicable portions of this part.



    Subpart C_Responsibilities of Participants Regarding Transactions

                    Doing Business With Other Persons



Sec. 1404.300  What must I do before I enter into a covered transaction 
with another person at the next lower tier?

    When you enter into a covered transaction with another person at the 
next lower tier, you must verify that the person with whom you intend to 
do business is not excluded or disqualified. You do this by:
    (a) Checking the EPLS; or
    (b) Collecting a certification from that person if allowed by this 
rule; or
    (c) Adding a clause or condition to the covered transaction with 
that person.



Sec. 1404.305  May I enter into a covered transaction with an excluded 
or disqualified person?

    (a) You as a participant may not enter into a covered transaction 
with an excluded person, unless the Office of National Drug Control 
Policy grants an exception under Sec. 1404.120.
    (b) You may not enter into any transaction with a person who is 
disqualified from that transaction, unless you have obtained an 
exception under the disqualifying statute, Executive order, or 
regulation.



Sec. 1404.310  What must I do if a Federal agency excludes a person 
with whom I am already doing business in a covered transaction?

    (a) You as a participant may continue covered transactions with an 
excluded person if the transactions were in existence when the agency 
excluded the person. However, you are not required to continue the 
transactions, and you may consider termination. You should make a 
decision about whether to terminate and the type of termination action, 
if any, only after a thorough review to ensure that the action is proper 
and appropriate.
    (b) You may not renew or extend covered transactions (other than no-
cost time extensions) with any excluded

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person, unless the Office of National Drug Control Policy grants an 
exception under Sec. 1404.120.



Sec. 1404.315  May I use the services of an excluded person as a 
principal under a covered transaction?

    (a) You as a participant may continue to use the services of an 
excluded person as a principal under a covered transaction if you were 
using the services of that person in the transaction before the person 
was excluded. However, you are not required to continue using that 
person's services as a principal. You should make a decision about 
whether to discontinue that person's services only after a thorough 
review to ensure that the action is proper and appropriate.
    (b) You may not begin to use the services of an excluded person as a 
principal under a covered transaction unless the Office of National Drug 
Control Policy grants an exception under Sec. 1404.120.



Sec. 1404.320  Must I verify that principals of my covered transactions 
are eligible to participate?

    Yes, you as a participant are responsible for determining whether 
any of your principals of your covered transactions is excluded or 
disqualified from participating in the transaction. You may decide the 
method and frequency by which you do so. You may, but you are not 
required to, check the EPLS.



Sec. 1404.325  What happens if I do business with an excluded person 
in a covered transaction?

    If as a participant you knowingly do business with an excluded 
person, we may disallow costs, annul or terminate the transaction, issue 
a stop work order, debar or suspend you, or take other remedies as 
appropriate.



Sec. 1404.330  What requirements must I pass down to persons at lower 
tiers with whom I intend to do business?

    Before entering into a covered transaction with a participant at the 
next lower tier, you must require that participant to--
    (a) Comply with this subpart as a condition of participation in the 
transaction. You may do so using any method(s), unless Sec. 1404.440 
requires you to use specific methods.
    (b) Pass the requirement to comply with this subpart to each person 
with whom the participant enters into a covered transaction at the next 
lower tier.

            Disclosing Information--Primary Tier Participants



Sec. 1404.335  What information must I provide before entering into a 
covered transaction with the Office of National Drug Control Policy?

    Before you enter into a covered transaction at the primary tier, you 
as the participant must notify the Office of National Drug Control 
Policy office that is entering into the transaction with you, if you 
know that you or any of the principals for that covered transaction:
    (a) Are presently excluded or disqualified;
    (b) Have been convicted within the preceding three years of any of 
the offenses listed in Sec. 1404.800(a) or had a civil judgment 
rendered against you for one of those offenses within that time period;
    (c) Are presently indicted for or otherwise criminally or civilly 
charged by a governmental entity (Federal, State or local) with 
commission of any of the offenses listed in Sec. 1404.800(a); or
    (d) Have had one or more public transactions (Federal, State, or 
local) terminated within the preceding three years for cause or default.



Sec. 1404.340  If I disclose unfavorable information required under 
Sec. 1404.335, will I be prevented from participating in the transaction?

    As a primary tier participant, your disclosure of unfavorable 
information about yourself or a principal under Sec. 1404.335 will not 
necessarily cause us to deny your participation in the covered 
transaction. We will consider the information when we determine whether 
to enter into the covered transaction. We also will consider any 
additional information or explanation that you elect to submit with the 
disclosed information.

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Sec. 1404.345  What happens if I fail to disclose information required 
under Sec. 1404.335?

    If we later determine that you failed to disclose information under 
Sec. 1404.335 that you knew at the time you entered into the covered 
transaction, we may--
    (a) Terminate the transaction for material failure to comply with 
the terms and conditions of the transaction; or
    (b) Pursue any other available remedies, including suspension and 
debarment.



Sec. 1404.350  What must I do if I learn of information required under 

Sec. 1404.335 after entering into a covered transaction with the Office 
of National 
          Drug Control Policy?

    At any time after you enter into a covered transaction, you must 
give immediate written notice to the Office of National Drug Control 
Policy office with which you entered into the transaction if you learn 
either that--
    (a) You failed to disclose information earlier, as required by Sec. 
1404.335; or
    (b) Due to changed circumstances, you or any of the principals for 
the transaction now meet any of the criteria in Sec. 1404.335.

             Disclosing Information--Lower Tier Participants



Sec. 1404.355  What information must I provide to a higher tier participant 
before entering into a covered transaction with that participant?