[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2017 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 21

Food and Drugs


________________________

Part 1300 to End

                         Revised as of April 1, 2017

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2017
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

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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      275
  Finding Aids:
      Table of CFR Titles and Chapters........................     285
      Alphabetical List of Agencies Appearing in the CFR......     305
      List of CFR Sections Affected...........................     315

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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, 2017), 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.

PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
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Affected'' is published at the end of each CFR volume. For changes to 
the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not accidentally dropped due to a printing or computer error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
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to materials already published elsewhere. For an incorporation to be 
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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.
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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 Authorities 
and Rules. A list of CFR titles, chapters, subchapters, and parts and an 
alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

    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.

REPUBLICATION OF MATERIAL

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in the Code of Federal Regulations.

INQUIRIES

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the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-741-6000 
or write to the Director, Office of the Federal Register, National 
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register.
    The e-CFR is a regularly updated, unofficial editorial compilation 
of CFR material and Federal Register amendments, produced by the Office 
of the Federal Register and the Government Publishing Office. It is 
available at www.ecfr.gov.

    Oliver A. Potts,
    Director,
    Office of the Federal Register.
    April 1, 2017.

                                
                                      
                            

  

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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 to 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, 2017.

    For this volume, Michele Bugenhagen was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

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                         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.          23
1302            Labeling and packaging requirements for 
                    controlled substances...................          58
1303            Quotas......................................          60
1304            Records and reports of registrants..........          68
1305            Orders for schedule I and II controlled 
                    substances..............................          88
1306            Prescriptions...............................          96
1307            Miscellaneous...............................         108
1308            Schedules of controlled substances..........         110
1309            Registration of manufacturers, distributors, 
                    importers and exporters of list I 
                    chemicals...............................         135
1310            Records and reports of listed chemicals and 
                    certain machines; importation and 
                    exportation of certain machines.........         146
1311            Requirements for electronic orders and 
                    prescriptions...........................         172
1312            Importation and exportation of controlled 
                    substances..............................         193
1313            Importation and exportation of list I and 
                    list II chemicals.......................         217
1314            Retail sale of scheduled listed chemical 
                    products................................         230
1315            Importation and production quotas for 
                    ephedrine, pseudoephedrine, and 
                    phenylpropanolamine.....................         237
1316            Administrative functions, practices, and 
                    procedures..............................         248
1317            Disposal....................................         261
1321            DEA Mailing addresses.......................         270
1322-1399

  [Reserved]

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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.
1300.03  Definitions relating to electronic orders for controlled 
          substances and electronic prescriptions for controlled 
          substances.
1300.04  Definitions relating to the dispensing of controlled substances 
          by means of the Internet.
1300.05  Definitions relating to the disposal of controlled substances.

    Authority: 21 U.S.C. 802, 821, 822, 829, 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, 1312, and 1317 of this 
chapter, the following terms shall have the meanings specified:
    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).
    Administration means the Drug Enforcement Administration.
    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).
    Anabolic steroid means any drug or hormonal substance, chemically 
and pharmacologically related to testosterone (other than estrogens, 
progestins, corticosteroids, and dehydroepiandrosterone), and includes:

(1) 3[beta],17-dihydroxy-5a-androstane
(2) 3[alpha],17[beta]-dihydroxy-5a-androstane
(3) 5[alpha]-androstan-3,17-dione
(4) 1-androstenediol (3[beta],17[beta]-dihydroxy-5[alpha]-androst-1-ene)
(5) 1-androstenediol (3[alpha],17[beta]-dihydroxy-5[alpha]-androst-1-
ene)
(6) 4-androstenediol (3[beta],17[beta]-dihydroxy-androst-4-ene)
(7) 5-androstenediol (3[beta],17[beta]-dihydroxy-androst-5-ene)
(8) 1-androstenedione ([5[alpha]]-androst-1-en-3,17-dione)
(9) 4-androstenedione (androst-4-en-3,17-dione)
(10) 5-androstenedione (androst-5-en-3,17-dione)
(11) bolasterone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyandrost-4-
en-3-one)
(12) boldenone (17[beta]-hydroxyandrost-1,4-diene-3-one)
(13) boldione (androsta-1,4-diene-3,17-dione)
(14) calusterone (7[beta],17[alpha]-dimethyl-17[beta]-hydroxyandrost-4-
en-3-one)
(15) clostebol (4-chloro-17[beta]-hydroxyandrost-4-en-3-one)
(16) dehydrochloromethyltestosterone (4-chloro-17[beta]-hydroxy-
17[alpha]-methyl-androst-1,4-dien-3-one)
(17) desoxymethyltestosterone (17[alpha]-methyl-5[alpha]-androst-2-en-
17[beta]-ol) (a.k.a. `madol`)
(18) [Delta]1-dihydrotestosterone (a.k.a.`1-testosterone`) (17[beta]-
hydroxy-5[alpha]-androst-1-en-3-one)
(19) 4-dihydrotestosterone (17[beta]-hydroxy-androstan-3-one)
(20) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-5[alpha]-androstan-
3-one)
(21) ethylestrenol (17[alpha]-ethyl-17[beta]-hydroxyestr-4-ene)
(22) fluoxymesterone (9-fluoro-17[alpha]-methyl-11[beta],17[beta]-
dihydroxyandrost-4-en-3-one)
(23) formebolone (2-formyl-17[alpha]-methyl-11[alpha],17[beta]-
dihydroxyandrost-1,4-dien-3-one)
(24) furazabol (17[alpha]-methyl-17[beta]-hydroxyandrostano[2,3-c]-
furazan)
(25) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one
(26) 4-hydroxytestosterone (4,17[beta]-dihydroxy-androst-4-en-3-one)
(27) 4-hydroxy-19-nortestosterone (4,17[beta]-dihydroxy-estr-4-en-3-one)
(28) mestanolone (17[alpha]-methyl-17[beta]-hydroxy-5-androstan-3-one)
(29) mesterolone (1[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-androstan-
3-one)
(30) methandienone (17[alpha]-methyl-17[beta]-hydroxyandrost-1,4-dien-3-
one)
(31) methandriol (17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-5-
ene)
(32) Methasterone (2[alpha],17[alpha]-dimethyl-5[alpha]-androstan-
17[beta]-ol-3-one)
(33) methenolone (1-methyl-17[beta]-hydroxy-5[alpha]-androst-1-en-3-one)

[[Page 6]]

(34) 17[alpha]-methyl-3[beta],17[beta]-dihydroxy-5a-androstane
(35) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy-5a-androstane
(36) 17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-4-ene
(37) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-methyl-4-hydroxy-
17[beta]-hydroxyestr-4-en-3-one)
(38) methyldienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9(10)-
dien-3-one)
(39) methyltrienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9,11-
trien-3-one)
(40) methyltestosterone (17[alpha]-methyl-17[beta]-hydroxyandrost-4-en-
3-one)
(41) mibolerone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyestr-4-en-
3-one)
(42) 17[alpha]-methyl-[Delta]1-dihydrotestosterone (17[beta]-hydroxy-
17[alpha]-methyl-5[alpha]-androst-1-en-3-one) (a.k.a. `17-[alpha]-
methyl-1-testosterone`)
(43) nandrolone (17[beta]-hydroxyestr-4-en-3-one)
(44) 19-nor-4-androstenediol (3[beta], 17[beta]-dihydroxyestr-4-ene)
(45) 19-nor-4-androstenediol (3[alpha], 17[beta]-dihydroxyestr-4-ene)
(46) 19-nor-5-androstenediol (3[beta], 17[beta]-dihydroxyestr-5-ene)
(47) 19-nor-5-androstenediol (3[alpha], 17[beta]-dihydroxyestr-5-ene)
(48) 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-diene-3,17-dione)
(49) 19-nor-4-androstenedione (estr-4-en-3,17-dione)
(50) 19-nor-5-androstenedione (estr-5-en-3,17-dione)
(51) norbolethone (13[beta], 17[alpha]-diethyl-17[beta]-hydroxygon-4-en-
3-one)
(52) norclostebol (4-chloro-17[beta]-hydroxyestr-4-en-3-one)
(53) norethandrolone (17[alpha]-ethyl-17[beta]-hydroxyestr-4-en-3-one)
(54) normethandrolone (17[alpha]-methyl-17[beta]-hydroxyestr-4-en-3-one)
(55) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-2-oxa-[5[alpha]]-
androstan-3-one)
(56) oxymesterone (17[alpha]-methyl-4,17[beta]-dihydroxyandrost-4-en-3-
one)
(57) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-17[beta]-hydroxy-
[5[alpha]]-androstan-3-one)
(58) Prostanozol (17[beta]-hydroxy-5[alpha]-androstano[3,2-c]pyrazole)
(59) stanozolol (17[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-androst-2-
eno[3,2-c]-pyrazole)
(60) stenbolone (17[beta]-hydroxy-2-methyl-[5[alpha]]-androst-1-en-3-
one)
(61) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic 
acid lactone)
(62) testosterone (17[beta]-hydroxyandrost-4-en-3-one)
(63) tetrahydrogestrinone (13[beta], 17[alpha]-diethyl-17[beta]-
hydroxygon-4,9,11-trien-3-one)
(64) trenbolone (17[beta]-hydroxyestr-4,9,11-trien-3-one)
(65) Any salt, ester, or ether of a drug or substance described in this 
paragraph. Except such term does not include an anabolic steroid that is 
expressly intended for administration through implants to cattle or 
other nonhuman species and that 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, the 
person shall be considered to have prescribed, dispensed, or distributed 
an anabolic steroid within the meaning of this paragraph.

    Automated dispensing system means a mechanical system that performs 
operations or activities, other than compounding or administration, 
relative to the storage, packaging, counting, labeling, and dispensing 
of medications, and which collects, controls, and maintains all 
transaction information.
    Basic class means, as to controlled substances listed in Schedules I 
and II:
    (1) 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;
    (2) 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;
    (3) 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;
    (4) Each of the following substances, whether produced directly or 
indirectly

[[Page 7]]

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, including raw opium, opium extracts, opium fluid 
extracts, powdered opium, granulated opium, deodorized opium and 
tincture of opium;
    (ii) Apomorphine;
    (iii) Codeine;
    (iv) Etorphine hydrochloride;
    (v) Ethylmorphine;
    (vi) Hydrocodone;
    (vii) Hydromorphone;
    (viii) Metopon;
    (ix) Morphine;
    (x) Oxycodone;
    (xi) Oxymorphone;
    (xii) Thebaine;
    (xiii) Mixed alkaloids of opium listed in Sec. 1308.12(b)(2) of this 
chapter;
    (xiv) Cocaine; and
    (xv) Ecgonine;
    (5) 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
    (6) Methamphetamine, its salts, isomers, and salts of its isomers;
    (7) Amphetamine, its salts, optical isomers, and salts of its 
optical isomers;
    (8) Phenmetrazine and its salts;
    (9) Methylphenidate;
    (10) 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.
    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.
    Collection means to receive a controlled substance for the purpose 
of destruction from an ultimate user, a person lawfully entitled to 
dispose of an ultimate user decedent's property, or a long-term care 
facility on behalf of an ultimate user who resides or has resided at 
that facility. The term collector means a registered manufacturer, 
distributor, reverse distributor, narcotic treatment program, hospital/
clinic with an on-site pharmacy, or retail pharmacy that is authorized 
under this chapter to so receive a controlled substance for the purpose 
of destruction.
    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.
    Competent national authority, for purposes of importation and 
exportation of controlled substances and listed chemicals, means an 
entity lawfully entitled to authorize the import and export of 
controlled substances, and to regulate or enforce national controls over 
listed chemicals, and included as such in the directory of ``Competent 
National Authorities Under the International Drug Control Treaties'' 
published by the United Nations Office on Drugs and Crime. For purposes 
of exports of narcotic drugs, the term also includes freely associated 
states authorized to receive such exports pursuant to 48 U.S.C. 1972.
    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.

[[Page 8]]

    Controlled substance has the meaning given in section 802(6) of 
Title 21, United States Code (U.S.C.).
    Customs officer means either an Officer of the Customs as defined in 
19 U.S.C. 1401(i) (that is, of the U.S. Customs and Border Protection), 
or any individual duly authorized to accept entries of merchandise, to 
collect duties, and to enforce the customs laws of any commonwealth, 
territory, or possession of the United States.
    Customs territory of the United States means the several States, the 
District of Columbia, and Puerto Rico.
    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.
    (1) Short-term detoxification treatment is for a period not in 
excess of 30 days.
    (2) Long-term detoxification treatment is for a period more than 30 
days but not in excess of 180 days.
    Dispenser means an individual practitioner, institutional 
practitioner, pharmacy or pharmacist who dispenses a controlled 
substance.
    Export means, with respect to any article, any taking out or removal 
of such article from the United States (whether or not such taking out 
or removal constitutes an exportation within the meaning of the customs 
laws, export control laws enforced by other agencies, or related laws of 
the United States).
    Exporter includes every person who exports, or who acts as an export 
broker for exportation of, controlled substances listed in any schedule.
    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 (excluding reverse distributor), and/or importer.
    Hearing means:
    (1) In part 1301 of this chapter, 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).
    (2) 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.
    (3) 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).
    Import means, with respect to any article, any bringing in or 
introduction of such article into the customs territory of the United 
States from any place outside thereof (but within the United States), or 
into the United States from any place outside thereof (whether or not 
such bringing in or introduction constitutes an importation within the 
meaning of the tariff laws of the United States).
    Importer includes every person who imports, or who acts as an import 
broker for importation of, controlled substances listed in any schedule.
    Individual practitioner means a physician, dentist, veterinarian, or 
other individual licensed, registered, or otherwise permitted, by the 
United States or

[[Page 9]]

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.
    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.
    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).
    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).
    Isomer means:
    (1) 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 any optical, positional, or geometric 
isomer. As used in Sec. 1308.12(b)(4) of this chapter, the term 
``isomer'' means any optical or geometric isomer;
    (2) As used in Sec. 1308.11(d) of this chapter, the term 
``positional isomer'' means any substance possessing the same molecular 
formula and core structure and having the same functional group(s) and/
or substituent(s) as those found in the respective Schedule I 
hallucinogen, attached at any position(s) on the core structure, but in 
such manner that no new chemical functionalities are created and no 
existing chemical functionalities are destroyed relative to the 
respective Schedule I hallucinogen. Rearrangements of alkyl moieties 
within or between functional group(s) or substituent(s), or divisions or 
combinations of alkyl moieties, that do not create new chemical 
functionalities or destroy existing chemical functionalities, are 
allowed i.e., result in compounds which are positional isomers. For 
purposes of this definition, the ``core structure'' is the parent 
molecule that is the common basis for the class; for example, 
tryptamine, phenethylamine, or ergoline. Examples of rearrangements 
resulting in creation and/or destruction of chemical functionalities 
(and therefore resulting in compounds which are not positional isomers) 
include, but are not limited to: Ethoxy to alpha-hydroxyethyl, hydroxy 
and methyl to methoxy, or the repositioning of a phenolic or alcoholic 
hydroxy group to create a hydroxyamine. Examples of rearrangements 
resulting in compounds which would be positional isomers include: Tert-
butyl to sec-butyl, methoxy and ethyl to isopropoxy, N,N-diethyl to N-
methyl-N-propyl, or alpha-methylamino to N-methylamino.
    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.
    Labeling means all labels and other written, printed, or graphic 
matter:
    (1) Upon any controlled substance or any of its commercial 
containers or wrappers, or
    (2) Accompanying such controlled substance.
    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.
    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.
    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 substance in the course of his/her 
professional practice, prepares, compounds, packages or labels such 
substance.

[[Page 10]]

    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.
    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.
    Name means the official name, common or usual name, chemical name, 
or brand name of a substance.
    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:
    (1) 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.
    (2) Poppy straw and concentrate of poppy straw.
    (3) Coca leaves, except coca leaves and extracts of coca leaves from 
which cocaine, ecgonine and derivatives of ecgonine or their salts have 
been removed.
    (4) Cocaine, its salts, optical and geometric isomers, and salts of 
isomers.
    (5) Ecgonine, its derivatives, their salts, isomers and salts of 
isomers.
    (6) Any compound, mixture, or preparation which contains any 
quantity of any of the substances referred to in paragraphs (1) through 
(5) of this definition.
    Narcotic treatment program means a program engaged in maintenance 
and/or detoxification treatment with narcotic drugs.
    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.
    Person includes any individual, corporation, government or 
governmental subdivision or agency, business trust, partnership, 
association, or other legal entity.
    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.
    Port of entry means, unless distinguished as being a foreign port of 
entry, any place at which a customs officer is duly authorized to accept 
entries of merchandise, to collect duties, and to enforce the various 
provisions of the customs laws of the United States (whether or not such 
place is a port of entry as defined in title 19 of the United States 
Code or its associated implementing regulations). Examples of ports of 
entry include, but are not limited to, places designated as ports of 
entry or customs stations in title 19 of the Code of Federal Regulations 
or by the governing customs authority of that area. When shipments are 
transported under U.S. Customs and Border Protection's immediate 
transportation

[[Page 11]]

procedures, the port of entry shall be the port of final destination.
    Port of export means, unless distinguished as being a foreign port 
of export, any place under the control of a customs officer where goods 
are loaded on an aircraft, vessel or other conveyance for export outside 
of the United States. For goods loaded aboard an aircraft or vessel in 
the United States, that stops at several ports before departing the 
United States, the port of export is the first port where the goods were 
actually loaded. For goods off-loaded from the original conveyance to 
another conveyance (even if the aircraft or vessel belongs to the same 
carrier) at any port subsequent to the port where the first on-loading 
occurred in the United States, the port where the goods were loaded onto 
the last conveyance before departing the United States is the port of 
export.
    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).
    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 
proposed rule, amended rule, or repeal in the Federal Register.
    Purchaser means any registered person entitled to obtain and execute 
order forms pursuant to Secs. 1305.04 and 1305.06.
    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.
    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).
    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).
    Return information means supplemental information required to be 
reported to the Administration following an import or export transaction 
containing the particulars of the transaction and any other information 
as the Administration may specify.
    Reverse distribute means to acquire controlled substances from 
another registrant or law enforcement for the purpose of:
    (1) Return to the registered manufacturer or another registrant 
authorized by the manufacturer to accept returns on the manufacturer's 
behalf; or
    (2) Destruction.
    Reverse distributor is a person registered with the Administration 
as a reverse distributor.
    Supplier means any registered person entitled to fill order forms 
pursuant to Sec. 1305.06 of this chapter.
    United States, when used in a geographic sense, means all places and 
waters, continental or insular, subject to the jurisdiction of the 
United States, which, in addition to the customs territory of the United 
States, include but are not limited to the U.S. Virgin Islands, Guam, 
American Samoa, and the Northern Mariana Islands.

[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; 70 FR 25465, May 
13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR 60427, Oct. 13, 2006; 72 FR 
67852, Dec. 3, 2007; 74 FR 63609, Dec. 4, 2009; 77 FR 4230, Jan. 27, 
2012; 77 FR 44461, July 30, 2012; 79 FR 53559, Sept. 9, 2014; 81 FR 
97018, Dec. 30, 2016]



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:
    Act means the Controlled Substances Act, as amended (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances

[[Page 12]]

Import and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).
    Administration means the Drug Enforcement Administration.
    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).
    At retail, with respect to the sale or purchase of a scheduled 
listed chemical product, means a sale or purchase for personal use, 
respectively.
    Broker and trader mean any individual, corporation, corporate 
division, partnership, association, or other legal entity which assists 
in arranging an international transaction in a listed chemical by--
    (1) Negotiating contracts;
    (2) Serving as an agent or intermediary; or
    (3) 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.
    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).
    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.
    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.
    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.
    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.
    Competent national authority, for purposes of importation and 
exportation of controlled substances and listed chemicals, means an 
entity lawfully entitled to authorize the import and export of 
controlled substances, and to regulate or enforce national controls over 
listed chemicals, and included as such in the directory of ``Competent 
National Authorities Under the International Drug Control Treaties'' 
published by the United Nations Office on Drugs and Crime.
    Customs officer means either an Officer of the Customs as defined in 
19 U.S.C. 1401(i) (that is, of the U.S. Customs and Border Protection), 
or any individual duly authorized to accept entries of merchandise, to 
collect duties, and to enforce the customs laws of any commonwealth, 
territory, or possession of the United States.
    Customs territory of the United States means the several States, the 
District of Columbia, and Puerto Rico.
    Drug product means an active ingredient in dosage form that has been 
approved or otherwise may be lawfully marketed under the Federal Food, 
Drug, and Cosmetic Act for distribution in the United States.
    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.
    Established business relationship means the regulated person has 
imported or exported a listed chemical at least once within the past six 
months, or twice within the past twelve months from or to a foreign 
manufacturer, distributor, or end user of the chemical that has an 
established business with a fixed street address. A person or business 
that functions as a broker or intermediary is not a customer for 
purposes of this definition.
    Established record as an importer means that the regulated person 
has imported a listed chemical at least once within the past six months, 
or

[[Page 13]]

twice within the past twelve months from a foreign supplier.
    Export means, with respect to any article, any taking out or removal 
of such article from the United States (whether or not such taking out 
or removal constitutes an exportation within the meaning of the customs 
laws, export control laws enforced by other agencies, or related laws of 
the United States).
    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).
    Import means, with respect to any article, any bringing in or 
introduction of such article into the customs territory of the United 
States from any place outside thereof (but within the United States), or 
into the United States from any place outside thereof (whether or not 
such bringing in or introduction constitutes an importation within the 
meaning of the tariff laws of the United States).
    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.
    Listed chemical means any List I chemical or List II chemical.
    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.
    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.
    Mobile retail vendor means a person or entity that makes sales at 
retail from a stand that is intended to be temporary or is capable of 
being moved from one location to another, whether the stand is located 
within or on the premises of a fixed facility (such as a kiosk at a 
shopping center or an airport) or whether the stand is located on 
unimproved real estate (such as a lot or field leased for retail 
purposes).
    Name means the official name, common or usual name, chemical name, 
or brand name of a substance.
    Person includes any individual, corporation, government or 
governmental subdivision or agency, business trust, partnership, 
association, or other legal entity.
    Port of entry, unless distinguished as being a foreign port of 
entry, means any place at which a customs officer is duly authorized to 
accept entries of merchandise, to collect duties, and to enforce the 
various provisions of the customs laws of the United States (whether or 
not such place is a port of entry as defined in title 19 of the United 
States Code or its associated implementing regulations). Examples of 
ports of entry include, but are not limited to, places designated as 
ports of entry or customs stations in title 19 of the Code of Federal 
Regulations or by the governing customs authority of that area. When 
shipments are transported under U.S. Customs and Border Protection 
immediate transportation procedures, the port of entry shall be the port 
of final destination.
    Port of export means, unless distinguished as being a foreign port 
of export, any place under the control of a customs officer where goods 
are loaded on an aircraft, vessel or other conveyance for export outside 
of the United States. For goods loaded aboard an aircraft or vessel in 
the United States that stops at several ports before departing the 
United States, the port of export is the first port where the goods were 
loaded. For goods off-loaded from the original conveyance to another 
conveyance (even if the aircraft or vessel belongs to the same carrier) 
at any port subsequent to the port where the first on-loading occurred 
in the United States, the port where the goods were loaded onto the last 
conveyance before departing the United States is the port of export. For 
reporting purposes, in the case of an otherwise lawful export occurring 
by mail, the port of export is the place of mailing.
    Readily retrievable means that certain records are kept by automatic 
data processing systems or other electronic

[[Page 14]]

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.
    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).
    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).
    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 part 1313 of this chapter.
    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.
    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.
    Regulated seller means a retail distributor (including a pharmacy or 
a mobile retail vendor), except that the term does not include an 
employee or agent of the distributor.
    Regulated transaction means:
    (1) 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:
    (i) 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;
    (ii) 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, 1313, and 1315 of 
this chapter;
    (iii) 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;
    (iv) Any transaction in a listed chemical that is contained in a 
drug other than a scheduled listed chemical product that may be marketed 
or distributed lawfully in the United States under the Federal Food, 
Drug, and Cosmetic Act, subject to paragraph (1)(v) of this definition, 
unless--
    (A) 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
    (B) The quantity of the listed chemical contained in the drug 
included in the transaction or multiple transactions equals or exceeds 
the threshold established for that chemical;
    (v) Any transaction in a scheduled listed chemical product that is a 
sale at retail by a regulated seller or a distributor required to submit 
reports under Sec. 1310.03(c) of this chapter; or
    (vi) Any transaction in a chemical mixture designated in 
Secs. 1310.12 and 1310.13 of this chapter that the Administrator has 
exempted from regulation.
    (2) A distribution, importation, or exportation of a tableting 
machine or encapsulating machine except that such

[[Page 15]]

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.
    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 or 
phenylpropanolamine 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. 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.
    Return information means supplemental information required to be 
reported to the Administration following an import or export transaction 
containing the particulars of the transaction and any other information 
as the Administration may specify.
    Scheduled listed chemical product means:
    (1) A product that contains ephedrine, pseudoephedrine, or 
phenylpropanolamine and may be marketed or distributed lawfully in the 
United States under the Federal Food, Drug, and Cosmetic Act as a 
nonprescription drug. Ephedrine, pseudoephedrine, and 
phenylpropanolamine include their salts, optical isomers, and salts of 
optical isomers.
    (2) Scheduled listed chemical product does not include any product 
that is a controlled substance under part 1308 of this chapter. In the 
absence of such scheduling by the Attorney General, a chemical specified 
in paragraph (1) of this definition may not be considered to be a 
controlled substance.
    Tableting machine means any manual, semi-automatic, or fully 
automatic equipment which may be used for the compaction or molding of 
powdered or granular solids, or semi-solid material, to produce coherent 
solid tablets.
    United States, when used in a geographic sense, means all places and 
waters, continental or insular, subject to the jurisdiction of the 
United States, which, in addition to the customs territory of the United 
States, include but are not limited to the U.S. Virgin Islands, Guam, 
American Samoa, and the Northern Mariana Islands.
    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.

[75 FR 16304, Mar. 31, 2010, as amended at 77 FR 4233, Jan. 27, 2012; 81 
FR 97019, Dec. 30, 2016]



Sec. 1300.03  Definitions relating to electronic orders for controlled
substances and electronic prescriptions for controlled substances.

    For the purposes of this chapter, the following terms shall have the 
meanings specified:
    Application service provider means an entity that sells electronic 
prescription or pharmacy applications as a hosted service, where the 
entity controls access to the application and maintains the software and 
records on its servers.
    Audit trail means a record showing who has accessed an information 
technology application and what operations the user performed during a 
given period.
    Authentication means verifying the identity of the user as a 
prerequisite to allowing access to the information application.
    Authentication protocol means a well specified message exchange 
process that verifies possession of a token to remotely authenticate a 
person to an application.
    Biometric authentication means authentication based on measurement 
of the individual's physical features or repeatable actions where those 
features or actions are both distinctive to the individual and 
measurable.
    Biometric subsystem means the hardware and software used to capture, 
store, and compare biometric data. The biometric subsystem may be part 
of a

[[Page 16]]

larger application. The biometric subsystem is an automated system 
capable of:
    (1) Capturing a biometric sample from an end user.
    (2) Extracting and processing the biometric data from that sample.
    (3) Storing the extracted information in a database.
    (4) Comparing the biometric data with data contained in one or more 
reference databases.
    (5) Determining how well the stored data matches the newly captured 
data and indicating whether an identification or verification of 
identity has been achieved.
    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.
    Certified information systems auditor (CISA) means an individual who 
has been certified by the Information Systems Audit and Control 
Association as qualified to audit information systems and who performs 
compliance audits as a regular ongoing business activity.
    Credential means an object or data structure that authoritatively 
binds an identity (and optionally, additional attributes) to a token 
possessed and controlled by a person.
    Credential service provider (CSP) means a trusted entity that issues 
or registers tokens and issues electronic credentials to individuals. 
The CSP may be an independent third party or may issue credentials for 
its own use.
    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.
    Digitally sign means to affix a digital signature to a data file.
    Electronic prescription means a prescription that is generated on an 
electronic application and transmitted as an electronic data file.
    Electronic prescription application provider means an entity that 
develops or markets electronic prescription software either as a stand-
alone application or as a module in an electronic health record 
application.
    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.
    False match rate means the rate at which an impostor's biometric is 
falsely accepted as being that of an authorized user. It is one of the 
statistics used to measure biometric performance when operating in the 
verification or authentication task. The false match rate is similar to 
the false accept (or acceptance) rate.
    False non-match rate means the rate at which a genuine user's 
biometric is falsely rejected when the user's biometric data fail to 
match the enrolled data for the user. It is one of the statistics used 
to measure biometric performance when operating in the verification or 
authentication task. The false match rate is similar to the false reject 
(or rejection) rate, except

[[Page 17]]

that it does not include the rate at which a biometric system fails to 
acquire a biometric sample from a genuine user.
    FIPS means Federal Information Processing Standards. These Federal 
standards, as incorporated by reference in Sec. 1311.08 of this chapter, 
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 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Security Requirements for Cryptographic 
Modules,'' a Federal standard for security requirements for 
cryptographic modules.
    FIPS 180-2, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Secure Hash Standard,'' a Federal secure hash 
standard.
    FIPS 180-3, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Secure Hash Standard (SHS),'' a Federal secure 
hash standard.
    FIPS 186-2, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Digital Signature Standard,'' a Federal standard 
for applications used to generate and rely upon digital signatures.
    FIPS 186-3, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Digital Signature Standard (DSS),'' a Federal 
standard for applications used to generate and rely upon digital 
signatures.
    Hard token means a cryptographic key stored on a special hardware 
device (e.g., a PDA, cell phone, smart card, USB drive, one-time 
password device) rather than on a general purpose computer.
    Identity proofing means the process by which a credential service 
provider or certification authority validates sufficient information to 
uniquely identify a person.
    Installed electronic prescription application means software that is 
used to create electronic prescriptions and that is installed on a 
practitioner's computers and servers, where access and records are 
controlled by the practitioner.
    Installed pharmacy application means software that is used to 
process prescription information and that is installed on a pharmacy's 
computers or servers and is controlled by the pharmacy.
    Intermediary means any technology system that receives and transmits 
an electronic prescription between the practitioner and pharmacy.
    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.
    NIST SP 800-63-1, as incorporated by reference in Sec. 1311.08 of 
this chapter, means the National Institute of Standards and Technology 
publication entitled ``Electronic Authentication Guideline,'' a Federal 
standard for electronic authentication.
    NIST SP 800-76-1, as incorporated by reference in Sec. 1311.08 of 
this chapter, means the National Institute of Standards and Technology 
publication entitled ``Biometric Data Specification for Personal 
Identity Verification,'' a Federal standard for biometric data 
specifications for personal identity verification.
    Operating point means a point chosen on a receiver operating 
characteristic (ROC) curve for a specific algorithm at which the 
biometric system is set to function. It is defined by its corresponding 
coordinates--a false match rate and a false non-match rate. An ROC curve 
shows graphically the trade-off between the principal two types of 
errors (false match rate and false non-match rate) of a biometric system 
by plotting the performance of a specific algorithm on a specific set of 
data.
    Paper prescription means a prescription created on paper or computer 
generated to be printed or transmitted via

[[Page 18]]

facsimile that meets the requirements of part 1306 of this chapter 
including a manual signature.
    Password means a secret, typically a character string (letters, 
numbers, and other symbols), that a person memorizes and uses to 
authenticate his identity.
    PDA means a Personal Digital Assistant, a handheld computer used to 
manage contacts, appointments, and tasks.
    Pharmacy application provider means an entity that develops or 
markets software that manages the receipt and processing of electronic 
prescriptions.
    Private key means the key of a key pair that is used to create a 
digital signature.
    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.
    Readily retrievable means that certain records are kept by automatic 
data processing applications 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.
    SAS 70 Audit means a third-party audit of a technology provider that 
meets the American Institute of Certified Public Accountants (AICPA) 
Statement of Auditing Standards (SAS) 70 criteria.
    Signing function means any keystroke or other action used to 
indicate that the practitioner has authorized for transmission and 
dispensing a controlled substance prescription. The signing function may 
occur simultaneously with or after the completion of the two-factor 
authentication protocol that meets the requirements of part 1311 of this 
chapter. The signing function may have different names (e.g., approve, 
sign, transmit), but it serves as the practitioner's final authorization 
that he intends to issue the prescription for a legitimate medical 
reason in the normal course of his professional practice.
    SysTrust means a professional service performed by a qualified 
certified public accountant to evaluate one or more aspects of 
electronic systems.
    Third-party audit means an independent review and examination of 
records and activities to assess the adequacy of system controls, to 
ensure compliance with established policies and operational procedures, 
and to recommend necessary changes in controls, policies, or procedures.
    Token means something a person possesses and controls (typically a 
key or password) used to authenticate the person's identity.
    Trusted agent means an entity authorized to act as a representative 
of a certification authority or credential service provider in 
confirming practitioner identification during the enrollment process.
    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.
    WebTrust means a professional service performed by a qualified 
certified public accountant to evaluate one or more aspects of Web 
sites.

[75 FR 16304, Mar. 31, 2010]



Sec. 1300.04  Definitions relating to the dispensing of controlled
substances by means of the Internet.

    (a) Any term not defined in this part or elsewhere in this chapter 
shall have the definition set forth in sections 102 and 309 of the Act 
(21 U.S.C. 802, 829).
    (b) The term covering practitioner means, with respect to a patient, 
a practitioner who conducts a medical evaluation (other than an in-
person medical evaluation) at the request of a practitioner who:
    (1) Has conducted at least one in-person medical evaluation of the 
patient or an evaluation of the patient through

[[Page 19]]

the practice of telemedicine, within the previous 24 months; and
    (2) Is temporarily unavailable to conduct the evaluation of the 
patient.
    (c) The term deliver, distribute, or dispense by means of the 
Internet refers, respectively, to any delivery, distribution, or 
dispensing of a controlled substance that is caused or facilitated by 
means of the Internet.
    (d) The term filling new prescriptions for controlled substances in 
Schedule III, IV, or V means filling a prescription for an individual 
for a controlled substance in Schedule III, IV, or V, if:
    (1) The pharmacy dispensing that prescription has previously 
dispensed to the patient a controlled substance other than by means of 
the Internet and pursuant to the valid prescription of a practitioner 
that meets the applicable requirements of subsections (b) and (c) of 
section 309 of the Act (21 U.S.C. 829) and Secs. 1306.21 and 1306.22 of 
this chapter (for purposes of this definition, such a prescription shall 
be referred to as the ``original prescription'');
    (2) The pharmacy contacts the practitioner who issued the original 
prescription at the request of that individual to determine whether the 
practitioner will authorize the issuance of a new prescription for that 
individual for the controlled substance described in paragraph (d)(1) of 
this section (i.e., the same controlled substance as described in 
paragraph (d)(1)); and
    (3) The practitioner, acting in the usual course of professional 
practice, determines there is a legitimate medical purpose for the 
issuance of the new prescription.
    (e) The term homepage means the opening or main page or screen of 
the Web site of an online pharmacy that is viewable on the Internet.
    (f) The term in-person medical evaluation means a medical evaluation 
that is conducted with the patient in the physical presence of the 
practitioner, without regard to whether portions of the evaluation are 
conducted by other health professionals. Nothing in this paragraph shall 
be construed to imply that one in-person medical evaluation demonstrates 
that a prescription has been issued for a legitimate medical purpose 
within the usual course of professional practice.
    (g) The term Internet means collectively the myriad of computer and 
telecommunications facilities, including equipment and operating 
software, which comprise the interconnected worldwide network of 
networks that employ the Transmission Control Protocol/Internet 
Protocol, or any predecessor or successor protocol to such protocol, to 
communicate information of all kinds by wire or radio.
    (h) The term online pharmacy means a person, entity, or Internet 
site, whether in the United States or abroad, that knowingly or 
intentionally delivers, distributes, or dispenses, or offers or attempts 
to deliver, distribute, or dispense, a controlled substance by means of 
the Internet. The term includes, but is not limited to, a pharmacy that 
has obtained a modification of its registration pursuant to 
Secs. 1301.13 and 1301.19 of this chapter that currently authorizes it 
to dispense controlled substances by means of the Internet, regardless 
of whether the pharmacy is currently dispensing controlled substances by 
means of the Internet. The term does not include:
    (1) Manufacturers or distributors registered under subsection (a), 
(b), (d), or (e) of section 303 of the Act (21 U.S.C. 823(a), (b), (d), 
or (e)) (Sec. 1301.13 of this chapter) who do not dispense controlled 
substances to an unregistered individual or entity;
    (2) Nonpharmacy practitioners who are registered under section 
303(f) of the Act (21 U.S.C. 823(f)) (Sec. 1301.13 of this chapter) and 
whose activities are authorized by that registration;
    (3) Any hospital or other medical facility that is operated by an 
agency of the United States (including the Armed Forces), provided such 
hospital or other facility is registered under section 303(f) of the Act 
(21 U.S.C. 823(f)) (Sec. 1301.13 of this chapter);
    (4) A health care facility owned or operated by an Indian tribe or 
tribal organization, only to the extent such facility is carrying out a 
contract or compact under the Indian Self-Determination and Education 
Assistance Act;

[[Page 20]]

    (5) Any agent or employee of any hospital or facility referred to in 
paragraph (h)(3) or (h)(4) of this section, provided such agent or 
employee is lawfully acting in the usual course of business or 
employment, and within the scope of the official duties of such agent or 
employee, with such hospital or facility, and, with respect to agents or 
employees of health care facilities specified in paragraph (h)(4) of 
this section, only to the extent such individuals are furnishing 
services pursuant to the contracts or compacts described in such 
paragraph;
    (6) Mere advertisements that do not attempt to facilitate an actual 
transaction involving a controlled substance;
    (7) A person, entity, or Internet site that is not in the United 
States and does not facilitate the delivery, distribution, or dispensing 
of a controlled substance by means of the Internet to any person in the 
United States;
    (8) A pharmacy registered under section 303(f) of the Act (21 U.S.C. 
823(f)) (Sec. 1301.13 of this chapter) whose dispensing of controlled 
substances via the Internet consists solely of:
    (i) Refilling prescriptions for controlled substances in Schedule 
III, IV, or V, as defined in paragraph (k) of this section; or
    (ii) Filling new prescriptions for controlled substances in Schedule 
III, IV, or V, as defined in paragraph (d) of this section;
    (9)(i) Any registered pharmacy whose delivery, distribution, or 
dispensing of controlled substances by means of the Internet consists 
solely of filling prescriptions that were electronically prescribed in a 
manner authorized by this chapter and otherwise in compliance with the 
Act.
    (ii) A registered pharmacy will be deemed to meet this exception if, 
in view of all of its activities other than those referred to in 
paragraph (h)(9)(i) of this section, it would fall outside the 
definition of an online pharmacy; or
    (10)(i) Any registered pharmacy whose delivery, distribution, or 
dispensing of controlled substances by means of the Internet consists 
solely of the transmission of prescription information between a 
pharmacy and an automated dispensing system located in a long term care 
facility when the registration of the automated dispensing system is 
held by that pharmacy as described in Secs. 1301.17 and 1301.27 and the 
pharmacy is otherwise complying with this chapter.
    (ii) A registered pharmacy will be deemed to meet this exception if, 
in view of all of its activities other than those referred to in 
paragraph (h)(10)(i) of this section, it would fall outside the 
definition of an online pharmacy.
    (i) Effective January 15, 2010, the term practice of telemedicine 
means the practice of medicine in accordance with applicable Federal and 
State laws by a practitioner (other than a pharmacist) who is at a 
location remote from the patient and is communicating with the patient, 
or health care professional who is treating the patient, using a 
telecommunications system referred to in section 1834(m) of the Social 
Security Act (42 U.S.C. 1395m(m)), which practice falls within a 
category listed in the following paragraphs (i)(1) through (7):
    (1) Treatment in a hospital or clinic. The practice of telemedicine 
is being conducted while the patient is being treated by, and physically 
located in, a hospital or clinic registered under section 303(f) of the 
Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of 
professional practice, who is acting in accordance with applicable State 
law, and who is registered under section 303(f) of the Act (21 U.S.C. 
823(f)) in the State in which the patient is located, unless the 
practitioner:
    (i) Is exempted from such registration in all States under section 
302(d) of the Act (21 U.S.C. 822(d); or
    (ii) Is an employee or contractor of the Department of Veterans 
Affairs who is acting in the scope of such employment or contract, and 
registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any 
State or is utilizing the registration of a hospital or clinic operated 
by the Department of Veterans Affairs registered under section 303(f);
    (2) Treatment in the physical presence of a practitioner. The 
practice of telemedicine is being conducted while the patient is being 
treated by, and in the physical presence of, a practitioner

[[Page 21]]

acting in the usual course of professional practice, who is acting in 
accordance with applicable State law, and who is registered under 
section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the 
patient is located, unless the practitioner:
    (i) Is exempted from such registration in all States under section 
302(d) of the Act (21 U.S.C. 822(d)); or
    (ii) Is an employee or contractor of the Department of Veterans 
Affairs who is acting in the scope of such employment or contract, and 
registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any 
State or is using the registration of a hospital or clinic operated by 
the Department of Veterans Affairs registered under section 303(f);
    (3) Indian Health Service or tribal organization. The practice of 
telemedicine is being conducted by a practitioner who is an employee or 
contractor of the Indian Health Service, or is working for an Indian 
tribe or tribal organization under its contract or compact with the 
Indian Health Service under the Indian Self-Determination and Education 
Assistance Act; who is acting within the scope of the employment, 
contract, or compact; and who is designated as an Internet Eligible 
Controlled Substances Provider by the Secretary of Health and Human 
Services under section 311(g)(2) of the Act (21 U.S.C. 831(g)(2));
    (4) Public health emergency declared by the Secretary of Health and 
Human Services. The practice of telemedicine is being conducted during a 
public health emergency declared by the Secretary of Health and Human 
Services under section 319 of the Public Health Service Act (42 U.S.C. 
247d), and involves patients located in such areas, and such controlled 
substances, as the Secretary of Health and Human Services, with the 
concurrence of the Administrator, designates, provided that such 
designation shall not be subject to the procedures prescribed by the 
Administrative Procedure Act (5 U.S.C. 551-559 and 701-706);
    (5) Special registration. The practice of telemedicine is being 
conducted by a practitioner who has obtained from the Administrator a 
special registration under section 311(h) of the Act (21 U.S.C. 831(h));
    (6) Department of Veterans Affairs medical emergency. The practice 
of telemedicine is being conducted:
    (i) In a medical emergency situation:
    (A) That prevents the patient from being in the physical presence of 
a practitioner registered under section 303(f) of the Act (21 U.S.C. 
823(f)) who is an employee or contractor of the Veterans Health 
Administration acting in the usual course of business and employment and 
within the scope of the official duties or contract of that employee or 
contractor;
    (B) That prevents the patient from being physically present at a 
hospital or clinic operated by the Department of Veterans Affairs 
registered under section 303(f) of the Act (21 U.S.C. 823(f));
    (C) During which the primary care practitioner of the patient or a 
practitioner otherwise practicing telemedicine within the meaning of 
this paragraph is unable to provide care or consultation; and
    (D) That requires immediate intervention by a health care 
practitioner using controlled substances to prevent what the 
practitioner reasonably believes in good faith will be imminent and 
serious clinical consequences, such as further injury or death; and
    (ii) By a practitioner that:
    (A) Is an employee or contractor of the Veterans Health 
Administration acting within the scope of that employment or contract;
    (B) Is registered under section 303(f) of the Act (21 U.S.C. 823(f)) 
in any State or is utilizing the registration of a hospital or clinic 
operated by the Department of Veterans Affairs registered under section 
303(f); and
    (C) Issues a controlled substance prescription in this emergency 
context that is limited to a maximum of a five-day supply which may not 
be extended or refilled; or
    (7) Other circumstances specified by regulation. The practice of 
telemedicine is being conducted under any other circumstances that the 
Administrator and the Secretary of Health and Human Services have 
jointly, by regulation, determined to be consistent

[[Page 22]]

with effective controls against diversion and otherwise consistent with 
the public health and safety.
    (j) Temporary definition of practice of telemedicine. Prior to 
January 15, 2010, or as otherwise specified by regulation prior to that 
date, instead of the definition in paragraph (i), the term practice of 
telemedicine means the practice of medicine in accordance with 
applicable Federal and State laws by a practitioner (as that term is 
defined in section 102 of the Act (21 U.S.C. 802)) (other than a 
pharmacist) who is at a location remote from the patient and is 
communicating with the patient, or health care professional who is 
treating the patient, using a telecommunications system referred to in 
section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if the 
practitioner is using an interactive telecommunications system that 
satisfies the requirements of section 410.78(a)(3) of title 42, Code of 
Federal Regulations.
    (k) The term refilling prescriptions for controlled substances in 
Schedule III, IV, or V:
    (1) Means the dispensing of a controlled substance in Schedule III, 
IV, or V in accordance with refill instructions issued by a practitioner 
as part of a valid prescription that meets the requirements of 
subsections (b) and (c) of section 309 of the Act (21 U.S.C. 829) and 
Secs. 1306.21 and 1306.22 of this chapter, as appropriate; and
    (2) Does not include the issuance of a new prescription to an 
individual for a controlled substance that individual was previously 
prescribed.
    (l)(1) The term valid prescription means a prescription that is 
issued for a legitimate medical purpose in the usual course of 
professional practice by:
    (i) A practitioner who has conducted at least one in-person medical 
evaluation of the patient; or
    (ii) A covering practitioner.
    (2) Nothing in this paragraph (l) shall be construed to imply that 
one in-person medical evaluation demonstrates that a prescription has 
been issued for a legitimate medical purpose within the usual course of 
professional practice.

[74 FR 15619, Apr. 6, 2009]



Sec. 1300.05  Definitions relating to the disposal of controlled substances.

    (a) Any term not defined in this part or elsewhere in this chapter 
shall have the definition set forth in section 102 of the Act (21 U.S.C. 
802).
    (b) As used in part 1317 of this chapter, the following terms shall 
have the meanings specified:
    Employee means an employee as defined under the general common law 
of agency. Some of the factors relevant to the determination of employee 
status include: The hiring party's right to control the manner and means 
by which the product is accomplished; the skill required; the source of 
the instrumentalities and tools; the location of the work; the duration 
of the relationship between the parties; whether the hiring party has 
the right to assign additional projects to the hired party; the extent 
of the hired party's discretion over when and how long to work; the 
method of payment; the hired party's role in hiring and paying 
assistants; whether the work is part of the regular business of the 
hiring party; whether the hiring party is in business; the provision of 
employee benefits; and the tax treatment of the hired party. Other 
applicable factors may be considered and no one factor is dispositive. 
The following criteria will determine whether a person is an employee of 
a registrant for the purpose of disposal: The person is directly paid by 
the registrant; subject to direct oversight by the registrant; required, 
as a condition of employment, to follow the registrant's procedures and 
guidelines pertaining to the handling of controlled substances; subject 
to receive a performance rating or performance evaluation on a regular/
routine basis from the registrant; subject to disciplinary action by the 
registrant; and required to render services at the registrant's 
registered location.
    Law enforcement officer means a person who is described in paragraph 
(1), (2) or (3) of this definition:
    (1) Meets all of the following criteria:
    (i) Employee of either a law enforcement agency, or law enforcement 
component of a Federal agency;
    (ii) Is under the direction and control of a Federal, State, tribal, 
or local government;

[[Page 23]]

    (iii) Acting in the course of his/her official duty; and
    (iv) Duly sworn and given the authority by a Federal, State, tribal, 
or local government to carry firearms, execute and serve warrants, make 
arrests without warrant, and make seizures of property;
    (2) Is a Veterans Health Administration (VHA) police officer 
authorized by the Department of Veterans Affairs to participate in 
collection activities conducted by the VHA; or
    (3) Is a Department of Defense (DOD) police officer authorized by 
the DOD to participate in collection activities conducted by the DOD.
    Non-retrievable means, for the purpose of destruction, the condition 
or state to which a controlled substance shall be rendered following a 
process that permanently alters that controlled substance's physical or 
chemical condition or state through irreversible means and thereby 
renders the controlled substance unavailable and unusable for all 
practical purposes. The process to achieve a non-retrievable condition 
or state may be unique to a substance's chemical or physical properties. 
A controlled substance is considered ``non-retrievable'' when it cannot 
be transformed to a physical or chemical condition or state as a 
controlled substance or controlled substance analogue. The purpose of 
destruction is to render the controlled substance(s) to a non-
retrievable state and thus prevent diversion of any such substance to 
illicit purposes.
    On-site means located on or at the physical premises of the 
registrant's registered location. A controlled substance is destroyed 
on-site when destruction occurs on the physical premises of the 
destroying registrant's registered location. A hospital/clinic has an 
on-site pharmacy when it has a pharmacy located on the physical premises 
of the registrant's registered location.

[79 FR 53560, Sept. 9, 2014]



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; requirement of modification of 
          registration authorizing activity as an online pharmacy.
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.
1301.19  Special requirements for online pharmacies.

                   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.
1301.27  Separate registration by retail pharmacies for installation and 
          operation of automated dispensing systems at long term care 
          facilities.
1301.28  Exemption from separate registration for practitioners 
          dispensing or prescribing Schedule III, IV, or V narcotic 
          controlled drugs approved by the Food and Drug Administration 
          specifically for use in maintenance or detoxification 
          treatment.
1301.29  [Reserved]

  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.

[[Page 24]]

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.
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, 831, 871(b), 875, 877, 
886a, 951, 952, 953, 956, 957, 958, 965.

    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 Section, Drug Enforcement Administration. See the Table 
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.

[75 FR 10676, Mar. 9, 2010]

                              Registration



Sec. 1301.11  Persons required to register; requirement of modification
of registration authorizing activity as an online pharmacy.

    (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 Secs. 1301.22 through 1301.26. Except as provided in 
paragraph (b) of this section, 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.)

[[Page 25]]

    (b) As provided in sections 303(f) and 401(h) of the Act (21 U.S.C. 
823(f) and 841(h)), it is unlawful for any person who falls within the 
definition of ``online pharmacy'' (as set forth in section 102(52) of 
the Act (21 U.S.C. 802(52)) and Sec. 1300.04(h) of this chapter) to 
deliver, distribute, or dispense a controlled substance by means of the 
Internet if such person is not validly registered with a modification of 
such registration authorizing such activity (unless such person is 
exempt from such modified registration requirement under the Act or this 
chapter). The Act further provides that the Administrator may only issue 
such modification of registration to a person who is registered as a 
pharmacy under section 303(f) of the Act (21 U.S.C. 823(f)). 
Accordingly, any pharmacy registered pursuant to Sec. 1301.13 of this 
part that falls within the definition of an online pharmacy and proposes 
to dispense controlled substances by means of the Internet must obtain a 
modification of its registration authorizing such activity following the 
submission of an application in accordance with Sec. 1301.19 of this 
part. This requirement does not apply to a registered pharmacy that does 
not fall within the definition of an online pharmacy set forth in 
Sec. 1300.04(h). Under the Act, persons other than registered pharmacies 
are not eligible to obtain such a modification of registration but 
remain liable under section 401(h) of the Act (21 U.S.C. 841(h)) if they 
deliver, distribute, or dispense a controlled substance while acting as 
an online pharmacy without being validly registered with a modification 
authorizing such activity.

[74 FR 15621, Apr. 6, 2009]



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 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 in the same State in which he or she practices) 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

[[Page 26]]

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; 71 FR 69480, Dec. 1, 2006; 81 FR 97019, Dec. 
30, 2016]



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 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

[[Page 27]]

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      Coincident
       Business activity           Controlled      DEA Application  Application     period         activities
                                   substances           forms         fee ($)       (years)         allowed
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing.............  Schedules I-V...  New--225                3,047             1  Schedules I-V:
                                                   Renewal--225a.                               May distribute
                                                                                                that substance
                                                                                                or class for
                                                                                                which
                                                                                                registration was
                                                                                                issued; may not
                                                                                                distribute any
                                                                                                substance or
                                                                                                class for which
                                                                                                not registered.
                                                                                               Schedules II-V:
                                                                                                May conduct
                                                                                                chemical
                                                                                                analysis and
                                                                                                preclinical
                                                                                                research
                                                                                                (including
                                                                                                quality control
                                                                                                analysis) with
                                                                                                substances
                                                                                                listed in those
                                                                                                schedules for
                                                                                                which
                                                                                                authorization as
                                                                                                a mfr. was
                                                                                                issued.
(ii) Distributing.............  Schedules I-V...  New--225                1,523             1  May acquire
                                                   Renewal--225a.                               Schedules II-V
                                                                                                controlled
                                                                                                substances from
                                                                                                collectors for
                                                                                                the purposes of
                                                                                                destruction.
(iii) Reverse distributing....  Schedules I-V...  New-225 Renewal-        1,523             1
                                                   225a.
(iv) Dispensing or instructing  Schedules II-V..  New-224 Renewal-          731             3  May conduct
 (includes Practitioner,                           224a.                                        research and
 Hospital/Clinic, Retail                                                                        instructional
 Pharmacy, Central fill                                                                         activities with
 pharmacy, Teaching                                                                             those substances
 Institution).                                                                                  for which
                                                                                                registration was
                                                                                                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 Renewal-          244             1  A researcher may
                                                   225a.                                        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 Sec.
                                                                                                 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.

[[Page 28]]

 
(vi) Research.................  Schedules II-V..  New-225 Renewal-          244             1  May conduct
                                                   225a.                                        chemical
                                                                                                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 Sec.
                                                                                                 1301.24; and
                                                                                                conduct
                                                                                                instructional
                                                                                                activities with
                                                                                                controlled
                                                                                                substances.
(vii) Narcotic Treatment        Narcotic Drugs    New-363 Renewal-          244             1
 Program (including              in Schedules II-  363a.
 compounder).                    V.
(viii) Importing..............  Schedules I-V...  New-225 Renewal-        1,523             1  May distribute
                                                   225a.                                        that 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 Renewal-        1,523             1
                                                   225a.
(x) Chemical Analysis.........  Schedules I-V...  New-225 Renewal-          244             1  May manufacture
                                                   225a.                                        and 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 Sec.
                                                                                                 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 Section, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (3) Registrants will receive renewal notifications approximately 60 
days prior to the registration expiration date. DEA Forms 224a, 225a, 
and 363a may be mailed, as applicable, to registrants; if any registered 
person does not receive such notification within 45 days before the 
registration expiration date, the registrant must promptly give notice 
of such fact and may request such forms by writing to the Registration 
Section, Drug Enforcement Administration.
    (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.

[[Page 29]]

    (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 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; 71 FR 51112, 
Aug. 29, 2006; 74 FR 15622, Apr. 6, 2009; 75 FR 10676, Mar. 9, 2010; 77 
FR 15248, Mar. 15, 2012; 79 FR 53560, Sept. 9, 2014]



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. The 
appropriate registration fee and any required attachments must accompany 
the application. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (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, as amended at 75 FR 10676, Mar. 9, 2010]

[[Page 30]]



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:

                       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

[[Page 31]]

__________ (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) If at the time of application for a separate registration at a 
long term care facility, the retail pharmacy has been issued a license, 
permit, or other form of authorization from the appropriate State agency 
to install and operate an automated dispensing system for the dispensing 
of controlled substances at the long term care facility, the applicant 
must include with his/her application for registration (DEA Form 224) an 
affidavit as to the existence of the State authorization. Exact language 
for this affidavit may be found at the DEA Diversion Control Program Web 
site. The affidavit must include the following information:
    (1) The name and title of the corporate officer or official signing 
the affidavit;
    (2) The name of the corporation, partnership or sole proprietorship 
operating the retail pharmacy;
    (3) The name and complete address (including city, state, and Zip 
code) of the retail pharmacy;
    (4) The name and complete address (including city, state, and Zip 
code) of the long term care facility at which DEA registration is 
sought;
    (5) Certification that the named retail pharmacy has been authorized 
by the state Board of Pharmacy or licensing agency to install and 
operate an automated dispensing system for the dispensing of controlled 
substances at the named long term care facility (including the license 
or permit number, if applicable);
    (6) The date on which the authorization was issued;
    (7) Statements attesting to the following:
    (i) The affidavit is submitted to obtain a Drug Enforcement 
Administration registration number;
    (ii) If any material information is false, the Administrator may 
commence proceedings to deny the application under section 304 of the 
Act (21 U.S.C. 824(a));
    (iii) Any false or fraudulent material information contained in this 
affidavit may subject the person signing this affidavit and the above-
named corporation/partnership/business to prosecution under section 403 
of the Act (21 U.S.C. 843);
    (8) Signature of the person authorized to sign the Application for 
Registration for the named retail pharmacy;
    (9) Notarization of the affidavit.
    (d) 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 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

[[Page 32]]

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, as amended at 70 FR 25465, May 13, 2005]



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, by registered mail, return receipt 
requested. See the Table of DEA Mailing Addresses in Sec. 1321.01 of 
this chapter for the current mailing address. The request shall contain 
the following information: DEA registration number;

[[Page 33]]

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, as amended at 75 FR 10676, Mar. 9, 2010]



Sec. 1301.19  Special requirements for online pharmacies.

    (a) A pharmacy that has been issued a registration under 
Sec. 1301.13 may request that the Administrator modify its registration 
to authorize the pharmacy to dispense controlled substances by means of 
the Internet as an online pharmacy. The Administrator may deny an 
application for a modification of registration if the Administrator 
determines that the issuance of a modification would be inconsistent 
with the public interest. In determining the public interest, the 
Administrator will consider the factors listed in section 303(f) of the 
Act (21 U.S.C. 823(f)).
    (b) Each online pharmacy shall comply with the requirements of State 
law concerning licensure of pharmacies in each State from which it, and 
in each State to which it, delivers, distributes, or dispenses, or 
offers to deliver, distribute, or dispense controlled substances by 
means of the Internet.
    (c) Application for a modified registration authorizing the 
dispensing of controlled substances by means of the Internet will be 
made by an online application process as specified in Sec. 1301.13 of 
this part. Subsequent online pharmacy registration renewals will be 
accomplished by an online process.
    (d) A pharmacy that seeks to discontinue its modification of 
registration authorizing it to dispense controlled substances by means 
of the Internet as an online pharmacy (but continue its business 
activity as a non-online pharmacy) shall so notify the Administrator by 
requesting to modify its registration to reflect the appropriate 
business activity. Once the registration has been so changed, the 
pharmacy may no longer dispense controlled substances by means of the 
Internet. A pharmacy that has so changed its registration status back to 
that of a non-online pharmacy remains responsible for submitting reports 
in accordance with Sec. 1304.55 of this chapter with respect to any 
controlled substances that it dispensed while it was registered with a 
modification authorizing it to operate as an online pharmacy.
    (e) Registrants applying for modified registrations under this 
section must comply with notification and reporting requirements set 
forth in Secs. 1304.40, 1304.45, 1304.50, and 1304.55 of this chapter.
    (f) No person (including a registrant) required to obtain a 
modification of a registration under Secs. 1301.11(b) and 1301.13 of 
this part authorizing it to operate as an online pharmacy may engage in 
any activity for which such modification of registration is required 
until the application for such modified registration is granted and an 
active Certificate of Registration indicating the modification of the 
registration has been issued by the Administrator to such person.

[74 FR 15622, Apr. 6, 2009]

[[Page 34]]

                   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;
    (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.

[[Page 35]]

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 customs 
officer, any officer or employee of the U.S. Food and Drug 
Administration, and any other Federal or Insular 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 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, as amended at 81 FR 97019, Dec. 30, 2016]



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

[[Page 36]]

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 (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)

[[Page 37]]

________________________________________________________________________

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 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 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 be distributed only to persons 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 part 
1317 of this chapter.

[62 FR 13951, Mar. 24, 1997, as amended at 79 FR 53561, Sept. 9, 2014]



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/

[[Page 38]]

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 customs 
officer 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, as amended at 81 FR 97019, Dec. 30, 2016]



Sec. 1301.27  Separate registration by retail pharmacies for installation
and operation of automated dispensing systems at long term care facilities.

    (a) A retail pharmacy may install and operate automated dispensing 
systems, as defined in Sec. 1300.01 of this chapter, at long term care 
facilities, under the requirements of Sec. 1301.17. No person other than 
a registered retail pharmacy may install and operate an automated 
dispensing system at a long term care facility.
    (b) Retail pharmacies installing and operating automated dispensing 
systems at long term care facilities must maintain a separate 
registration at the location of each long term care facility at which 
automated dispensing systems are located. If more than one registered 
retail pharmacy operates automated dispensing systems at the same long 
term care facility, each retail pharmacy must maintain a registration at 
the long term care facility.
    (c) A registered retail pharmacy applying for a separate 
registration to operate an automated dispensing system for the 
dispensing of controlled substances at a long term care facility is 
exempt from application fees for any such additional registrations.

[70 FR 25465, May 13, 2005]



Sec. 1301.28  Exemption from separate registration for practitioners 
dispensing or prescribing Schedule III, IV, or V narcotic controlled 
drugs approved by the Food and Drug Administration specifically for
use in maintenance or detoxification treatment.

    (a) An individual practitioner may dispense or prescribe Schedule 
III, IV, or V narcotic controlled drugs or combinations of narcotic 
controlled drugs which have been approved by the Food and Drug 
Administration (FDA) specifically for use in maintenance or 
detoxification treatment without obtaining the separate registration 
required by Sec. 1301.13(e) if all of the following conditions are met:
    (1) The individual practitioner meets the conditions specified in 
paragraph (b) of this section.
    (2) The narcotic drugs or combination of narcotic drugs meet the 
conditions specified in paragraph (c) of this section.
    (3) The individual practitioner is in compliance with either 
paragraph (d) or paragraph (e) of this section.
    (b)(1) The individual practitioner must submit notification to the 
Secretary of Health and Human Services stating the individual 
practitioner's intent to dispense or prescribe narcotic

[[Page 39]]

drugs under paragraph (a) of this section. The notice must contain all 
of the following certifications:
    (i) The individual practitioner is registered under Sec. 1301.13 as 
an individual practitioner and is a ``qualifying physician'' as defined 
in section 303(g)(2)(G) of the Act (21 U.S.C. 823(g)(2)(G)).
    (ii) The individual practitioner has the capacity to refer the 
patients to whom the individual practitioner will provide narcotic drugs 
or combinations of narcotic drugs for appropriate counseling and other 
appropriate ancillary services.
    (iii) The total number of patients to whom the individual 
practitioner will provide narcotic drugs or combinations of narcotic 
drugs under this section will not exceed 30 at any one time unless, not 
sooner than 1 year after the date on which the practitioner submitted 
the initial notification to the Secretary of Health and Human Services, 
the practitioner submits a second notification to the Secretary of the 
need and intent of the practitioner to treat up to 100 patients. A 
second notification under this subparagraph shall contain the 
certifications required by subparagraphs (i) and (ii) of this paragraph. 
The Secretary of Health and Human Services may promulgate regulations to 
change the total number of patients.
    (2) If an individual practitioner wishes to prescribe or dispense 
narcotic drugs pursuant to paragraph (e) of this section, the individual 
practitioner must provide the Secretary of Health and Human Services the 
following:
    (i) Notification as required under paragraph (b)(1) of this section 
in writing, stating the individual practitioner's name and DEA 
registration number issued under Sec. 1301.13.
    (ii) If the individual practitioner is a member of a group practice, 
the names of the other individual practitioners in the group and the DEA 
registration numbers issued to the other individual practitioners under 
Sec. 1301.13.
    (c) The narcotic drugs or combination of narcotic drugs to be 
dispensed or prescribed under this section must meet all of the 
following conditions:
    (1) The drugs or combination of drugs have been approved for use in 
``maintenance treatment'' or ``detoxification treatment'' under the 
Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health 
Service Act.
    (2) The drugs or combination of drugs have not been the subject of 
an adverse determination by the Secretary of Health and Human Services, 
after consultation with the Attorney General, that the use of the drugs 
or combination of drugs requires additional standards respecting the 
qualifications of practitioners or the quantities of the drugs that may 
be provided for unsupervised use.
    (d)(1) After receiving the notification submitted under paragraph 
(b) of this section, the Secretary of Health and Human Services will 
forward a copy of the notification to the Administrator. The Secretary 
of Health and Human Services will have 45 days from the date of receipt 
of the notification to make a determination of whether the individual 
practitioner involved meets all requirements for a waiver under section 
303(g)(2)(B) of the Act (21 U.S.C. 823(g)(2)(B)). Health and Human 
Services will notify DEA of its determination regarding the individual 
practitioner. If the individual practitioner has the appropriate 
registration under Sec. 1301.13, then the Administrator will issue the 
practitioner an identification number as soon as one of the following 
conditions occurs:
    (i) The Administrator receives a positive determination from the 
Secretary of Health and Human Services before the conclusion of the 45-
day review period, or
    (ii) The 45-day review period has concluded and no determination by 
the Secretary of Health and Human Services has been made.
    (2) If the Secretary denies certification to an individual 
practitioner or withdraws such certification once it is issued, then DEA 
will not issue the individual practitioner an identification number, or 
will withdraw the identification number if one has been issued.
    (3) The individual practitioner must include the identification 
number on all records when dispensing and on all prescriptions when 
prescribing narcotic drugs under this section.
    (e) An individual practitioner may begin to prescribe or dispense 
narcotic drugs to a specific individual patient

[[Page 40]]

under this section before receiving an identification number from the 
Administrator if the following conditions are met:
    (1) The individual practitioner has submitted a written notification 
under paragraph (b) of this section in good faith to the Secretary of 
Health and Human Services.
    (2) The individual practitioner reasonably believes that the 
conditions specified in paragraphs (b) and (c) of this section have been 
met.
    (3) The individual practitioner reasonably believes that the 
treatment of an individual patient would be facilitated if narcotic 
drugs are prescribed or dispensed under this section before the sooner 
of:
    (i) Receipt of an identification number from the Administrator, or
    (ii) Expiration of the 45-day period.
    (4) The individual practitioner has notified both the Secretary of 
Health and Human Services and the Administrator of his or her intent to 
begin prescribing or dispensing the narcotic drugs before expiration of 
the 45-day period.
    (5) The Secretary has not notified the registrant that he/she is not 
qualified under paragraph (d) of this section.
    (6) The individual practitioner has the appropriate registration 
under Sec. 1301.13.
    (f) If an individual practitioner dispenses or prescribes Schedule 
III, IV, or V narcotic drugs approved by the Food and Drug 
Administration specifically for maintenance or detoxification treatment 
in violation of any of the conditions specified in paragraphs (b), (c) 
or (e) of this section, the Administrator may revoke the individual 
practitioner's registration in accordance with Sec. 1301.36.

[70 FR 36342, June 23, 2005, as amended at 73 FR 29688, May 22, 2008]



Sec. 1301.29  [Reserved]

  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) 
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

[[Page 41]]

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 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

[[Page 42]]

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 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 
Secs. 1301.71-1301.76; and
    (2) Employment of security procedures to guard against in-transit 
losses.
    (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;

[[Page 43]]

    (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, as amended at 81 FR 97019, Dec. 30, 2016]



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.
    (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)).

[[Page 44]]

    (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 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

[[Page 45]]

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.
    (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 
Secs. 1301.42-1301.46 of this part, and by the procedures for 
administrative hearings under the Act set forth in Secs. 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

[[Page 46]]

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 
Secs. 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 Secs. 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 Secs. 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]



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.

[[Page 47]]

    (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.

    (a) 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 written request to the 
Registration Unit, Drug Enforcement Administration. See the Table of DEA 
Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address. Additionally, such a request may be submitted on-line 
at www.DEAdiversion.usdoj.gov.
    (1) The request shall contain:
    (i) The registrant's name, address, and registration number as 
printed on the certificate of registration;
    (ii) The substances and/or schedules to be added to the registration 
or the new name or address; and
    (iii) A signature in accordance with Sec. 1301.13(j).
    (2) If the registrant is seeking to handle additional controlled 
substances listed in Schedule I for the purpose of research or 
instructional activities, the registrant shall attach three copies of a 
research protocol describing each research project involving the 
additional substances, or two copies of a statement describing the 
nature, extent, and duration of such instructional activities, as 
appropriate.
    (b) Any manufacturer, distributor, reverse distributor, narcotic 
treatment program, hospital/clinic with an on-site pharmacy, or retail 
pharmacy registered pursuant to this part, may apply to modify its 
registration to become authorized as a collector by submitting a written 
request to the Registration Unit, Drug Enforcement Administration. See 
the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for 
the current mailing address. Additionally, such request may be submitted 
on-line at www.DEAdiversion.usdoj.gov.
    (1) The request shall contain:
    (i) The registrant's name, address, and registration number as 
printed on the certificate of registration;
    (ii) The method(s) of collection the registrant intends to conduct 
(collection receptacle and/or mail-back program); and
    (iii) A signature in accordance with Sec. 1301.13(j).
    (2) If a hospital/clinic with an on-site pharmacy or retail pharmacy 
is applying for a modification in registration to authorize such 
registrant to be a collector to maintain a collection receptacle at a 
long-term care facility in accordance with Sec. 1317.80 of this chapter, 
the request shall also include the name and physical location of each 
long-term care facility at which the

[[Page 48]]

hospital/clinic with an on-site pharmacy, or the retail pharmacy, 
intends to operate a collection receptacle.
    (c) No fee shall be required for modification. The request for 
modification shall be handled in the same manner as an application for 
registration. If the modification of 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.

[79 FR 53561, Sept. 9, 2014]



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, and any modifications of that registration, 
shall terminate, without any further action by the Administration, if 
and when such person dies, ceases legal existence, discontinues business 
or professional practice, or surrenders a registration. Any registrant 
who ceases legal existence or discontinues business or professional 
practice shall notify the Administrator promptly of such fact. In the 
case of a surrender, termination shall occur upon receipt by any 
employee of the Administration of a duly executed DEA form 104 or any 
signed writing indicating the desire to surrender a registration.
    (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. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (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. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. Any 
controlled substances in his/her possession may be disposed of in 
accordance with part 1317 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

[[Page 49]]

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 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.
    (f) Any registrant that has been authorized as a collector and 
desires to discontinue its collection of controlled substances from 
ultimate users shall notify the Administration of its intent by 
submitting a written notification to the Registration Unit, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. 
Additionally, such notice may be submitted on-line at 
www.DEAdiversion.usdoj.gov. When ceasing collection activities of an 
authorized mail-back program, the registrant shall provide the 
Administration with the name, registered address, and registration 
number of the collector that will receive the remaining mail-back 
packages in accordance with Sec. 1317.70(e)(3) of this chapter.

[62 FR 13957, Mar. 24, 1997, as amended at 74 FR 15623, Apr. 6, 2009; 75 
FR 10676, Mar. 9, 2010; 76 FR 61564, Oct. 5, 2011; 79 FR 53561, Sept. 9, 
2014]

                          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 Secs. 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 
Secs. 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 
Secs. 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;

[[Page 50]]

    (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
    (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 Secs. 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 Secs. 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 
Regulatory Section, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.
    (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 Secs. 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 Secs. 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.
    (f) A collector shall not employ, as an agent or employee who has 
access to or influence over controlled substances acquired by 
collection, any person who has been convicted of any felony offense 
relating to controlled substances or who, at any time, had an 
application for registration with DEA denied, had a DEA registration 
revoked or suspended, or has surrendered a DEA registration for cause. 
For purposes of this subsection, ``for cause'' means in lieu of, or as a 
consequence of, any Federal

[[Page 51]]

or State administrative, civil, or criminal action resulting from an 
investigation of the individual's handling of controlled substances.

[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973, 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; 75 FR 
10677, Mar. 9, 2010; 79 FR 53561, Sept. 9, 2014]



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, 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 
Federal Food Drug and Cosmetic Act which shall be subject to the 
requirements of paragraph (b) of this section), and sealed mail-back 
packages and inner liners acquired in accordance with part 1317 of this 
chapter, 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 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

[[Page 52]]

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 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

[[Page 53]]

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. Redesignated at 38 FR 26609, Sept. 24, 
1973]

    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 at www.fdsys.gov.



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 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, 
1973 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

[[Page 54]]

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 must notify the Field Division Office of the 
Administration in his or her area, in writing, of any theft or 
significant loss of any controlled substances within one business day of 
discovery of the theft or loss. Unless the theft or loss occurs during 
an import or export transaction, the supplier is responsible for 
reporting all in-transit losses of controlled substances by their agent 
or the common or contract carrier selected pursuant to paragraph (e) of 
this section, within one business day of discovery of such theft or 
loss. In an import transaction, once a shipment has been released by the 
customs officer at the port of entry, the importer is responsible for 
reporting all in-transit losses of controlled substances by their agent 
or the common or contract carrier selected pursuant to paragraph (e) of 
this section, within one business day of discovery of such theft or 
loss. In an export transaction, the exporter is responsible for 
reporting all in-transit losses of controlled substances by their agent 
or the common or contract carrier selected pursuant to paragraph (e) of 
this section within one business day of discovery of such theft or loss, 
until the shipment has been released by the customs officer at the port 
of export. The registrant must also complete, and submit to the Field 
Division Office in his or her area, DEA Form 106 regarding the theft or 
loss. Thefts and significant losses must be reported whether or not the 
controlled substances are subsequently recovered or the responsible 
parties are identified and action taken against them. When determining 
whether a loss is significant, a registrant should consider, among 
others, the following factors:
    (1) The actual quantity of controlled substances lost in relation to 
the type of business;
    (2) The specific controlled substances lost;
    (3) Whether the loss of the controlled substances can be associated 
with access to those controlled substances by specific individuals, or 
whether the loss can be attributed to unique activities that may take 
place involving the controlled substances;
    (4) A pattern of losses over a specific time period, whether the 
losses appear to be random, and the results of efforts taken to resolve 
the losses; and, if known,
    (5) Whether the specific controlled substances are likely candidates 
for diversion;
    (6) Local trends and other indicators of the diversion potential of 
the missing controlled substance.
    (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 55]]

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 thiafentanil, carfentanil, 
etorphine hydrochloride and/or diprenorphine to any person, the 
registrant must verify that the person is authorized to handle the 
substance(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.
    (m) A reverse distributor shall not employ, as an agent or employee 
who has access to or influence over controlled substances, any person 
who has been convicted of any 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 suspended, or has 
surrendered a DEA registration for cause. For purposes of this 
subsection, ``for cause'' means 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.

[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

    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 at www.fdsys.gov.



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,

[[Page 56]]

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) Sealed mail-back packages and inner liners collected in 
accordance with part 1317 of this chapter shall only be stored at the 
registered location in a securely locked, substantially constructed 
cabinet or a securely locked room with controlled access, except as 
authorized by Sec. 1317.80(d).
    (d) This section shall also apply to nonpractitioners authorized to 
conduct research or chemical analysis under another registration.
    (e) Thiafentanil, carfentanil, etorphine hydrochloride and 
diprenorphine shall be 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; 79 FR 53562, Sept. 
9, 2014; 81 FR 58839, Aug. 26, 2016]



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, in writing, of the theft or significant loss 
of any controlled substances within one business day of discovery of 
such loss or theft. The registrant shall also complete, and submit to 
the Field Division Office in his area, DEA Form 106 regarding the loss 
or theft. When determining whether a loss is significant, a registrant 
should consider, among others, the following factors:
    (1) The actual quantity of controlled substances lost in relation to 
the type of business;
    (2) The specific controlled substances lost;
    (3) Whether the loss of the controlled substances can be associated 
with access to those controlled substances by specific individuals, or 
whether the loss can be attributed to unique activities that may take 
place involving the controlled substances;
    (4) A pattern of losses over a specific time period, whether the 
losses appear to be random, and the results of efforts taken to resolve 
the losses; and, if known,
    (5) Whether the specific controlled substances are likely candidates 
for diversion;
    (6) Local trends and other indicators of the diversion potential of 
the missing controlled substance.
    (c) Whenever the registrant distributes a controlled substance 
(without being registered as a distributor as permitted in 
Secs. 1301.13(e)(1), 1307.11, 1317.05, and/or 1317.10 of this chapter), 
he/she shall comply with the requirements imposed on non-practitioners 
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

[[Page 57]]

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, 1973; 
47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957, 
Mar. 24, 1997; 68 FR 37409, June 24, 2003; 70 FR 47097, Aug. 12, 2005; 
79 FR 53562, Sept. 9, 2014]



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 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

[[Page 58]]

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]



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, 
1973]



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:

[[Page 59]]



 
                 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 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 Secs. 1302.03 through 1302.05 apply 
to every commercial container containing, and to all labeling of, 
controlled substances imported into the customs territory of the United 
States from any place outside thereof (but within the United States), or 
imported into the United States from any place outside thereof.
    (b) The symbol requirements of Secs. 1302.03 through 1302.05 do not 
apply to any commercial containers containing, or any labeling of, a 
controlled substance intended for export.
    (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 the customs 
territory of the United States from any place outside thereof (but 
within the United States), or imported into the United States from any 
place outside thereof. 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, exported or intended 
for export from the United States. These sealing and labeling 
requirements are in addition to any sealing requirements required under 
applicable customs laws.

[81 FR 97020, Dec. 30, 2016]

[[Page 60]]



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.
    (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

[[Page 61]]

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 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 shall issue and publish in the Federal Register his final 
order determining the aggregate production quota for the basic class of 
controlled substances. 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; 77 FR 4235, Jan. 27, 2012]



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 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 UN Reporting and Quota 
Section, Diversion Control Division. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.
    (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

[[Page 62]]

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 UN Reporting and Quota Section, 
Diversion Control Division. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. 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 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. 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 at www.fdsys.gov.



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;

[[Page 63]]

    (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 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 Secs. 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]

[[Page 64]]



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 UN Reporting and Quota Section, Diversion 
Control Division. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. 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; 75 FR 10677, Mar. 9, 2010; 81 FR 97020, Dec. 30, 
2016]



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 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

[[Page 65]]

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 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

[[Page 66]]

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 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 Secs. 1303.32-1303.37, and by 
the procedures for administrative hearings under the Act set forth in 
Secs. 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 
Secs. 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 Secs. 1303.32-1303.37, and by the procedures for 
administrative hearings under the Act set forth in Secs. 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

[[Page 67]]

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, 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]

[[Page 68]]



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.
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.
1304.06  Records and reports for electronic prescriptions.

                         Inventory Requirements

1304.11  Inventory requirements.

                           Continuing Records

1304.21  General requirements for continuing records.
1304.22  Records for manufacturers, distributors, dispensers, 
          researchers, importers, exporters, registrants that reverse 
          distribute, and collectors.
1304.23  Records for chemical analysts.
1304.24  Records for maintenance treatment programs and detoxification 
          treatment programs.
1304.25  Records for treatment programs that 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 Automation of Reports and Consolidated Orders System 
          (ARCOS).

[[Page 69]]

                            Online Pharmacies

1304.40  Notification by online pharmacies.
1304.45  Internet Web site disclosure requirements.
1304.50  Disclosure requirements for Web sites of nonpharmacy 
          practitioners that dispense controlled substances by means of 
          the Internet.
1304.55  Reports by online pharmacies.

    Authority: 21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 965, 
unless otherwise noted.

                           General Information



Sec. 1304.01  Scope of part 1304.

    Inventory and other records and reports required under section 307, 
section 311, or section 1008(e) of the Act (21 U.S.C. 827, 831, and 
958(e)) shall be in accordance with, and contain the information 
required by, those sections and by the sections of this part.

[74 FR 15623, Apr. 6, 2009]



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 Sec. 1300.01, Sec. 1300.03, 
Sec. 1300.04, or Sec. 1300.05 of this chapter.

[81 FR 97020, Dec. 30, 2016]



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

    (a) Every registrant, including collectors, shall maintain the 
records and inventories and shall file the reports required by this 
part, except as exempted by this section. Any registrant that is 
authorized to conduct other activities without being registered to 
conduct those activities, pursuant to Secs. 1301.22(b), 1307.11, 
1307.13, or part 1317 of this chapter, shall maintain the records and 
inventories and shall file the reports required by this part for persons 
registered or authorized 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 require 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 which are dispensed, other than by 
prescribing or administering in the lawful course of professional 
practice.
    (c) Except as provided in Sec. 1304.06, a registered individual 
practitioner is not required to keep records of controlled substances in 
Schedules II, III, IV, and V that 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

[[Page 70]]

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.
    (h) A person is required to keep the records and file the reports 
specified in Sec. 1304.06 and part 1311 of this chapter if they are 
either of the following:
    (1) An electronic prescription application provider.
    (2) An electronic pharmacy application provider.

[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; 75 FR 16306, Mar. 31, 2010; 77 FR 
4235, Jan. 27, 2012; 79 FR 53562, Sept. 9, 2014]



Sec. 1304.04  Maintenance of records and inventories.

    (a) Except as provided in paragraphs (a)(1) and (a)(2) of this 
section, every inventory and other records required to be kept under 
this part must 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.
    (1) Financial and shipping records (such as invoices and packing 
slips but not executed order forms subject to Secs. 1305.17 and 1305.27 
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 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 the following:
    (i) The nature of the records to be kept centrally.

[[Page 71]]

    (ii) The exact location where the records will be kept.
    (iii) The name, address, DEA registration number and type of DEA 
registration of the registrant whose records are being maintained 
centrally.
    (iv) Whether central records will be maintained in a manual, or 
computer readable, form.
    (2) A registered retail pharmacy that possesses additional 
registrations for automated dispensing systems at long term care 
facilities may keep all records required by this part for those 
additional registered sites at the retail pharmacy or other approved 
central location.
    (3) A collector that is authorized to maintain a collection 
receptacle at a long-term care facility shall keep all records required 
by this part relating to those collection receptacles at the registered 
location, or other approved central location.
    (b) All registrants that are authorized to maintain a central 
recordkeeping system under paragraph (a) of this section shall be 
subject to the following conditions:
    (1) The records to be maintained at the central record location 
shall not include executed order forms and 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 the ARCOS Unit. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (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:

[[Page 72]]

    (1) Inventories and records of all controlled substances listed in 
Schedule I and II shall be maintained separately from all other records 
of the pharmacy.
    (2) Paper prescriptions for Schedule II controlled substances shall 
be maintained at the registered location in a separate prescription 
file.
    (3) Inventories and records of Schedules III, IV, and V controlled 
substances 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.
    (4) Paper prescriptions for Schedules III, IV, and V controlled 
substances shall be maintained at the registered location either in a 
separate prescription file for Schedules III, IV, and V controlled 
substances 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 
noncontrolled substances. However, if a pharmacy employs a computer 
application for prescriptions that permits identification by 
prescription number and retrieval of original documents by prescriber 
name, patient's name, drug dispensed, and date filled, then the 
requirement to mark the hard copy prescription with a red ``C'' is 
waived.
    (5) Records of electronic prescriptions for controlled substances 
shall be maintained in an application that meets the requirements of 
part 1311 of this chapter. The computers on which the records are 
maintained may be located at another location, but the records must be 
readily retrievable at the registered location if requested by the 
Administration or other law enforcement agent. The electronic 
application must be capable of printing out or transferring the records 
in a format that is readily understandable to an Administration or other 
law enforcement agent at the registered location. Electronic copies of 
prescription records must be sortable by prescriber name, patient name, 
drug dispensed, and date filled.

(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, 1973, 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; 70 FR 25466, May 
13, 2005; 75 FR 10677, Mar. 9, 2010; 75 FR 16306, Mar. 31, 2010; 79 FR 
53562, Sept. 9, 2014]



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]



Sec. 1304.06  Records and reports for electronic prescriptions.

    (a) As required by Sec. 1311.120 of this chapter, a practitioner who 
issues electronic prescriptions for controlled substances must use an 
electronic prescription application that retains the following 
information:
    (1) The digitally signed record of the information specified in part 
1306 of this chapter.
    (2) The internal audit trail and any auditable event identified by 
the internal audit as required by Sec. 1311.150 of this chapter.

[[Page 73]]

    (b) An institutional practitioner must retain a record of identity 
proofing and issuance of the two-factor authentication credential, where 
applicable, as required by Sec. 1311.110 of this chapter.
    (c) As required by Sec. 1311.205 of this chapter, a pharmacy that 
processes electronic prescriptions for controlled substances must use an 
application that retains the following:
    (1) All of the information required under Sec. 1304.22(c) and part 
1306 of this chapter.
    (2) The digitally signed record of the prescription as received as 
required by Sec. 1311.210 of this chapter.
    (3) The internal audit trail and any auditable event identified by 
the internal audit as required by Sec. 1311.215 of this chapter.
    (d) A registrant and application service provider must retain a copy 
of any security incident report filed with the Administration pursuant 
to Secs. 1311.150 and 1311.215 of this chapter.
    (e) An electronic prescription or pharmacy application provider must 
retain third party audit or certification reports as required by 
Sec. 1311.300 of this chapter.
    (f) An application provider must retain a copy of any notification 
to the Administration regarding an adverse audit or certification report 
filed with the Administration on problems identified by the third-party 
audit or certification as required by Sec. 1311.300 of this chapter.
    (g) Unless otherwise specified, records and reports must be retained 
for two years.

[75 FR 16306, Mar. 31, 2010]

                         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. 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 Secs. 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

[[Page 74]]

pursuant to paragraph (c) of this section.
    (e) Inventories of manufacturers, distributors, registrants that 
reverse distribute, importers, exporters, chemical analysts, dispensers, 
researchers, and collectors. Each person registered or authorized (by 
Secs. 1301.13, 1307.11, 1307.13, or part 1317 of this chapter) to 
manufacture, distribute, reverse distribute, dispense, import, export, 
conduct research or chemical analysis with controlled substances, or 
collect controlled substances from ultimate users, 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. Each 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 registrants that reverse distribute. Each person 
registered or authorized to reverse distribute controlled substances 
shall include in the inventory, the following information:
    (i) The name of the substance, and
    (ii) The total quantity of the substance:
    (A) For controlled substances in bulk form, to the nearest metric 
unit weight consistent with unit size;
    (B) For each controlled substance in finished form: Each finished 
form of the substance (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter); the number of units or 
volume of each finished form in each commercial container (e.g., 100-
tablet bottle or 3-milliliter vial); and the number of commercial 
containers of each such finished form (e.g., four 100-tablet bottles or 
six 3-milliliter vials); and

[[Page 75]]

    (C) For controlled substances in a commercial container, carton, 
crate, drum, or other receptacle that has been opened: If the substance 
is listed in Schedule I or II, make an exact count or measure of the 
contents; or 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 an exact count 
of the contents shall be made; or
    (iii) For controlled substances acquired from collectors and law 
enforcement: The number and size (e.g., five 10-gallon liners, etc.) of 
sealed inner liners on hand, or
    (iv) For controlled substances acquired from law enforcement: the 
number of sealed mail-back packages on hand.
    (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.
    (6) Inventories of dispensers and researchers. Each person 
registered or authorized to dispense or conduct research 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 that has been opened, the 
dispenser or researcher shall do as follows:
    (i) If the substance is listed in Schedules 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.
    (7) Inventories of collectors. Each registrant authorized to collect 
controlled substances from ultimate users shall include in the inventory 
the following information:
    (i) For registrants authorized to collect through a mail-back 
program, the record shall include the following information about each 
unused mail-back package and each returned mail-back package on hand 
awaiting destruction:
    (A) The date of the inventory;
    (B) The number of mail-back packages; and
    (C) The unique identification number of each package on hand, 
whether unused or awaiting destruction.
    (ii) For registrants authorized to collect through a collection 
receptacle, the record shall include the following information about 
each unused inner liner on hand and each sealed inner liner on hand 
awaiting destruction:
    (A) The date of the inventory;
    (B) The number and size of inner liners (e.g., five 10-gallon 
liners, etc.);

[[Page 76]]

    (C) The unique identification number of each inner liner.

[62 FR 13959, Mar. 24, 1997, as amended at 68 FR 41228, July 11, 2003; 
79 FR 53562, Sept. 9, 2014]

                           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 substance manufactured, imported, received, sold, 
delivered, exported, or otherwise disposed of by him/her, and each inner 
liner, sealed inner liner, and unused and returned mail-back package, 
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 and collection activity for which he/she is 
registered or authorized, except as provided in Sec. 1304.22(d).
    (d) In recording dates of receipt, distribution, other transfers, or 
destruction, the date on which the controlled substances are actually 
received, distributed, otherwise transferred, or destroyed will be used 
as the date of receipt, distribution, transfer, or destruction (e.g., 
invoices or packing slips, or DEA Form 41). In maintaining records 
concerning imports and exports, the registrant must record the 
anticipated date of release by a customs official for permit 
applications and declarations and the date on which the controlled 
substances are released by a customs officer at the port of entry or 
port of export for return information.
    (e) Record of destruction. In addition to any other recordkeeping 
requirements, any registered person that destroys a controlled substance 
pursuant to Sec. 1317.95(d), or causes the destruction of a controlled 
substance pursuant to Sec. 1317.95(c), shall maintain a record of 
destruction on a DEA Form 41. The records shall be complete and 
accurate, and include the name and signature of the two employees who 
witnessed the destruction. Except, destruction of a controlled substance 
dispensed by a practitioner for immediate administration at the 
practitioner's registered location, when the substance is not fully 
exhausted (e.g., some of the substance remains in a vial, tube, or 
syringe after administration but cannot or may not be further utilized), 
shall be properly recorded in accordance with Sec. 1304.22(c), and such 
record need not be maintained on a DEA Form 41.

[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; 79 FR 53563, Sept. 9, 2014; 81 FR 97020, Dec. 30, 2016]



Sec. 1304.22  Records for manufacturers, distributors, dispensers,
researchers, importers, exporters, registrants that reverse distribute,
and collectors.

    Each person registered or authorized (by Secs. 1301.13(e), 1307.11, 
1307.13, or part 1317 of this chapter) to manufacture, distribute, 
dispense, import, export, reverse distribute, destroy, conduct research 
with controlled substances, or collect controlled substances from 
ultimate users, shall maintain records with the information listed in 
paragraphs (a) through (f) of this section.
    (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

[[Page 77]]

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 
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

[[Page 78]]

    (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 
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 registrants that reverse distribute. Each person 
registered or authorized to reverse distribute controlled substances 
shall maintain records with the following information for each 
controlled substance:
    (1) For controlled substances acquired for the purpose of return or 
recall to the manufacturer or another registrant authorized by the 
manufacturer to accept returns on the manufacturer's behalf pursuant to 
part 1317 of this chapter:
    (i) The date of receipt; the name and quantity of each controlled 
substance received; the name, address, and registration number of the 
person from whom the substance was received; and the reason for return 
(e.g., recall or return); and
    (ii) The date of return to the manufacturer or other registrant 
authorized by the manufacturer to accept returns on the manufacturer's 
behalf; the name and quantity of each controlled substance returned; the 
name, address, and registration number of the person from whom the 
substance was received; the name, address, and registration number of 
the registrant to whom the

[[Page 79]]

substance was returned; and the method of return (e.g., common or 
contract carrier).
    (2) For controlled substances acquired from registrant inventory for 
destruction pursuant to Sec. 1317.05(a)(2), (b)(2), and (b)(4) of this 
chapter:
    (i) The date of receipt; the name and quantity of each controlled 
substance received; and the name, address, and registration number of 
the person from whom the substance was received; and
    (ii) The date, place, and method of destruction; the name and 
quantity of each controlled substance destroyed; the name, address, and 
registration number of the person from whom the substance was received; 
and the name and signatures of the two employees of the registrant that 
witnessed the destruction.
    (3) The total quantity of each controlled substance shall be 
recorded in accordance with the following:
    (i) For controlled substances in bulk form: To the nearest metric 
unit weight or volume consistent with unit size;
    (ii) For controlled substances in finished form: Each finished form 
(e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce 
or milliliter); the number of units or volume of finished form in each 
commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and 
the number of commercial containers of each such finished form (e.g., 
four 100-tablet bottles or six 3-milliliter vials); and
    (iii) For controlled substances in a commercial container, carton, 
crate, drum, or other receptacle that has been opened: If the substance 
is listed in Schedule I or II make an exact count or measure of the 
contents; or 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 an exact count 
of the contents shall be made.
    (4) For each sealed inner liner acquired from collectors or law 
enforcement and each sealed mail-back package acquired from law 
enforcement pursuant to Sec. 1317.55 of this chapter:
    (i) The number of sealed inner liners acquired from other persons, 
including the date of acquisition, the number and, for sealed inner 
liners the size (e.g., five 10-gallon liners, etc.), of all sealed inner 
liners and mail-back packages acquired to inventory, the unique 
identification number of each sealed inner liner and mail-back package, 
and the name, address, and, for registrants, the registration number of 
the person from whom the sealed inner liners and mail-back packages were 
received, and
    (ii) The date, place, and method of destruction; the number of 
sealed inner liners and mail-back packages destroyed; the name, address, 
and, for registrants, the registration number of the person from whom 
the sealed inner liners and mail-back packages were received; the number 
and, for sealed inner liners the size (e.g., five 10-gallon liners, 
etc.), of all sealed inner liners and mail-back packages destroyed; the 
unique identification number of each sealed inner liner and sealed mail-
back package destroyed; and the name and signatures of the two employees 
of the registrant that witnessed the destruction.
    (5) For all records, the record of receipt shall be maintained 
together with the corresponding record of return or destruction (DEA 
Form 41).
    (f) Records for collectors. Each person registered or authorized to 
collect controlled substances from ultimate users shall maintain the 
following records:
    (1) Mail-Back Packages:
    (i) For unused packages that the collector makes available to 
ultimate users and other authorized non-registrants at the collector's 
registered address: The date made available, the number of packages, and 
the unique identification number of each package;
    (ii) For unused packages provided to a third party to make available 
to ultimate users and other authorized non-registrants: The name of the 
third party and physical address of the location receiving the unused 
packages, date sent, and the number of unused packages sent with the 
corresponding unique identification numbers;
    (iii) For sealed mail-back packages received by the collector: Date 
of receipt and the unique identification number on the individual 
package; and
    (iv) For sealed mail-back packages destroyed on-site by the 
collector: Number of sealed mail-back packages

[[Page 80]]

destroyed, the date and method of destruction, the unique identification 
number of each mail-back package destroyed, and the names and signatures 
of the two employees of the registrant who witnessed the destruction.
    (2) Collection receptacle inner liners:
    (i) Date each unused inner liner acquired, unique identification 
number and size (e.g., 5-gallon, 10-gallon, etc.) of each unused inner 
liner acquired;
    (ii) Date each inner liner is installed, the address of the location 
where each inner liner is installed, the unique identification number 
and size (e.g., 5-gallon, 10-gallon, etc.) of each installed inner 
liner, the registration number of the collector, and the names and 
signatures of the two employees that witnessed each installation;
    (iii) Date each inner liner is removed and sealed, the address of 
the location from which each inner liner is removed, the unique 
identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each 
inner liner removed, the registration number of the collector, and the 
names and signatures of the two employees that witnessed each removal;
    (iv) Date each sealed inner liner is transferred to storage, the 
unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) 
of each sealed inner liner stored, and the names and signatures of the 
two employees that transferred each sealed inner liner to storage;
    (v) Date each sealed inner liner is transferred for destruction, the 
address and registration number of the reverse distributor or 
distributor to whom each sealed inner liner was transferred, the unique 
identification number and the size (e.g., 5-gallon, 10-gallon, etc.) of 
each sealed inner liner transferred, and the names and signatures of the 
two employees that transferred each sealed inner liner to the reverse 
distributor or distributor; and
    (vi) For sealed inner liners destroyed on-site by the collector: The 
same information required of reverse distributors in paragraph 
(e)(4)(ii) of this section.

[62 FR 13960, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 
70 FR 293, Jan. 4, 2005; 79 FR 53564, Sept. 9, 2014]



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.
    (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

[[Page 81]]

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 that 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;
    (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.
    (b) For each narcotic controlled substance in finished form:

[[Page 82]]

    (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, date, and manner of destruction.

[39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997; 
79 FR 53564, Sept. 9, 2014]



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 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

[[Page 83]]

shall be signed by the authorized official and submitted quarterly on 
company letterhead to the UN Reporting and Quota Section, Diversion 
Control Division, on or before the 15th day of the month immediately 
following the period for which it is submitted. See the Table of DEA 
Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.
    (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, as amended at 75 FR 10677, Mar. 9, 2010; 81 
FR 97020, Dec. 30, 2016]



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 UN 
Reporting and Quota Section, Diversion Control Division, on or before 
the 15th day of the month immediately following the period for which it 
is submitted. See the Table of DEA Mailing Addresses in Sec. 1321.01 of 
this chapter for the current mailing address.
    (b) The following information shall be submitted for raw coca leaf, 
ecgonine, ecgonine for conversion or further manufacture, 
benzoylecgonine, manufacturing coca extracts (list for

[[Page 84]]

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, as amended at 75 FR 10678, Mar. 9, 2010; 81 
FR 97020, Dec. 30, 2016]



Sec. 1304.33  Reports to Automation of Reports and Consolidated Orders
System (ARCOS).

    (a) Reports generally. All reports required by this section shall be 
filed with the Pharmaceutical Investigations Section, Diversion Control 
Division, Drug Enforcement Administration on DEA Form 333, or on media 
which contains the data required by DEA Form 333 and which is acceptable 
to the Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (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 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

[[Page 85]]

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 substancefor 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. (1) A registered institutional practitioner that 
repackages or relabels exclusively for distribution or that 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 Pharmaceutical 
Investigations Section, Diversion Control Division, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (2) Registrants that acquire recalled controlled substances from 
ultimate users pursuant to Sec. 1317.85 of this chapter may report as a 
single transaction all recalled controlled substances of the same name 
and finished form (e.g., all 10-milligram tablets or all 5-milligram 
concentration per fluid ounce or milliliter) received from ultimate 
users for the purpose of reporting acquisition transactions.
    (g) Exemptions. (1) Collectors that acquire controlled substances 
from ultimate users are exempt from the ARCOS reporting requirements 
only with respect to controlled substances collected through mail-back 
programs and collection receptacles for the purpose of disposal.
    (2) Reverse distributors and distributors that acquire controlled 
substances pursuant to Sec. 1317.55(a) or (b) of this chapter are exempt 
from the ARCOS

[[Page 86]]

reporting requirements in this section with regard to any controlled 
substances acquired pursuant to Sec. 1317.55(a) or (b) of this chapter.

(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; 75 FR 10678, Mar. 9, 2010; 79 FR 53564, Sept. 
9, 2014; 81 FR 97020, Dec. 30, 2016]

                            Online Pharmacies



Sec. 1304.40  Notification by online pharmacies.

    (a) Thirty days prior to offering a controlled substance for sale, 
delivery, distribution, or dispensing by means of the Internet, an 
online pharmacy shall:
    (1) Notify the Administrator of its intent to do so by submitting an 
application for a modified registration in accordance with Secs. 1301.13 
and 1301.19 of this chapter, with such application containing the 
information required by this section; and
    (2) Notify the State boards of pharmacy in any States in which the 
online pharmacy offers to sell, deliver, distribute, or dispense 
controlled substances.
    (b) The following information must be included in the notification 
submitted under paragraph (a) of this section:
    (1) The pharmacy's Internet Pharmacy Site Disclosure information 
required to be posted on the homepage of the online pharmacy's Internet 
site under section 311(c) of the Act (21 U.S.C. 831(c)) and Sec. 1304.45 
of this part.
    (2) Certification that the information disclosed on its Internet 
site under the Internet Pharmacy Site Disclosure is true and accurate. 
The statement shall be in a form similar to the following: ``The above-
named pharmacy, a DEA registrant, certifies, under penalty of perjury, 
that the information contained in this statement is true and accurate.''
    (3) Each Internet site address utilized by the online pharmacy and a 
certification that the online pharmacy shall notify the Administrator of 
any change in any such Internet address at least 30 days in advance. In 
the event that a pharmacy delivers, distributes, or dispenses controlled 
substances pursuant to orders made on, through, or on behalf of, more 
than one Web site, the pharmacy shall provide, for purposes of complying 
with this paragraph, the Internet site address of each such site.
    (4) The DEA registration numbers of:
    (i) Every pharmacy that delivers, distributes, or dispenses 
controlled substances pursuant to orders made on, through, or on behalf 
of, each Web site referred to in paragraph (b)(3) of this section; and
    (ii) Every practitioner who has a contractual relationship to 
provide medical evaluations or issue prescriptions for controlled 
substances, through referrals from the Web site or at the request of the 
owner or operator of the Web site, or any employee or agent thereof.
    (c) An online pharmacy that is in operation at the time Public Law 
110-425 becomes effective (April 13, 2009) must make the notifications 
required in this section on or before May 13, 2009. However, in 
accordance with section 401(h) of the Act (21 U.S.C. 841(h)), as of 
April 13, 2009, it is unlawful for any online pharmacy to deliver, 
distribute, or dispense a controlled substance by means of the Internet 
unless such online pharmacy is validly registered with a modification of 
such registration authorizing such activity.
    (d) On and after the date an online pharmacy makes the notifications 
required under this section, each online pharmacy shall display on the 
homepage of its Internet site, a declaration that it has made such 
notifications to the Administrator in the following form: ``In 
accordance with the Controlled Substances Act and the DEA regulations, 
this online pharmacy has made the notifications to the DEA Administrator 
required by 21 U.S.C. 831 and 21 CFR 1304.40.''
    (e)(1) Except as provided in paragraphs (e)(2) and (e)(3) of this 
section, if any of the information required to be submitted under this 
section changes after the online pharmacy submits the notification to 
the Administrator, the online pharmacy shall notify the Administrator of 
the updated information no later than 30 days before the change becomes 
effective via the online process.

[[Page 87]]

    (2) If a pharmacy referred to in paragraph (b)(4)(i) of this section 
ceases to deliver, distribute, or dispense controlled substances 
pursuant to orders made on, through, or on behalf of, each Web site 
referred to in paragraph (b)(3) of this section, the online pharmacy 
shall notify the Administrator no later than 30 days after the change 
becomes effective via the online process.
    (3) If a practitioner referred to in paragraph (b)(4)(ii) of this 
section ceases to have a contractual relationship with the online 
pharmacy, the online pharmacy shall notify the Administrator no later 
than 30 days after the change becomes effective via the online process.

[74 FR 15623, Apr. 6, 2009]



Sec. 1304.45  Internet Web site disclosure requirements.

    (a) Each online pharmacy shall display, at all times and in a 
visible and clear manner, on its homepage a statement that it complies 
with the requirements of section 311 of the Act (21 U.S.C. 831) with 
respect to the delivery or sale or offer for sale of controlled 
substances. This statement must include the name of the pharmacy as it 
appears on the DEA Certificate of Registration.
    (b) Each online pharmacy shall clearly display the following 
information on the homepage of each Internet site it operates, or on a 
page directly linked to the homepage. If the information is displayed on 
a page directly linked to the homepage, that link on the homepage must 
be visible and clear. The information must be displayed for each 
pharmacy that delivers, distributes, or dispenses controlled substances 
pursuant to orders made on, through, or on behalf of that Web site.
    (1) The name and address of the pharmacy as it appears on the 
pharmacy's DEA Certificate of Registration.
    (2) The pharmacy's telephone number and e-mail address.
    (3) The name, professional degree, and States of licensure of the 
pharmacist-in-charge, and a telephone number at which the pharmacist-in-
charge can be contacted.
    (4) A list of the States in which the pharmacy is licensed to 
dispense controlled substances.
    (5) A certification that the pharmacy is registered under part 1301 
of this chapter with a modification of its registration authorizing it 
to deliver, distribute, or dispense controlled substances by means of 
the Internet.
    (6) The name, address, telephone number, professional degree, and 
States of licensure with State license number of any practitioner who 
has a contractual relationship to provide medical evaluations or issue 
prescriptions for controlled substances, through referrals from the Web 
site or at the request of the owner or operator of the Web site, or any 
employee or agent thereof.
    (7) The following statement: ``This online pharmacy is obligated to 
comply fully with the Controlled Substances Act and DEA regulations. As 
part of this obligation, this online pharmacy has obtained a modified 
DEA registration authorizing it to operate as an online pharmacy. In 
addition, this online pharmacy will only dispense a controlled substance 
to a person who has a valid prescription issued for a legitimate medical 
purpose based upon a medical relationship with a prescribing 
practitioner. This includes at least one prior in-person medical 
evaluation in accordance with section 309 of the Controlled Substances 
Act (21 U.S.C. 829) or a medical evaluation via telemedicine in 
accordance with section 102(54) of the Controlled Substances Act (21 
U.S.C. 802(54)).''

[74 FR 15623, Apr. 6, 2009]



Sec. 1304.50  Disclosure requirements for Web sites of nonpharmacy
practitioners that dispense controlled substances by means of the 
Internet.

    For a Web site to identify itself as being exempt from the 
definition of an online pharmacy by virtue of section 102(52)(B)(ii) of 
the Act (21 U.S.C. 802(52)(B)(ii)) and Sec. 1300.04(h)(2) of this 
chapter, the Web site shall post in a visible and clear manner on its 
homepage, or on a page directly linked thereto in which the hyperlink is 
also visible and clear on the homepage, a list of the DEA-registered 
nonpharmacy practitioners who are affiliated with the Web site. Any 
nonpharmacy practitioner affiliated with such a Web

[[Page 88]]

site is responsible for compliance with this section. An institutional 
practitioner that otherwise complies with the requirements of the Act 
and this chapter will be deemed to meet the requirements of this section 
if, in lieu of posting the names of each affiliated individual 
practitioner, it posts its name (as it appears on its Certificate of 
Registration) in a visible and clear manner on its homepage and in a 
manner that identifies itself as being responsible for the operation of 
the Web site.

[74 FR 15623, Apr. 6, 2009]



Sec. 1304.55  Reports by online pharmacies.

    (a) Each online pharmacy shall report to the Administrator the total 
quantity of each controlled substance that the pharmacy has dispensed 
each calendar month. The report must include the total quantity of such 
dispensing by any means, regardless of whether the controlled substances 
are dispensed by means of the Internet. Thus, such reporting shall 
include all controlled substances dispensed via Internet transactions, 
mail-order transactions, face-to-face transactions, or any other means. 
However, the pharmacy is not required to describe in its report to the 
Administrator such means of dispensing. Such reporting is required for 
every calendar month in which the total quantity of controlled 
substances dispensed by the pharmacy meets or exceeds one of the 
following thresholds:
    (1) 100 or more prescriptions for controlled substances filled; or
    (2) 5,000 or more dosage units dispensed of all controlled 
substances combined.
    (b) Each online pharmacy shall report a negative response if, during 
a given calendar month, its total dispensing of controlled substances 
falls below both of the thresholds in paragraph (a) of this section.
    (c) The reporting requirements of this section apply to every 
pharmacy that, at any time during a calendar month, holds a modified 
registration authorizing it to operate as an online pharmacy, regardless 
of whether the online pharmacy dispenses any controlled substances by 
means of the Internet during the month.
    (d) Reports will be submitted to DEA electronically via online 
reporting, electronic file upload, or other means as approved by DEA.
    (e) Reports shall be filed every month not later than the fifteenth 
day of the month succeeding the month for which they are submitted.
    (f) An online pharmacy filing a report under paragraph (a) of this 
section shall utilize the National Drug Code number assigned to the 
product under the National Drug Code System of the Food and Drug 
Administration, and indicate the total number of dosage units dispensed 
for each such National Drug Code number.
    (g) Records required to be kept under this section must be kept by 
the registrant for at least two years from the date of such records. The 
information shall be readily retrievable from the ordinary business 
records of the registrant and available for inspection and copying by 
authorized employees of the Administration.

[74 FR 15623, Apr. 6, 2009]



PART 1305_ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
--Table of Contents



                     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.

[[Page 89]]

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.

    Source: 70 FR 16911, Apr. 1, 2005, unless otherwise noted.



                     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 of this chapter, to a retail pharmacy.
    (e) Deliveries to an authorized DEA registrant by an ultimate user, 
a long-term care facility on behalf of an ultimate user who resides or 
has resided at that facility, or a person authorized to dispose of the 
ultimate user decedent's property.
    (f) Distributions to reverse distributors and distributors by 
collectors and law enforcement pursuant to Sec. 1317.55 of this chapter.
    (g) Deliveries of controlled substances from ultimate users for the 
purpose of recalls pursuant to Sec. 1317.85 of this chapter.

[70 FR 16911, Apr. 1, 2005, as amended at 77 FR 4235, Jan. 27, 2012; 79 
FR 53564, Sept. 9, 2014]



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.

[[Page 90]]

    (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. ______

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

[[Page 91]]

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 thiafentanil, 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 thiafentanil, 
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.

[70 FR 16911, Apr. 1, 2005, as amended at 81 FR 58839, Aug. 26, 2016]



                         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.
    (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

[[Page 92]]

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

[[Page 93]]

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.



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.

[[Page 94]]



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 thiafentanil, 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.

[70 FR 16911, Apr. 1, 2005, as amended at 81 FR 58839, Aug. 26, 2016]



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 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

[[Page 95]]

(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.
    (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.

[[Page 96]]

    (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.
1306.08  Electronic prescriptions.
1306.09  Prescription requirements for online pharmacies.

               Controlled Substances Listed in Schedule II

1306.11  Requirement of prescription.
1306.12  Refilling prescriptions; issuance of multiple prescriptions.
1306.13  Partial filling of prescriptions.
1306.14  Labeling of substances and filling of prescriptions.

[[Page 97]]

1306.15  Provision of prescription information between retail pharmacies 
          and central fill pharmacies for prescriptions of Schedule II 
          controlled substances.

        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 prescription 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, 831, 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 
Secs. 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 ``detoxification 
treatment'' or ``maintenance treatment,'' unless the prescription is for 
a Schedule III, IV, or V narcotic drug approved by the Food and Drug 
Administration specifically for use in maintenance or detoxification 
treatment and the practitioner is in compliance with requirements in 
Sec. 1301.28 of this chapter.

[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005]



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

[[Page 98]]

the patient, the drug name, strength, dosage form, quantity prescribed, 
directions for use, and the name, address and registration number of the 
practitioner.
    (b) A prescription for a Schedule III, IV, or V narcotic drug 
approved by FDA specifically for ``detoxification treatment'' or 
``maintenance treatment'' must include the identification number issued 
by the Administrator under Sec. 1301.28(d) of this chapter or a written 
notice stating that the practitioner is acting under the good faith 
exception of Sec. 1301.28(e) of this chapter.
    (c) 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.
    (d) A practitioner may sign a paper prescription in the same manner 
as he would sign a check or legal document (e.g., J.H. Smith or John H. 
Smith). Where an oral order is not permitted, paper prescriptions shall 
be written with ink or indelible pencil, typewriter, or printed on a 
computer printer and shall be manually signed by the practitioner. A 
computer-generated prescription that is printed out or faxed by the 
practitioner must be manually signed.
    (e) Electronic prescriptions shall be created and signed using an 
application that meets the requirements of part 1311 of this chapter.
    (f) A prescription 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.
    (g) An individual practitioner exempted from registration under 
Sec. 1301.22(c) of this chapter shall include on all prescriptions 
issued by him the registration number of the hospital or other 
institution and the special internal code number assigned to him 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 paper prescription shall have the name of the 
practitioner stamped, typed, or handprinted on it, as well as the 
signature of the practitioner.
    (h) An official exempted from registration under Sec. 1301.23(a) of 
this chapter must 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 paper prescription shall have the 
name of the officer stamped, typed, or handprinted on it, as well as the 
signature of the officer.

[75 FR 16307, Mar. 31, 2010]



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, as amended at 70 FR 36343, June 23, 2005]



Sec. 1306.07  Administering or dispensing of narcotic drugs.

    (a) A practitioner may administer or dispense directly (but not 
prescribe) a narcotic drug listed in any schedule to a narcotic 
dependant person for the purpose of maintenance or detoxification 
treatment if the practitioner meets both of the following conditions:
    (1) The practitioner is separately registered with DEA as a narcotic 
treatment program.
    (2) The practitioner is in compliance with DEA regulations regarding 
treatment qualifications, security, records, and unsupervised use of the 
drugs pursuant to the Act.
    (b) Nothing in this section shall prohibit a physician who is not 
specifically registered to conduct a narcotic treatment program from 
administering

[[Page 99]]

(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.
    (d) A practitioner may administer or dispense (including prescribe) 
any Schedule III, IV, or V narcotic drug approved by the Food and Drug 
Administration specifically for use in maintenance or detoxification 
treatment to a narcotic dependent person if the practitioner complies 
with the requirements of Sec. 1301.28 of this chapter.

[39 FR 37986, Oct. 25, 1974, as amended at 70 FR 36344, June 23, 2005]



Sec. 1306.08  Electronic prescriptions.

    (a) An individual practitioner may sign and transmit electronic 
prescriptions for controlled substances provided the practitioner meets 
all of the following requirements:
    (1) The practitioner must comply with all other requirements for 
issuing controlled substance prescriptions in this part;
    (2) The practitioner must use an application that meets the 
requirements of part 1311 of this chapter; and
    (3) The practitioner must comply with the requirements for 
practitioners in part 1311 of this chapter.
    (b) A pharmacy may fill an electronically transmitted prescription 
for a controlled substance provided the pharmacy complies with all other 
requirements for filling controlled substance prescriptions in this part 
and with the requirements of part 1311 of this chapter.
    (c) To annotate an electronic prescription, a pharmacist must 
include all of the information that this part requires in the 
prescription record.
    (d) If the content of any of the information required under 
Sec. 1306.05 for a controlled substance prescription is altered during 
the transmission, the prescription is deemed to be invalid and the 
pharmacy may not dispense the controlled substance.

[75 FR 16307, Mar. 31, 2010]



Sec. 1306.09  Prescription requirements for online pharmacies.

    (a) No controlled substance that is a prescription drug may be 
delivered, distributed, or dispensed by means of the Internet without a 
valid prescription.
    (b) In accordance with the Act, it is unlawful for any person to 
knowingly or intentionally fill a prescription for a controlled 
substance that was issued in a manner that constitutes dispensing by 
means of the Internet unless such person is a pharmacist who is acting 
in the usual course of his professional practice and is acting on behalf 
of a pharmacy whose registration has been modified under sections 
1301.13 and 1301.19 of this chapter to authorize it to operate as an 
online pharmacy.
    (c) Any online pharmacy that participates in the transfer between 
pharmacies of prescription information must do so in accordance with the 
requirements of Secs. 1306.15 and 1306.25 of this part.

[74 FR 15624, Apr. 6, 2009]

               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 that is a prescription drug as determined under section 
503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only 
pursuant to a written prescription signed by the practitioner, except as 
provided in paragraph (d) of this section. A paper prescription for a 
Schedule II controlled substance may be transmitted

[[Page 100]]

by the practitioner or the practitioner's agent to a pharmacy via 
facsimile equipment, provided that the original manually 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 that 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 paper or electronic 
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 paper 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 must attach 
this paper prescription to the oral emergency prescription that had 
earlier been reduced to writing. For electronic prescriptions, the 
pharmacist must annotate the record of the electronic prescription with 
the original authorization and date of the oral order. The pharmacist 
must 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 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

[[Page 101]]

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; 75 FR 16307, Mar. 31, 2010]



Sec. 1306.12  Refilling prescriptions; issuance of multiple prescriptions.

    (a) The refilling of a prescription for a controlled substance 
listed in Schedule II is prohibited.
    (b)(1) An individual practitioner may issue multiple prescriptions 
authorizing the patient to receive a total of up to a 90-day supply of a 
Schedule II controlled substance provided the following conditions are 
met:
    (i) Each separate prescription is issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of 
professional practice;
    (ii) The individual practitioner provides written instructions on 
each prescription (other than the first prescription, if the prescribing 
practitioner intends for that prescription to be filled immediately) 
indicating the earliest date on which a pharmacy may fill each 
prescription;
    (iii) The individual practitioner concludes that providing the 
patient with multiple prescriptions in this manner does not create an 
undue risk of diversion or abuse;
    (iv) The issuance of multiple prescriptions as described in this 
section is permissible under the applicable state laws; and
    (v) The individual practitioner complies fully with all other 
applicable requirements under the Act and these regulations as well as 
any additional requirements under state law.
    (2) Nothing in this paragraph (b) shall be construed as mandating or 
encouraging individual practitioners to issue multiple prescriptions or 
to see their patients only once every 90 days when prescribing Schedule 
II controlled substances. Rather, individual practitioners must 
determine on their own, based on sound medical judgment, and in 
accordance with established medical standards, whether it is appropriate 
to issue multiple prescriptions and how often to see their patients when 
doing so.

[72 FR 64929, Nov. 19, 2007]



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, written record of the emergency oral 
prescription, or in the electronic prescription record. 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 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

[[Page 102]]

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 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; 75 FR 16308, Mar. 31, 2010]



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.

[[Page 103]]

    (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.
    (e) Where a prescription that has been prepared in accordance with 
section 1306.12(b) contains instructions from the prescribing 
practitioner indicating that the prescription shall not be filled until 
a certain date, no pharmacist may fill the prescription before that 
date.

[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; 72 FR 64930, Nov. 19, 2007]



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 words ``CENTRAL FILL'' on the face of the original 
paper prescription and record the name, address, and DEA registration 
number of the central fill pharmacy to which the prescription has been 
transmitted, the name of the retail pharmacy pharmacist transmitting the 
prescription, and the date of transmittal. For electronic prescriptions 
the name, address, and DEA registration number of the central fill 
pharmacy to which the prescription has been transmitted, the name of the 
retail pharmacy pharmacist transmitting the prescription, and the date 
of transmittal must be added to the electronic prescription record.
    (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);
    (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, as amended at 75 FR 16308, Mar. 31, 2010]

        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 that is a prescription drug as determined 
under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(b)) only pursuant to either a paper prescription signed by a 
practitioner, a facsimile of a signed paper prescription transmitted by 
the practitioner or the practitioner's agent to the pharmacy, an 
electronic prescription that meets the requirements of this part and 
part 1311 of this chapter, or 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,

[[Page 104]]

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 paper prescription signed by an 
individual practitioner, a facsimile of a paper prescription or order 
for medication transmitted by the practitioner or the practitioner's 
agent to the institutional practitioner-pharmacist, an electronic 
prescription that meets the requirements of this part and part 1311 of 
this chapter, or 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 
individual practitioner), or pursuant to an order for medication made by 
an individual practitioner that is dispensed for immediate 
administration to the ultimate user, subject to Sec. 1306.07.

[62 FR 13965, Mar. 24, 1997, as amended at 75 FR 16308, Mar. 31, 2010]



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. No prescription for a 
controlled substance listed in Schedule III or IV authorized to be 
refilled may be refilled more than five times.
    (b) Each refilling of a prescription shall be entered on the back of 
the prescription or on another appropriate document or electronic 
prescription record. If entered on another document, such as a 
medication record, or electronic prescription record, the document or 
record must be uniformly maintained and readily retrievable.
    (c) The following information must be retrievable by the 
prescription number:
    (1) The name and dosage form of the controlled substance.
    (2) The date filled or refilled.
    (3) The quantity dispensed.
    (4) The initials of the dispensing pharmacist for each refill.
    (5) The total number of refills for that prescription.
    (d) If the pharmacist merely initials and dates the back of the 
prescription or annotates the electronic prescription record, it shall 
be deemed that the full face amount of the prescription has been 
dispensed.
    (e) 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 date of issue of the original prescription.
    (2) The pharmacist obtaining the oral authorization records on the 
reverse of the original paper prescription or annotates the electronic 
prescription record with the date, quantity of refill, number of 
additional refills authorized, and initials the paper prescription or 
annotates the electronic prescription record 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.
    (f) As an alternative to the procedures provided by paragraphs (a) 
through (e) of this section, a computer application may be used for the 
storage and retrieval of refill information for original paper 
prescription orders for controlled substances in Schedule III and IV, 
subject to the following conditions:
    (1) Any such proposed computerized application must provide online 
retrieval (via computer monitor or hard-copy printout) of original 
prescription order information for those prescription orders that 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

[[Page 105]]

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 application must also provide 
online retrieval (via computer monitor 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 paper, fax, 
or oral prescription order for a Schedule III or IV controlled substance 
is correct must be provided by the individual pharmacist who makes use 
of such an application. If such an application 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 are 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 application 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 an 
application for a period of two years after the date of dispensing the 
appropriately authorized refill.
    (4) Any such computerized application shall have the capability of 
producing a printout of any refill data that 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 (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 
application 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 application by documentation (e.g., postmark).
    (5) In the event that a pharmacy which employs such a computerized 
application experiences system down-time, the pharmacy must have an 
auxiliary procedure which will be used for documentation of refills of 
Schedule III and IV controlled substance prescription orders. This 
auxiliary procedure must ensure 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 are retained for 
online data entry as soon as the computer system is available for use 
again.
    (g) When filing refill information for original paper, fax, or oral 
prescription

[[Page 106]]

orders for Schedule III or IV controlled substances, a pharmacy may use 
only one of the two applications described in paragraphs (a) through (e) 
or (f) of this section.
    (h) When filing refill information for electronic prescriptions, a 
pharmacy must use an application that meets the requirements of part 
1311 of this chapter.

[75 FR 16308, Mar. 31, 2010]



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 filling 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.
    (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 Schedule 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, online 
database may transfer up to the maximum refills permitted by law and the 
prescriber's authorization.
    (b) Transfers are subject to the following requirements:
    (1) The transfer must be communicated directly between two licensed 
pharmacists.
    (2) The transferring pharmacist must do the following:
    (i) Write the word ``VOID'' on the face of the invalidated 
prescription; for electronic prescriptions, information that the 
prescription has been transferred must be added to the prescription 
record.

[[Page 107]]

    (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; for electronic prescriptions, such information must be 
added to the prescription record.
    (iii) Record the date of the transfer and the name of the pharmacist 
transferring the information.
    (3) For paper prescriptions and prescriptions received orally and 
reduced to writing by the pharmacist pursuant to Sec. 1306.21(a), the 
pharmacist receiving the transferred prescription information must write 
the word ``transfer'' on the face of the transferred prescription and 
reduce to writing all information required to be on a prescription 
pursuant to Sec. 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.
    (4) For electronic prescriptions being transferred electronically, 
the transferring pharmacist must provide the receiving pharmacist with 
the following information in addition to the original electronic 
prescription data:
    (i) The date of the original dispensing.
    (ii) The number of refills remaining and the date(s) and locations 
of previous refills.
    (iii) The transferring pharmacy's name, address, DEA registration 
number, and prescription number for each dispensing.
    (iv) The name of the pharmacist transferring the prescription.
    (v) The name, address, DEA registration number, and prescription 
number from the pharmacy that originally filled the prescription, if 
different.
    (5) The pharmacist receiving a transferred electronic prescription 
must create an electronic record for the prescription that includes the 
receiving pharmacist's name and all of the information transferred with 
the prescription under paragraph (b)(4) of this section.
    (c) The original and transferred prescription(s) must be maintained 
for a period of two years from the date of last refill.
    (d) Pharmacies electronically accessing the same prescription record 
must satisfy all information requirements of a manual mode for 
prescription transferal.
    (e) The procedure allowing the transfer of prescription information 
for refill purposes is permissible only if allowable under existing 
State or other applicable law.

[75 FR 16309, Mar. 31, 2010]



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;

[[Page 108]]

    (d) The pharmacist requires every purchaser of a controlled 
substance under this section not known to him to 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 redesignated 
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.
1307.13  Incidental manufacture of controlled substances.

                    Disposal of Controlled Substances

1307.22  Delivery of surrendered and forfeited controlled substances.

[[Page 109]]

                         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 with the Office of 
Diversion Control, Drug Enforcement Administration, stating the reasons 
for such exception. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. 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.

[75 FR 10678, Mar. 9, 2010]

   Special Exceptions for Manufacture and Distribution of Controlled 
                               Substances



Sec. 1307.11  Distribution by dispenser to another practitioner.

    (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) [Reserved]
    (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.
    (c) The distributions that a registered retail pharmacy makes to 
automated dispensing systems at long term care facilities for which the 
retail pharmacy also holds registrations do

[[Page 110]]

not count toward the 5 percent limit in paragraphs (a)(1)(iv) and (b) of 
this section.

[68 FR 41229, July 11, 2003, as amended at 70 FR 25466, May 13, 2005; 79 
FR 53565, Sept. 9, 2014]



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 part 1317 of this chapter.

[79 FR 53565, Sept. 9, 2014]

                    Disposal of Controlled Substances



Sec. 1307.22  Delivery of surrendered and forfeited controlled substances.

    Any controlled substance surrendered by delivery to the 
Administration under part 1317 of this chapter 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 Office of Diversion Control, 
Drug Enforcement Administration. See the Table of DEA Mailing Addresses 
in Sec. 1321.01 of this chapter for the current mailing address. 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.

[75 FR 10678, Mar. 9, 2010, as amended at 79 FR 53565, Sept. 9, 2014]

                         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 this part.
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.

[[Page 111]]

                    Exempt Anabolic Steroid Products

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

   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  Temporary scheduling.

    Authority: 21 U.S.C. 811, 812, 871(b), 956(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 this part.

    Schedules of controlled substances established by section 202 of the 
Act (21 U.S.C. 812) and nonnarcotic substances, chemical preparations, 
veterinary anabolic steroid implant products, prescription products, 
anabolic steroid products, and cannabis plant material and products made 
therefrom that contain tetrahydrocannabinols excluded pursuant to 
section 201 of the Act (21 U.S.C. 811), as they are changed, updated, 
and republished from time to time, are set forth in this part.

[81 FR 97021, Dec. 30, 2016]



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 
Secs. 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 
Secs. 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 Secs. 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 Secs. 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

[[Page 112]]

(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) AH-7921 (3,4-dichloro-N-[(1-dimethylamino)                      9551
 cyclohexylmethyl]benzamide.....................................
(4) Allylprodine................................................    9602
(5) Alphacetylmethadol (except levo-alphacetylmethadol also         9603
 known as levo-alpha-acetylmethadol, levomethadyl acetate, or
 LAAM)..........................................................
(6) Alphameprodine..............................................    9604
(7) Alphamethadol...............................................    9605
(8) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-   9814
 piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-
 propanilido) piperidine).......................................
(9) Alpha-methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-     9832
 piperidinyl]-N-phenylpropanamide)..............................
(10) Benzethidine...............................................    9606
(11) Betacetylmethadol..........................................    9607
(12) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4-          9830
 piperidinyl]-N-phenylpropanamide)..............................
(13) Beta-hydroxy-3-methylfentanyl (other name: N-[1-(2-hydroxy-    9831
 2-phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide.......
(14) Betameprodine..............................................    9608
(15) Betamethadol...............................................    9609
(16) Betaprodine................................................    9611
(17) Clonitazene................................................    9612
(18) Dextromoramide.............................................    9613
(19) Diampromide................................................    9615
(20) Diethylthiambutene.........................................    9616
(21) Difenoxin..................................................    9168
(22) Dimenoxadol................................................    9617
(23) Dimepheptanol..............................................    9618
(24) Dimethylthiambutene........................................    9619
(25) Dioxaphetyl butyrate.......................................    9621
(26) Dipipanone.................................................    9622
(27) Ethylmethylthiambutene.....................................    9623
(28) Etonitazene................................................    9624
(29) Etoxeridine................................................    9625
(30) Furethidine................................................    9626
(31) Hydroxypethidine...........................................    9627
(32) Ketobemidone...............................................    9628
(33) Levomoramide...............................................    9629
(34) Levophenacylmorphan........................................    9631
(35) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4-             9813
 piperidyl]-N-phenylpropanamide)................................
(36) 3-methylthiofentanyl (N-[(3-methyl-1-(2-thienyl)ethyl-4-       9833
 piperidinyl]-N-phenylpropanamide)..............................
(37) Morpheridine...............................................    9632
(38) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine)............    9661
(39) Noracymethadol.............................................    9633
(40) Norlevorphanol.............................................    9634
(41) Normethadone...............................................    9635
(42) Norpipanone................................................    9636
(43) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenethyl)-    9812
 4-piperidinyl] propanamide.....................................
(44) PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine.......    9663
(45) Phenadoxone................................................    9637
(46) Phenampromide..............................................    9638
(47) Phenomorphan...............................................    9647
(48) Phenoperidine..............................................    9641
(49) Piritramide................................................    9642
(50) Proheptazine...............................................    9643
(51) Properidine................................................    9644
(52) Propiram...................................................    9649
(53) Racemoramide...............................................    9645
(54) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]-   9835
 propanamide....................................................
(55) Tilidine...................................................    9750
(56) 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

[[Page 113]]

 
(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:       7348
 2C-T-7).......................................................
(7) 4-methoxyamphetamine.......................................     7411
  Some trade or other names: 4-methoxy-[alpha]-
   methylphenethylamine; paramethoxyamphetamine, PMA
(8) 5-methoxy-3,4-methylenedioxy-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-        7404
 ethyl-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) 5-methoxy-N,N-dimethyltryptamine Some trade or other           7431
 names: 5-methoxy-3-[2-(dimethylamino)ethyl]indole; 5-MeO-DMT..
(16) Alpha-methyltryptamine (other name: AMT)..................     7432
(17) 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
(18) Diethyltryptamine.........................................     7434
  Some trade and other names: N,N-Diethyltryptamine; DET
(19) Dimethyltryptamine........................................     7435

[[Page 114]]

 
  Some trade or other names: DMT
(20) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-        7439
 DIPT).........................................................
(21) 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
(22) Lysergic acid diethylamide................................     7315
(23) Marihuana.................................................     7360
(24) Mescaline.................................................     7381
(25) 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.
(26) 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))
(27) N-ethyl-3-piperidyl benzilate.............................     7482
(28) N-methyl-3-piperidyl benzilate............................     7484
(29) Psilocybin................................................     7437
(30) Psilocyn..................................................     7438
(31) 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.)
(32) Ethylamine analog of phencyclidine........................     7455
  Some trade or other names: N-ethyl-1-phenylcyclohexylamine,
   (1-phenylcyclohexyl)ethylamine, N-(1-
   phenylcyclohexyl)ethylamine, cyclohexamine, PCE
(33) Pyrrolidine analog of phencyclidine.......................     7458
  Some trade or other names: 1-(1-phenylcyclohexyl)-
   pyrrolidine, PCPy, PHP
(34) Thiophene analog of phencyclidine.........................     7470

[[Page 115]]

 
  Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]-
   piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP
(35) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine....................     7473
  Some other names: TCPy
(36) 4-methylmethcathinone (Mephedrone)........................     1248
(37) 3,4-methylenedioxypyrovalerone (MDPV).....................     7535
(38) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)..........     7509
(39) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).........     7508
(40) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).........     7519
(41) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)...........     7518
(42) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)..     7385
(43) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-     7532
 4)............................................................
(44) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)..................     7517
(45) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).........     7521
(46) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P).....     7524
(47) 3,4-Methylenedioxy-N-methylcathinone (Methylone)..........     7540
(48) (1-pentyl-1H-indol-3-yl)(2,2,3,3-                            (7144)
 tetramethylcyclopropyl)methanone (UR-144).....................
(49) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                 (7011)
 tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11).....
(50) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide           (7048)
 (APINACA, AKB48)..............................................
(51) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22;       (7222)
 QUPIC)........................................................
(52) quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate     (7225)
 (5-fluoro-PB-22; 5F-PB-22)....................................
(53) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-  (7012)
 indazole-3-carboxamide (AB-FUBINACA)..........................
(54) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-        (7035)
 indazole-3-carboxamide (ADB-PINACA)...........................
(55) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-                         (7538)
 methoxybenzyl)ethanamine (25I-NBOMe, 2C-I-NBOMe)..............
(56) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-                       (7537)
 methoxybenzyl)ethanamine (25C-NBOMe, 2C-C-NBOMe)..............
(57) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-                        (7536)
 methoxybenzyl)ethanamine (25B-NBOMe, 2C-B-NBOMe)..............
(58) Marihuana Extract--Meaning an extract containing one or      (7350)
 more cannabinoids that has been derived from any plant of the
 genus Cannabis, other than the separated resin (whether crude
 or purified) obtained from the plant..........................
(59) 4-methyl-N-ethylcathinone (4-MEC).........................   (1249)
(60) 4-methyl-alpha-pyrrolidinopropiophenone (4-MePPP).........   (7498)
(61) alpha-pyrrolidinopentiophenone ([alpha]-PVP)..............   (7545)
(62) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one          (7541)
 (butylone, bk-MBDB)...........................................
(63) 2-(methylamino)-1-phenylpentan-1-one (pentedrone).........   (1246)
(64) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one         (7542)
 (pentylone, bk-MBDP)..........................................
(65) 4-fluoro-N-methylcathinone (4-FMC; flephedrone)...........   (1238)
(66) 3-fluoro-N-methylcathinone (3-FMC)........................   (1233)
(67) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one          (1258)
 (naphyrone)...................................................

[[Page 116]]

 
(68) alpha-pyrrolidinobutiophenone ([alpha]-PBP)...............   (7546)
 

    (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-         1590
 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) Cannabimimetic agents. Unless specifically exempted or unless 
listed in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of the following substances, or 
which contains their 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) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-         7297
 phenol (CP-47,497).............................................
(2) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol    7298
 (cannabicyclohexanol or CP-47,497 C8-homolog)..................
(3) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)..........    7118
(4) 1-butyl-3-(1-naphthoyl)indole (JWH-073).....................    7173
(5) 1-hexyl-3-(1-naphthoyl)indole (JWH-019).....................    7019
(6) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)..    7200
(7) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)..........    6250
(8) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).........    7081
(9) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)...........    7122

[[Page 117]]

 
(10) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)..........    7398
(11) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201)..........    7201
(12) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694).........    7694
(13) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and RCS-4)...    7104
(14) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 7008 (SR-    7008
 18 and RCS-8)..................................................
(15) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)..........    7203
 

    (h) 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-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-
 1H-indazole-3-carboxamide, its optical, positional, and
 geometric isomers, salts, and salts of isomers--7031 (Other
 names: AB-CHMINACA)..........................................
(2) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-
 3-carboxamide, its optical, positional, and geometric
 isomers, salts, and salts of isomers--7023 (Other names: AB-
 PINACA)......................................................
(3) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-
 yl)methanone, its optical, positional, and geometric isomers,
 salts, and salts of isomers--7024 (Other names: THJ-2201)....
(4) N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its         (9821).
 optical, positional, and geometric isomers, salts and salts
 of isomers (Other names: acetyl fentanyl)....................
(5) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-                   (7032)
 (cyclohexylmethyl)-1H-indazole-3-carboxamide, its optical,
 positional, and geometric isomers, salts and salts of isomers
 (Other names: MAB-CHMINACA; ADB-CHMINACA)....................
(6) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, its         (9822)
 isomers, esters, ethers, salts and salts of isomers, esters
 and ethers (Other names: Butyryl fentanyl)...................
(7) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-     (9836)
 phenylpropionamide, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other names: beta-
 hydroxythiofentanyl).........................................
(8) 3,4-Dichloro-N-[2-(dimethylamino)cyclohexyl]-N-               (9547)
 methylbenzamide, its isomers, esters, ethers, salts and salts
 of isomers, esters and ethers (Other name: U-47700)..........
(9) N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide,   (9834).
 its isomers, esters, ethers, salts and salts of isomers,
 esters and ethers (Other name: Furanyl fentanyl).............
 


[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 at www.fdsys.gov.



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 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

[[Page 118]]

apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, 
nalmefene, naloxegol, naloxone, and naltrexone, and their respective 
salts, but including the following:

(i) Codeine.....................................................    9050
(ii) Dihydroetorphine...........................................    9334
(iii) Ethylmorphine.............................................    9190
(iv) Etorphine hydrochloride....................................    9059
(v) Granulated opium............................................    9640
(vi) Hydrocodone................................................    9193
(vii) Hydromorphone.............................................    9150
(viii) Metopon..................................................    9260
(ix) Morphine...................................................    9300
(x) Opium extracts..............................................    9610
(xi) Opium fluid................................................    9620
(xii) Oripavine.................................................    9330
(xiii) Oxycodone................................................    9143
(xiv) Oxymorphone...............................................    9652
(xv) Powdered opium.............................................    9639
(xvi) Raw opium.................................................    9600
(xvii) Thebaine.................................................    9333
(xviii) Tincture of opium.......................................    9630
 

    (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:
    (i) Decocainized coca leaves or extraction of coca leaves, which 
extractions do not contain cocaine or ecgonine; or
    (ii) [\123\I]ioflupane.
    (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-           9254
 diphenyl 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
(28) Tapentadol.................................................    9780
(29) Thiafentanil...............................................    9729
 

    (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................................................

[[Page 119]]

 
(2) Methamphetamine, its salts, isomers, and salts of its           1105
 isomers........................................................
(3) Phenmetrazine and its salts.................................    1631
(4) Methylphenidate.............................................    1724
(5) Lisdexamfetamine, its salts, isomers, and salts of its         1205.
 isomers........................................................
 

    (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) 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]
(2) Dronabinol [(-)-delta-9-trans tetrahydrocannabinol] in an     (7365)
 oral solution in a drug product approved for marketing by the
 U.S. Food and Drug Administration.............................
 

    (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
 

    (3) Immediate precursor to fentanyl:

(i) 4-anilino-N-phenethyl-4-piperidine (ANPP)...................    8333
 

    (ii) [Reserved]

[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 at www.fdsys.gov.



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 system, including its salts, isomers 
(whether optical, positional, 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

[[Page 120]]

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) Embutramide.................................................    2020
(6) 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...................................
(7) Ketamine, its salts, isomers, and salts of isomers..........    7285
  [Some other names for ketamine: ([)-2-(2-chlorophenyl)-2-
   (methylamino)-cyclohexanone]
(8) Lysergic acid...............................................    7300
(9) Lysergic acid amide.........................................    7310
(10) Methyprylon................................................    2575
(11) Perampanel, and its salts, isomers, and salts of isomers...    2261
(12) Sulfondiethylmethane.......................................    2600
(13) Sulfonethylmethane.........................................    2605
(14) Sulfonmethane..............................................    2610
(15) 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:

(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      9803
     or 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 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.............................

[[Page 121]]

 
    (iv) 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.............................
    (v) 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..............
    (vi) 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, esters and ethers:
    (1) Anabolic steroids (see Sec. 1300.01 of this chapter)--4000
    (2) [Reserved]

    (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]

    Editorial Note: For Federal Register citations affecting 
Sec. 1308.13, see the List of CFR Sections Affected, which appears in 
the Finding Aids section of the printed volume and at www.fdsys.gov.



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).....................................
(3) 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol,      9752
 its salts, optical and geometric isomers and salts of these
 isomers (including tramadol)...................................
 

    (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)  Alfaxalone.................................................    2731
(2)  Alprazolam.................................................    2882
(3)  Barbital...................................................    2145
(4)  Bromazepam.................................................    2748
(5)  Camazepam..................................................    2749
(6)   Carisoprodol..............................................    8192
(7)  Chloral betaine............................................    2460
(8)  Chloral hydrate............................................    2465
(9)  Chlordiazepoxide...........................................    2744
(10)  Clobazam..................................................    2751
(11)  Clonazepam................................................    2737

[[Page 122]]

 
(12) Clorazepate................................................    2768
(13) Clotiazepam................................................    2752
(14) Cloxazolam.................................................    2753
(15) Delorazepam................................................    2754
(16) Diazepam...................................................    2765
(17) Dichloralphenazone.........................................    2467
(18) Estazolam..................................................    2756
(19) Ethchlorvynol..............................................    2540
(20) Ethinamate.................................................    2545
(21) Ethyl loflazepate..........................................    2758
(22) Fludiazepam................................................    2759
(23) Flunitrazepam..............................................    2763
(24) Flurazepam.................................................    2767
(25) Fospropofol................................................    2138
(26) Halazepam..................................................    2762
(27) Haloxazolam................................................    2771
(28) Ketazolam..................................................    2772
(29) Loprazolam.................................................    2773
(30) Lorazepam..................................................    2885
(31) Lormetazepam...............................................    2774
(32) Mebutamate.................................................    2800
(33) Medazepam..................................................    2836
(34) Meprobamate................................................    2820
(35) Methohexital...............................................    2264
(36) Methylphenobarbital (mephobarbital)........................    2250
(37) Midazolam..................................................    2884
(38) Nimetazepam................................................    2837
(39) Nitrazepam.................................................    2834
(40) Nordiazepam................................................    2838
(41) Oxazepam...................................................    2835
(42) Oxazolam...................................................    2839
(43) Paraldehyde................................................    2585
(44) Petrichloral...............................................    2591
(45) Phenobarbital..............................................    2285
(46) Pinazepam..................................................    2883
(47) Prazepam...................................................    2764
(48) Quazepam...................................................    2881
(49) Suvorexant.................................................    2223
(50) Temazepam..................................................    2925
(51) Tetrazepam.................................................    2886
(52) Triazolam..................................................    2887
(53) Zaleplon...................................................    2781
(54) Zolpidem...................................................    2783
(55) Zopiclone..................................................    2784
 

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

(1) Lorcaserin..................................................    1625
 

    (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) 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
 

    (g) 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
(3) Eluxadoline (5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-
 dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-
 yl)ethyl]amino]methyl]-2-methoxybenzoic acid) (including its
 optical isomers) and its salts, isomers, and salts of isomers
 (9725).........................................................
 


[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 at www.fdsys.gov.

[[Page 123]]



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.
    (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]..................................................
 

    (e) Depressants. 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 depressant effect on the central nervous system, including its 
salts:

(1) Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]       2710
 butanamide) (also referred to as BRV; UCB-34714; Briviact)
 (including its salts)..........................................
(2) Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]-          2779
 carbamic acid ethyl ester].....................................
(3) Lacosamide [(R)-2-acetoamido-N-benzyl-3-methoxy-                2746
 propionamide]..................................................
(4) Pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid]......    2782
 


[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; 70 FR 43635, July 28, 
2005; 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, 2011; 81 FR 
29491, May 12, 2016]

                     Excluded Nonnarcotic Substances



Sec. 1308.21  Application for exclusion of a nonnarcotic substance.

    (a) Any person seeking to have any nonnarcotic drug that 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 Drug and Chemical Evaluation Section, 
Diversion Control Division, Drug Enforcement Administration. See the 
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address.
    (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.

[[Page 124]]

    (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.

[38 FR 8254, Mar. 30, 1973, as amended at 70 FR 74657, Dec. 16, 2005; 75 
FR 10678, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]



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)
----------------------------------------------------------------------------------------------------------------
Aphena Pharma Solutions--New     Nasal Decongestant  ..............  IN          Levmetamfetamine          50.00
 York, LLC.                       Inhaler/Vapor                                   (l-
                                  Inhaler.                                        Desoxyephedrine).
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
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
Procter & Gamble Co., The......  Vicks VapoInhaler.    37000-686-01  IN          Levmetamfetamine          50.00
                                                                                  (l-
                                                                                  Desoxyephedrine).
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
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, 1973, 
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; 74 FR 
44283, Aug. 28, 2009; 80 FR 65634, 65637, Oct. 27, 2015; 81 FR 6453, 
Feb. 8, 2016]

[[Page 125]]

                      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 Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (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;
    (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,

[[Page 126]]

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; 75 
FR 10678, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]



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 Secs. 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 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

[[Page 127]]

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. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address. 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. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.
    (j) The following substances are designated as exempt chemical 
preparations for the purposes set forth in this section.
    (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 at www.fdsys.gov.

[[Page 128]]

          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 Drug and Chemical Evaluation 
Section, Diversion Control Division, Drug Enforcement Administration. 
See the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter 
for the current mailing address.
    (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 an exclusion which has been accepted for 
filing.

[56 FR 42936, Aug. 30, 1991, as amended at 75 FR 10679, Mar. 9, 2010; 81 
FR 97021, Dec. 30, 2016]



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

[[Page 129]]

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. 
See the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter 
for the current mailing address.
    (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; 75 FR 10679, Mar. 
9, 2010]

                     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 Drug and Chemical Evaluation Section, Diversion Control 
Division, Drug Enforcement Administration. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.
    (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 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

[[Page 130]]

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; 75 
FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]



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, and 
1002 through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) 
and Secs. 1301.13, 1301.22, and Secs. 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. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.

[75 FR 10679, Mar. 9, 2010]

                    Exempt Anabolic Steroid Products



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

    (a) The Administrator, upon the recommendation of 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, which is intended for administration to a human being or 
animal, if, because of its concentration, preparation, formulation, or 
delivery system, it has no significant potential for abuse.
    (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 Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (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
    (ii) a granting of an exemption under this section.

[[Page 131]]

    (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; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, 
Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]



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 Secs. 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. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.

[75 FR 10679, Mar. 9, 2010]

   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.

[[Page 132]]

    (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 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 Secs. 1308.42-1308.51, and by 
Secs. 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. See the Table of DEA Mailing Addresses in Sec. 1321.01 of 
this chapter for the current mailing address. Petitions shall be in the 
following form:

__________ (Date)
Administrator, Drug Enforcement Administration ______ (Mailing Address)

    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:

[[Page 133]]

    (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.)
    (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; 75 
FR 10679, Mar. 9, 2010]



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 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.

[[Page 134]]

    (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 immediate precursor. The 
order shall designate the schedule in which the immediate precursor is 
to be placed, which shall be the same schedule in

[[Page 135]]

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  Temporary scheduling.

    (a) 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 Drug 
Enforcement Administration may place a substance into Schedule I on a 
temporary basis, if it 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 calendar days 
from:
    (1) The date of publication by the Administration of a notice in the 
Federal Register of its intention to issue such order and the grounds 
upon which such order is to be issued; and
    (2) The date the Administration has transmitted notification to the 
Secretary of Health and Human Services of the Administration's intention 
to issue such order.
    (b) An order issued under this section will 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 two years 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 
Administration may extend the temporary scheduling for up to one year.

[81 FR 97021, Dec. 30, 2017]



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 136]]

         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. 802, 821, 822, 823, 824, 830, 871(b), 875, 877, 
886a, 952, 953, 957, 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 Registration Section, Drug Enforcement Administration. See the Table 
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.

[75 FR 10680, Mar. 9, 2010]

                Fees for Registration and Reregistration



Sec. 1309.11  Fee amounts.

    (a) For each application for registration or reregistration to 
manufacture the applicant shall pay an annual fee of $3,047.
    (b) For each application for registration or reregistration to 
distribute, import, or export a List I chemical, the applicant shall pay 
an annual fee of $1,523.

[77 FR 15250, Mar. 15, 2012]



Sec. 1309.12  Time and method of payment; refund.

    (a) For each application for registration or reregistration to 
manufacture, distribute, import, or export, the applicant shall pay the 
fee when the application for registration or reregistration is submitted 
for filing.
    (b) Payments should be made in the form of a credit card; a 
personal, certified, or cashier's check; or a 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.

[75 FR 4980, Feb. 1, 2010]

                      Requirements for Registration



Sec. 1309.21  Persons required to register.

    (a) Unless exempted by law or under Secs. 1309.24 through 1309.26 or 
Secs. 1310.12 through 1310.13 of this chapter, the following persons 
must annually obtain a registration specific to the List I chemicals to 
be handled:
    (1) Every person who manufactures or imports or proposes to 
manufacture or import a List I chemical or a drug product containing 
ephedrine, pseudoephedrine, or phenylpropanolamine.
    (2) Every person who distributes or exports or proposes to 
distribute or export any List I chemical, other than those List I 
chemicals contained in a product exempted under paragraph (1)(iv) of the 
definition of regulated transaction in Sec. 1300.02 of this chapter.
    (b) Only persons actually engaged in the activities are required to 
obtain a registration; related or affiliated persons who are not engaged 
in the 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.)
    (c) The registration requirements are summarized in the following 
table:

[[Page 137]]



                              Summary of Registration Requirements and Limitations
----------------------------------------------------------------------------------------------------------------
                                                                                   Registration     Coincident
      Business activity            Chemicals         DEA Forms       Application      period        activities
                                                                         fee          (years)        allowed
----------------------------------------------------------------------------------------------------------------
Manufacturing................  List I..........  New-510.........          $3,047             1  May distribute
                                                                                                  that chemical
                                                                                                  for which
                                                                                                  registration
                                                                                                  was issued;
                                                                                                  may not
                                                                                                  distribute any
                                                                                                  chemical for
                                                                                                  which not
                                                                                                  registered.
                               Drug products     Renewal-510a....           3,047
                                containing
                                ephedrine,
                                pseudoephedrine
                                ,
                                phenylpropanola
                                mine.
Distributing.................  List I..........  New-510.........           1,523             1
                               Scheduled listed  Renewal-510a....           1,523
                                chemical
                                products.
Importing....................  List I..........  New-510.........           1,523             1  May distribute
                                                                                                  that chemical
                                                                                                  for which
                                                                                                  registration
                                                                                                  was issued;
                                                                                                  may not
                                                                                                  distribute any
                                                                                                  chemical for
                                                                                                  which not
                                                                                                  registered.
                               Drug Products     Renewal-510a....           1,523
                                containing
                                ephedrine,
                                pseudoephedrine
                                ,
                                phenylpropanola
                                mine.
Exporting....................  List I..........  New-510.........           1,523             1
                               Scheduled listed  Renewal-510a....           1,523
                                chemical
                                products.
----------------------------------------------------------------------------------------------------------------


[75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77 
FR 15250, Mar. 15, 2012]



Sec. 1309.22  Separate registration for independent activities.

    (a) The following groups of activities are deemed to be independent 
of each other:
    (1) Manufacturing of List I chemicals or drug products containing 
ephedrine, pseudoephedrine, or phenylpropanolamine.
    (2) Distributing of List I chemicals and scheduled listed chemical 
products.
    (3) Importing List I chemicals or drug products containing 
ephedrine, pseudoephedrine, or phenylpropanolamine.
    (4) Exporting List I chemicals and scheduled listed chemical 
products.
    (b) Except as provided in paragraphs (c) and (d) of this section, 
every person who engages in more than one group of independent 
activities must obtain a separate registration for each group of 
activities, unless otherwise exempted by the Act or Secs. 1309.24 
through 1309.26.
    (c) 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.
    (d) A person registered to manufacture any List I chemical shall be 
authorized to distribute that List I chemical after manufacture, but no 
other chemical that the person is not registered to manufacture.

[75 FR 4981, Feb. 1, 2010]



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 
manufactured, 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

[[Page 138]]

(other than chemicals for display purposes) nor serves as a distribution 
point for filling sales orders.

[60 FR 32454, June 22, 1995, as amended at 75 FR 4981, Feb. 1, 2010]



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 the 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 
manufactures or distributes a scheduled listed chemical product or other 
product containing a List I chemical that is described and included in 
paragraph (1)(iv) of the definition of regulated transaction in 
Sec. 1300.02 of this chapter, if that person is registered with the 
Administration to engage in the same activity with a controlled 
substance.
    (c) The requirement of registration is waived for any person who 
imports or exports a scheduled listed chemical product or other product 
containing a List I chemical that is described and included in paragraph 
(1)(iv) of the definition of regulated transaction in Sec. 1300.02 of 
this chapter, 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 
only distributes a prescription drug product containing a List I 
chemical that is regulated pursuant to paragraph (1)(iv) of the 
definition of regulated transaction in Sec. 1300.02 of this chapter.
    (e) 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.
    (f) 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).
    (g) The requirement of registration is waived for any person whose 
activities with respect to List I chemicals are limited solely to the 
distribution of Lugol's Solution (consisting of 5 percent iodine and 10 
percent potassium iodide in an aqueous solution) in original 
manufacturer's packaging of one fluid ounce (30 ml) or less.
    (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), or 
(f) 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 the activities, as 
required by Sec. 1309.21.
    (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), or (f) of this section 
pursuant to the procedures set forth in Secs. 1309.43 through 1309.46 
and Secs. 1309.51 through 1309.55. 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 section 304 of the Act (21 U.S.C. 824) is warranted.
    (k) Any person exempted from the registration requirement under this 
section must comply with the security requirements set forth in 
Secs. 1309.71 through 1309.73 and the recordkeeping and reporting 
requirements set forth under Parts 1310, 1313, 1314, and 1315 of this 
chapter.

[75 FR 4981, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 25, 2012]

[[Page 139]]



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.
    (c) Each person required by sections 302 or 1007 of the Act (21 
U.S.C. 822 or 957) to obtain a registration to manufacture or import 
prescription drug products containing ephedrine, pseudoephedrine, or 
phenylpropanolamine is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before March 3, 2010. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied the application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in this part and parts 1310, 1313, and 1315 of this chapter 
remain in full force and effect.

[67 FR 14860, Mar. 28, 2002, as amended at 75 FR 4982, Feb. 1, 2010]



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 customs 
officer, any officer or employee of the U.S. Food and Drug 
Administration, and any Federal or Insular 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 
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 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.

[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]

                      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.

[[Page 140]]

    (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 Section, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. 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 Section of the Administration at the foregoing address.
    (d) Each application for registration must include the 
Administration Chemical Code Number, as set forth in Sec. 1310.02 of 
this chapter, for each List I chemical to be manufactured, 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.
    (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.

[60 FR 32454, June 22, 1995, as amended at 75 FR 10680, Mar. 9, 2010; 81 
FR 97021, Dec. 30, 2016]



Sec. 1309.33  Filing of application; joint filings.

    (a) All applications for registration shall be submitted for filing 
to the Registration Section, Drug Enforcement Administration. See the 
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address. 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.

[60 FR 32454, June 22, 1995, as amended at 75 FR 10680, Mar. 9, 2010]



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

[[Page 141]]

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.

  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.

[[Page 142]]

    (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, 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,

[[Page 143]]

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.
    (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. 1309.53. 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.

[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]

                                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 Secs. 1309.52 
through 1309.55, and by the procedures for administrative hearings under 
the Act set forth in Secs. 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.

[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]



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

[[Page 144]]

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 Secs. 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 Secs. 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 Secs. 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]



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 
Registration Section, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address. 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.

[75 FR 10680, Mar. 9, 2010]



Sec. 1309.62  Termination of registration.

    (a) The registration of any person shall terminate, without any 
further action by the Administration, if and

[[Page 145]]

when such person dies, ceases legal existence, discontinues business or 
professional practice, or surrenders a registration. Any registrant who 
ceases 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. Any registrant who ceases 
legal existence or discontinues business or professional practice or 
wishes to surrender a registration shall 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; 76 
FR 61564, Oct. 5, 2011; 77 FR 4236, Jan. 27, 2012]



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 must provide effective controls 
and procedures to guard against theft and diversion of List I chemicals. 
Chemicals must 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.
    (b) In evaluating the effectiveness of security controls and 
procedures, the Administrator shall consider the following factors:
    (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; and
    (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 Regulatory 
Section, Drug Enforcement Administration. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.

[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997; 
67 FR 14861, Mar. 28, 2002; 71 FR 56023, Sept. 26, 2006; 75 FR 10680, 
Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]

[[Page 146]]



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.



PART 1310_RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES;
IMPORTATION AND EXPORTATION OF 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 Federal 
          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  Removal of exemption from definition of regulated transaction.
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

[[Page 147]]

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     8113
 isomers........................................................
(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    8317
 optical isomers................................................
(8) Phenylacetic acid, its esters, and its salts................    8791
(9) Phenylpropanolamine, its salts, optical isomers, and salts      1225
 of optical isomers.............................................
(10) Piperidine and its salts...................................    2704
(11) Pseudoephedrine, its salts, optical isomers, and salts of      8112
 optical isomers................................................
(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    8115
 optical isomers (N-Methylephedrine)............................
(20) N-Methylpseudoephedrine, its salts, optical isomers, and       8119
 salts of optical isomers.......................................
(21) Hydriodic Acid.............................................    6695
(22) Benzaldehyde...............................................    8256
(23) Nitroethane................................................    6724
(24) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2       2011
 (3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-
 Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid
 lactone).......................................................
(25) Red phosphorus.............................................    6795
(26) White phosphorus (Other names: Yellow Phosphorus)..........    6796
(27) Hypophosphorous acid and its salts (Including ammonium         6797
 hypophosphite, calcium hypophosphite, iron hypophosphite,
 potassium hypophosphite, manganese hypophosphite, magnesium
 hypophosphite and sodium hypophosphite)........................
(28) N-phenethyl-4-piperidone (NPP).............................    8332
(29) Iodine.....................................................    6699
(30) Ergocristine and its salts.................................    8612
 

    (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
(8) Hydrochloric acid (including anhydrous hydrogen chloride)...    6545
(9) Sulfuric acid...............................................    6552
(10) Methyl Isobutyl Ketone (MIBK)..............................    6715
(11) Sodium Permanganate........................................    6588
 

    (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);

[[Page 148]]

    (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; 71 FR 60826, Oct. 
17, 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, July 2, 2007; 72 FR 
40238, July 24, 2007; 76 FR 17781, Mar. 31, 2011]



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 
Sec. 1310.05.
    (c)(1) Each regulated person who engages in a transaction with a 
nonregulated person which:
    (i) Involves ephedrine, pseudoephedrine, phenylpropanolamine, or 
gamma hydroxybutyric acid (including drug products containing these 
chemicals or controlled substance); and
    (ii) Uses or attempts to use the U.S. Postal Service or any private 
or commercial carrier must, on a monthly basis, report to the 
Administration each such transaction conducted during the previous month 
as specified in Secs. 1310.05(e) and 1310.06(k) on DEA Form 453 through 
the DEA Diversion Control Division secure network application.
    (2) Each regulated person who engages in an export transaction 
which:
    (i) Involves ephedrine, pseudoephedrine, phenylpropanolamine, or 
gamma hydroxybutyric acid (including drug products containing these 
chemicals or controlled substance); and
    (ii) Uses or attempts to use the U.S. Postal Service or any private 
or commercial carrier must, on a monthly basis, report each such 
transaction conducted during the previous month as specified in 
Secs. 1310.05(e) and 1310.06(k) on DEA Form 453 through the DEA 
Diversion Control Division secure network application.

[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; 81 FR 97022, Dec. 30, 2016]



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 149]]

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.

------------------------------------------------------------------------
                                                          Threshold by
             Code                      Chemical            base weight
------------------------------------------------------------------------
8522..........................  N-Acetylanthranilic     40 kilograms.
                                 acid, its esters, and
                                 its salts.
8530..........................  Anthranilic acid, its   30 kilograms.
                                 esters, and its salts.
8256..........................  Benzaldehyde..........  4 kilograms.
8735..........................  Benzyl cyanide........  1 kilogram.
8675..........................  Ergonovine and its      10 grams.
                                 salts.
8676..........................  Ergotamine and its      20 grams.
                                 salts.
8678..........................  Ethylamine and its      1 kilogram.
                                 salts.
6695..........................  Hydriodic acid........  1.7 kilograms
                                                         (or 1 liter by
                                                         volume).
8704..........................  Isosafrole............  4 kilograms.
8520..........................  Methylamine and its     1 kilogram.
                                 salts.
8502..........................  3,4-Methylenedioxyphen  4 kilograms.
                                 yl-2-propanone.
8115..........................  N-Methylephedrine, its  1 kilogram.
                                 salts, optical
                                 isomers, and salts of
                                 optical isomers.
8119..........................  N-Methylpseudoephedrin  1 kilogram.
                                 e, its salts, optical
                                 isomers, and salts of
                                 optical isomers.
6724..........................  Nitroethane...........  2.5 kilograms.
8317..........................  Norpseudoephedrine,     2.5 kilograms.
                                 its salts, optical
                                 isomers, and salts of
                                 optical isomers.
8791..........................  Phenylacetic acid, its  1 kilogram.
                                 esters, and its salts.
2704..........................  Piperidine and its      500 grams.
                                 salts.
8750..........................  Piperonal (also called  4 kilograms.
                                 heliotropine).
8328..........................  Propionic anhydride...  1 gram.
8323..........................  Safrole...............  4 kilograms.
------------------------------------------------------------------------

    (ii) For List I chemicals that are contained in scheduled listed 
chemical products as defined in Sec. 1300.02 of this chapter, the 
thresholds established in paragraph (g) of this section apply only to 
non-retail distribution, import, and export. Sales of these products at 
retail are subject to the requirements of part 1314 of this chapter.
    (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.

[[Page 150]]

 
(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.
(H) Sodium permanganate................  N/A................................  500 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) Anhydrous Hydrogen chloride........  N/A................................  0.0 kilograms.
(I) Sodium permanganate................  N/A................................  55 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 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) Ergocristine and its salts
    (iii) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid 
lactone; gamma-hydroxybutyric acid lactone)
    (iv) Hypophosphorous acid and its salts (including ammonium 
hypophosphite, calcium hypophosphite, iron hypophosphite, potassium 
hypophosphite, manganese hypophosphite, magnesium hypophosphite, and 
sodium hypophosphite)
    (v) Iodine
    (vi) N-phenethyl-4-piperidone (NPP)
    (vii) Pseudoephedrine, its salts, optical isomers, and salts of 
optical isomers
    (viii) Phenylpropanolamine, its salts, optical isomers, and salts of 
optical isomers
    (ix) Red phosphorus
    (x) White phosphorus (Other names: Yellow Phosphorus)
    (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

[[Page 151]]

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]

    Editorial Note: For Federal Register citations affecting 
Sec. 1310.04, see the List of CFR Sections Affected, which appears in 
the Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1310.05  Reports.

    (a)(1) Each regulated person must 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 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. The regulated person will orally report to the Special 
Agent in Charge of the DEA Divisional Office 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. The regulated person must file a written report 
of the transaction(s) with the Special Agent in Charge of the DEA 
Divisional Office as set forth in Sec. 1310.06 within 15 calendar days 
after the regulated person becomes aware of the circumstances of the 
event.
    (2) Each regulated person must 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 any proposed regulated transaction with a 
person whose description or other identifying characteristic the 
Administration has previously furnished to the regulated person. The 
regulated person will orally report to the Special Agent in Charge of 
the DEA Divisional Office at the earliest practicable opportunity after 
the regulated person becomes aware of the circumstances involved. 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.
    (b)(1) Each regulated person must 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 any unusual or excessive loss or 
disappearance of a listed chemical under the control of the regulated 
person. The regulated person will orally report to the Special Agent in 
Charge of the DEA Divisional Office at the earliest practicable 
opportunity after the regulated person becomes aware of the 
circumstances involved. Unless the loss or disappearance occurs during 
an import or export transaction, the supplier is responsible for 
reporting all in-transit losses of any listed chemical by their agent or 
the common or contract carrier. In an import transaction, once a 
shipment has been released by the customs officer at the port of entry, 
the importer is responsible for reporting all in-transit losses of any 
listed chemical by their agent or the common or contract carrier. In an 
export transaction, the exporter is responsible for reporting all in-
transit losses of any listed chemical by their agent or the common or 
contract carrier until the shipment has been released by the customs 
officer at the port of export. The regulated person must also file a 
complete and accurate DEA Form 107, in accordance with Sec. 1310.06(d), 
with the Administration through the DEA Diversion Control Division 
secure network application within 15 calendar days after becoming aware 
of the circumstances requiring the report. Unusual or excessive losses 
or disappearances must be reported whether or not the listed chemical is

[[Page 152]]

subsequently recovered or the responsible parties are identified and 
action taken against them. When determining whether a loss or 
disappearance of a listed chemical was unusual or excessive, the 
regulated persons should consider, among others, the following factors:
    (i) The actual quantity of a listed chemical;
    (ii) The specific listed chemical involved;
    (iii) Whether the loss or disappearance of the listed chemical can 
be associated with access to those listed chemicals by specific 
individuals, or whether the loss or disappearance can be attributed to 
unique activities that may take place involving the listed chemical; and
    (iv) A pattern of losses or disappearances over a specific time 
period, whether the losses or disappearances appear to be random, and 
the result of efforts taken to resolve the losses.
    (v) If known, the regulated person should also consider whether the 
specific listed chemical was a likely candidate for diversion as well as 
local trends and other indicators of the diversion potential of the 
listed chemical.
    (2) Each regulated person must orally report any domestic regulated 
transaction in a tableting machine or an encapsulating machine to the 
Special Agent in Charge of the DEA Divisional Office for the area in 
which the regulated person making the report is located when the order 
is placed with the seller. The regulated person also must file a report 
of the transaction (on DEA Form 452) with the Administration through the 
DEA Diversion Control Division secure network application within 15 
calendar days after the order has been shipped by the seller. A report 
(DEA Form 452) may list more than one machine for a single transaction. 
Upon receipt and review, the Administration will assign a completed 
report a transaction identification number. The report will not be 
deemed filed until a transaction identification number has been issued 
by the Administration.
    (c) Imports and exports of tableting machines and encapsulating 
machines. (1) Each regulated person who imports or exports a tableting 
machine, or encapsulating machine, must file a report of such 
importation or exportation on DEA Form 452 with the Administration 
through the DEA Diversion Control Division secure network application, 
at least 15 calendar days before the anticipated arrival at the port of 
entry or port of export. 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 report to the 
Administration as far in advance as possible. A separate report (DEA 
Form 452) must be filed for each shipment, in accordance with 
Sec. 1310.06(e). Upon receipt and review, the Administration will assign 
a completed report a transaction identification number. The report will 
not be deemed filed until a transaction identification number has been 
issued by the Administration. The importer or exporter may only proceed 
with the transaction once the transaction identification number has been 
issued. 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.
    (2) Denied release at the port of entry. In the event that a 
shipment of tableting or encapsulating machine(s) has been denied 
release by a customs officer at the port of entry for any reason, the 
importer who attempted to import the shipment must, within 5 business 
days of the denial, report to the Administration that the shipment was 
denied, the basis for denial, and such other information as is required 
by Sec. 1310.06(g). Such report must be transmitted to the 
Administration through the DEA Diversion Control Division secure network 
application. Upon the importer's report of a denied entry, DEA will 
assign the report a transaction identification number and the original 
import notification will be void and of no effect. No shipment of

[[Page 153]]

tableting machines or encapsulating machines denied entry for any reason 
will be allowed entry without a subsequent refiling of an amended DEA 
Form 452 by the regulated person. In such circumstances, the regulated 
person may proceed with the release of the tableting machines or 
encapsulating machines upon receipt of a transaction identification 
number for the refiled and amended DEA Form 452 without regard to the 
15-day advance filing requirement in paragraph (c)(1) of this section, 
so long as the article is otherwise cleared for entry under U.S. customs 
laws.
    (d) Each regulated bulk manufacturer of a listed chemical must 
submit manufacturing, inventory and use data on an annual basis as set 
forth in Sec. 1310.06(j). This data must be submitted annually to the 
Drug and Chemical Evaluation Section, Diversion Control Division, Drug 
Enforcement Administration, on or before the 15th day of March of the 
year immediately following the calendar year for which submitted. See 
the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for 
the current mailing address. 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 drugs or other products that are exempted 
under paragraph (1)(iv) or (v) of the definition of regulated 
transaction in Sec. 1300.02 of this chapter except as set forth in 
Sec. 1310.06(i)(5). Bulk manufacturers that produce a listed chemical 
solely for internal consumption are not required to report for that 
listed chemical. For purposes of these reporting requirements, internal 
consumption consists of any quantity of a listed chemical otherwise not 
available for further resale or distribution. Internal consumption 
includes (but is not 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(j) and 
such information is separate or readily retrievable from the report, 
that report may be submitted in satisfaction of this requirement. Each 
report must be submitted to the DEA under company letterhead and signed 
by an appropriate, responsible official. For purposes of this paragraph 
(d) only, the term regulated bulk manufacturer of a listed chemical 
means a person who manufactures a listed chemical by means of 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 forms of products which contain a listed 
chemical.
    (e) Each regulated person required to report pursuant to 
Sec. 1310.03(c) must file a report containing the transaction 
identification number for each such transaction (if the regulated person 
is required to obtain a transaction identification number under part 
1313of this chapter) and information set forth in Sec. 1310.06(k), on or 
before the 15th day of each month following the month in which the 
distributions took place.
    (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 defined in Sec. 1300.02 of this chapter, except that this 
paragraph does not apply to sales of scheduled listed chemical products 
at retail.
    (3) Distributions of drug products to a resident of a long term care 
facility

[[Page 154]]

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 
Secs. 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; 71 FR 56024, Sept. 26, 2006; 75 FR 10680, Mar. 9, 
2010; 77 FR 4236, Jan. 27, 2012; 81 FR 97022, Dec. 30, 2016]



Sec. 1310.06  Content of records and reports.

    (a) Each record required by Sec. 1310.03(a) must include the 
following:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address (es), etc.), and, 
if required, DEA registration number of each party to the regulated 
transaction.
    (2) The date of the regulated transaction.
    (3) The quantity, chemical name, and, if applicable, National Drug 
Code (NDC) number. If NDC number is not applicable, the form of 
packaging of the listed chemical or a description of the tableting 
machine or encapsulating machine (including make, model, serial number, 
if any, and whether the machine is manual or electric).
    (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.
    (b) For purposes of this section, normal business records will 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 will 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 U.S. Food and Drug 
Administration regulations relating to the distribution of prescription 
drugs, as set forth in 21 CFR part 205, will be considered adequate for 
satisfying the requirements of paragraph (a) of this section with 
respect to distributions.
    (c)(1) Each report required by Sec. 1310.05(a) must include the 
information as specified by paragraph (a) of this section, the basis for 
making the report, and, where obtainable, the registration number of the 
other party, if such party is registered. A report of an uncommon method 
of payment or delivery submitted in accordance with Sec. 1310.05(a)(1) 
must also include a reason why the method of payment or delivery was 
uncommon.
    (2) A suggested format for the reports in Sec. 1310.05(a)(1) is 
provided below:


    Shipping Address (if different than purchaser Address):

Street__________________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Date of Shipment________________________________________________________

    Description of Listed Chemical:
Chemical Name___________________________________________________________
Quantity________________________________________________________________
National Drug Code (NDC) Number(s), or Form(s) of Packaging_____________

    Other:
The basis (i.e., reason) for making the report:_________________________
Any additional pertinent information:___________________________________

    (d) Each report of an unusual or excessive loss or disappearance of 
a listed chemical required by Sec. 1310.05(b)(1) (on DEA Form 107), must 
include the following information:

[[Page 155]]

    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address (es), etc.), and, 
if applicable, DEA registration number of each party to the regulated 
transaction.
    (2) The date (or estimated date) on which unusual or excessive loss 
or disappearance occurred, and the actual date on which the unusual or 
excessive loss or disappearance was discovered by the regulated person.
    (3) The quantity, chemical name, and National Drug Code (NDC) 
number, if applicable or if not the form of packaging of the listed 
chemical.
    (4) The type of business conducted by the regulated person, (e.g., 
grocery store, pharmacy/drug store, discount department store, warehouse 
club or superstore, convenience store, specialty food store, gas 
station, mobile retail vendor, mail-order, etc.) if the regulated person 
is not a DEA registrant.
    (e)(1) Each report of an importation of a tableting machine or an 
encapsulating machine required by Sec. 1310.05(c)(1) (on DEA Form 452) 
must include the following information:
    (i) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
regulated person; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), etc.) 
of the import broker or forwarding agent, if any;
    (ii) A description of each machine (including make, model, serial 
number, if any, and whether the machine is manual or electric) and the 
number of machines being received;
    (iii) The anticipated date of arrival at the port of entry, and the 
anticipated port of entry;
    (iv) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignor in the foreign country of exportation;
    (v) The intended medical, commercial, scientific, or other 
legitimate use of the machine; and
    (vi) Any proposed changes in identifying information of the imported 
machines (e.g., name, brand, serial number, if any, etc.) that will take 
place after importation.
    (2) Each report of an exportation of a tableting machine or an 
encapsulating machine required by Sec. 1310.05(c)(1) (on DEA Form 452) 
must include the following information:
    (i) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
regulated person; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), etc.) 
of the export broker (if applicable);
    (ii) A description of each machine (including make, model, serial 
number, if any, and whether the machine is manual or electric) and the 
number of machines being received;
    (iii) The anticipated date of arrival at the port of export, the 
foreign port and country of entry; and
    (iv) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignee in the country where the shipment is destined; the name(s)/
business name(s) and address(es)/business address(es), and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
intermediate consignee(s) (if any).
    (f) Each report of a domestic regulated transaction in a tableting 
machine or encapsulating machine required by Sec. 1310.05(b)(2) (on DEA 
Form 452) must include the following information:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
regulated person; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), etc.) 
of the purchaser;
    (2) A description of each machine (including make, model, serial 
number, if any, and whether the machine is manual or electric) and the 
number of machines being received; and
    (3) Any changes made by the regulated person in identifying 
information of the machines (e.g., name, brand, serial number, etc.).

[[Page 156]]

    (g) Each report of a denied release by a customs officer at the port 
of entry of a tableting machine or an encapsulating machine required by 
Sec. 1310.05(c)(2) must include the following information: the quantity 
of machines denied release; a concise description of the machines denied 
release; the date on which release was denied; the port where the denial 
of release was issued from; and the basis for the denial.
    (h) Return information. (1) Within 30 calendar days after actual 
receipt of a tableting or encapsulating machine, or within 10 calendar 
days after receipt of a written request by the Administration to the 
importer, whichever is sooner, the importer must file a report with the 
Administration (on DEA Form 452) specifying the particulars of the 
transaction utilizing the DEA Diversion Control Division secure network 
application. This report must include the following information: The 
date on which a customs officer at the port of entry released the 
machine(s); the date on which the machine(s) arrived at the final 
destination; the port of entry where the machine(s) were actually 
released by a customs officer; the actual quantity of machines released 
by a customs officer; the actual quantity of machines that arrived at 
the final destination; a description of each tableting or encapsulating 
machine imported (including make, model, and serial number, if any); any 
changes in identifying information of the imported machines (e.g., name, 
brand, serial number, if any, etc.) that will take place after 
importation; and any other information as the Administration may from 
time to time specify. Upon receipt and review, the Administration will 
assign a transaction identification number to a completed report. The 
report will not be deemed filed until the Administration has issued a 
transaction identification number. A single return declaration may 
include the particulars of both the importation and distribution. For 
DEA reporting purposes, import responsibilities are concluded upon the 
receipt of the machines by the importer. Once machines are received by 
the importer, domestic transaction reporting requirements commence. 
Distributions of tableting and encapsulating machines from the importer 
to their customers must be reported as domestic regulated transactions 
in accordance with Sec. 1310.05(b)(2).
    (2) Within 30 calendar days after the tableting or encapsulating 
machine is released by a customs officer at the port of export, or 
within 10 calendar days after receipt of a written request by the 
Administration to the exporter, whichever is sooner, the exporter must 
file a report with the Administration (on DEA Form 452) through the DEA 
Diversion Control Division secure network application specifying the 
particulars of the transaction. This report must include the following 
information: The date on which the machine(s) was (were) released by a 
customs officer at the port of export; the actual quantity of machines 
released; a description of each tableting or encapsulating machine 
released (including make, model, serial number, if any, and whether the 
machine is manual or electric); and any other information as the 
Administration may from time to time specify.
    (i) 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 filed 
with the Administration through the DEA Diversion Control Division 
secure network application, following the return at the earliest 
practicable opportunity after the regulated person becomes aware of the 
circumstances involved. 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.
    (j) Each annual report required by Sec. 1310.05(d) must provide the 
following information for each listed chemical manufactured:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) and 
chemical registration number (if any) of the manufacturer.

[[Page 157]]

    (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 paragraph (1)(iv) 
or (v) of the definition of regulated transaction in Sec. 1300.02 of 
this chapter 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.
    (k) Each monthly report required by Secs. 1310.03(c) and 1310.05(e) 
(on DEA Form 453) must provide the following information for each 
transaction:
    (1) Supplier name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), etc.) 
and registration number.
    (2) Purchaser's name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), 
etc.).
    (3) Name/business name, address/business address shipped to (if 
different from purchaser's name/address).
    (4) Chemical name, National Drug Code (NDC) number, if applicable, 
and total amount shipped.
    (5) Date of shipment.
    (6) Product name (if drug product).
    (7) Dosage form (if drug product) (e.g., pill, tablet, liquid).
    (8) Dosage strength (if drug product) (e.g., 30mg, 60mg, per dose 
etc.).
    (9) Number of dosage units (if drug product) (e.g., 100 doses per 
package).
    (10) Package type (if drug product) (e.g., bottle, blister pack, 
etc.).
    (11) Number of packages (if drug product) (e.g., 10 bottles).
    (12) Lot number (if drug product).
    (l) Information provided in reports required by Sec. 1310.05(e) 
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 the Act 
(21 U.S.C. 830(c)) for confidential business information.

[81 FR 97023, Dec. 30, 2016]



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

[[Page 158]]

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 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) Domestic and international transactions of Lugol's Solution 
(consisting of 5 percent iodine and 10 percent potassium iodide in an 
aqueous solution) in original manufacturer's packaging of one-fluid-
ounce (30 milliliters) or less, and no greater than one package per 
transaction.

[[Page 159]]

    (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, and/or toluene, unless 
regulated because of being formulated with other List I or List II 
chemical(s) 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; 72 FR 10928, Mar. 
12, 2007; 72 FR 35931, July 2, 2007]



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 paragraph (1)(iv) of the definition of regulated transaction 
in Sec. 1300.02 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 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-

[[Page 160]]

methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or 
pseudoephedrine, pursuant to Secs. 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 Secs. 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.
    (h) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 to 
obtain a registration to manufacture, distribute, import, or export 
regulated N-phenethyl-4-piperidone (NPP), including regulated chemical 
mixtures pursuant to Sec. 1310.12, is temporarily exempted from the 
registration requirement, provided that DEA receives a proper 
application for registration or application for exemption for a chemical 
mixture containing NPP pursuant to Sec. 1310.13 on or before June 22, 
2007. 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 the Act and parts 1309, 1310, 
1313, and 1316 of this chapter remain in full force and effect. Any 
person who manufactures, distributes, imports or exports a chemical 
mixture containing N-phenethyl-4-piperidone (NPP) 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 those persons whose application for exemption are 
denied, 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 been denied. The 
temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
    (i) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to manufacture, distribute, import, or export 
regulated iodine, including regulated iodine chemical mixtures pursuant 
to Secs. 1310.12 and

[[Page 161]]

1310.13, is temporarily exempted from the registration requirement, 
provided that the Administration receives a proper application for 
registration or application for exemption for a chemical mixture 
containing iodine on or before August 31, 2007. 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 the Act and parts 1309, 1310, and 1313 of this chapter 
remain in full force and effect. Any person who distributes, imports, or 
exports a chemical mixture containing iodine whose application for 
exemption is subsequently denied by the Administration must obtain a 
registration with the Administration. A temporary exemption from the 
registration requirement will also be provided for these persons, 
provided that the Administration receives a properly completed 
application for registration on or before 30 days following the date of 
official Administration notification that the application for exemption 
has not been approved. The temporary exemption for such persons will 
remain in effect until the Administration takes final action on their 
registration application.
    (j) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to manufacture, distribute, import, or export 
regulated chemical mixtures which contain ephedrine, and/or 
pseudoephedrine, pursuant to Sections 1310.12 and 1310.13, is 
temporarily exempted from the registration requirement, provided that 
DEA receives a properly completed application for registration or 
application for exemption on or before August 24, 2007. 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, 1313, and 1315 of this 
chapter remain in full force and effect. Any person who manufactures, 
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.
    (k)(1) Each person required by sections 302 or 1007 of the Act (21 
U.S.C. 822, 957) to obtain a registration to manufacture, distribute, 
import, or export regulated GBL-containing chemical mixtures, pursuant 
to sections 1310.12 and 1310.13, is temporarily exempted from the 
registration requirement, provided that DEA receives a properly 
completed application for registration or application for exemption on 
or before July 29, 2010. 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.
    (2) Any person who manufactures, distributes, imports or exports a 
GBL-containing 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 those persons whose applications for exemption are denied, 
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 been denied. The 
temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
    (l)(1) Each person required under sections 302 and 1007 of the Act 
(21 U.S.C. 822, 957) to obtain a registration to manufacture, 
distribute, import, or export regulated ergocristine and its salts, 
including regulated chemical

[[Page 162]]

mixtures pursuant to Sec. 1310.12, is temporarily exempted from the 
registration requirement, provided that DEA receives a properly 
completed application for registration or application for exemption for 
a chemical mixture containing ergocristine and its salts pursuant to 
Sec. 1310.13 on or before May 2, 2011. 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 the Act and parts 1309, 1310, 1313, and 1316 of this 
chapter remain in full force and effect.
    (2) Any person who manufactures, distributes, imports, or exports a 
chemical mixture containing ergocristine and its salts 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 those persons whose applications for exemption are 
denied, 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 been denied. The 
temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
    (m)(1) Each person required by Sections 302 or 1007 of the Act (21 
U.S.C. 822, 957) to obtain a registration to manufacture, distribute, 
import, or export regulated chemical mixtures which contain red 
phosphorus, white phosphorus, hypophosphorous acid (and its salts), 
pursuant to Secs. 1310.12 and 1310.13, is temporarily exempted from the 
registration requirement, provided that DEA receives a properly 
completed application for registration or application for exemption on 
or before July 5, 2011. 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.
    (2) Any person who manufactures, distributes, imports, or exports a 
chemical mixture which contains red phosphorus, white phosphorus, 
hypophosphorous acid (and its salts) 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 those persons whose applications are denied, 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; 72 FR 20046, Apr. 23, 2007; 72 FR 
35931, July 2, 2007; 72 FR 40239, July 24, 2007; 72 FR 40744, July 25, 
2007; 75 FR 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; 76 FR 
31829, June 2, 2011; 77 FR 4237, Jan. 27, 2012]



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

    (a) The Administrator may remove from exemption under paragraph 
(1)(iv) of the definition of regulated transaction in Sec. 1300.02 of 
this chapter any drug or group of drugs that the Administrator finds 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

[[Page 163]]

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.
    (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; 75 FR 38922, July 7, 2010; 77 FR 4237, Jan. 
27, 2012]

[[Page 164]]



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, 1008, and 1018 of the Act (21 U.S.C. 
822, 823, 830, 957, 958, and 971) 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  Not exempt at any           Chemical mixtures containing
 and salts of optical isomers.                         concentration.              any amount of ephedrine and/
                                                                                   or pseudoephedrine, and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers are
                                                                                   not exempt due to
                                                                                   concentration, unless
                                                                                   otherwise exempted.
Ergocristine and its salts.............         8612  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of ergocristine
                                                                                   and its salts are not exempt.
Ergonovine and its salts...............         8675  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of ergonovine,
                                                                                   including its salts, are not
                                                                                   exempt.
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.
Gamma-Butyrolactone....................         2011  70% by weight or volume.
Hydriodic acid.........................         6695  20% by Weight or Volume...

[[Page 165]]

 
Hypophosphorous acid and its salts.....         6797  30% by weight if a solid,   The weight is determined by
                                                       weight or volume if a       measuring the mass of
                                                       liquid.                     hypophosphorous acid and its
                                                                                   salts in the mixture, the
                                                                                   concentration limit is
                                                                                   calculated by summing the
                                                                                   concentrations of all forms
                                                                                   of hypophosphorous acid and
                                                                                   its salts in the mixture. The
                                                                                   Administration does not
                                                                                   consider a chemical mixture
                                                                                   to mean the combination of a
                                                                                   listed chemical and an inert
                                                                                   carrier. Therefore, any
                                                                                   solution consisting of
                                                                                   hypophosphorous acid (and its
                                                                                   salts), dispersed in water,
                                                                                   alcohol, or another inert
                                                                                   carrier, is not considered a
                                                                                   chemical mixture and is
                                                                                   therefore subject to chemical
                                                                                   regulatory controls at all
                                                                                   concentrations.
Iodine.................................         6699  2.2.......................  Calculated as weight/volume (w/
                                                                                   v).
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.
N-phenethyl-4-piperidone (NPP).........         8332  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of NPP are not
                                                                                   exempt.
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  Not exempt at any           Chemical mixtures containing
 isomers, and salts of optical isomers.                concentration.              any amount of ephedrine and/
                                                                                   or pseudoephedrine, and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers are
                                                                                   not exempt due to
                                                                                   concentration, unless
                                                                                   otherwise exempted.
Red Phosphorus.........................         6795  80% by weight.
Safrole................................         8323  20% by Volume.............  Concentration in a mixture
                                                                                   cannot exceed 20% if taken
                                                                                   alone or in any combination
                                                                                   with isosafrole.
White phosphorus.......................         6796  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of white
                                                                                   phosphorus are not exempt due
                                                                                   to concentration, unless
                                                                                   otherwise exempted.
                                                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...

[[Page 166]]

 
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.
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.............
Sodium Permanganate....................         6588  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) 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.
    (2) Completely formulated paints and coatings: Completely formulated 
paints and coatings are only those formulations that contain all of 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, top-coats, primers, varnishes, sealers, adhesives, 
lacquers, stains, shellacs, inks, temporary protective coatings and 
film-forming agents.
    (3) Iodine products classified as iodophors that exist as an iodine 
complex to include poloxamer-iodine complex, polyvinyl pyrrolidone-
iodine complex (i.e., povidone-iodine), undecoylium chloride iodine, 
nonylphenoxypoly (ethyleneoxy) ethanol-iodine complex, iodine complex 
with phosphate ester of alkylaryloxy polyethylene glycol, and iodine 
complex with ammonium ether sulfate/polyoxyethylene sorbitan 
monolaurate.
    (4) Iodine products that consist of organically bound iodine (a non-
ionic complex) (e.g., iopamidol, iohexol, and amiodarone.)

[[Page 167]]

    (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 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; 71 
FR 60826, Oct. 17, 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, July 
2, 2007; 72 FR 40745, July 25, 2007; 75 FR 37306, June 29, 2010; 76 FR 
17781, Mar. 31, 2011; 76 FR 31830, June 2, 2011]



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 Drug and Chemical Evaluation Section, 
Diversion Control Division, Drug Enforcement Administration. See the 
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address.
    (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.

[[Page 168]]

    (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 a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator will 
notify the applicant in writing of the acceptance or rejection of the 
application for filing. If the application is not accepted for filing, 
an explanation will be provided. The Administrator is not required to 
accept an application if any information required pursuant to 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 subsequently granted, 
the applicant shall again 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

[[Page 169]]

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, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 
958, and 971):

                                            Exempt Chemical Mixtures
----------------------------------------------------------------------------------------------------------------
            Manufacturer                         Product name \1\                      Form              Date
----------------------------------------------------------------------------------------------------------------
Cerilliant Corporation..............  1R,2S(-)-Ephedrine hydrochloride 1.0    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  1S,2R(+)-Ephedrine-D3 hydrochloride     Liquid...............     8/2/2007
                                       0.1 mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  1S,2R(+)-Ephedrine-D3 hydrochloride     Liquid...............     8/2/2007
                                       1.0 mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  1S,2R(+)-Ephedrine hydrochloride 1.0    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  Pseudoephedrine-D3 hydrochloride 0.1    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  R,R(-)-Pseudoephedrine 1.0 mg/ml as     Liquid...............     8/2/2007
                                       free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20)
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  S,S(+)-Pseudoephedrine 1.0 mg/ml as     Liquid...............     8/2/2007
                                       free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
E.I. DuPont deNemours & Co..........  RC-5156...............................  Liquid...............    4/22/2005
E.I. DuPont deNemours & Co..........  VH-6037...............................  Liquid...............    4/22/2005
Hawthorne Products, Inc.............  Sole Pack Hoof Dressing...............  Paste................    8/14/2007
Hawthorne Products, Inc.............  Sole Pack Hoof Packing................  Paste................    8/14/2007
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          ephedrine in blood, serum, or urine.
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          pseudoephedrine in blood, serum, or
                                       urine.
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          phenylpropanolamine in blood, serum,
                                       or urine.
Reichhold, Inc......................  Beckosol[supreg] 12021-00 AA-200, IA-   Liquid...............    5/05/2005
                                       441, P531-T.
Reichhold, Inc......................  Urotuf[supreg] L06-30S, F78-50T.......  Liquid...............    5/05/2005
Reichhold, Inc......................  Beckosol AA-220.......................  Liquid...............    6/14/2005
Waterbury Companies, Inc............  Waterbury 332500......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 332762......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 332400......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 346201......................  Liquid...............    4/11/2005
----------------------------------------------------------------------------------------------------------------
\1\ Designate product line if a group.


[[Page 170]]


[68 FR 23204, May 1, 2003, as amended at 75 FR 10681, Mar. 9, 2010; 75 
FR 53869, Sept. 2, 2010; 76 FR 31830, June 2, 2011; 81 FR 97025, Dec. 
30, 2016]



Sec. 1310.14  Removal of exemption from definition of regulated transaction.

    The Administrator finds that the following drugs or groups of drugs 
are being diverted to obtain a listed chemical for use in the illicit 
production of a controlled substance and removes the drugs or groups of 
drugs from exemption under paragraph (1)(iv) of the definition of 
regulated transaction in Sec. 1300.02 of this chapter pursuant to the 
criteria listed in Sec. 1310.10 of this part:
    (a) Nonprescription drugs containing ephedrine, its salts, optical 
isomers, and salts of optical isomers.
    (b) Nonprescription drugs containing phenylpropanolamine, its salts, 
optical isomers, and salts of optical isomers.
    (c) Nonprescription drugs containing pseudoephedrine, its salts, 
optical isomers, and salts of optical isomers.

[75 FR 38922, July 7, 2010, as amended at 77 FR 4237, Jan. 27, 2012]



Sec. 1310.16  Exemptions for certain scheduled listed chemical products.

    (a) Upon the application of a manufacturer of a scheduled listed 
chemical product, the Administrator may by regulation provide that the 
product is exempt from part 1314 of this chapter if the Administrator 
determines that the product cannot be used in the illicit manufacture of 
a controlled substance.
    (b) An application for an exemption under this section must contain 
all of the following information:
    (1) The name and address of the applicant.
    (2) The exact trade name of the scheduled listed chemical product 
for which exemption is sought.
    (3) The complete quantitative and qualitative composition of the 
drug product.
    (4) A brief statement of the facts that the applicant believes 
justify the granting of an exemption under this section.
    (5) Certification by the applicant that the product may be lawfully 
marketed or distributed under the Federal, Food, Drug, and Cosmetic Act.
    (6) 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 by government employees.
    (c) The Administrator may require the applicant to submit additional 
documents or written statements of fact relevant to the application that 
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 under 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.
    (e) 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.
    (f) 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 
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.

[71 FR 56024, Sept. 26, 2006]

[[Page 171]]



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. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. A request for 
certification may be transmitted directly to the Office of Diversion 
Control, Drug Enforcement Administration, 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 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

[[Page 172]]

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, as amended at 75 FR 10681, Mar. 9, 2010]



PART 1311_REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS
--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.
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.

                   Subpart C_Electronic Prescriptions

1311.100  General.

[[Page 173]]

1311.102  Practitioner responsibilities.
1311.105  Requirements for obtaining an authentication credential--
          Individual practitioners.
1311.110  Requirements for obtaining an authentication credential--
          Individual practitioners eligible to use an electronic 
          prescription application of an institutional practitioner.
1311.115  Additional requirements for two-factor authentication.
1311.116  Additional requirements for biometrics.
1311.120  Electronic prescription application requirements.
1311.125  Requirements for establishing logical access control--
          Individual practitioner.
1311.130  Requirements for establishing logical access control--
          Institutional practitioner.
1311.135  Requirements for creating a controlled substance prescription.
1311.140  Requirements for signing a controlled substance prescription.
1311.145  Digitally signing the prescription with the individual 
          practitioner's private key.
1311.150  Additional requirements for internal application audits.
1311.170  Transmission requirements.
1311.200  Pharmacy responsibilities.
1311.205  Pharmacy application requirements.
1311.210  Archiving the initial record.
1311.215  Internal audit trail.
1311.300  Application provider requirements--Third-party audits or 
          certifications.
1311.302  Additional application provider requirements.
1311.305  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.



                            Subpart A_General



Sec. 1311.01  Scope.

    This part sets forth the rules governing the creation, transmission, 
and storage of electronic orders and prescriptions.

[75 FR 16310, Mar. 31, 2010]



Sec. 1311.02  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.

[75 FR 16310, Mar. 31, 2010]



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) 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 the Drug Enforcement Administration, call (202) 307-
1000. 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.

[[Page 174]]

    (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, (301) 975-6478 or TTY 
(301) 975-8295, [email protected], and are available at http://
csrc.nist.gov/. The following standards are incorporated by reference:
    (1) Federal Information Processing Standard Publication (FIPS PUB) 
140-2, Change Notices (12-03-2002), Security Requirements for 
Cryptographic Modules, May 25, 2001 (FIPS 140-2) including Annexes A 
through D; incorporation by reference approved for Secs. 1311.30(b), 
1311.55(b), 1311.115(b), 1311.120(b), 1311.205(b).
    (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) Federal Information Processing Standard Publication (FIPS PUB) 
180-2, Secure Hash Standard, August 1, 2002, as amended by change notice 
1, February 25, 2004 (FIPS 180-2); incorporation by reference approved 
for Secs. 1311.30(b) and 1311.55(b).
    (3) Federal Information Processing Standard Publication (FIPS PUB) 
180-3, Secure Hash Standard (SHS), October 2008 (FIPS 180-3); 
incorporation by reference approved for Secs. 1311.120(b) and 
1311.205(b).
    (4) Federal Information Processing Standard Publication (FIPS PUB) 
186-2, Digital Signature Standard, January 27, 2000, as amended by 
Change Notice 1, October 5, 2001 (FIPS 186-2); incorporation by 
reference approved for Secs. 1311.30(b) and 1311.55(b).
    (5) Federal Information Processing Standard Publication (FIPS PUB) 
186-3, Digital Signature Standard (DSS), June 2009 (FIPS 186-3); 
incorporation by reference approved for Secs. 1311.120(b), 1311.205(b), 
and 1311.210(c).
    (6) Draft NIST Special Publication 800-63-1, Electronic 
Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. 
et al.; incorporation by reference approved for Sec. 1311.105(a).
    (7) NIST Special Publication 800-76-1, Biometric Data Specification 
for Personal Identity Verification, January 2007 (NIST SP 800-76-1); 
Wilson, C. et al.; incorporation by reference approved for 
Sec. 1311.116(d).

[75 FR 16310, Mar. 31, 2010]



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.
    (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,

[[Page 175]]

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.
    (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.

[[Page 176]]



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.
    (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.

[[Page 177]]



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 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

[[Page 178]]

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.



                   Subpart C_Electronic Prescriptions

    Source: 75 FR 16310, Mar. 31, 2010, unless otherwise noted.



Sec. 1311.100  General.

    (a) This subpart addresses the requirements that must be met to 
issue and process Schedule II, III, IV, and V controlled substance 
prescriptions electronically.
    (b) A practitioner may issue a prescription for a Schedule II, III, 
IV, or V controlled substance electronically if all of the following 
conditions are met:
    (1) The practitioner is registered as an individual practitioner or 
exempt from the requirement of registration under part 1301 of this 
chapter and is authorized under the registration or exemption to 
dispense the controlled substance;
    (2) The practitioner uses an electronic prescription application 
that meets all of the applicable requirements of this subpart; and
    (3) The prescription is otherwise in conformity with the 
requirements of the Act and this chapter.
    (c) An electronic prescription for a Schedule II, III, IV, or V 
controlled substance created using an electronic prescription 
application that does not meet the requirements of this subpart is not a 
valid prescription, as that term is defined in Sec. 1300.03 of this 
chapter.
    (d) A controlled substance prescription created using an electronic 
prescription application that meets the requirements of this subpart is 
not a valid prescription if any of the functions required under this 
subpart were disabled when the prescription was indicated as ready for 
signature and signed.
    (e) A registered pharmacy may process electronic prescriptions for 
controlled substances only if all of the following conditions are met:
    (1) The pharmacy uses a pharmacy application that meets all of the 
applicable requirements of this subpart; and
    (2) The prescription is otherwise in conformity with the 
requirements of the Act and this chapter.
    (f) Nothing in this part alters the responsibilities of the 
practitioner and pharmacy, specified in part 1306 of this chapter, to 
ensure the validity of a controlled substance prescription.



Sec. 1311.102  Practitioner responsibilities.

    (a) The practitioner must retain sole possession of the hard token, 
where applicable, and must not share the password or other knowledge 
factor, or biometric information, with any other person. The 
practitioner must not allow any other person to use the token or enter 
the knowledge factor or other identification means to sign prescriptions 
for controlled substances. Failure by the practitioner to secure the 
hard token, knowledge factor, or biometric information may provide a 
basis for revocation or suspension of registration pursuant to section 
304(a)(4) of the Act (21 U.S.C. 824(a)(4)).

[[Page 179]]

    (b) The practitioner must notify the individuals designated under 
Sec. 1311.125 or Sec. 1311.130 within one business day of discovery that 
the hard token has been lost, stolen, or compromised or the 
authentication protocol has been otherwise compromised. A practitioner 
who fails to comply with this provision may be held responsible for any 
controlled substance prescriptions written using his two-factor 
authentication credential.
    (c) If the practitioner is notified by an intermediary or pharmacy 
that an electronic prescription was not successfully delivered, as 
provided in Sec. 1311.170, he must ensure that any paper or oral 
prescription (where permitted) issued as a replacement of the original 
electronic prescription indicates that the prescription was originally 
transmitted electronically to a particular pharmacy and that the 
transmission failed.
    (d) Before initially using an electronic prescription application to 
sign and transmit controlled substance prescriptions, the practitioner 
must determine that the third-party auditor or certification 
organization has found that the electronic prescription application 
records, stores, and transmits the following accurately and 
consistently:
    (1) The information required for a prescription under 
Sec. 1306.05(a) of this chapter.
    (2) The indication of signing as required by Sec. 1311.120(b)(17) or 
the digital signature created by the practitioner's private key.
    (3) The number of refills as required by Sec. 1306.22 of this 
chapter.
    (e) If the third-party auditor or certification organization has 
found that an electronic prescription application does not accurately 
and consistently record, store, and transmit other information required 
for prescriptions under this chapter, the practitioner must not create, 
sign, and transmit electronic prescriptions for controlled substances 
that are subject to the additional information requirements.
    (f) The practitioner must not use the electronic prescription 
application to sign and transmit electronic controlled substance 
prescriptions if any of the functions of the application required by 
this subpart have been disabled or appear to be functioning improperly.
    (g) If an electronic prescription application provider notifies an 
individual practitioner that a third-party audit or certification report 
indicates that the application or the application provider no longer 
meets the requirements of this part or notifies him that the application 
provider has identified an issue that makes the application non-
compliant, the practitioner must do the following:
    (1) Immediately cease to issue electronic controlled substance 
prescriptions using the application.
    (2) Ensure, for an installed electronic prescription application at 
an individual practitioner's practice, that the individuals designated 
under Sec. 1311.125 terminate access for signing controlled substance 
prescriptions.
    (h) If an electronic prescription application provider notifies an 
institutional practitioner that a third-party audit or certification 
report indicates that the application or the application provider no 
longer meets the requirements of this part or notifies it that the 
application provider has identified an issue that makes the application 
non-compliant, the institutional practitioner must ensure that the 
individuals designated under Sec. 1311.130 terminate access for signing 
controlled substance prescriptions.
    (i) An individual practitioner or institutional practitioner that 
receives a notification that the electronic prescription application is 
not in compliance with the requirements of this part must not use the 
application to issue electronic controlled substance prescriptions until 
it is notified that the application is again compliant and all relevant 
updates to the application have been installed.
    (j) The practitioner must notify both the individuals designated 
under Sec. 1311.125 or Sec. 1311.130 and the Administration within one 
business day of discovery that one or more prescriptions that were 
issued under a DEA registration held by that practitioner were 
prescriptions the practitioner had not signed or were not consistent 
with the prescriptions he signed.

[[Page 180]]

    (k) The practitioner has the same responsibilities when issuing 
prescriptions for controlled substances via electronic means as when 
issuing a paper or oral prescription. Nothing in this subpart relieves a 
practitioner of his responsibility to dispense controlled substances 
only for a legitimate medical purpose while acting in the usual course 
of his professional practice. If an agent enters information at the 
practitioner's direction prior to the practitioner reviewing and 
approving the information and signing and authorizing the transmission 
of that information, the practitioner is responsible in case the 
prescription does not conform in all essential respects to the law and 
regulations.



Sec. 1311.105  Requirements for obtaining an authentication credential
--Individual practitioners.

    (a) An individual practitioner must obtain a two-factor 
authentication credential from one of the following:
    (1) A credential service provider that has been approved by the 
General Services Administration Office of Technology Strategy/Division 
of Identity Management to conduct identity proofing that meets the 
requirements of Assurance Level 3 or above as specified in NIST SP 800-
63-1 as incorporated by reference in Sec. 1311.08.
    (2) For digital certificates, a certification authority that is 
cross-certified with the Federal Bridge certification authority and that 
operates at a Federal Bridge Certification Authority basic assurance 
level or above.
    (b) The practitioner must submit identity proofing information to 
the credential service provider or certification authority as specified 
by the credential service provider or certification authority.
    (c) The credential service provider or certification authority must 
issue the authentication credential using two channels (e.g., e-mail, 
mail, or telephone call). If one of the factors used in the 
authentication protocol is a biometric, or if the practitioner has a 
hard token that is being enabled to sign controlled substances 
prescriptions, the credential service provider or certification 
authority must issue two pieces of information used to generate or 
activate the authentication credential using two channels.



Sec. 1311.110  Requirements for obtaining an authentication credential
--Individual practitioners eligible to use an electronic prescription
application of an institutional practitioner.

    (a) For any registrant or person exempted from the requirement of 
registration under Sec. 1301.22(c) of this chapter who is eligible to 
use the institutional practitioner's electronic prescription application 
to sign prescriptions for controlled substances, the entity within a 
DEA-registered institutional practitioner that grants that individual 
practitioner privileges at the institutional practitioner (e.g., a 
hospital credentialing office) may conduct identity proofing and 
authorize the issuance of the authentication credential. That entity 
must do the following:
    (1) Ensure that photographic identification issued by the Federal 
Government or a State government matches the person presenting the 
identification.
    (2) Ensure that the individual practitioner's State authorization to 
practice and, where applicable, State authorization to prescribe 
controlled substances, is current and in good standing.
    (3) Either ensure that the individual practitioner's DEA 
registration is current and in good standing or ensure that the 
institutional practitioner has granted the individual practitioner 
exempt from the requirement of registration under Sec. 1301.22 of this 
chapter privileges to prescribe controlled substances using the 
institutional practitioner's DEA registration number.
    (4) If the individual practitioner is an employee of a health care 
facility that is operated by the Department of Veterans Affairs, confirm 
that the individual practitioner has been duly appointed to practice at 
that facility by the Secretary of the Department of Veterans Affairs 
pursuant to 38 U.S.C. 7401-7408.
    (5) If the individual practitioner is working at a health care 
facility operated by the Department of Veterans Affairs on a contractual 
basis pursuant to 38 U.S.C. 8153 and, in the performance of his duties, 
prescribes controlled substances, confirm that the individual

[[Page 181]]

practitioner meets the criteria for eligibility for appointment under 38 
U.S.C. 7401-7408 and is prescribing controlled substances under the 
registration of such facility.
    (b) An institutional practitioner that elects to conduct identity 
proofing must provide authorization to issue the authentication 
credentials to a separate entity within the institutional practitioner 
or to an outside credential Service provider or certification authority 
that meets the requirements of Sec. 1311.105(a).
    (c) When an institutional practitioner is conducting identity 
proofing and submitting information to a credential service provider or 
certification authority to authorize the issuance of authentication 
credentials, the institutional practitioner must meet any requirements 
that the credential service provider or certification authority imposes 
on entities that serve as trusted agents.
    (d) An institutional practitioner that elects to conduct identity 
proofing and authorize the issuance of the authentication credential as 
provided in paragraphs (a) through (c) of this section must do so in a 
manner consistent with the institutional practitioner's general 
obligation to maintain effective controls against diversion. Failure to 
meet this obligation may result in remedial action consistent with 
Sec. 1301.36 of this chapter.
    (e) An institutional practitioner that elects to conduct identity 
proofing must retain a record of the identity-proofing. An institutional 
practitioner that elects to issue the two-factor authentication 
credential must retain a record of the issuance of the credential.



Sec. 1311.115  Additional requirements for two-factor authentication.

    (a) To sign a controlled substance prescription, the electronic 
prescription application must require the practitioner to authenticate 
to the application using an authentication protocol that uses two of the 
following three factors:
    (1) Something only the practitioner knows, such as a password or 
response to a challenge question.
    (2) Something the practitioner is, biometric data such as a 
fingerprint or iris scan.
    (3) Something the practitioner has, a device (hard token) separate 
from the computer to which the practitioner is gaining access.
    (b) If one factor is a hard token, it must be separate from the 
computer to which it is gaining access and must meet at least the 
criteria of FIPS 140-2 Security Level 1, as incorporated by reference in 
Sec. 1311.08, for cryptographic modules or one-time-password devices.
    (c) If one factor is a biometric, the biometric subsystem must 
comply with the requirements of Sec. 1311.116.



Sec. 1311.116  Additional requirements for biometrics.

    (a) If one of the factors used to authenticate to the electronic 
prescription application is a biometric as described in Sec. 1311.115, 
it must comply with the following requirements.
    (b) The biometric subsystem must operate at a false match rate of 
0.001 or lower.
    (c) The biometric subsystem must use matching software that has 
demonstrated performance at the operating point corresponding with the 
false match rate described in paragraph (b) of this section, or a lower 
false match rate. Testing to demonstrate performance must be conducted 
by the National Institute of Standards and Technology or another DEA-
approved government or nongovernment laboratory. Such testing must 
comply with the requirements of paragraph (h) of this section.
    (d) The biometric subsystem must conform to Personal Identity 
Verification authentication biometric acquisition specifications, 
pursuant to NIST SP 800-76-1 as incorporated by reference in 
Sec. 1311.08, if they exist for the biometric modality of choice.
    (e) The biometric subsystem must either be co-located with a 
computer or PDA that the practitioner uses to issue electronic 
prescriptions for controlled substances, where the computer or PDA is 
located in a known, controlled location, or be built directly into the 
practitioner's computer or PDA that he uses to issue electronic 
prescriptions for controlled substances.

[[Page 182]]

    (f) The biometric subsystem must store device ID data at enrollment 
(i.e., biometric registration) with the biometric data and verify the 
device ID at the time of authentication to the electronic prescription 
application.
    (g) The biometric subsystem must protect the biometric data (raw 
data or templates), match results, and/or non-match results when 
authentication is not local. If sent over an open network, biometric 
data (raw data or templates), match results, and/or non-match results 
must be:
    (1) Cryptographically source authenticated;
    (2) Combined with a random challenge, a nonce, or a time stamp to 
prevent replay;
    (3) Cryptographically protected for integrity and confidentiality; 
and
    (4) Sent only to authorized systems.
    (h) Testing of the biometric subsystem must have the following 
characteristics:
    (1) The test is conducted by a laboratory that does not have an 
interest in the outcome (positive or negative) of performance of a 
submission or biometric.
    (2) Test data are sequestered.
    (3) Algorithms are provided to the testing laboratory (as opposed to 
scores or other information).
    (4) The operating point(s) corresponding with the false match rate 
described in paragraph (b) of this section, or a lower false match rate, 
is tested so that there is at least 95% confidence that the false match 
and non-match rates are equal to or less than the observed value.
    (5) Results of the testing are made publicly available.



Sec. 1311.120  Electronic prescription application requirements.

    (a) A practitioner may only use an electronic prescription 
application that meets the requirements in paragraph (b) of this section 
to issue electronic controlled substance prescriptions.
    (b) The electronic prescription application must meet the 
requirements of this subpart including the following:
    (1) The electronic prescription application must do the following:
    (i) Link each registrant, by name, to at least one DEA registration 
number.
    (ii) Link each practitioner exempt from registration under 
Sec. 1301.22(c) of this chapter to the institutional practitioner's DEA 
registration number and the specific internal code number required under 
Sec. 1301.22(c)(5) of this chapter.
    (2) The electronic prescription application must be capable of the 
setting of logical access controls to limit permissions for the 
following functions:
    (i) Indication that a prescription is ready for signing and signing 
controlled substance prescriptions.
    (ii) Creating, updating, and executing the logical access controls 
for the functions specified in paragraph (b)(2)(i) of this section.
    (3) Logical access controls must be set by individual user name or 
role. If the application sets logical access control by role, it must 
not allow an individual to be assigned the role of registrant unless 
that individual is linked to at least one DEA registration number as 
provided in paragraph (b)(1) of this section.
    (4) The application must require that the setting and changing of 
logical access controls specified under paragraph (b)(2) of this section 
involve the actions of two individuals as specified in Secs. 1311.125 or 
1311.130. Except for institutional practitioners, a practitioner 
authorized to sign controlled substance prescriptions must approve 
logical access control entries.
    (5) The electronic prescription application must accept two-factor 
authentication that meets the requirements of Sec. 1311.115 and require 
its use for signing controlled substance prescriptions and for approving 
data that set or change logical access controls related to reviewing and 
signing controlled substance prescriptions.
    (6) The electronic prescription application must be capable of 
recording all of the applicable information required in part 1306 of 
this chapter for the controlled substance prescription.
    (7) If a practitioner has more than one DEA registration number, the 
electronic prescription application must require the practitioner or his 
agent to select the DEA registration number to be included on the 
prescription.

[[Page 183]]

    (8) The electronic prescription application must have a time 
application that is within five minutes of the official National 
Institute of Standards and Technology time source.
    (9) The electronic prescription application must present for the 
practitioner's review and approval all of the following data for each 
controlled substance prescription:
    (i) The date of issuance.
    (ii) The full name of the patient.
    (iii) The drug name.
    (iv) The dosage strength and form, quantity prescribed, and 
directions for use.
    (v) The number of refills authorized, if applicable, for 
prescriptions for Schedule III, IV, and V controlled substances.
    (vi) For prescriptions written in accordance with the requirements 
of Sec. 1306.12(b) of this chapter, the earliest date on which a 
pharmacy may fill each prescription.
    (vii) The name, address, and DEA registration number of the 
prescribing practitioner.
    (viii) The statement required under Sec. 1311.140(a)(3).
    (10) The electronic prescription application must require the 
prescribing practitioner to indicate that each controlled substance 
prescription is ready for signing. The electronic prescription 
application must not permit alteration of the DEA elements after the 
practitioner has indicated that a controlled substance prescription is 
ready to be signed without requiring another review and indication of 
readiness for signing. Any controlled substance prescription not 
indicated as ready to be signed shall not be signed or transmitted.
    (11) While the information required by paragraph (b)(9) of this 
section and the statement required by Sec. 1311.140(a)(3) remain 
displayed, the electronic prescription application must prompt the 
prescribing practitioner to authenticate to the application, using two-
factor authentication, as specified in Sec. 1311.140(a)(4), which will 
constitute the signing of the prescription by the practitioner for 
purposes of Sec. 1306.05(a) and (e) of this chapter.
    (12) The electronic prescription application must not permit a 
practitioner other than the prescribing practitioner whose DEA number 
(or institutional practitioner DEA number and extension data for the 
individual practitioner) is listed on the prescription as the 
prescribing practitioner and who has indicated that the prescription is 
ready to be signed to sign the prescription.
    (13) Where a practitioner seeks to prescribe more than one 
controlled substance at one time for a particular patient, the 
electronic prescription application may allow the practitioner to sign 
multiple prescriptions for a single patient at one time using a single 
invocation of the two-factor authentication protocol provided the 
following has occurred: The practitioner has individually indicated that 
each controlled substance prescription is ready to be signed while the 
information required by paragraph (b)(9) of this section for each such 
prescription is displayed along with the statement required by 
Sec. 1311.140(a)(3).
    (14) The electronic prescription application must time and date 
stamp the prescription when the signing function is used.
    (15) When the practitioner uses his two-factor authentication 
credential as specified in Sec. 1311.140(a)(4), the electronic 
prescription application must digitally sign at least the information 
required by part 1306 of this chapter and electronically archive the 
digitally signed record. If the practitioner signs the prescription with 
his own private key, as provided in Sec. 1311.145, the electronic 
prescription application must electronically archive a copy of the 
digitally signed record, but need not apply the application's digital 
signature to the record.
    (16) The digital signature functionality must meet the following 
requirements:
    (i) The cryptographic module used to digitally sign the data 
elements required by part 1306 of this chapter must be at least FIPS 
140-2 Security Level 1 validated. FIPS 140-2 is incorporated by 
reference in Sec. 1311.08.
    (ii) The digital signature application and hash function must comply 
with

[[Page 184]]

FIPS 186-3 and FIPS 180-3, as incorporated by reference in Sec. 1311.08.
    (iii) The electronic prescription application's private key must be 
stored encrypted on a FIPS 140-2 Security Level 1 or higher validated 
cryptographic module using a FIPS-approved encryption algorithm. FIPS 
140-2 is incorporated by reference in Sec. 1311.08.
    (iv) For software implementations, when the signing module is 
deactivated, the application must clear the plain text password from the 
application memory to prevent the unauthorized access to, or use of, the 
private key.
    (17) Unless the digital signature created by an individual 
practitioner's private key is being transmitted to the pharmacy with the 
prescription, the electronic prescription application must include in 
the data file transmitted an indication that the prescription was signed 
by the prescribing practitioner.
    (18) The electronic prescription application must not transmit a 
controlled substance prescription unless the signing function described 
in Sec. 1311.140(a)(4) has been used.
    (19) The electronic prescription application must not allow 
alteration of any of the information required by part 1306 of this 
chapter after the prescription has been digitally signed. Any alteration 
of the information required by part 1306 of this chapter after the 
prescription is digitally signed must cancel the prescription.
    (20) The electronic prescription application must not allow 
transmission of a prescription that has been printed.
    (21) The electronic prescription application must allow printing of 
a prescription after transmission only if the printed prescription is 
clearly labeled as a copy not for dispensing. The electronic 
prescription application may allow printing of prescription information 
if clearly labeled as being for informational purposes. The electronic 
prescription application may transfer such prescription information to 
medical records.
    (22) If the transmission of an electronic prescription fails, the 
electronic prescription application may print the prescription. The 
prescription must indicate that it was originally transmitted 
electronically to, and provide the name of, a specific pharmacy, the 
date and time of transmission, and that the electronic transmission 
failed.
    (23) The electronic prescription application must maintain an audit 
trail of all actions related to the following:
    (i) The creation, alteration, indication of readiness for signing, 
signing, transmission, or deletion of a controlled substance 
prescription.
    (ii) Any setting or changing of logical access control permissions 
related to the issuance of controlled substance prescriptions.
    (iii) Notification of a failed transmission.
    (iv) Auditable events as specified in Sec. 1311.150.
    (24) The electronic prescription application must record within each 
audit record the following information:
    (i) The date and time of the event.
    (ii) The type of event.
    (iii) The identity of the person taking the action, where 
applicable.
    (iv) The outcome of the event (success or failure).
    (25) The electronic prescription application must conduct internal 
audits and generate reports on any of the events specified in 
Sec. 1311.150 in a format that is readable by the practitioner. Such 
internal audits may be automated and need not require human intervention 
to be conducted.
    (26) The electronic prescription application must protect the stored 
audit records from unauthorized deletion. The electronic prescription 
application shall prevent modifications to the audit records.
    (27) The electronic prescription application must do the following:
    (i) Generate a log of all controlled substance prescriptions issued 
by a practitioner during the previous calendar month and provide the log 
to the practitioner no later than seven calendar days after that month.
    (ii) Be capable of generating a log of all controlled substance 
prescriptions issued by a practitioner for a period specified by the 
practitioner upon request. Prescription information available from which 
to generate the log must span at least the previous two years.

[[Page 185]]

    (iii) Archive all logs generated.
    (iv) Ensure that all logs are easily readable or easily rendered 
into a format that a person can read.
    (v) Ensure that all logs are sortable by patient name, drug name, 
and date of issuance of the prescription.
    (28) Where the electronic prescription application is required by 
this part to archive or otherwise maintain records, it must retain such 
records electronically for two years from the date of the record's 
creation and comply with all other requirements of Sec. 1311.305.



Sec. 1311.125  Requirements for establishing logical access control
--Individual practitioner.

    (a) At each registered location where one or more individual 
practitioners wish to use an electronic prescription application meeting 
the requirements of this subpart to issue controlled substance 
prescriptions, the registrant(s) must designate at least two individuals 
to manage access control to the application. At least one of the 
designated individuals must be a registrant who is authorized to issue 
controlled substance prescriptions and who has obtained a two-factor 
authentication credential as provided in Sec. 1311.105.
    (b) At least one of the individuals designated under paragraph (a) 
of this section must verify that the DEA registration and State 
authorization(s) to practice and, where applicable, State 
authorization(s) to dispense controlled substances of each registrant 
being granted permission to sign electronic prescriptions for controlled 
substances are current and in good standing.
    (c) After one individual designated under paragraph (a) of this 
section enters data that grants permission for individual practitioners 
to have access to the prescription functions that indicate readiness for 
signature and signing or revokes such authorization, a second individual 
designated under paragraph (a) of this section must use his two-factor 
authentication credential to satisfy the logical access controls. The 
second individual must be a DEA registrant.
    (d) A registrant's permission to indicate that controlled substances 
prescriptions are ready to be signed and to sign controlled substance 
prescriptions must be revoked whenever any of the following occurs, on 
the date the occurrence is discovered:
    (1) A hard token or any other authentication factor required by the 
two-factor authentication protocol is lost, stolen, or compromised. Such 
access must be terminated immediately upon receiving notification from 
the individual practitioner.
    (2) The individual practitioner's DEA registration expires, unless 
the registration has been renewed.
    (3) The individual practitioner's DEA registration is terminated, 
revoked, or suspended.
    (4) The individual practitioner is no longer authorized to use the 
electronic prescription application (e.g., when the individual 
practitioner leaves the practice).



Sec. 1311.130  Requirements for establishing logical access control
--Institutional practitioner.

    (a) The entity within an institutional practitioner that conducts 
the identity proofing under Sec. 1311.110 must develop a list of 
individual practitioners who are permitted to use the institutional 
practitioner's electronic prescription application to indicate that 
controlled substances prescriptions are ready to be signed and to sign 
controlled substance prescriptions. The list must be approved by two 
individuals.
    (b) After the list is approved, it must be sent to a separate entity 
within the institutional practitioner that enters permissions for 
logical access controls into the application. The institutional 
practitioner must authorize at least two individuals or a role filled by 
at least two individuals to enter the logical access control data. One 
individual in the separate entity must authenticate to the application 
and enter the data to grant permissions to individual practitioners to 
indicate that controlled substances prescriptions are ready to be signed 
and to sign controlled substance prescriptions. A second individual must 
authenticate to the application to execute the logical access controls.
    (c) The institutional practitioner must retain a record of the 
individuals or roles that are authorized to conduct

[[Page 186]]

identity proofing and logical access control data entry and execution.
    (d) Permission to indicate that controlled substances prescriptions 
are ready to be signed and to sign controlled substance prescriptions 
must be revoked whenever any of the following occurs, on the date the 
occurrence is discovered:
    (1) An individual practitioner's hard token or any other 
authentication factor required by the practitioner's two-factor 
authentication protocol is lost, stolen, or compromised. Such access 
must be terminated immediately upon receiving notification from the 
individual practitioner.
    (2) The institutional practitioner's or, where applicable, 
individual practitioner's DEA registration expires, unless the 
registration has been renewed.
    (3) The institutional practitioner's or, where applicable, 
individual practitioner's DEA registration is terminated, revoked, or 
suspended.
    (4) An individual practitioner is no longer authorized to use the 
institutional practitioner's electronic prescription application (e.g., 
when the individual practitioner is no longer associated with the 
institutional practitioner.)



Sec. 1311.135  Requirements for creating a controlled substance prescription.

    (a) The electronic prescription application may allow the registrant 
or his agent to enter data for a controlled substance prescription, 
provided that only the registrant may sign the prescription in 
accordance with Secs. 1311.120(b)(11) and 1311.140.
    (b) If a practitioner holds multiple DEA registrations, the 
practitioner or his agent must select the appropriate registration 
number for the prescription being issued in accordance with the 
requirements of Sec. 1301.12 of this chapter.
    (c) If required by State law, a supervisor's name and DEA number may 
be listed on a prescription, provided the prescription clearly indicates 
who is the supervisor and who is the prescribing practitioner.



Sec. 1311.140  Requirements for signing a controlled substance prescription.

    (a) For a practitioner to sign an electronic prescription for a 
controlled substance the following must occur:
    (1) The practitioner must access a list of one or more controlled 
substance prescriptions for a single patient. The list must display the 
information required by Sec. 1311.120(b)(9).
    (2) The practitioner must indicate the prescriptions that are ready 
to be signed.
    (3) While the prescription information required in 
Sec. 1311.120(b)(9) is displayed, the following statement or its 
substantial equivalent is displayed: ``By completing the two-factor 
authentication protocol at this time, you are legally signing the 
prescription(s) and authorizing the transmission of the above 
information to the pharmacy for dispensing. The two-factor 
authentication protocol may only be completed by the practitioner whose 
name and DEA registration number appear above.''
    (4) While the prescription information required in 
Sec. 1311.120(b)(9) and the statement required by paragraph (a)(3) of 
this section remain displayed, the practitioner must be prompted to 
complete the two-factor authentication protocol.
    (5) The completion by the practitioner of the two-factor 
authentication protocol in the manner provided in paragraph (a)(4) of 
this section will constitute the signing of the prescription by the 
practitioner for purposes of Sec. 1306.05(a) and (e) of this chapter.
    (6) Except as provided under Sec. 1311.145, the practitioner's 
completion of the two-factor authentication protocol must cause the 
application to digitally sign and electronically archive the information 
required under part 1306 of this chapter.
    (b) The electronic prescription application must clearly label as 
the signing function the function that prompts the practitioner to 
execute the two-factor authentication protocol using his credential.
    (c) Any prescription not signed in the manner required by this 
section shall not be transmitted.

[[Page 187]]



Sec. 1311.145  Digitally signing the prescription with the individual
practitioner's private key.

    (a) An individual practitioner who has obtained a digital 
certificate as provided in Sec. 1311.105 may digitally sign a controlled 
substance prescription using the private key associated with his digital 
certificate.
    (b) The electronic prescription application must require the 
individual practitioner to complete a two-factor authentication protocol 
as specified in Sec. 1311.140(a)(4) to use his private key.
    (c) The electronic prescription application must digitally sign at 
least all information required under part 1306 of this chapter.
    (d) The electronic prescription application must electronically 
archive the digitally signed record.
    (e) A prescription that is digitally signed with a practitioner's 
private key may be transmitted to a pharmacy without the digital 
signature.
    (f) If the electronic prescription is transmitted without the 
digital signature, the electronic prescription application must check 
the certificate revocation list of the certification authority that 
issued the practitioner's digital certificate. If the digital 
certificate is not valid, the electronic prescription application must 
not transmit the prescription. The certificate revocation list may be 
cached until the certification authority issues a new certificate 
revocation list.
    (g) When the individual practitioner digitally signs a controlled 
substance prescription with the private key associated with his own 
digital certificate obtained as provided under Sec. 1311.105, the 
electronic prescription application is not required to digitally sign 
the prescription using the application's private key.



Sec. 1311.150  Additional requirements for internal application audits.

    (a) The application provider must establish and implement a list of 
auditable events. Auditable events must, at a minimum, include the 
following:
    (1) Attempted unauthorized access to the electronic prescription 
application, or successful unauthorized access where the determination 
of such is feasible.
    (2) Attempted unauthorized modification or destruction of any 
information or records required by this part, or successful unauthorized 
modification or destruction of any information or records required by 
this part where the determination of such is feasible.
    (3) Interference with application operations of the prescription 
application.
    (4) Any setting of or change to logical access controls related to 
the issuance of controlled substance prescriptions.
    (5) Attempted or successful interference with audit trail functions.
    (6) For application service providers, attempted or successful 
creation, modification, or destruction of controlled substance 
prescriptions or logical access controls related to controlled substance 
prescriptions by any agent or employee of the application service 
provider.
    (b) The electronic prescription application must analyze the audit 
trail at least once every calendar day and generate an incident report 
that identifies each auditable event.
    (c) Any person designated to set logical access controls under 
Secs. 1311.125 or 1311.130 must determine whether any identified 
auditable event represents a security incident that compromised or could 
have compromised the integrity of the prescription records. Any such 
incidents must be reported to the electronic prescription application 
provider and the Administration within one business day.



Sec. 1311.170  Transmission requirements.

    (a) The electronic prescription application must transmit the 
electronic prescription as soon as possible after signature by the 
practitioner.
    (b) The electronic prescription application may print a prescription 
that has been transmitted only if an intermediary or the designated 
pharmacy notifies a practitioner that an electronic prescription was not 
successfully delivered to the designated pharmacy. If this occurs, the 
electronic prescription application may print the prescription for the 
practitioner's manual signature. The printed prescription

[[Page 188]]

must include information noting that the prescription was originally 
transmitted electronically to [name of the specific pharmacy] on [date/
time] and that transmission failed.
    (c) The electronic prescription application may print copies of the 
transmitted prescription if they are clearly labeled: ``Copy only--not 
valid for dispensing.'' Data on the prescription may be electronically 
transferred to medical records, and a list of prescriptions written may 
be printed for patients if the list indicates that it is for 
informational purposes only and not for dispensing.
    (d) The electronic prescription application must not allow the 
transmission of an electronic prescription if an original prescription 
was printed prior to attempted transmission.
    (e) The contents of the prescription required by part 1306 of this 
chapter must not be altered during transmission between the practitioner 
and pharmacy. Any change to the content during transmission, including 
truncation or removal of data, will render the electronic prescription 
invalid. The electronic prescription data may be converted from one 
software version to another between the electronic prescription 
application and the pharmacy application; conversion includes altering 
the structure of fields or machine language so that the receiving 
pharmacy application can read the prescription and import the data.
    (f) An electronic prescription must be transmitted from the 
practitioner to the pharmacy in its electronic form. At no time may an 
intermediary convert an electronic prescription to another form (e.g., 
facsimile) for transmission.



Sec. 1311.200  Pharmacy responsibilities.

    (a) Before initially using a pharmacy application to process 
controlled substance prescriptions, the pharmacy must determine that the 
third-party auditor or certification organization has found that the 
pharmacy application does the following accurately and consistently:
    (1) Import, store, and display the information required for 
prescriptions under Sec. 1306.05(a) of this chapter.
    (2) Import, store, and display the indication of signing as required 
by Sec. 1311.120(b)(17).
    (3) Import, store, and display the number of refills as required by 
Sec. 1306.22 of this chapter.
    (4) Import, store, and verify the practitioner's digital signature, 
as provided in Sec. 1311.210(c), where applicable.
    (b) If the third-party auditor or certification organization has 
found that a pharmacy application does not accurately and consistently 
import, store, and display other information required for prescriptions 
under this chapter, the pharmacy must not process electronic 
prescriptions for controlled substances that are subject to the 
additional information requirements.
    (c) If a pharmacy application provider notifies a pharmacy that a 
third-party audit or certification report indicates that the application 
or the application provider no longer meets the requirements of this 
part or notifies it that the application provider has identified an 
issue that makes the application non-compliant, the pharmacy must 
immediately cease to process controlled substance prescriptions using 
the application.
    (d) A pharmacy that receives a notification that the pharmacy 
application is not in compliance with the requirements of this part must 
not use the application to process controlled substance prescriptions 
until it is notified that the application is again compliant and all 
relevant updates to the application have been installed.
    (e) The pharmacy must determine which employees are authorized to 
enter information regarding the dispensing of controlled substance 
prescriptions and annotate or alter records of these prescriptions (to 
the extent such alterations are permitted under this chapter). The 
pharmacy must ensure that logical access controls in the pharmacy 
application are set so that only such employees are granted access to 
perform these functions.
    (f) When a pharmacist fills a prescription in a manner that would 
require, under part 1306 of this chapter, the pharmacist to make a 
notation on the prescription if the prescription

[[Page 189]]

were a paper prescription, the pharmacist must make the same notation 
electronically when filling an electronic prescription and retain the 
annotation electronically in the prescription record or in linked files. 
When a prescription is received electronically, the prescription and all 
required annotations must be retained electronically.
    (g) When a pharmacist receives a paper or oral prescription that 
indicates that it was originally transmitted electronically to the 
pharmacy, the pharmacist must check its records to ensure that the 
electronic version was not received and the prescription dispensed. If 
both prescriptions were received, the pharmacist must mark one as void.
    (h) When a pharmacist receives a paper or oral prescription that 
indicates that it was originally transmitted electronically to another 
pharmacy, the pharmacist must check with that pharmacy to determine 
whether the prescription was received and dispensed. If the pharmacy 
that received the original electronic prescription had not dispensed the 
prescription, that pharmacy must mark the electronic version as void or 
canceled. If the pharmacy that received the original electronic 
prescription dispensed the prescription, the pharmacy with the paper 
version must not dispense the paper prescription and must mark the 
prescription as void.
    (i) Nothing in this part relieves a pharmacy and pharmacist of the 
responsibility to dispense controlled substances only pursuant to a 
prescription issued for a legitimate medical purpose by a practitioner 
acting in the usual course of professional practice.



Sec. 1311.205  Pharmacy application requirements.

    (a) The pharmacy may only use a pharmacy application that meets the 
requirements in paragraph (b) of this section to process electronic 
controlled substance prescriptions.
    (b) The pharmacy application must meet the following requirements:
    (1) The pharmacy application must be capable of setting logical 
access controls to limit access for the following functions:
    (i) Annotation, alteration, or deletion of prescription information.
    (ii) Setting and changing the logical access controls.
    (2) Logical access controls must be set by individual user name or 
role.
    (3) The pharmacy application must digitally sign and archive a 
prescription on receipt or be capable of receiving and archiving a 
digitally signed record.
    (4) For pharmacy applications that digitally sign prescription 
records upon receipt, the digital signature functionality must meet the 
following requirements:
    (i) The cryptographic module used to digitally sign the data 
elements required by part 1306 of this chapter must be at least FIPS 
140-2 Security Level 1 validated. FIPS 140-2 is incorporated by 
reference in Sec. 1311.08.
    (ii) The digital signature application and hash function must comply 
with FIPS 186-3 and FIPS 180-3, as incorporated by reference in 
Sec. 1311.08.
    (iii) The pharmacy application's private key must be stored 
encrypted on a FIPS 140-2 Security Level 1 or higher validated 
cryptographic module using a FIPS-approved encryption algorithm. FIPS 
140-2 is incorporated by reference in Sec. 1311.08.
    (iv) For software implementations, when the signing module is 
deactivated, the pharmacy application must clear the plain text password 
from the application memory to prevent the unauthorized access to, or 
use of, the private key.
    (v) The pharmacy application must have a time application that is 
within five minutes of the official National Institute of Standards and 
Technology time source.
    (5) The pharmacy application must verify a practitioner's digital 
signature (if the pharmacy application accepts prescriptions that were 
digitally signed with an individual practitioner's private key and 
transmitted with the digital signature).
    (6) If the prescription received by the pharmacy application has not 
been digitally signed by the practitioner and transmitted with the 
digital signature, the pharmacy application must either:
    (i) Verify that the practitioner signed the prescription by checking 
the data

[[Page 190]]

field that indicates the prescription was signed; or
    (ii) Display the field for the pharmacist's verification.
    (7) The pharmacy application must read and retain the full DEA 
number including the specific internal code number assigned to 
individual practitioners authorized to prescribe controlled substances 
by the hospital or other institution as provided in Sec. 1301.22(c) of 
this chapter.
    (8) The pharmacy application must read and store, and be capable of 
displaying, all information required by part 1306 of this chapter.
    (9) The pharmacy application must read and store in full the 
information required under Sec. 1306.05(a) of this chapter. The pharmacy 
application must either verify that such information is present or must 
display the information for the pharmacist's verification.
    (10) The pharmacy application must provide for the following 
information to be added or linked to each electronic controlled 
substance prescription record for each dispensing:
    (i) Number of units or volume of drug dispensed.
    (ii) Date dispensed.
    (iii) Name or initials of the person who dispensed the prescription.
    (11) The pharmacy application must be capable of retrieving 
controlled substance prescriptions by practitioner name, patient name, 
drug name, and date dispensed.
    (12) The pharmacy application must allow downloading of prescription 
data into a database or spreadsheet that is readable and sortable.
    (13) The pharmacy application must maintain an audit trail of all 
actions related to the following:
    (i) The receipt, annotation, alteration, or deletion of a controlled 
substance prescription.
    (ii) Any setting or changing of logical access control permissions 
related to the dispensing of controlled substance prescriptions.
    (iii) Auditable events as specified in Sec. 1311.215.
    (14) The pharmacy application must record within each audit record 
the following information:
    (i) The date and time of the event.
    (ii) The type of event.
    (iii) The identity of the person taking the action, where 
applicable.
    (iv) The outcome of the event (success or failure).
    (15) The pharmacy application must conduct internal audits and 
generate reports on any of the events specified in Sec. 1311.215 in a 
format that is readable by the pharmacist. Such an internal audit may be 
automated and need not require human intervention to be conducted.
    (16) The pharmacy application must protect the stored audit records 
from unauthorized deletion. The pharmacy application shall prevent 
modifications to the audit records.
    (17) The pharmacy application must back up the controlled substance 
prescription records daily.
    (18) The pharmacy application must retain all archived records 
electronically for at least two years from the date of their receipt or 
creation and comply with all other requirements of Sec. 1311.305.



Sec. 1311.210  Archiving the initial record.

    (a) Except as provided in paragraph (c) of this section, a copy of 
each electronic controlled substance prescription record that a pharmacy 
receives must be digitally signed by one of the following:
    (1) The last intermediary transmitting the record to the pharmacy 
must digitally sign the prescription immediately prior to transmission 
to the pharmacy.
    (2) The first pharmacy application that receives the electronic 
prescription must digitally sign the prescription immediately on 
receipt.
    (b) If the last intermediary digitally signs the record, it must 
forward the digitally signed copy to the pharmacy.
    (c) If a pharmacy receives a digitally signed prescription that 
includes the individual practitioner's digital signature, the pharmacy 
application must do the following:
    (1) Verify the digital signature as provided in FIPS 186-3, as 
incorporated by reference in Sec. 1311.08.
    (2) Check the validity of the certificate holder's digital 
certificate by checking the certificate revocation list. The pharmacy 
may cache the CRL until it expires.

[[Page 191]]

    (3) Archive the digitally signed record. The pharmacy record must 
retain an indication that the prescription was verified upon receipt. No 
additional digital signature is required.



Sec. 1311.215  Internal audit trail.

    (a) The pharmacy application provider must establish and implement a 
list of auditable events. The auditable events must, at a minimum, 
include the following:
    (1) Attempted unauthorized access to the pharmacy application, or 
successful unauthorized access to the pharmacy application where the 
determination of such is feasible.
    (2) Attempted or successful unauthorized modification or destruction 
of any information or records required by this part, or successful 
unauthorized modification or destruction of any information or records 
required by this part where the determination of such is feasible.
    (3) Interference with application operations of the pharmacy 
application.
    (4) Any setting of or change to logical access controls related to 
the dispensing of controlled substance prescriptions.
    (5) Attempted or successful interference with audit trail functions.
    (6) For application service providers, attempted or successful 
annotation, alteration, or destruction of controlled substance 
prescriptions or logical access controls related to controlled substance 
prescriptions by any agent or employee of the application service 
provider.
    (b) The pharmacy application must analyze the audit trail at least 
once every calendar day and generate an incident report that identifies 
each auditable event.
    (c) The pharmacy must determine whether any identified auditable 
event represents a security incident that compromised or could have 
compromised the integrity of the prescription records. Any such 
incidents must be reported to the pharmacy application service provider, 
if applicable, and the Administration within one business day.



Sec. 1311.300  Application provider requirements--Third-party audits
or certifications.

    (a) Except as provided in paragraph (e) of this section, the 
application provider of an electronic prescription application or a 
pharmacy application must have a third-party audit of the application 
that determines that the application meets the requirements of this part 
at each of the following times:
    (1) Before the application may be used to create, sign, transmit, or 
process controlled substance prescriptions.
    (2) Whenever a functionality related to controlled substance 
prescription requirements is altered or every two years, whichever 
occurs first.
    (b) The third-party audit must be conducted by one of the following:
    (1) A person qualified to conduct a SysTrust, WebTrust, or SAS 70 
audit.
    (2) A Certified Information System Auditor who performs compliance 
audits as a regular ongoing business activity.
    (c) An audit for installed applications must address processing 
integrity and determine that the application meets the requirements of 
this part.
    (d) An audit for application service providers must address 
processing integrity and physical security and determine that the 
application meets the requirements of this part.
    (e) If a certifying organization whose certification process has 
been approved by DEA verifies and certifies that an electronic 
prescription or pharmacy application meets the requirements of this 
part, certification by that organization may be used as an alternative 
to the audit requirements of paragraphs (b) through (d) of this section, 
provided that the certification that determines that the application 
meets the requirements of this part occurs at each of the following 
times:
    (1) Before the application may be used to create, sign, transmit, or 
process controlled substance prescriptions.
    (2) Whenever a functionality related to controlled substance 
prescription requirements is altered or every two years, whichever 
occurs first.
    (f) The application provider must make the audit or certification 
report

[[Page 192]]

available to any practitioner or pharmacy that uses the application or 
is considering use of the application. The electronic prescription or 
pharmacy application provider must retain the most recent audit or 
certification results and retain the results of any other audits or 
certifications of the application completed within the previous two 
years.
    (g) Except as provided in paragraphs (h) and (i) of this section, if 
the third-party auditor or certification organization finds that the 
application does not meet one or more of the requirements of this part, 
the application must not be used to create, sign, transmit, or process 
electronic controlled substance prescriptions. The application provider 
must notify registrants within five business days of the issuance of the 
audit or certification report that they should not use the application 
for controlled substance prescriptions. The application provider must 
also notify the Administration of the adverse audit or certification 
report and provide the report to the Administration within one business 
day of issuance.
    (h) For electronic prescription applications, the third-party 
auditor or certification organization must make the following 
determinations:
    (1) If the information required in Sec. 1306.05(a) of this chapter, 
the indication that the prescription was signed as required by 
Sec. 1311.120(b)(17) or the digital signature created by the 
practitioner's private key, if transmitted, and the number of refills as 
required by Sec. 1306.22 of this chapter, cannot be consistently and 
accurately recorded, stored, and transmitted, the third-party auditor or 
certification organization must indicate that the application does not 
meet the requirements of this part.
    (2) If other information required under this chapter cannot be 
consistently and accurately recorded, stored, and transmitted, the 
third-party auditor or certification organization must indicate that the 
application has failed to meet the requirements for the specific 
information and should not be used to create, sign, and transmit 
prescriptions that require the additional information.
    (i) For pharmacy applications, the third-party auditor or 
certification organization must make the following determinations:
    (1) If the information required in Sec. 1306.05(a) of this chapter, 
the indication that the prescription was signed as required by 
Sec. 1311.205(b)(6), and the number of refills as required by 
Sec. 1306.22 of this chapter, cannot be consistently and accurately 
imported, stored, and displayed, the third-party auditor or 
certification organization must indicate that the application does not 
meet the requirements of this part.
    (2) If the pharmacy application accepts prescriptions with the 
practitioner's digital signature, the third-party auditor or 
certification organization must indicate that the application does not 
meet the requirements of this part if the application does not 
consistently and accurately import, store, and verify the digital 
signature.
    (3) If other information required under this chapter cannot be 
consistently and accurately imported, stored, and displayed, the third-
party auditor or certification organization must indicate that the 
application has failed to meet the requirements for the specific 
information and should not be used to process electronic prescriptions 
that require the additional information.



Sec. 1311.302  Additional application provider requirements.

    (a) If an application provider identifies or is made aware of any 
issue with its application that make the application non-compliant with 
the requirements of this part, the application provider must notify 
practitioners or pharmacies that use the application as soon as 
feasible, but no later than five business days after discovery, that the 
application should not be used to issue or process electronic controlled 
substance prescriptions.
    (b) When providing practitioners or pharmacies with updates to any 
issue that makes the application non-compliant with the requirements of 
this part, the application provider must indicate that the updates must 
be installed before the practitioner or pharmacy may use the application 
to issue or process electronic controlled substance prescriptions.

[[Page 193]]



Sec. 1311.305  Recordkeeping.

    (a) If a prescription is created, signed, transmitted, and received 
electronically, all records related to that prescription must be 
retained electronically.
    (b) Records required by this subpart must be maintained 
electronically for two years from the date of their creation or receipt. 
This record retention requirement shall not pre-empt any longer period 
of retention which may be required now or in the future, by any other 
Federal or State law or regulation, applicable to practitioners, 
pharmacists, or pharmacies.
    (c) Records regarding controlled substances prescriptions must be 
readily retrievable from all other records. Electronic records must be 
easily readable or easily rendered into a format that a person can read.
    (d) Records required by this part must be made available to the 
Administration upon request.
    (e) If an application service provider ceases to provide an 
electronic prescription application or an electronic pharmacy 
application or if a registrant ceases to use an application service 
provider, the application service provider must transfer any records 
subject to this part to the registrant in a format that the registrant's 
applications are capable of retrieving, displaying, and printing in a 
readable format.
    (f) If a registrant changes application providers, the registrant 
must ensure that any records subject to this part are migrated to the 
new application or are stored in a format that can be retrieved, 
displayed, and printed in a readable format.
    (g) If a registrant transfers its electronic prescription files to 
another registrant, both registrants must ensure that the records are 
migrated to the new application or are stored in a format that can be 
retrieved, displayed, and printed in a readable format.
    (h) Digitally signed prescription records must be transferred or 
migrated with the digital signature.



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



Sec.
1312.01  Scope of part 1312.
1312.02  Definitions.
1312.03  Forms applicable to this part.

                  Importation of Controlled Substances

1312.11  Requirement of authorization to import.
1312.12  Application for import permit; return information..
1312.13  Issuance of import permit.
1312.14  Distribution of import permits.
1312.15  Shipments in greater or less amount than authorized.
1312.16  Amendment, cancellation, expiration of import permit.
1312.17  Special report from importers.
1312.18  Import declaration.
1312.19  Distribution of import declaration.

                  Exportation of Controlled Substances

1312.21  Requirement of authorization to export.
1312.22  Application for export or reexport permit; return information.
1312.23  Issuance of export permit.
1312.24  Distribution of export permit.
1312.25  Amendment, cancellation, expiration of export permit.
1312.26  Records required of exporter.
1312.27  Export/reexport declaration.
1312.28  Distribution of export declaration.
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.

    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.

[[Page 194]]



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]



Sec. 1312.03  Forms applicable to this part.

------------------------------------------------------------------------
                   Form                          Access/ submission
------------------------------------------------------------------------
DEA Form 35, Permit to Import.............  electronic.
DEA Form 36, Permit to Export.............  electronic.
DEA Form 161, Application for Permit to     electronic.
 Export Controlled Substances.
DEA Form 161R, Application for Permit to    electronic.
 Export Controlled Substances For
 Subsequent Reexport.
DEA Form 161R-EEA, Application for Permit   electronic.
 to Export Controlled Substances for
 Subsequent Reexport Among Members of the
 European Economic Area.
DEA Form 236, Controlled Substances Import/ electronic.
 Export Declaration.
DEA Form 357, Application for Permit to     electronic.
 Import Controlled Substances for Domestic
 And/Or Scientific Purposes.
------------------------------------------------------------------------


[81 FR 97025, Dec. 30, 2016]

                  Importation of Controlled Substances



Sec. 1312.11  Requirement of authorization to import.

    (a) No person shall import, or cause to be imported, into the 
customs territory of the United States from any place outside thereof 
(but within the United States), or into the United States from any place 
outside thereof, any controlled substances listed in Schedule I or II, 
or any narcotic controlled substance listed in Schedule III, IV, or V, 
or any non-narcotic controlled substance listed in Schedule III which 
the Administrator has specifically designated by regulation in 
Sec. 1312.30 or any non-narcotic controlled substance listed in Schedule 
IV or V which is also listed in Schedule I or II of the Convention on 
Psychotropic Substances, 1971, unless and until such person is properly 
registered under the Act (or, in accordance with part 1301 of this 
chapter, exempt from registration) and the Administration has issued him 
or her a permit to do so in accordance with Sec. 1312.13.
    (b) No person shall import, or cause to be imported, into the 
customs territory of the United States from any place outside thereof 
(but within the United States), or into the United States from any place 
outside thereof, 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, in accordance with part 1301 of this chapter, exempt from 
registration) and has filed an import declaration to do so in accordance 
with Sec. 1312.18.
    (c) A separate permit or declaration is required for each shipment 
of a controlled substance to be imported.

[81 FR 97026, Dec. 30, 2016]



Sec. 1312.12  Application for import permit; return information.

    (a) Registered importers, other registrants authorized to import as 
a coincident activity of their registrations, and persons who in 
accordance with part 1301 of this chapter are exempt from registration, 
seeking to import a controlled substance in schedule I or II; any 
narcotic drug in schedule III, IV, or V; any non-narcotic drug in 
schedule III that has been specifically designated by regulation in 
Sec. 1312.30; or any non-narcotic substance listed in schedule IV or V 
that is also listed in schedule I or II of the Convention on 
Psychotropic Substances, 1971, must submit an application for a permit 
to import controlled substances on DEA Form 357. All applications and 
supporting materials must be submitted to the Administration through the 
DEA

[[Page 195]]

Diversion Control Division secure network application. The application 
must be signed and dated by the importer and must contain the importer's 
registered address to which the controlled substances will be imported.
    (b) The applicant must include on the DEA Form 357 the registration 
number of the importer and 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 
the 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 must also include 
the following:
    (1) The name/business name, address/business address, contact 
information (e.g., telephone number(s), email address(es), etc.), and 
business of the consignor, if known at the time the application is 
submitted, but if unknown at that time, the fact should be indicated and 
the name and address afterwards furnished to the Administration as soon 
as ascertained by the importer;
    (2) The foreign port and country of initial 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 or 
country;
    (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 the shipment will be made by 
express, freight, or otherwise, imports of controlled substances in 
Schedules I or II and narcotic drugs 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; and
    (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.
    (c) If desired, alternative foreign ports of exportation within the 
same country may be indicated upon the application (e.g., 1. Kolkata, 2. 
Mumbai). If a 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. Alternative ports in 
different countries will not be authorized in the same permit.
    (d) Return information. Within 30 calendar days after actual receipt 
of a controlled substance at the importer's registered location, or 
within 10 calendar days after receipt of a written request by the 
Administration to the importer, whichever is sooner, the importer must 
file a report with the Administration through the DEA Diversion Control 
Division secure network application specifying the particulars of the 
transaction. This report must include the following information: The 
date the controlled substance was released by a customs officer at the 
port of entry; the date on which the controlled substance arrived at the 
registered location; the actual quantity of the controlled substance 
released by a customs officer at the port of entry; and the actual 
quantity of the controlled substance that arrived at the registered 
location. Upon receipt and review, the Administration will assign a 
transaction identification number to a completed report. The report will 
not be deemed filed until the Administration has issued a transaction 
identification number.
    (e) Denied release at the port of entry. In the event that a 
shipment of controlled substances has been denied release by a customs 
officer at the port of entry for any reason, the importer who attempted 
to have the shipment released must, within 5 business days of the 
denial, report to the Administration that the shipment was denied and 
the reason for denial. Such report must be transmitted to the 
Administration through the DEA Diversion Control Division secure network 
application. This

[[Page 196]]

report must include the following information: The quantity of the 
controlled substance denied release; the date on which release was 
denied; and the basis for the denied release. Upon the importer's report 
of a denied release at the port of entry, the DEA will assign the report 
a transaction identification number and the import permit will be void 
and of no effect. No shipment of controlled substances denied release 
for any reason will be allowed to be released into the United States 
unless the importer submits a new DEA Form 357 and the Administration 
issues a new import permit.

[81 FR 97026, Dec. 30, 2016]



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) If an importation is approved, the Administrator will issue an 
import permit bearing his or her signature or that of his or her 
delegate. Each permit will be assigned a unique permit number. A permit 
must not be altered or changed by any person after being signed. Any 
change or alteration upon the face of any permit after it has been 
signed renders it void and of no effect. Permits are not transferable. 
The Administrator or his/her delegate will date and certify on each 
permit that the importer named therein is thereby permitted as a 
registrant under the Act, to import, through the port of entry named, 
one shipment of not to

[[Page 197]]

exceed the specified quantity of the named controlled substances, 
shipment to be made before a specified date. Only one shipment may be 
made on a single import permit. A single import permit shall authorize a 
quantity of goods to be imported/exported at one place, at one time, for 
delivery to one consignee, on a single conveyance, at one place, on one 
bill of lading, air waybill, or commercial loading document; a single 
permit shall not authorize a quantity of goods to be imported/exported 
if the goods are divided onto two or more conveyances. The permit must 
state that the Administration 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 section 1002(a)(1) or 
1002(a)(2)(A) of the Act (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) Spain,
    (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 Spain, 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; 73 FR 6851, Feb. 6, 2008; 81 FR 
97027, Dec. 30, 2016]



Sec. 1312.14  Distribution of import permits.

    The Administration shall transmit the import permit to the competent 
national authority of the exporting country and shall make an official 
record of the import permit available to the importer through secure 
electronic means. The importer, or their agent, must submit an official 
record of the import permit and/or required data concerning the import 
transaction to a customs officer at the port of entry in compliance with 
all import control requirements of agencies with import control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. The importer must maintain 
an official record of the import permit (available from the DEA 
Diversion Control Division secure network application after issuance) in 
accordance with part 1304 of this chapter as the record of authority for 
the importation and shall transmit an official record of the permit to 
the foreign exporter. If required by the foreign competent national 
authority, the importer shall ensure that an official record of the 
import permit is provided (e.g., by transmitting an official record of 
the permit to the foreign exporter who shall transmit such record to the 
competent national authority of the exporting county). The importer must 
ensure that an official record of the permit accompanies the shipment of 
controlled substances to its final destination, the registered location 
of the importer (i.e., drop shipments are prohibited).

[81 FR 97027, Dec. 30, 2016]



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 and Border 
Protection or customs service of an Insular Area, 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 in accordance with Sec. 1312.16(a). If the 
substance is included in Schedule I, it will be summarily forfeited to 
the Government.

[[Page 198]]

    (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 and Border 
Protection or customs service of an Insular Area, 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 Administrator 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; 81 FR 97027, Dec. 30, 2016]



Sec. 1312.16  Amendment, cancellation, expiration of import permit.

    (a) Importers may only request that an import permit or application 
for an import permit be amended in accordance with paragraphs (a)(1) 
through (7) of this section. Requests for an amendment must be submitted 
through the DEA Diversion Control Division secure network application. 
Except as provided in paragraph (a)(5) of this section and 
Sec. 1312.15(a), importers must submit all requests for an amendment at 
least one full business day in advance of the date of release by a 
customs officer. Importers must specifically request that an amendment 
be made; supplementary information submitted by an importer through the 
DEA Diversion Control Division secure network application will not 
automatically trigger the amendment process. While the request for an 
amendment is being reviewed by the Administration, the original permit 
will be temporarily stayed and may not be used to authorize entry of a 
shipment of controlled substances. If the importer's request for an 
amendment to an issued permit is granted by the Administration, the 
Administration will immediately cancel the original permit and re-issue 
the permit, as amended, with a revised permit number. The DEA and 
importer will distribute the amended permit in accordance with 
Sec. 1312.14. If a request for an amendment is denied by the 
Administration, the temporary stay will be lifted; once lifted, the 
originally issued permit may immediately be used to authorize entry of a 
shipment in accordance with the terms of the permit, subject to the 
shipment being compliant with all other applicable laws.
    (1) An importer may request that an import permit or application for 
a permit be amended to change the National Drug Control number, 
description of the packaging, or trade name of the product, so long as 
the description is for the same basic class of controlled substance as 
in the original permit.
    (2) An importer may request that an import permit or application for 
a permit be amended to change the proposed port of entry, the date of 
release by a customs officer, or the method of transport.
    (3) An importer may request that an import permit or application for 
a permit be amended to change the justification provided as to why an 
import shipment is needed to meet the legitimate scientific or medical 
needs of the United States.
    (4) An importer may request that an import permit or application for 
a permit be amended to change any registrant notes.
    (5) Prior to departure of the shipment from its original foreign 
location, an importer may request that an import permit or application 
for a permit be amended to increase the total base weight of a 
controlled substance. At the U.S. port of entry, an importer may request 
that an import permit be amended in accordance with Sec. 1312.15(a). 
Importers are not required to amend an import permit for the sole 
purpose of decreasing the total base weight of a controlled substance 
authorized to be imported. However, the balance of any

[[Page 199]]

unimported authorized quantity of controlled substances on an import 
permit is void upon entry of a shipment on the issued permit or upon 
expiration of the unused permit in accordance with paragraph (b) of this 
section, whichever is sooner. Other than for an amendment to an import 
permit under Sec. 1312.15(a), importers must submit a request for an 
amendment to increase the total base weight of a controlled substance at 
least three business days in advance of the date of release by a customs 
officer.
    (6) An importer may request that an import permit be amended to 
remove a controlled substance from the permit. However, an importer may 
not amend an import permit to add or replace a controlled substance/
Administration controlled substance code number to the item(s) to be 
imported. Importers who desire to import a different controlled 
substance than that contained on their issued import permit or permit 
application must submit a request for the permit or permit application 
to be canceled and request a new permit in accordance with Sec. 1312.12.
    (7) An importer may not amend the importer's name (as it appears on 
their DEA certificate of registration) or the name of the foreign 
exporter as provided in the DEA Form 357. Importers who need to make any 
changes to any of these fields must submit a request for the permit or 
permit application to be canceled and request a new permit in accordance 
with Sec. 1312.12.
    (b) An import permit will be void and of no effect after the 
expiration date specified therein, and in no event will the date be more 
than 180 calendar days after the date the permit is issued. Amended 
import permits will retain the original expiration date.
    (c) An import permit may be canceled after being issued, at the 
request of the importer submitted to the Administration through the DEA 
Diversion Control Division secure network application, provided that no 
shipment has been made thereunder.
    Nothing in this part will affect the right, hereby reserved by the 
Administration, to cancel a permit at any time for proper cause.

[81 FR 97027, Dec. 30, 2016]



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]



1312.18  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) 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 seeking to 
import any non-narcotic controlled substance listed 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 file a controlled 
substances import declaration (DEA Form 236) with the Administration 
through the DEA Diversion Control Division secure network application 
not later than 15 calendar days prior to the anticipated date of release 
by a customs officer and distribute an official record of the 
declaration as hereinafter directed in Sec. 1312.19. The declaration 
must be signed and dated by the importer and must specify the address of 
the final destination for the shipment, which must be the importer's 
registered location. Upon receipt and review, the Administration will 
assign a transaction identification number to each completed 
declaration. The

[[Page 200]]

import declaration is not deemed filed, and therefore is not valid, 
until the Administration has issued a transaction identification number. 
The importer may only proceed with the import transaction once the 
transaction identification number has been issued.
    (c) DEA Form 236 must 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 anticipated date of release by a customs officer at the port 
of entry, the foreign port and country 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 (b) 
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.
    (e) Return information. Within 30 calendar days after actual receipt 
of a controlled substance at the importer's registered location, or 
within 10 calendar days after receipt of a written request by the 
Administration to the importer, whichever is sooner, the importer must 
file a report with the Administration through the DEA Diversion Control 
Division secure network application specifying the particulars of the 
transaction. This report must include the following information: The 
date on which the controlled substance was released by a customs officer 
at the port of entry; the date on which the controlled substance arrived 
at the registered location; the actual quantity of the controlled 
substance released by a customs officer at the port of entry; the actual 
quantity of the controlled substance that arrived at the registered 
location; and the actual port of entry. Upon receipt and review, the 
Administration will assign a transaction identification number to a 
completed report. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (f) An importer may amend an import declaration in the same 
circumstances in which an importer may request amendment to an import 
permit, as set forth in Sec. 1312.16(a)(1) through (7). Amendments to 
declarations must be submitted through the DEA Diversion Control 
Division secure network application. Except as provided in 
Secs. 1312.16(a)(5) and 1312.15(a), importers must submit all amendments 
at least one full business day in advance of the date of release by a 
customs officer. Importers must specifically note that an amendment is 
being made; supplementary information submitted by an importer through 
the DEA Diversion Control Division secure network application will not 
automatically be considered an amendment. While the amendment is being 
processed by the Administration, the original declaration will be 
temporarily stayed and may not be used to authorize release of a 
shipment of controlled substances. Upon receipt and review, the 
Administration will assign each completed amendment a transaction 
identification number. The amendment will not be deemed filed until the 
Administration issues a transaction identification number. The DEA and 
importer will distribute the amended declaration in accordance with 
Sec. 1312.19. A filed amendment will not change the date that the 
declaration becomes void and of no effect pursuant to paragraph (g) of 
this section.

[[Page 201]]

    (g) An import declaration may be canceled after being filed with the 
Administration, at the request of the importer by the importer 
submitting to the Administration the request through the DEA Diversion 
Control Division secure network application, provided that no shipment 
has been made thereunder. Import declarations shall become void and of 
no effect 180 calendar days after the date the declaration is deemed 
filed with the Administration.
    (h) Denied release at the port of entry. In the event that a 
shipment of controlled substances has been denied release by a customs 
officer at the port of entry for any reason, the importer who attempted 
to have the shipment released, within 5 business days of the denial, 
report to the Administration that the shipment was denied release and 
the reason for denial. Such report must be transmitted to the 
Administration through the DEA Diversion Control Division secure network 
application. This report must include the following information: The 
quantity of the controlled substance denied release; the date on which 
release was denied; and the basis for the denied release. Upon the 
importer's report of a denied release, the DEA will assign the report a 
transaction identification number and the import declaration will become 
void and of no effect. No shipment of controlled substances denied 
release for any reason will be allowed to be released into the United 
States until the importer has filed a new import declaration and the 
Administration has issued a new transaction identification number.

[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; 75 FR 10682, Mar. 9, 2010; 77 FR 4237, Jan. 27, 
2012; 81 FR 97028, Dec. 30, 2016]



Sec. 1312.19  Distribution of import declaration.

    The importer must furnish an official record of the declaration 
(available through the DEA Diversion Control Division secure network 
application after the Administration issues a transaction identification 
number) to the foreign shipper. The foreign shipper must submit an 
official record of the declaration to the competent national authority 
of the exporting country, if required as a prerequisite to export 
authorization. The importer, or their agent, must submit an official 
record of the declaration and/or required data concerning the import 
transaction to a customs officer at the port of entry in compliance with 
all import control requirements of agencies with import control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. The importer must ensure 
that an official record of the declaration accompanies the shipment to 
its final destination, which must only be the registered location of the 
importer (i.e., drop shipments are prohibited). The importer must 
maintain an official record of the declaration in accordance with part 
1304 of this chapter.

[81 FR 97029, Dec. 30, 2016]

                  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 listed in Schedule I or 
II, or any narcotic controlled substance listed in Schedule III or IV, 
or any non-narcotic controlled substance in Schedule III which the 
Administrator has specifically designated by regulation in Sec. 1312.30 
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, 1971, unless and until such person is properly registered 
under the Act (or, in accordance with part 1301 of this chapter, exempt 
from registration) and the Administrator has issued him or her a permit 
to do so in accordance with Sec. 1312.23.
    (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

[[Page 202]]

Schedule V, unless and until such person is properly registered under 
the Act (or, in accordance with part 1301 of this chapter, exempt from 
registration) and has furnished an export declaration as provided by 
section 1003 of the Act (21 U.S.C. 953(e)) to the Administration in 
accordance with Sec. 1312.28.
    (c) A separate permit or declaration is required for each shipment 
of controlled substance to be exported.

[81 FR 97029, Dec. 30, 2016]



Sec. 1312.22  Application for export or reexport permit; return information.

    (a) Registered exporters, and persons who in accordance with part 
1301 of this chapter are exempt from registration, seeking to export 
controlled substances must submit an application for a permit to export 
controlled substances on DEA Form 161. Registered exporters, and persons 
who in accordance with part 1301 of this chapter are exempt from 
registration, seeking to reexport controlled substances must submit an 
application for a permit to reexport controlled substances on DEA Form 
161R or DEA Form 161R-EEA, whichever applies. All applications and 
supporting materials must be submitted to the Administration through the 
DEA Diversion Control Division secure network application. The 
application must be signed and dated by the exporter and contain the 
exporter's registered address from which the controlled substances will 
be exported. Controlled substances may not be exported until a permit 
number has been issued.
    (b) Exports of controlled substances by mail are prohibited.
    (c) Applications. (1) Except as provided in paragraph (c)(2) of this 
section, each application for a permit to export or reexport must 
include the following information:
    (i) The exporter's name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address (es), 
etc.);
    (ii) The exporter's registration number, address, and contact 
information (e.g., telephone number(s), etc.) from which the controlled 
substances will be exported;
    (iii) A detailed description of each controlled substance to be 
exported including the drug name, dosage form, National Drug Code (NDC) 
number, Administration Controlled Substance Code Number as set forth in 
part 1308 of this chapter, the number and size of the 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;
    (iv) The name/business name, address/business address, contact 
information (e.g., telephone number(s), email address(es), etc.) and 
business of the consignee in the first country (the country to which the 
controlled substance is exported from the United States), foreign port 
and country of entry/first country of entry, the port of export, the 
anticipated date of release by a customs officer at the port of export, 
the name of the exporting carrier or vessel (if known), or if unknown it 
should be stated whether the shipment will be made by express, freight, 
or otherwise), 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; and
    (v) An affidavit that the packages or containers are labeled in 
conformance with obligations of the United States under international 
treaties, conventions, or protocols in effect at the time of the export 
or reexport. The affidavit shall further state that to the best of the 
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, unless the application is submitted for reexport in 
accordance with paragraphs (f), (g), and (h) of this section. In the 
case of exportation of crude cocaine, the affidavit may state that to 
the best of affiant's 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

[[Page 203]]

the laws of that country to another for medical or scientific use within 
that country.
    (2) With respect to reexports among members of the European Economic 
Area in accordance with section 1003(f) of the Act (21 U.S.C. 953(f)), 
the requirements of paragraph (c)(1) of this section shall apply only 
with respect to the export from the United States to the first country 
and not to any subsequent export from that country to another country of 
the European Economic Area.
    (d)(1) Except as provided in paragraph (d)(2) of this section, the 
applicant must also submit with the application any import license or 
permit or a certified copy of any such license or permit issued by the 
competent national authority in the country of destination, or other 
documentary evidence deemed adequate by the Administration, showing: 
That the merchandise is consigned to an authorized permittee; that it is 
to be applied exclusively to medical or scientific use within the 
country of destination; that it will not be reexported from such country 
(unless the application is submitted for reexport in accordance with 
paragraphs (f), (g), and (h) of this section); and that there is an 
actual need for the controlled substance for medical or scientific use 
within such country or countries. If the import license or permit, or 
the certified copy of such, is not written in English or bilingual with 
another language and English, the registrant must also submit with their 
application a certified translation of the permit or license. For 
purposes of this requirement, certified translation means that the 
translator has signed the translation legally attesting the accuracy of 
the translation. (In the case of exportation of bulk coca leaf alkaloid, 
the applicant need only include with the application the material 
outlined in paragraph (c) of this section.)
    (2) With respect to reexports among members of the European Economic 
Area in accordance with section 1003(f) of the Act (21 U.S.C. 953(f)), 
the requirements of paragraph (d)(1) of this section shall apply only 
with respect to the export from the United States to the first country 
and not to any subsequent export from that country to another country of 
the European Economic Area.
    (e) Return information for exports (on a DEA Form 161). Within 30 
calendar days after the controlled substance is released by a customs 
officer at the port of export, or within 10 calendar days after receipt 
of a written request by the Administration to the exporter, whichever is 
sooner, the exporter must report to the Administration through the DEA 
Diversion Control Division secure network application the particulars of 
the transaction. This report must include the following information: The 
date on which the controlled substance left the registered location; the 
date on which the controlled substance was released by a customs officer 
at the port of export; the actual quantity of controlled substance that 
left the registered location; and the actual quantity of the controlled 
substance released by a customs officer at the port of export; the 
actual port of export, and any other information as the Administration 
may from time to time specify. Upon receipt and review, the 
Administration will assign a transaction identification number to a 
completed report. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (f) Reexports outside of the European Economic Area. Except as 
provided in paragraph (g) of this section, the Administration may 
authorize any controlled substance listed in Schedule I or II, or any 
narcotic drug listed in Schedule III or IV, to be exported from the 
United States to a country for subsequent export from that country to 
another country, if each of the following conditions is met, in 
accordance with section 1003(f) of the Act (21 U.S.C. 953(f)):
    (1) Both the country to which the controlled substance is exported 
from the United States (referred to in this section as the ``first 
country'') and the country to which the controlled substance is exported 
from the first country (referred to in this section as the ``second 
country'') are parties to the Single Convention on Narcotic Drugs, 1961, 
and the Convention on Psychotropic Substances, 1971;

[[Page 204]]

    (2) The first country and the second country have each instituted 
and maintain, in conformity with such Conventions, a system of controls 
of imports of controlled substances which the Administration deems 
adequate;
    (3) With respect to the first country, the controlled substance is 
consigned to a holder of such permits or licenses as may be required 
under the laws of such country, and a permit or license to import the 
controlled substance has been issued by the country;
    (4) With respect to the second country, substantial evidence is 
furnished to the Administration by the applicant for the export permit 
that--
    (i) The controlled substance is to be consigned to a holder of such 
permits or licenses as may be required under the laws of such country, 
and a permit or license to import the controlled substance is to be 
issued by the country; and
    (ii) The controlled substance is to be applied exclusively to 
medical, scientific, or other legitimate uses within the country;
    (5) The controlled substance will not be exported from the second 
country;
    (6) The exporter has complied with paragraph (h) of this section and 
a permit to export the controlled substance from the United States has 
been issued by the Administration; and
    (7) Return information for reexports outside of the European 
Economic Area (on DEA Form 161R)--(i) Return information for export from 
the United States, for reexport. Within 30 calendar days after the 
controlled substance is released by a customs officer at the port of 
export the exporter must file a report with the Administration through 
the DEA Diversion Control Division secure network application specifying 
the particulars of the transaction. This report must include the 
following information: The date on which the controlled substance left 
the registered location; the date on which the controlled substance was 
released by a customs officer at the port of export; the actual quantity 
of controlled substance released by a customs officer at the port of 
export; and the actual port of export. Upon receipt and review, the 
Administration will assign a completed report a transaction 
identification number. The report will not be deemed filed until the 
Administration has issued a transaction identification number. In 
determining whether the exporter has complied with the requirement to 
file within 30 calendar days, the report shall be deemed filed on the 
first date on which a complete report is filed.
    (ii) Return information for export from a first country that is or 
is not a member of the European Economic Area to a country outside of 
the European Economic Area; return information for export from a first 
country that is not a member of the European Economic Area to a member 
of the European Economic Area. Within 30 calendar days after the 
controlled substance is exported from the first country to the second 
country the exporter must file a report with the Administration through 
the DEA Diversion Control Division secure network application specifying 
the particulars of the export from the first country. If the permit 
issued by the Administration authorized the reexport of a controlled 
substance from the first country to more than one second country, a 
report for each individual reexport is required. These reports must 
include the following information: Name of second country; actual 
quantity of controlled substance shipped; and the date shipped from the 
first country, the actual port from which the controlled substances were 
shipped from the first country. Upon receipt and review, the 
Administration will assign each completed report a transaction 
identification number. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (g) Reexports among members of the European Economic Area (on DEA 
Form 161R-EEA). The Administration may authorize any controlled 
substance listed in Schedule I or II, or any narcotic drug listed in 
Schedule III or IV, to be exported from the United States to a country 
of the European Economic Area for subsequent export from that country to 
another country of the European Economic Area, if the following 
conditions and the conditions of paragraphs (f)(1) through (4) and (6) 
of this section are met, in accordance with

[[Page 205]]

section 1003(f) of the Act (21 U.S.C. 953(f)):
    (1)(i) The controlled substance will not be exported from the second 
country, except that the controlled substance may be exported from a 
second country that is a member of the European Economic Area to another 
country that is a member of the European Economic Area, provided that 
the first country is also a member of the European Economic Area; and
    (ii) Subsequent to any reexportation described in paragraph 
(g)(1)(i) of this section, a controlled substance may continue to be 
exported from any country that is a member of the European Economic Area 
to any other such country, if--
    (A) The conditions applicable with respect to the first country 
under paragraphs (f)(1) through (4) and (6) of this section and 
paragraph (g)(2) are met with respect to each subsequent country from 
which the controlled substance is exported pursuant to this paragraph 
(g); and
    (B) The conditions applicable with respect to the second country 
under paragraphs (f)(1) through (4) and (6) of this section and 
paragraph (g)(2) of this section are met with respect to each subsequent 
country to which the controlled substance is exported pursuant to this 
paragraph (g).
    (2) Return information for reexports among members of the European 
Economic Area--(i) Return information for export from the United States, 
for reexport among members of the European Economic Area. Exporters must 
comply with the return reporting requirements of paragraph (f)(7)(i) of 
this section.
    (ii) Reexports among members of the European Economic Area. Within 
30 calendar days after the controlled substance is exported from the 
first country to the second country, and within 30 calendar days of each 
subsequent reexport within the European Economic Area, if any, the U.S. 
exporter must file a report with the Administration through the DEA 
Diversion Control Division secure network application specifying the 
particulars of the export. These reports must include the name of 
country to which the controlled substance was reexported, i.e., another 
member of the European Economic Area; the actual quantity of controlled 
substance shipped; the date shipped from the first country, the name/
business name, address/business address, contact information (e.g., 
telephone number(s), email address(es), etc.) and business of the 
consignee; and the name/business name, address/business address, contact 
information (e.g., telephone number(s), email address(es), etc.) and 
business of the exporter. Upon receipt and review, the Administration 
will assign each completed report a transaction identification number. 
The report will not be deemed filed until the Administration has issued 
a transaction identification number.
    (h) Where a person is seeking to export a controlled substance for 
reexport outside of the European Economic Area in accordance with 
paragraph (f) of this section, the requirements of paragraphs (h)(1) 
through (7) of this section shall apply in addition to (and not in lieu 
of) the requirements of paragraphs (a) through (d) of this section. 
Where a person is seeking to export a controlled substance for reexport 
among members of the European Economic Area in accordance with paragraph 
(g) of this section, the requirements of paragraph (h)(4) of this 
section shall apply in addition to (and not in lieu of) the requirements 
of paragraphs (a) through (d) of this section.
    (1) 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 second country.
    (2) Finished dosage units, if reexported, must be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
second country.
    (3) Any proposed reexportation must be made known to the 
Administration at the time the initial DEA Form 161R is submitted. In 
addition, the following information must also be provided where 
indicated on the form:
    (i) Whether the drug or preparation will be reexported in bulk or 
finished dosage units;

[[Page 206]]

    (ii) The product name, dosage strength, commercial package size, and 
quantity; and
    (iii) The name of consignee, complete address, and expected shipment 
date, as well as the name and address of the ultimate consignee in the 
second country.
    (4) The application must contain an affidavit that the consignee in 
the second country, and any country of subsequent reexport within the 
European Economic Area, is authorized under the laws and regulations of 
the second and/or subsequent country to receive the controlled 
substances. The affidavit must also contain the following statements, in 
addition to the statements required under paragraph (c) of this section:
    (i) That the packages are labeled in conformance with the 
obligations of the United States under the Single Convention on Narcotic 
Drugs, 1961, the Convention on Psychotropic Substances, 1971, and any 
amendments to such treaties in effect;
    (ii) That the controlled substances are to be applied exclusively to 
medical or scientific uses within the second country, or country of 
subsequent reexport within the European Economic Area;
    (iii) That the controlled substances will not be further reexported 
from the second country except as provided by paragraph (f) of section 
1003 of the Act (21 U.S.C. 953(f)); and
    (iv) That there is an actual need for the controlled substances for 
medical or scientific uses within the second country, or country of 
subsequent reexport within the European Economic Area.
    (5) If the applicant proposes that the shipment of controlled 
substances will be separated into parts after it arrives in the first 
country and then reexported to more than one second country, the 
applicant must so indicate on the DEA Form 161R and provide all the 
information required in this section for each second country.
    (6) Except in the case of reexports among countries of the European 
Economic Area in accordance with section 1003(f) of the Act (21 U.S.C. 
953(f)), the controlled substance will be reexported from the first 
country to the second country (or second countries) no later than 180 
calendar days after the controlled substance was released by a customs 
officer from the United States.
    (7) Shipments that have been exported from the United States and are 
refused by the consignee in either the first or second country, or 
subsequent member of the European Economic Area, or are otherwise 
unacceptable or undeliverable, may be returned to the registered 
exporter in the United States upon authorization of the Administration. 
In these circumstances, the exporter in the United States must submit a 
written request for the return of the controlled substances to the 
United States with a brief summary of the facts that warrant the return, 
along with a completed DEA Form 357 through the DEA Diversion Control 
Division secure network application. The Administration will evaluate 
the request after considering all the facts as well as the exporter's 
registration status with the Administration. If the exporter provides 
sufficient justification, the Administration may issue an import permit 
for the return of these drugs, and the exporter may then obtain an 
export permit from the country of original importation. The substance 
may not be returned to the United States until after a permit has been 
issued by the Administration.
    (i) In considering whether to grant an application for a permit 
under paragraphs (f), (g), and (h) of this section, the Administration 
shall consider whether the applicant has previously obtained such a 
permit and, if so, whether the applicant complied fully with the 
requirements of this section with respect to that previous permit.
    (j) Denied release at the port of export. In the event that a 
shipment of controlled substances has been denied release by a customs 
officer at the port export from the United States for any reason, the 
exporter who attempted to have the shipment released must, within 5 
business days of the denial, report to the Administration that the 
shipment was denied release and the reason for denial. Such report must 
be transmitted to the Administration through the DEA Diversion Control 
Division secure network application. This report

[[Page 207]]

must include the following information: The quantity of the controlled 
substance denied release; the date on which release was denied; the 
basis for the denied release, the port from which the denial was issued, 
and any other information as the Administration may from time to time 
specify. Upon the exporter's report of a denied release, DEA will assign 
the report a transaction identification number and the export permit 
will be void and of no effect. No shipment of controlled substances 
denied release for any reason will be allowed to be released from the 
United States unless the exporter submits a new DEA Form 161, 161R, or 
161R-EEA, as appropriate, and the Administration issues a new export 
permit.

[81 FR 97029, Dec. 30, 2016]



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), (d), or (f) of the Act 
(21 U.S.C. 953(a), (b), (c), (d), or (f).
    (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) If an exportation is approved, the Administrator shall issue an 
export permit bearing his or her signature or that of his or her 
delegate. Each permit will be assigned a permit number that is a unique, 
randomly generated identifier. A permit shall not be altered or changed 
by any person after being signed. Any change or alteration upon the face 
of any permit after it has been signed renders it void and of no effect. 
Permits are not transferable. The Administrator or his/her delegate 
shall date and certify on each permit that the exporter named therein is 
thereby permitted as a registrant under the Act, to export, through the 
port of export named, one shipment of not to exceed the specified 
quantity of the named controlled substances, shipment to be made before 
a specified date. Only one shipment may be made on a single export 
permit. A single export permit shall authorize a quantity of goods to be 
exported at one place, at one time, for delivery to one consignee, on a 
single conveyance, at one place, on one bill of lading, air waybill, or 
commercial loading document; a single permit shall not authorize a 
quantity of goods to be exported if the goods are divided onto two or 
more conveyances. Each export permit shall be predicated upon, inter 
alia, an import certificate or other documentary evidence issued by a 
foreign competent national authority.
    (f) No export permit shall be issued for the exportation, or 
reexportation, of any controlled substance to any country when the 
Administration has information to show that the estimates or assessments 
submitted with respect to that country for the current period, under the 
Single Convention on Narcotic Drugs, 1961, or the Convention on 
Psychotropic Substances, 1971, have been, or, considering the quantity 
proposed to be imported, will be exceeded. If it shall appear through 
subsequent advice received from the International Narcotics Control 
Board of the United

[[Page 208]]

Nations that the estimates or assessments of the country of destination 
have been adjusted to permit further importation of the controlled 
substance, 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; 72 FR 72929, Dec. 26, 2007; 81 FR 97032, Dec. 30, 2016]



Sec. 1312.24  Distribution of export permit.

    The Administration shall transmit the export permit to the competent 
national authority of the importing country and shall make available to 
the exporter an official record of the export permit through secure 
electronic means. The exporter, or their agent, must submit an official 
record of the export permit and/or required data concerning the export 
transaction to a customs officer at the port of export in compliance 
with all export control requirements of agencies with export control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. The exporter must maintain 
an official record of the export permit (available from the secure 
network application on the DEA Diversion Control Division Web site after 
the Administration issues a transaction identification number) in 
accordance with part 1304 of this chapter as the record of authority for 
the exportation and shall transmit an official record of the export 
permit to the foreign importer. The exporter must ensure that an 
official record of the permit accompanies the shipment to its final 
destination. No shipment of controlled substances denied release for any 
reason shall be allowed to be released from the United States without 
subsequent authorization from the Administration.

[81 FR 97032, Dec. 30, 2016]



Sec. 1312.25  Amendment, cancellation, expiration of export permit.

    (a) Exporters may only request that an export permit or application 
for an export permit be amended in accordance with paragraphs (a)(1) 
through (7) of this section. Requests for an amendment must be submitted 
through the DEA Diversion Control Division secure network application. 
Except as provided in paragraph (a)(5) of this section exporters must 
submit all requests for an amendment at least one full business day in 
advance of the date of release from the port of export. Exporters must 
specifically request that an amendment be made; supplementary 
information submitted by an exporter through the DEA Diversion Control 
Division secure network application will not automatically trigger the 
amendment process. While the request for an amendment is being reviewed 
by the Administration, the original permit will be temporarily stayed 
and may not be used to authorize release of a shipment of controlled 
substances. If the exporter's request for an amendment to an issued 
permit is granted by the Administration, the Administration will 
immediately cancel the original permit and re-issue the permit, as 
amended, with a revised permit number. The DEA and exporter will 
distribute the amended permit in accordance with Sec. 1312.24. If a 
request for an amendment is denied by the Administration, the temporary 
stay will be lifted; once lifted, the originally issued permit may 
immediately be used to authorize release of a shipment in accordance 
with the terms of the permit.
    (1) An exporter may request that an export permit or application for 
a permit be amended to change the National Drug Control number, 
description of the packaging, or trade name of the product, so long as 
the description is for the same basic class of controlled substance as 
in the original permit.
    (2) An exporter may request that an export permit or application for 
a permit be amended to change the proposed port of export, the 
anticipated date of release by a customs officer, or the method of 
transport.
    (3) An exporter may request that an export permit or application for 
a permit be amended to change the justification provided as to why an 
export shipment is needed to meet the legitimate scientific or medical 
needs of the country of import.
    (4) An exporter may request that an export permit or application for 
a permit be amended to change any registrant notes.

[[Page 209]]

    (5) Prior to departure of the shipment from the exporter's 
registered location, an exporter may request that an export permit or 
application for a permit be amended to increase the total base weight of 
a controlled substance. However, the total base weight or the strength 
of the product (if listed) of a controlled substance may not exceed that 
permitted for import as indicated on the import permit from the foreign 
competent national authority. Exporters are not required to amend an 
export permit for the sole purpose of decreasing the total base weight 
of a controlled substance authorized to be exported. However, the 
balance of any unexported authorized quantity of controlled substances 
on an export permit is void upon release of a shipment on the issued 
permit or upon expiration of the unused permit in accordance with 
paragraph (b) of this section, whichever is sooner. Exporters must 
submit a request for an amendment to increase the total base weight of a 
controlled substance at least three business days in advance of the date 
of release from the port of export.
    (6) An exporter may request that an export permit be amended to 
remove a controlled substance from the permit. However, an exporter may 
not amend an export permit to add or replace a controlled substance to 
the item(s) to be exported. Exporters who desire to export a different 
controlled substance than that contained on their issued export permit 
or permit application must submit a request for the permit or permit 
application to be canceled and request a new permit in accordance with 
Sec. 1312.22.
    (7) An exporter may not amend the exporter's name (as it appears on 
their DEA certificate of registration), the name of the foreign 
importer(s), or the foreign permit information as provided in the DEA 
Form 161, 161R, or 161R-EEA. Exporters who need to make any changes to 
any of these fields must submit a request for the permit or permit 
application to be canceled and request a new permit in accordance with 
Sec. 1312.22.
    (b) An export permit will be void and of no effect after the date 
specified therein, which date must 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 will 
the date be more than 180 calendar days after the date the permit is 
issued.
    (c) An export permit may be canceled after being issued, at the 
request of the exporter submitted to the Administration through the DEA 
Diversion Control Division secure network application, provided that no 
shipment has been made thereunder. Nothing in this part will affect the 
right, hereby reserved by the Administration, to cancel an export permit 
at any time for proper cause.

[81 FR 97032, Dec. 30, 2016]



Sec. 1312.26  Records required of exporter.

    In addition to any other records required by this chapter, the 
exporter must 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 an official 
record of the export permit, in accordance with part 1304 of this 
chapter.

[81 FR 97033, Dec. 30, 2016]



Sec. 1312.27  Export/reexport declaration.

    (a) Any person registered or authorized to export and seeking 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 and seeking to export any controlled substance in 
Schedule V, must file a controlled substances export declaration (DEA 
Form 236) with the Administration through the DEA Diversion Control 
Division secure network application not less than 15 calendar days prior 
to the anticipated date of release by a customs officer at the port of 
export, and distribute an official record of the declaration as 
hereinafter directed in Sec. 1312.28. The declaration must be signed and 
dated by the exporter and must contain the address of the registered 
location from which the substances will be shipped for exportation. Upon 
receipt and review, the Administration will issue a

[[Page 210]]

completed declaration a transaction identification number. The export 
declaration is not deemed filed, and therefore not valid, until the 
Administration has issued a transaction identification number. The 
exporter may only proceed with the export transaction once the 
transaction identification number has been issued.
    (b)(1) DEA Form 236 must include the following information:
    (i) The name/business name, address/business address, contact 
information (e.g., telephone number(s), email address(es), etc.), and 
registration number, if any, of the exporter; and the name/business 
name, address/business address, contact information (e.g., telephone 
number(s), email address(es), etc.), and registration number of the 
export broker, if any.
    (ii) A detailed description of each controlled substance to be 
exported including the drug name, dosage form, National Drug Code (NDC) 
number, Administration Controlled Substance Code Number as set forth in 
part 1308 of this chapter, the number and size of the 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.
    (iii) The anticipated date of release by a customs officer at the 
port of export, the port of export, the foreign port and country 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.
    (iv) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) 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:
    (A) The consignee is authorized under the laws and regulations of 
the country of destination to receive the controlled substances; and
    (B) The substance is being imported for consumption within the 
importing country to satisfy medical, scientific or other legitimate 
purposes.
    (v) The reexport of non-narcotic controlled substances in Schedules 
III and IV, and controlled substances in Schedule V is not permitted 
under the authority of 21 U.S.C. 953(e), except as provided below and in 
paragraph (b)(1)(vi) of this section:
    (A) 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.
    (B) Finished dosage units, if reexported, will be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
country of destination.
    (C) 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:
    (1) Indicate ``for reexport''.
    (2) Indicate if reexport is bulk or finished dosage units.
    (3) Indicate product name, dosage strength, commercial package size, 
and quantity.
    (4) 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.
    (5) 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.
    (D) Shipments that have been exported from the United States and are 
refused by the consignee in either the first or second country, or 
subsequent member of the European Economic Area, or are otherwise 
unacceptable or undeliverable, may be returned to the registered 
exporter in the United States upon authorization of the Administration. 
In this circumstance, the

[[Page 211]]

exporter in the United States must file a written request for reexport, 
along with a completed DEA Form 236, with the Administration through the 
DEA Diversion Control Division secure network application. 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 
must 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.
    (vi) The reexport of non-narcotic controlled substances in Schedules 
III and IV, and controlled substances in Schedule V is permitted among 
members of the European Economic Area only as provided below:
    (A) The controlled substance will not be exported from the second 
country or a subsequent country, except that the controlled substance 
may be exported from a second country or a subsequent country that is a 
member of the European Economic Area to another country that is a member 
of the European Economic Area, provided that the first country is also a 
member of the European Economic Area; each country is a party to the 
Convention on Psychotropic Substances, 1971, as amended; and each 
country has instituted and maintains, in conformity with such 
Convention, a system of controls of imports of controlled substances 
which the Attorney General deems adequate.
    (B) Each shipment of finished dosage units, if reexported, must be 
in a commercial package, properly sealed and labeled for legitimate 
medical use in the country of destination.
    (C) Any reexportation must 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. In 
addition to the requirements of paragraph (b) of this section, the 
following information will be furnished in the remarks section:
    (1) Indicate ``for reexport among members of the European Economic 
Area''.
    (2) Indicate if reexport is bulk or finished dosage units.
    (3) Indicate product name, dosage strength, commercial package size, 
and quantity.
    (4) Indicate the name/business name, address/business address, 
contact information (e.g., telephone number(s), email address(es) and 
business of the consignee in the first country).
    (5) A statement that the consignee in the second country, and any 
subsequent consignee within the European Economic Area, is authorized 
under the laws and regulations of the second and/or subsequent country 
to receive the controlled substances.
    (2) With respect to reexports among members of the European Economic 
Area, the requirements of paragraph (b)(1) of this section shall apply 
only with respect to the export from the United States to the first 
country and not to any subsequent export from that country to another 
country of the European Economic Area.
    (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.
    (d) Return information--(1) Return information for exports. Within 
30 calendar days after the controlled substance is released by a customs 
officer at the port of export, or within 10 calendar days after receipt 
of a written request by the Administration to the exporter, whichever is 
sooner, the exporter must file a report with the Administration through 
the DEA Diversion Control Division secure network application specifying 
the particulars of the transaction. This report must include the 
following information: The date on which the controlled substance left 
the registered location; the date on which the controlled substance was 
released by a customs officer; the actual quantity of the controlled 
substance that left the registered location; and the actual quantity of 
the controlled substance released by a customs officer at the port of 
export; the actual port of export. Upon receipt and review, the

[[Page 212]]

Administration will assign a completed report a transaction 
identification number. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (2) Return information for reexports outside of the European 
Economic Area--(i) Return information for export from the United States, 
for reexport. Within 30 calendar days after the controlled substance is 
released by a customs officer at the port of export the exporter must 
file a report with the Administration through the DEA Diversion Control 
Division secure network application specifying the particulars of the 
transaction. This report must include the following information: The 
date on which the controlled substance left the registered location; the 
date on which the controlled substance was released by a customs officer 
at the port of export; the actual quantity of controlled substance 
released by a customs officer at the port of export; and the actual port 
of export. Upon receipt and review, the Administration will assign a 
completed report a transaction identification number. The report will 
not be deemed filed until the Administration has issued a transaction 
identification number.
    (ii) Return information for export from a first country that is or 
is not a member of the European Economic Area to a country outside of 
the European Economic Area; return information for export from a first 
country that is not a member of the European Economic Area to a member 
of the European Economic Area. Within 30 calendar days after the 
controlled substance is exported from the first country to the second 
country the exporter must file a report with the Administration through 
the DEA Diversion Control Division secure network application specifying 
the particulars of the export from the first country. If the permit 
issued by the Administration authorized the reexport of a controlled 
substance from the first country to more than one second country, a 
report for each individual reexport is required. These reports must 
include the following information: Name of second country; actual 
quantity of controlled substance shipped; the date shipped from the 
first country; and the actual port from which the controlled substances 
were shipped from the first country. Upon receipt and review, the 
Administration will assign each completed report a transaction 
identification number. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (3) Reexports among members of the European Economic Area--(i) 
Return information for exports from the United States, for reexport 
among members of the European Economic Area. Exporters must comply with 
the return reporting requirements of paragraph (d)(2)(i) of this 
section.
    (ii) Reexports among members of the European Economic Area. Within 
30 calendar days after the controlled substance is exported from the 
first country to the second country, and within 30 calendar days of each 
subsequent reexport within the European Economic Area, if any, the 
exporter must file a report with the Administration through the DEA 
Diversion Control Division secure network application specifying the 
particulars of the export. These reports must include the name of 
country to which the controlled substance was reexported to another 
member of the European Economic Area; the actual quantity of controlled 
substance shipped; the date shipped from the first country, the name/
business name, address/business address, contact information (e.g., 
telephone number(s), email address(es), etc.) and business of the 
consignee; and the name/business name, address/business address, contact 
information (e.g., telephone number(s), email address(es), etc.) and 
business of the exporter. Upon receipt and review, the Administration 
will assign each completed report a transaction identification number. 
The report will not be deemed filed until the Administration has issued 
a transaction identification number.
    (e) An exporter may amend an export declaration in the same 
circumstances in which an exporter may request amendment to an export 
permit, as set forth in Sec. 1312.25(a)(1) through (7). Amendments to 
declarations must be submitted through the DEA Diversion Control 
Division secure network application. Except as provided in

[[Page 213]]

Sec. 1312.25(a)(5) exporters must submit all amendments at least one 
full business day in advance of the date of release by a customs 
officer. Exporters must specifically note that an amendment is being 
made; supplementary information submitted by an exporter through the DEA 
Diversion Control Division secure network application will not 
automatically be considered an amendment. Upon receipt and review, the 
Administration will assign each completed amendment a transaction 
identification number. The amendment will not be deemed filed until the 
Administration issues a transaction identification number. The DEA and 
the exporter will distribute the amended declaration in accordance with 
Sec. 1312.28. A filed amendment will not change the date that the 
declaration becomes void and of no effect in accordance with paragraph 
(f) of this section.
    (f) An export declaration may be canceled after being filed with the 
Administration, at the request of the exporter, provided no shipment has 
been made thereunder. Export declarations shall become void and of no 
effect 180 calendar days after the date the declaration is deemed filed 
with the Administration.
    (g) Denied release at the port of export. In the event that a 
shipment of controlled substances has been denied release by a customs 
officer at the port of export for any reason, the exporter who attempted 
to have the shipment released must, within 5 business days of the 
denial, report to the Administration that the shipment was denied 
release and the reason for denial. Such report must be transmitted to 
the Administration through the DEA Diversion Control Division secure 
network application. This report must include the following information: 
The quantity of the controlled substance denied release; the date on 
which release was denied; and the basis for the denied release. Upon the 
exporter's report of a denied release, DEA will assign the report a 
transaction identification number and the export declaration will be 
void and of no effect. No shipment of controlled substances denied 
release for any reason will be allowed to be released unless the 
exporter files a new declaration and the Administration issues a new 
transaction identification number.

[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; 75 FR 10683, Mar. 9, 2010; 81 FR 97033, Dec. 
30, 2016]



Sec. 1312.28  Distribution of export declaration.

    (a) The exporter must ensure that an official record of the export 
declaration (available from the DEA Diversion Control Division secure 
network application after the Administration issues a transaction 
identification number) accompanies the shipment of controlled substances 
to its destination.
    (b) The exporter, or their agent, must submit an official record of 
the export declaration and/or required data concerning the export 
transaction to a customs officer at the port of export in compliance 
with all export control requirements of agencies with export control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act.
    (c) The exporter must maintain an official record of the export 
declaration and return information (both available from the Diversion 
Control Division secure network application after the Administration 
issues a transaction identification number) required pursuant to 
Sec. 1312.27(d) as his or her record of authority for the exportation, 
in accordance with part 1304 of this chapter.

[81 FR 97035, Dec. 30, 2016]



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.

[[Page 214]]



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 Regulatory Section, Diversion Control Division, Drug Enforcement 
Administration, at least 30 calendar days, or in the case of an 
emergency as soon as is practicable, prior to the expected date of 
arrival at the first port in the United States. See the Table of DEA 
Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address. A separate permit is required for each shipment of 
controlled substance to be imported, transferred, or transshipped. Each 
application must 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 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;
    (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; and

[[Page 215]]

    (4) If the import license or permit, or the certified copy of such, 
is not written in English or bilingual with another language and 
English, the application must include a certified translation of the 
permit or license. For purposes of this requirement, certified 
translation means that the translator has signed the translation legally 
attesting the accuracy of the translation.
    (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; 75 FR 10683, Mar. 9, 2010; 81 FR 
97035, Dec. 30, 2016]



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 Regulatory Section, 
Diversion Control Division, Drug Enforcement Administration, at least 15 
calendar days prior to the expected date of date of arrival at the first 
port in the United States. See the Table of DEA mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing addresses.
    (b) A separate advance notice is required for each shipment of 
controlled substance to be imported, transferred, or transshipped. Each 
advance notice must contain those items required by Sec. 1312.31(b) and 
(c). If the export license, permit, or other authorization, issued by a 
competent national authority of the country of origin, is not written in 
English or bilingual with another language and English, the notice must 
be accompanied by a certified translation of the export license, permit, 
or other authorization. For purposes of this requirement, certified 
translation means that the translator has signed the translation legally 
attesting the accuracy of the translation.

[81 FR 97036, Dec. 30, 2016]

                                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 Secs. 1312.42-1312.47, and 
by the procedures for administrative hearings under the Act set forth in 
Secs. 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

[[Page 216]]

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]



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

[[Page 217]]

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]



PART 1313_IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS
--Table of Contents



Sec.
1313.01  Scope.
1313.02  Definitions.
1313.03  Forms applicable to this part.
1313.05  Requirements for an established business relationship.
1313.08  Requirements for establishing a record as an importer.

                     Importation of Listed Chemicals

1313.12  Notification prior to import.
1313.13  Requirements of import declaration.
1313.14  Disposition of import declaration.
1313.15  Qualification of regular importers.
1313.16  Updated notice for change in circumstances.
1313.17  Return declaration for imports.

                     Exportation of Listed Chemicals

1313.21  Notification prior to export.
1313.22  Export declaration.
1313.23  Disposition of export declaration.
1313.24  Waiver of 15-day advance notice for chemical exporters.
1313.25  Foreign import restrictions.
1313.26  Updated notice for change in circumstances.
1313.27  Return declaration for exports.

  Transshipments, In-Transit Shipments and International Transactions 
                       Involving Listed Chemicals

1313.31  Advance notice of importation for transshipment or transfer.
1313.32  Notification of international transactions.
1313.33  Contents of an international transaction declaration.
Sec. 1313.34  Disposition of the international transaction declaration.
1313.35  Return declaration or amendment to Form 486 for international 
          transactions.
1313.41  Suspension of shipments.
1313.42  Prohibition of shipments from certain foreign sources.

                                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]



Sec. 1313.03  Forms applicable to this part.

------------------------------------------------------------------------
                   Form                          Access/ submission
------------------------------------------------------------------------
DEA Form 486, Import/Export Declaration     electronic.
 for List I and List II Chemicals.
DEA Form 486A Import Declaration for        electronic.
 ephedrine, pseudoephedrine, and
 phenylpropanolamine (including drug
 products containing these chemicals).
------------------------------------------------------------------------


[81 FR 97036, Dec. 30, 2016]



Sec. 1313.05  Requirements for an established business relationship.

    To document that an importer or exporter has an established business 
relationship with a customer, the importer or exporter must provide the 
Administrator with the following information in accordance with the 
waiver of 15-day advance notice requirements of Sec. 1313.15 or 
Sec. 1313.24:
    (a) The name and street address of the chemical importer or exporter 
and of each regular customer;
    (b) The telephone number, contact person, and where available, the 
facsimile number for the chemical importer or exporter and for each 
regular customer;

[[Page 218]]

    (c) 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;
    (d) The duration of the business relationship;
    (e) The frequency and number of transactions occurring during the 
preceding 12-month period;
    (f) The amounts and the listed chemical or chemicals involved in 
regulated transactions between the chemical importer or exporter and 
regular customer;
    (g) The method of delivery (direct shipment or through a broker or 
forwarding agent); and
    (h) Other information that the chemical importer or exporter 
considers relevant for determining whether a customer is a regular 
customer.

[72 FR 17407, Apr. 9, 2007]



Sec. 1313.08  Requirements for establishing a record as an importer.

    To establish a record as an importer, the regulated person must 
provide the Administrator with the following information in accordance 
with the waiver of the 15-day advance notice requirements of 
Sec. 1313.15:
    (a) The name, DEA registration number (where applicable), street 
address, telephone number, and, where available, the facsimile number of 
the regulated person and of each foreign supplier; and
    (b) The frequency and number of transactions occurring during the 
preceding 12 month period.

[72 FR 17407, Apr. 9, 2007]

                     Importation of Listed Chemicals



Sec. 1313.12  Notification prior to import.

    (a) Each regulated person who seeks to import a listed chemical that 
meets or exceeds the threshold quantities identified in Sec. 1310.04(f) 
of this chapter or is a listed chemical for which no threshold has been 
established as identified in Sec. 1310.04(g) of this chapter, must 
notify the Administration of the intended import by filing an import 
declaration (on DEA Form 486/486A) not later than 15 calendar days 
before the date of release by a customs officer at the port of entry. 
Regulated persons who seek to import a listed chemical below the 
threshold quantities identified in Sec. 1310.04(f) are not required to 
file an import declaration in advance of the release by a customs 
officer.
    (b) A complete and accurate declaration (DEA Form 486/486A) must be 
filed with the Administration through the DEA Diversion Control Division 
secure network application not later than 15 calendar days prior to the 
date of release by a customs officer at the port of entry. The 
declaration must be signed and dated by the importer and must contain 
the address of the final destination for the shipment, which for List I 
chemicals must be a registered location of the importer. Upon receipt 
and review, the Administration will assign a transaction identification 
number to each completed declaration. The 15 calendar days shall begin 
on the date that the regulated person submits a completed declaration, 
without regard to the date that the Administration assigns a transaction 
identification number. Listed chemicals meeting or exceeding the 
threshold quantities identified in Sec. 1310.04(f) of this chapter or 
for which no threshold has been established may not be imported until a 
transaction identification number has been issued.
    (c) The 15-calendar-day advance notification requirement for listed 
chemical imports may be waived, in whole or in part, for the following:
    (1) Any importation that meets both of the following requirements:
    (i) The regulated person has satisfied the requirements for 
reporting to the Administration as a regular importer of the listed 
chemicals.
    (ii) The importer intends to transfer the listed chemicals to a 
person who is a regular customer for the chemical, as defined in 
Sec. 1300.02 of this chapter.
    (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 meeting the requirements of paragraph (c)(1) of this 
section, the declaration (DEA Form 486/

[[Page 219]]

486A) must be filed with the Administration through the DEA Diversion 
Control Division secure network application at least three business days 
before the date of release by a customs officer at the port of entry. 
The declaration must be signed and dated by the importer and must 
contain the address of the final destination for the shipment, which 
must be a registered location of the importer (for List I chemicals). 
Upon receipt and review, the Administration will assign a transaction 
identification number to each completed declaration. The importer may 
proceed with the import transaction only once the transaction 
identification number has been issued.
    (e) For importations where advance notification is waived pursuant 
to paragraph (c)(2) of this section no DEA Form 486 is required; 
however, the regulated person must submit quarterly reports to the 
Regulatory Section, Diversion Control Division, Drug Enforcement 
Administration, not later than the 15th day of the month following the 
end of each quarter. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. 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; 72 FR 17407, Apr. 9, 2007; 75 FR 10683, Mar. 9, 2010; 77 FR 
4237, Jan. 27, 2012; 81 FR 97036, Dec. 30, 2016]



Sec. 1313.13  Requirements 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 and all other applicable laws.
    (b) The DEA Form 486/486A must include the following information:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
chemical importer; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), etc.) 
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 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; and
    (3) The date of release by a customs officer at the port of entry, 
the foreign port and country of export, and the port of entry; and
    (4) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignor in the foreign country of exportation; and
    (5) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
person or persons to whom the importer intends to transfer the listed 
chemical and the quantity to be transferred to each transferee.
    (c) Any regulated person importing ephedrine, pseudoephedrine, or 
phenylpropanolamine must submit, on the import declaration (DEA Form 
486A), all information known to the importer on the chain of 
distribution of the chemical from the manufacturer to the importer. 
Ephedrine, pseudoephedrine, or phenylpropanolamine include each of the 
salts, optical isomers, and salts of optical isomers of the chemical.

[[Page 220]]

    (d) Import declarations shall become void and of no effect 180 
calendar days after the date the declaration is deemed filed with the 
Administration.

[81 FR 97036, Dec. 30, 2016]



Sec. 1313.14  Disposition of import declaration.

    The importer, or their agent, must submit an official record of the 
import declaration and/or required data concerning the import 
transaction to a customs officer at the port of entry in compliance with 
all import control requirements of agencies with import control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. For List I chemicals, the 
final destination of the import transaction must only be the registered 
location of the importer (i.e., drop shipments are prohibited). A 
regulated person must maintain an official record of the declaration 
(available from the DEA Diversion Control Division secure network 
application after the Administration issues a transaction identification 
number) in accordance with part 1310 of this chapter as the record of 
the import. Official records of import declarations involving listed 
chemicals must be retained for two years.

[81 FR 97037, Dec. 30, 2016]



Sec. 1313.15  Qualification of regular importers.

    (a) Each regulated person seeking designation as a ``regular 
importer'' shall provide, by certified mail return receipt requested, to 
the Administration such information as is required under Sec. 1313.08 
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'' 30 calendar 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; 
72 FR 17407, Apr. 9, 2007; 81 FR 97037, Dec. 30, 2016]



Sec. 1313.16  Updated notice for change in circumstances.

    (a) In the case of a notice under Sec. 1313.12(a) submitted by a 
regulated person, if the transferee identified in the notice is not a 
regular customer, the importer may not transfer the listed chemical 
until after the expiration of the 15-day period beginning on the date on 
which the notice is submitted to the Administration.
    (b) After a notice under Sec. 1313.12(a) or (d) is submitted to the 
Administration, if circumstances change and the importer will not be 
transferring the listed chemical to the transferee identified in the 
notice, or will be transferring a greater quantity of the chemical than 
specified in the notice, the importer must update the notice to identify 
the most recent prospective transferee or the most recent quantity or 
both (as the case may be) and may not transfer the listed chemical until 
after the expiration of the 15 calendar day period beginning on the date 
on which the update is filed with the Administration, or, if the import 
is being made by a regular importer or intended for transfer to a 
regular customer, three business days. The preceding sentence applies 
with respect to changing circumstances regarding a transferee or 
quantity identified in an update to the same extent and in the same 
manner as the sentence applies with respect to changing circumstances 
regarding a transferee or quantity identified in the original notice 
under Sec. 1313.12(a) or (d). Amended declarations must be submitted to 
the Administration through

[[Page 221]]

the DEA Diversion Control Division secure network application. The 
amendment must be signed and dated by the importer. Upon receipt and 
review, the Administration will assign each completed amendment a 
transaction identification number. Such shipment of listed chemicals may 
not be imported into the United States until the transaction 
identification number has been issued.
    (c) In the case of a transfer of a listed chemical that is subject 
to a 15-day restriction, the transferee involved shall, upon the 
expiration of the 15-day period, be considered to qualify as a regular 
customer, unless the Administration otherwise notifies the importer 
involved in writing.
    (d) With respect to a transfer of a listed chemical with which a 
notice or update referred to in Sec. 1313.12(a) or (d) is concerned:
    (1) The Administration--
    (i) May, in accordance with the same procedures as apply under 
Secs. 1313.51 through 1313.57, order the suspension of the transfer of 
the listed chemical by the importer involved, except for a transfer to a 
regular customer, on the ground that the chemical may be diverted to the 
clandestine manufacture of a controlled substance (without regard to the 
form of the chemical that may be diverted, including the diversion of a 
finished drug product to be manufactured from bulk chemicals to be 
transferred), subject to the Administration ordering the suspension 
before the expiration of the 15-day period with respect to the 
importation (in any case in which such a period applies); and
    (ii) May, for purposes of this paragraph (d), disqualify a regular 
customer on that ground.
    (2) From and after the time when the Administration provides written 
notice of the order under paragraph (d)(1)(i) of this section (including 
a statement of the legal and factual basis for the order) to the 
importer, the importer may not carry out the transfer.
    (e) For purposes of this section:
    (1) The term transfer, with respect to a listed chemical, includes 
the sale of the chemical.
    (2) The term transferee means a person to whom an importer transfers 
a listed chemical.

[72 FR 17407, Apr. 9, 2007, as amended at 81 FR 97037, Dec. 30, 2016]



Sec. 1313.17  Return declaration for imports.

    (a) Return information. Within 30 calendar days after actual receipt 
of a listed chemical at the importer's registered location or place of 
business if not required to be registered, the importer must file a 
report with the Administration through the DEA Diversion Control 
Division secure network application specifying the particulars of the 
transaction. This report must include the following information: The 
date on which the listed chemical was released by a customs officer at 
the port of entry; the date on which the listed chemical arrived at the 
importer's registered location or place of business; the actual quantity 
of the listed chemical released; the actual quantity of the listed 
chemical that arrived at the importer's location; the date of any 
subsequent transfer; a description of the subsequent transfer, including 
the actual quantity transferred, chemical, container, and name of 
transferees; the actual port of entry; and any other information as the 
Administration may specify. A single report may include the particulars 
of both the importation and distribution. If the importer has not 
distributed all chemicals imported by the end of the initial 30 calendar 
day period, the importer must file supplemental reports not later than 
30 calendar days from the date of any further distribution, until the 
distribution or other disposition of all chemicals imported under the 
import declaration or any amendment or other update is accounted for. 
Upon receipt and review, the Administration will assign each completed 
report a transaction identification number. In determining whether the 
importer has complied with the requirement to file within 30 calendar 
days, the report shall be deemed filed on the first date on which a 
complete report is filed.
    (b) If an importation for which a DEA Form 486/486A has been filed 
fails to take place, the importer must report to

[[Page 222]]

the Administration that the importation did not occur through the DEA 
Diversion Control Division secure network application.
    (c) Denied release at the port of entry. In the event that a 
shipment of listed chemicals has been denied release by a customs 
officer at the port of entry for any reason, the importer who attempted 
to have the shipment released, within 5 business days of the denial, 
report to the Administration that the shipment was denied release and 
the reason for denial. Such report must be transmitted to the 
Administration through the DEA Diversion Control Division secure network 
application. This report must include the following information: The 
quantity of the listed chemical denied release; the date on which 
release was denied; and the basis for the denied release. Upon the 
importer's report of a denied release, the DEA will assign the report a 
transaction identification number and the import declaration will be 
void and of no effect. No shipment of listed chemicals denied release 
for any reason will be allowed entry into the United States without a 
subsequent refiling of an import declaration. Following such refiling 
the importer may request release of the listed chemicals immediately 
after receipt of a transaction identification number without regard to 
the 15 day advance filing requirement in Sec. 1313.12(b).

[81 FR 97037, Dec. 30, 2016]

                     Exportation of Listed Chemicals



Sec. 1313.21  Notification prior to export.

    (a) Each regulated person who seeks to export a listed chemical that 
meets or exceeds the threshold quantities identified in Sec. 1310.04(f) 
of this chapter, or is a listed chemical for which no threshold has been 
established as identified in Sec. 1310.04(g) of this chapter, must 
notify the Administration of the intended export by filing an export 
declaration (DEA Form 486) not later than 15 calendar days before the 
date of release by a customs officer at the port of export. Regulated 
persons who seek to export a listed chemical below the threshold 
quantities identified in Sec. 1310.04(f) are not required to file an 
export declaration in advance of the export.
    (b) A complete and accurate declaration (DEA Form 486) must be filed 
with the Administration through the DEA Diversion Control Division 
secure network application not later than 15 calendar days prior to the 
date of release by a customs officer at the port of export. The 
declaration must be signed and dated by the exporter and must contain 
the address from which the listed chemicals will be shipped for 
exportation. Upon receipt and review, the Administration will assign a 
transaction identification number to each completed declaration. The 15 
calendar days shall begin on the date that the regulated person files a 
completed declaration without regard to the date that the Administration 
assigns a transaction identification number. Exporters may not request 
release of a listed chemical until a transaction identification number 
has been issued.
    (c) The 15 calendar day advance notification requirement for listed 
chemical exports may be waived, in whole or in part, for:
    (1) Any regulated person who has satisfied the requirements of 
Sec. 1313.24 for reporting to the Administration an established business 
relationship, as defined in Sec. 1300.02 of this chapter, with a foreign 
customer.
    (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 meeting the requirements of paragraph (c)(1) of this 
section, the declaration (DEA Form 486) must be filed with the 
Administration through the DEA Diversion Control Division secure network 
application at least three business days before the date of release by a 
customs officer. The declaration must be signed and dated by the 
exporter and must contain the address from which the listed chemicals 
will be shipped for exportation. Upon receipt and review, the 
Administration will assign a transaction identification number to each 
completed declaration. The exporter may only proceed with the export

[[Page 223]]

transaction once the transaction identification number has been issued.
    (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 must submit quarterly reports with the 
Regulatory Section, Diversion Control Division, Drug Enforcement 
Administration, not later than the 15th day of the month following the 
end of each quarter. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. Such 
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:

------------------------------------------------------------------------
             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.
    (h) Export declarations shall become void and of no effect 180 
calendar days after the date the declaration is deemed filed with the 
Administration.

[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; 75 FR 10683, Mar. 9, 2010; 77 FR 
4237, Jan. 27, 2012; 81 FR 97038, Dec. 30, 2016]



Sec. 1313.22  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 or is a listed chemical 
for which no threshold has been established as identified in 
Sec. 1310.04(g) of this chapter, may be exported if that chemical is 
needed for medical, commercial, scientific, or other legitimate uses.
    (b) The export declaration (DEA Form 486) must include all the 
following information:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
chemical exporter; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), etc.) 
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 anticipated date of release by a customs officer at the port 
of export, the port of export, and the foreign port and country of 
entry; and
    (4) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignee in the country where the chemical shipment is destined; the 
name(s) and address(es) of any intermediate consignee(s); and a copy of 
the foreign permit, license or registration issued by the competent 
national authority of the consignee and any intermediate consignees.
    (c) Declared exports of listed chemicals which are refused, 
rejected, or otherwise deemed undeliverable by the foreign competent 
national authority may be returned to the U.S. chemical exporter of 
record. The regulated person must provide notification through

[[Page 224]]

the DEA Diversion Control Division secure network application (this does 
not require a DEA Form 486) outlining the circumstances within a 
reasonable time following the return. Upon receipt and review, the 
Administration will assign the completed notice a transaction 
identification number. The notice will not be deemed filed until the 
Administration issues a transaction identification number. Listed 
chemicals so returned may not be reexported until the exporter has filed 
a new DEA Form 486 and the Administration has issued a new transaction 
identification number. 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.

[81 FR 97038, Dec. 30, 2016]



Sec. 1313.23  Disposition of export declaration.

    The exporter, or their agent, must submit an official record of the 
export declaration and/or required data concerning the export 
transaction to a customs officer at the port of export in compliance 
with all export control requirements of agencies with export control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. An official record of the 
declaration (available from the DEA Diversion Control Division secure 
network application after the Administration issues a transaction 
identification number) must be maintained by the chemical exporter as 
the official record of the export in accordance with part 1310 of this 
chapter. Export declarations involving a listed chemical must be 
retained for two years.

[81 FR 97038, Dec. 30, 2016]



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 the definition of established 
business relationship in Sec. 1300.02 of this chapter 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.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 55077, Oct. 24, 1991; 62 
FR 13969, Mar. 24, 1997; 75 FR 10684, Mar. 9, 2010; 77 FR 4237, Jan. 27, 
2012]



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).



Sec. 1313.26  Updated notice for change in circumstances.

    (a) In the case of a notice under Sec. 1313.21(a) submitted by a 
regulated person, if the transferee identified in the notice, i.e., the 
foreign importer, is not a regular customer, the regulated person may 
not transfer the listed chemical until after the expiration of the 15-
day period beginning on the date on which the notice is submitted to the 
Administration.

[[Page 225]]

    (b) After a notice under Sec. 1313.21(a) is submitted to the 
Administration, if circumstances change and the exporter will not be 
transferring the listed chemical to the transferee identified in the 
notice, or will be transferring a greater quantity of the chemical than 
specified in the notice, the exporter must update the notice to identify 
the most recent prospective transferee or the most recent quantity or 
both (as the case may be). The exporter may not transfer the listed 
chemical until after the expiration of the 15 calendar day period 
beginning on the date on which the update is filed with the 
Administration. Except, if the listed chemical is intended for transfer 
to a regular customer, the exporter may not transfer the listed chemical 
until after the expiration of three business days. The preceding 
sentence applies with respect to changing circumstances regarding a 
transferee or quantity identified in an update to the same extent and in 
the same manner as the sentence applies with respect to changing 
circumstances regarding a transferee or quantity identified in the 
original notice under paragraph (a) of this section. Amended 
declarations must be submitted to the Administration through the DEA 
Diversion Control Division secure network application. The amendment 
must be signed and dated by the exporter. Upon receipt and review, the 
Administration will assign each completed amendment a transaction 
identification number. The amendment will not be deemed filed until the 
Administration issues a transaction identification number.
    (c) In the case of a transfer of a listed chemical that is subject 
to a 15-day restriction, the transferee involved shall, upon the 
expiration of the 15-day period, be considered to qualify as a regular 
customer, unless the Administration otherwise notifies the exporter 
involved in writing.
    (d) With respect to a transfer of a listed chemical with which a 
notice or update referred to in Sec. 1313.21(a) is concerned:
    (1) The Administration--
    (i) May, in accordance with the same procedures as apply under 
Secs. 1313.51 through 1313.57, order the suspension of the transfer of 
the listed chemical by the exporter involved, except for a transfer to a 
regular customer, on the ground that the chemical may be diverted to the 
clandestine manufacture of a controlled substance (without regard to the 
form of the chemical that may be diverted, including the diversion of a 
finished drug product to be manufactured from bulk chemicals to be 
transferred), subject to the Administration ordering the suspension 
before the expiration of the 15-day period with respect to the 
exportation (in any case in which such a period applies); and
    (ii) May, for purposes of this paragraph (d), disqualify a regular 
customer on that ground.
    (2) From and after the time when the Administration provides written 
notice of the order under paragraph (d)(1)(i) of this section (including 
a statement of the legal and factual basis for the order) to the 
exporter, the exporter may not carry out the transfer.
    (e) For purposes of this section:
    (1) The term transfer, with respect to a listed chemical, includes 
the sale of the chemical.
    (2) The term transferee means a person to whom an exporter transfers 
a listed chemical.

[72 FR 17408, Apr. 9, 2007, as amended at 81 FR 97039, Dec. 30, 2016]



Sec. 1313.27  Return declaration for exports.

    (a) Return information. Within 30 calendar days after a listed 
chemical is released by a customs officer at the port of export, the 
exporter must file a report with the Administration through the DEA 
Diversion Control Division secure network application specifying the 
particulars of the transaction. This report must include the following 
information: The date on which the listed chemical left the registered 
location or place of business; the date on which the listed chemical was 
released by a customs officer at the port of export; the actual quantity 
of listed chemical that left the registered location or place of 
business; the actual quantity of the listed chemical released by a 
customs officer at the port of export; chemical; container; name of 
transferees; and any other information as the Administration may 
specify. Upon receipt and review, the Administration

[[Page 226]]

will assign a completed report a transaction identification number. The 
report will not be deemed filed until the Administration has issued a 
transaction identification number. In determining whether the exporter 
has complied with the requirement to file within 30 calendar days, the 
report shall be deemed filed on the first date on which a complete 
report is filed.
    (b) If an exportation for which a DEA Form 486 has been filed fails 
to take place, the exporter must report to the Administration that the 
exportation did not occur through the DEA Diversion Control Division 
secure network application.
    (c) Denied release at the port of export. In the event that a 
shipment of listed chemicals has been denied release by a customs 
officer at the port of export for any reason, the exporter who attempted 
to have the shipment released must, within 5 business days of the 
denial, report to the Administration that the shipment was denied 
release and the reason for denial. Such report must be transmitted to 
the Administration through the DEA Diversion Control Division secure 
network application. This report must include the following information: 
The quantity of the listed chemicals denied release; the date on which 
release was denied; and the basis for the denied release. Upon the 
exporter's report of a denied release, DEA will assign the report a 
transaction identification number and the export declaration will be 
void and of no effect. No shipment of listed chemicals denied release 
for any reason will be allowed to be released from the United States 
without a subsequent refiling of a complete and accurate export 
declaration. Following such refiling, the exporter may request the 
release of the listed chemicals immediately after receipt of a 
transaction identification number without regard to the 15 day advance 
filing required by Sec. 1313.21(b).

[81 FR 97039, Dec. 30, 2016]

  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 Regulatory Section, 
Diversion Control Division, Drug Enforcement Administration, not later 
than 15 calendar days prior to the proposed date the listed chemical 
will transship or transfer through the United States. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address. A separate notification is required for each shipment 
of listed chemicals to be transferred or transshipped. The written 
notification (not a DEA Form 486) must 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;
    (5) The net 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/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) and 
type of business of the foreign exporter;
    (8) The foreign port and country of export;
    (9) The approximate date of exportation;
    (10) The complete identification of the exporting carrier;

[[Page 227]]

    (11) The name, address, business, telephone 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/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) and 
type of business of the consignee at the foreign port or country of 
entry;
    (15) The shipping route from the U.S. port of export to the foreign 
port or country 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; 75 
FR 10684, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012; 81 FR 97039, Dec. 30, 
2016]



Sec. 1313.32  Notification of international transactions.

    (a) A broker or trader must notify the Administration prior to an 
international transaction involving a listed chemical which meets or 
exceeds the threshold quantities identified in Sec. 1310.04(f) of this 
chapter or is a listed chemical for which no threshold has been 
established as identified in Sec. 1310.04(g) of this chapter, in which 
the broker or trader participates. Notification must be made not later 
than 15 calendar 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 calendar days as possible.
    (b) A completed DEA Form 486 must be submitted to the Administration 
through the DEA Diversion Control Division secure network application, 
not later than 15 calendar days prior to the international transaction. 
The DEA Form 486 must be signed and dated by the broker or trader. Upon 
receipt and review, the Administration will assign a transaction 
identification number to each completed notification. A notification is 
not deemed filed, and therefore is not valid, until the Administration 
assigns the notification a transaction identification number. An 
international transaction may not take place until after a transaction 
identification number has been assigned and the expiration of the 15 
calendar day period beginning on the date on which the broker or trader 
submits a complete notification to the Administration.
    (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 Sec. 1313.25.
    (d) After a notice under paragraph (a) of this section is submitted 
to the Administration, if circumstances change and the broker or trader 
will not be transferring the listed chemical to the transferee 
identified in the notice, or will be transferring a greater quantity of 
the chemical than specified in the notice, the broker or trader must 
amend the notice through the DEA Diversion Control Division secure 
network application to identify the most recent prospective transferee 
or the most recent quantity or both (as applicable) and may not transfer 
the listed chemical until after the expiration of the 15 calendar day 
period beginning on the date on which the update is submitted to the 
Administration. The preceding sentence applies with respect to changing 
circumstances regarding a

[[Page 228]]

transferee or quantity identified in an amendment to the same extent and 
in the same manner as the sentence applies with respect to changing 
circumstances regarding a transferee or quantity identified in the 
original notice under paragraph (a) of this section.
    (e) For purposes of this section:
    (1) The term transfer, with respect to a listed chemical, includes 
the sale of the chemical.
    (2) The term transferee means a person to whom an exporter transfers 
a listed chemical.

[81 FR 97039, Dec. 30, 2016]



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, defined in 21 U.S.C. 802(42), involving a listed chemical 
which meets the threshold criteria set forth in Sec. 1310.04 of this 
chapter must notify the Administration through the procedures outlined 
in Sec. 1313.32(b).
    (c) The DEA Form 486 must include:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
chemical exporter; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), etc.) 
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 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 anticipated date of release at the foreign port of export, 
the anticipated foreign port and country of export, and the foreign port 
and country of entry; and
    (4) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) 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, as amended at 77 FR 4238, Jan. 27, 2012; 81 
FR 97040, Dec. 30, 2016]



Sec. 1313.34  Disposition of the international transaction declaration.

    The broker or trader must retain an official record of the 
declaration (DEA Form 486) (available from the DEA Diversion Control 
Division secure network application after the Administration issues a 
transaction identification number) as the official record of the 
international transaction. In accordance with part 1310 of this chapter, 
declarations involving listed chemicals must be retained for two years.

[81 FR 97040, Dec. 30, 2016]



Sec. 1313.35  Return declaration or amendment to Form 486 for
international transactions.

    (a) Within 30 calendar days after an international transaction is 
completed, the broker or trader must file a report with the 
Administration through the DEA Diversion Control Division secure network 
application about the particulars of the transaction. This report must 
include the following information: The date(s) on which the listed 
chemical was released by the foreign customs officer(s) at the port(s); 
the actual quantity of listed chemical that left the country of export; 
the actual quantity of the listed chemical released by a customs officer 
at the port of entry; chemical; container; name of transferees; and the 
transaction identification and any other information as the 
Administration may specify. Upon receipt and review, the Administration 
will assign a completed report a transaction identification number. The 
report will not be deemed filed until the Administration has issued a 
transaction identification number.
    (b) If an international transaction for which a DEA Form 486 has 
been filed

[[Page 229]]

fails to take place, the broker or trader must report to the 
Administration that the international transaction did not occur 
utilizing the DEA Diversion Control Division secure network application 
as soon as the broker or trader becomes aware of the circumstances.

[81 FR 97040, Dec. 30, 2016]



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 
Secs. 1313.51-1313.57.



Sec. 1313.42  Prohibition of shipments from certain foreign sources.

    (a) If the Administrator determines that a foreign manufacturer or 
distributor of ephedrine, pseudoephedrine, or phenylpropanolamine has 
refused to cooperate with a request by the Administrator for information 
known to the manufacturer or distributor on the distribution of the 
chemical, including sales, the Administrator may issue an order 
prohibiting the importation of the chemical in any case where the 
manufacturer or distributor is part of the chain of distribution.
    (b) Not later than 60 days prior to issuing the order to prohibit 
importation, the Administrator shall publish in the Federal Register a 
notice of intent to issue the order. During the 60-day period, imports 
from the foreign manufacturer or distributor may not be restricted under 
this section.

[75 FR 10172, Mar. 5, 2010]

                                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 
Secs. 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 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.

[[Page 230]]

    (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.



PART 1314_RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS
--Table of Contents



                            Subpart A_General

Sec.
1314.01  Scope.
1314.02  Applicability.
1314.03  Definitions.
1314.05  Requirements regarding packaging of nonliquid forms.
1314.10  Effect on state laws.
1314.15  Loss reporting.

                  Subpart B_Sales by Regulated Sellers

1314.20  Restrictions on sales quantity.
1314.25  Requirements for retail transactions.
1314.30  Recordkeeping for retail transactions.
1314.35  Training of sales personnel.
1314.40  Self-certification.
1314.42  Self-certification fee; time and method of fee payment.
1314.45  Privacy protections.
1314.50  Employment measures.

                       Subpart C_Mail-Order Sales

1314.100  Sales limits for mail-order sales.
1314.101  Training of sales personnel.
1314.102  Self-certification.
1314.103  Self-certification fee; time and method of fee payment.
1314.105  Verification of identity for mail-order sales.
1314.110  Reports for mail-order sales.
1314.115  Distributions not subject to reporting requirements.

                      Subpart D_Order To Show Cause

1314.150  Order to show cause.
1314.155  Suspension pending final order.

    Authority: 21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a.

    Source: 71 FR 56024, Sept. 26, 2006, unless otherwise noted.



                            Subpart A_General



Sec. 1314.01  Scope.

    This part specifies the requirements for retail sales of scheduled 
listed chemical products to individuals for personal use.



Sec. 1314.02  Applicability.

    (a) This part applies to the following regulated persons who sell 
scheduled listed chemical products for personal use:
    (1) Regulated sellers of scheduled listed chemical products sold at 
retail for personal use through face-to-face sales at stores or mobile 
retail vendors.
    (2) Regulated persons who engage in a transaction with a non-
regulated person and who ship the products to the non-regulated person 
by the U.S. Postal Service or by private or common carriers.
    (b) The requirements in subpart A apply to all regulated persons 
subject

[[Page 231]]

to this part. The requirements in subpart B apply to regulated sellers 
as defined in Sec. 1300.02 of this chapter. The requirements in subpart 
C apply to regulated persons who ship the products to the customer by 
the U.S. Postal Service or by private or common carriers.



Sec. 1314.03  Definitions.

    As used in this part, the term ``mail-order sale'' means a retail 
sale of scheduled listed chemical products for personal use where a 
regulated person uses or attempts to use the U.S. Postal Service or any 
private or commercial carrier to deliver the product to the customer. 
Mail-order sale includes purchase orders submitted by phone, mail, fax, 
Internet, or any method other than face-to-face transaction.



Sec. 1314.05  Requirements regarding packaging of nonliquid forms.

    A regulated seller or mail order distributor may not sell a 
scheduled listed chemical product in nonliquid form (including gel caps) 
unless the product is packaged either in blister packs, with each 
blister containing no more than two dosage units or, if blister packs 
are technically infeasible, in unit dose packets or pouches.



Sec. 1314.10  Effect on State laws.

    Nothing in this part preempts State law on the same subject matter 
unless there is a positive conflict between this part and a State law so 
that the two cannot consistently stand together.



Sec. 1314.15  Loss reporting.

    (a) Each regulated person must 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, any unusual or excessive loss or 
disappearance of a scheduled listed chemical product under the control 
of the regulated person. The regulated person responsible for reporting 
a loss in-transit is the supplier.
    (b) Each report submitted under paragraph (a) of this section must, 
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.
    (c) Written reports of losses must be filed within 15 days after the 
regulated person becomes aware of the circumstances of the event.
    (d) A report submitted under this section must include a description 
of the circumstances of the loss (in-transit, theft from premises, 
etc.).
    (e) A suggested format for the report is provided below:

                            Regulated Person

 Registration number (if applicable)____________________________________
 Name___________________________________________________________________
 Business address_______________________________________________________
 City___________________________________________________________________
 State__________________________________________________________________
 Zip____________________________________________________________________
 Business phone_________________________________________________________
 Date of loss___________________________________________________________
 Type of loss___________________________________________________________
 Description of circumstances___________________________________________



                  Subpart B_Sales by Regulated Sellers



Sec. 1314.20  Restrictions on sales quantity.

    (a) Without regard to the number of transactions, a regulated seller 
(including a mobile retail vendor) may not in a single calendar day sell 
any purchaser more than 3.6 grams of ephedrine base, 3.6 grams of 
pseudoephedrine base, or 3.6 grams of phenylpropanolamine base in 
scheduled listed chemical products.
    (b) A mobile retail vendor may not in any 30-day period sell an 
individual purchaser more than 7.5 grams of ephedrine base, 7.5 grams of 
pseudoephedrine base, or 7.5 grams of phenylpropanolamine base in 
scheduled listed chemical products.



Sec. 1314.25  Requirements for retail transactions.

    (a) Each regulated seller must ensure that sales of a scheduled 
listed chemical product at retail are made in accordance with this 
section and Sec. 1314.20.
    (b) The regulated seller must place the product so that customers do 
not have direct access to the product before the sale is made (in this 
paragraph referred to as ``behind-the-counter'' placement). For purposes 
of this paragraph, a behind-the-counter placement

[[Page 232]]

of a product includes circumstances in which the product is stored in a 
locked cabinet that is located in an area of the facility where 
customers do have direct access. Mobile retail vendors must place the 
product in a locked cabinet.
    (c) The regulated seller must deliver the product directly into the 
custody of the purchaser.



Sec. 1314.30  Recordkeeping for retail transactions.

    (a) Except for purchase by an individual of a single sales package 
containing not more than 60 milligrams of pseudoephedrine, the regulated 
seller must maintain, in accordance with criteria issued by the 
Administrator, a written or electronic list of each scheduled listed 
chemical product sale that identifies the products by name, the quantity 
sold, the names and addresses of the purchasers, and the dates and times 
of the sales (referred to as the ``logbook'').
    (b) The regulated seller must not sell a scheduled listed chemical 
product at retail unless the sale is made in accordance with the 
following:
    (1) The purchaser presents an identification card that provides a 
photograph and is issued by a State or the Federal Government, or a 
document that, with respect to identification, is considered acceptable 
for purposes of 8 CFR 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B).
    (2) The purchaser signs the logbook as follows:
    (i) For written logbooks, enters in the logbook his name, address, 
and the date and time of the sale.
    (ii) For electronic logbooks, provides a signature using one of the 
following means:
    (A) Signing a device presented by the seller that captures 
signatures in an electronic format. The device must display the warning 
notice in paragraph (d) of this section. Any device used must preserve 
each signature in a manner that clearly links that signature to the 
other electronically captured logbook information relating to the 
prospective purchaser providing that signature.
    (B) Signing a bound paper book.
    (1) The bound paper book must include, for such purchaser, either--
    (i) A printed sticker affixed to the bound paper book at the time of 
sale that either displays the name of each product sold, the quantity 
sold, the name and address of the purchaser, and the date and time of 
the sale, or a unique identifier which can be linked to that electronic 
information, or
    (ii) A unique identifier that can be linked to that information and 
that is written into the book by the seller at the time of sale.
    (2) The purchaser must sign adjacent to the printed sticker or 
written unique identifier related to that sale. The bound paper book 
must display the warning notice in paragraph (d) of this section.
    (C) Signing a printed document that includes, for the purchaser, the 
name of each product sold, the quantity sold, the name and address of 
the purchaser, and the date and time of the sale. The document must be 
printed by the seller at the time of the sale. The document must contain 
a clearly identified signature line for a purchaser to sign. The printed 
document must display the warning notice in paragraph (d) of this 
section. Each signed document must be inserted into a binder or other 
secure means of document storage immediately after the purchaser signs 
the document.
    (3) The regulated seller must enter in the logbook the name of the 
product and the quantity sold. Examples of methods of recording the 
quantity sold include the weight of the product per package and number 
of packages of each chemical, the cumulative weight of the product for 
each chemical, or quantity of product by Universal Product Code. These 
examples do not exclude other methods of displaying the quantity sold. 
Such information may be captured through electronic means, including 
through electronic data capture through bar code reader or similar 
technology. Such electronic records must be provided pursuant to 
paragraph (g) of this section in a human readable form such that the 
requirements of paragraph (a) of this section are satisfied.
    (c) The logbook maintained by the seller must include the 
prospective purchaser's name, address, and the date and time of the 
sale, as follows:

[[Page 233]]

    (1) If the purchaser enters the information, the seller must 
determine that the name entered in the logbook corresponds to the name 
provided on the identification and that the date and time entered are 
correct.
    (2) If the seller enters the information, the prospective purchaser 
must verify that the information is correct.
    (3) Such information may be captured through electronic means, 
including through electronic data capture through bar code reader or 
similar technology.
    (d) The regulated seller must include in the written or electronic 
logbook or display by the logbook, the following notice:

WARNING: Section 1001 of Title 18, United States Code, states that 
whoever, with respect to the logbook, knowingly and willfully falsifies, 
conceals, or covers up by any trick, scheme, or device a material fact, 
or makes any materially false, fictitious, or fraudulent statement or 
representation, or makes or uses any false writing or document knowing 
the same to contain any materially false, fictitious, or fraudulent 
statement or entry, shall be fined not more than $250,000 if an 
individual or $500,000 if an organization, imprisoned not more than five 
years, or both.

    (e) The regulated seller must maintain each entry in the written or 
electronic logbook for not fewer than two years after the date on which 
the entry is made.
    (f) A record under this section must be kept at the regulated 
seller's place of business where the transaction occurred, except that 
records may be kept at a single, central location of the regulated 
seller if the regulated seller 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.
    (g) The records required to be kept under this section must be 
readily retrievable and available for inspection and copying by 
authorized employees of the Administration under the provisions of 
section 510 of the Act (21 U.S.C. 880).
    (h) A record developed and maintained to comply with a State law may 
be used to meet the requirements of this section if the record includes 
the information specified in this section.

[76 FR 74698, Dec. 1, 2011]



Sec. 1314.35  Training of sales personnel.

    Each regulated seller must ensure that its sales of a scheduled 
listed chemical product at retail are made in accordance with the 
following:
    (a) In the case of individuals who are responsible for delivering 
the products into the custody of purchasers or who deal directly with 
purchasers by obtaining payments for the products, the regulated seller 
has submitted to the Administration a self-certification that all such 
individuals have, in accordance with criteria issued by the 
Administration, undergone training provided by the regulated seller to 
ensure that the individuals understand the requirements that apply under 
this part.
    (b) The regulated seller maintains a copy of each self-certification 
and all records demonstrating that individuals referred to in paragraph 
(a) of this section have undergone the training.



Sec. 1314.40  Self-certification.

    (a) A regulated seller must submit to the Administration the self-
certification referred to in Sec. 1314.35(a) in order to sell any 
scheduled listed chemical product. The certification is not effective 
for purposes of this section unless, in addition to provisions regarding 
the training of individuals referred to in Sec. 1314.35(a), the 
certification includes a statement that the regulated seller understands 
each of the requirements that apply under this part and agrees to comply 
with the requirements.
    (b) When a regulated seller files the initial self-certification, 
the Administration will assign the regulated seller to one of twelve 
groups. The expiration date of the self-certification for all regulated 
sellers in any group will be the last day of the month designated for 
that group. In assigning a regulated seller to a group, the 
Administration may select a group with an expiration date that is not 
less than 12 months or more than 23 months from the date of the self-
certification. After the initial

[[Page 234]]

certification period, the regulated seller must update the self-
certifications annually.
    (c) The regulated seller must provide a separate certification for 
each place of business at which the regulated seller sells scheduled 
listed chemical products at retail.



Sec. 1314.42  Self-certification fee; time and method of fee payment.

    (a) A regulated seller must pay a fee for each self-certification. 
For each initial application to self-certify, and for the renewal of 
each existing self-certification, a regulated seller shall pay a fee of 
$21.
    (b) The fee for self-certification shall be waived for any person 
holding a current, DEA registration in good standing as a pharmacy to 
dispense controlled substances.
    (c) A regulated seller shall pay the fee at the time of self-
certification.
    (d) Payment shall be made by credit card.
    (e) The self-certification fee is not refundable.

[73 FR 79323, Dec. 29, 2008]



Sec. 1314.45  Privacy protections.

    To protect the privacy of individuals who purchase scheduled listed 
chemical products, the disclosure of information in logbooks under 
Sec. 1314.30 is restricted as follows:
    (a) The information shall be disclosed as appropriate to the 
Administration and to State and local law enforcement agencies.
    (b) The information in the logbooks shall not be accessed, used, or 
shared for any purpose other than to ensure compliance with this title 
or to facilitate a product recall to protect public health and safety.
    (c) A regulated seller who in good faith releases information in a 
logbook to Federal, State, or local law enforcement authorities is 
immune from civil liability for the release unless the release 
constitutes gross negligence or intentional, wanton, or willful 
misconduct.

[71 FR 56024, Sept. 26, 2006, as amended at 77 FR 4238, Jan. 27, 2012]



Sec. 1314.50  Employment measures.

    A regulated seller may take reasonable measures to guard against 
employing individuals who may present a risk with respect to the theft 
and diversion of scheduled listed chemical products, which may include, 
notwithstanding State law, asking applicants for employment whether they 
have been convicted of any crime involving or related to such products 
or controlled substances.



                       Subpart C_Mail-Order Sales



Sec. 1314.100  Sales limits for mail-order sales.

    (a) Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03(c) of this 
chapter to submit a report of the sales transaction to the 
Administration may not in a single calendar day sell to any purchaser 
more than 3.6 grams of ephedrine base, 3.6 grams of pseudoephedrine 
base, or 3.6 grams of phenylpropanolamine base in scheduled listed 
chemical products.
    (b) Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03(c) of this 
chapter to submit a report of the sales transaction to the 
Administration may not in any 30-day period sell to an individual 
purchaser more than 7.5 grams of ephedrine base, 7.5 grams of 
pseudoephedrine base, or 7.5 grams of phenylpropanolamine base in 
scheduled listed chemical products.



Sec. 1314.101  Training of sales personnel.

    Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03(c) of this 
chapter to submit a report of the sales transaction to the 
Administration must ensure that its sales of a scheduled listed chemical 
product at retail are made in accordance with the following:
    (a) In the case of individuals who are responsible for preparing and 
packaging scheduled listed chemical products for delivery to purchasers 
through the Postal Service or any private or commercial carrier or who 
deal either directly or indirectly with purchasers

[[Page 235]]

by obtaining payments for the products, the regulated person has 
submitted to the Administration a self-certification that all such 
individuals have, in accordance with criteria issued by the 
Administration, undergone training provided by the regulated person to 
ensure that the individuals understand the requirements that apply under 
this part.
    (b) The regulated person maintains a copy of each self-certification 
and all records demonstrating that individuals referred to in paragraph 
(a) of this section have undergone the training.

[76 FR 20523, Apr. 13, 2011]



Sec. 1314.102  Self-certification.

    (a) A regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03 of this 
chapter to submit a report of the sales transaction to the Attorney 
General must submit to the Administration the self-certification 
referred to in Sec. 1314.101(a) in order to sell any scheduled listed 
chemical product. The certification is not effective for purposes of 
this section unless, in addition to provisions regarding the training of 
individuals referred to in Sec. 1314.101(a), the certification includes 
a statement that the regulated person understands each of the 
requirements that apply in this part and agrees to comply with the 
requirements.
    (b) When a regulated person files the initial self-certification, 
the Administration will assign the regulated person to one of twelve 
groups. The expiration date of the self-certification for all regulated 
persons in any group will be the last day of the month designated for 
that group. In assigning a regulated person to a group, the 
Administration may select a group with an expiration date that is not 
less than 12 months or more than 23 months from the date of self-
certification. After the initial certification period, the regulated 
person must update the self-certification annually.
    (c) The regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03 of this 
chapter to submit a report of the sales transaction to the Attorney 
General must provide a separate certification for each place of business 
at which the regulated person sells scheduled listed chemical products 
at retail.

[76 FR 20523, Apr. 13, 2011]



Sec. 1314.103  Self-certification fee; time and method of fee payment.

    (a) Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03 of this 
chapter to submit a report of the sales transaction to the 
Administration must pay a fee for each self-certification. For each 
initial application to self-certify, and for the renewal of each 
existing self-certification, a regulated seller shall pay a fee of $21.
    (b) The fee for self-certification shall be waived for any person 
holding a current, DEA registration in good standing as a pharmacy to 
dispense controlled substances.
    (c) A regulated person shall pay the fee at the time of self-
certification.
    (d) Payment shall be made by credit card.
    (e) The self-certification fee is not refundable.

[76 FR 20523, Apr. 13, 2011]



Sec. 1314.105  Verification of identity for mail-order sales.

    (a) Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03(c) of this 
chapter to submit a report of the sales transaction to the 
Administration must, prior to shipping the product, receive from the 
purchaser a copy of an identification card that provides a photograph 
and is issued by a State or the Federal Government, or a document that, 
with respect to identification, is considered acceptable for purposes of 
8 CFR 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B). Prior to shipping the 
product, the regulated person must determine that the name and address 
on the identification correspond to the name and address provided by the 
purchaser as part of the sales transaction. If the regulated person 
cannot verify the identities of both the purchaser and the recipient, 
the person may not ship the scheduled listed chemical product.

[[Page 236]]

    (b) If the product is being shipped to a third party, the regulated 
person must comply with the requirements of paragraph (a) to verify that 
both the purchaser and the person to whom the product is being shipped 
live at the addresses provided. If the regulated person cannot verify 
the identities of both the purchaser and the recipient, the person may 
not ship the scheduled listed chemical product.



Sec. 1314.110  Reports for mail-order sales.

    (a) Each regulated person required to report under Sec. 1310.03(c) 
of this chapter must either:
    (1) Submit a written report, containing the information set forth in 
paragraph (b) of this section, on or before the 15th day of each month 
following the month in which the distributions took place. The report 
must be submitted under company letterhead, signed by the person 
authorized to sign on behalf of the regulated seller, to the Regulatory 
Section, Diversion Control Division, Drug Enforcement Administration 
(see the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter 
for the current mailing address); 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 
Regulatory Section, Diversion Control Division, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (b) Each monthly report must 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) Method used to verify the identity of the purchaser and, where 
applicable, person to whom product is shipped;
    (5) Name of the chemical contained in the scheduled listed chemical 
product and total quantity shipped (e.g. pseudoephedrine, 3 grams);
    (6) Date of shipment;
    (7) Product name;
    (8) Dosage form (e.g., tablet, liquid);
    (9) Dosage strength (e.g., 30mg, 60mg, per dose etc.);
    (10) Number of dosage units (e.g., 100 doses per package);
    (11) Package type (blister pack, etc.);
    (12) Number of packages;
    (13) Lot number.

[71 FR 56024, Sept. 26, 2006, as amended at 75 FR 10684, Mar. 9, 2010; 
81 FR 97040, Dec. 30, 2016]



Sec. 1314.115  Distributions not subject to reporting requirements.

    (a) The following distributions to nonregulated persons are not 
subject to the reporting requirements in Sec. 1314.110:
    (1) Distributions of sample packages 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 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 the definition of retail distributor in Sec. 1300.02 of 
this chapter, except that this paragraph (a)(2) does not apply to sales 
of scheduled listed chemical products at retail.
    (3) Distributions to a resident of a long term care facility or 
distributions to a long term care facility for dispensing to or for use 
by a resident of that facility.
    (4) Distributions in accordance with a valid prescription.
    (b) The Administrator may revoke any or all of the exemptions listed 
in paragraph (a) 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.

[[71 FR 56024, Sept. 26, 2006, as amended at 77 FR 4238, Jan. 27, 2012]

[[Page 237]]



                      Subpart D_Order to Show Cause



Sec. 1314.150  Order To show cause.

    (a) If, upon information gathered by the Administration regarding 
any regulated seller or a distributor required to submit reports under 
Sec. 1310.03(c) of this chapter, the Administrator determines that a 
regulated seller or distributor required to submit reports under 
Sec. 1310.03(c) of this chapter has sold a scheduled listed chemical 
product in violation of Section 402 of the Act (21 U.S.C. 842(a)(12) or 
(13)), the Administrator will serve upon the regulated seller or 
distributor an order to show cause why the regulated seller or 
distributor should not be prohibited from selling scheduled listed 
chemical products.
    (b) The order to show cause shall call upon the regulated seller or 
distributor 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 prohibition 
and a summary of the matters of fact and law asserted.
    (c) Upon receipt of an order to show cause, the regulated seller or 
distributor must, if he desires a hearing, file a request for a hearing 
as specified in subpart D of part 1316 of this chapter. If a hearing is 
requested, the Administrator shall hold a hearing at the time and place 
stated in the order, as provided in part 1316 of this chapter.
    (d) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.



Sec. 1314.155  Suspension pending final order.

    (a) The Administrator may suspend the right to sell scheduled listed 
chemical products simultaneously with, or at any time subsequent to, the 
service upon the seller or distributor required to file reports under 
Sec. 1310.03(c) of this chapter of an order to show cause why the 
regulated seller or distributor should not be prohibited from selling 
scheduled listed chemical products, 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 
under Sec. 1314.150 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 regulated 
seller or distributor 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 scheduled listed 
chemical products in his or her possession; or
    (2) Place all of the scheduled listed chemical products under seal 
as described in Section 304 of the Act (21 U.S.C. 824(f)).
    (c) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the prohibition, including any judicial review, 
unless sooner withdrawn by the Administrator or dissolved by a court of 
competent jurisdiction. Any regulated seller or distributor whose right 
to sell scheduled listed chemical products is suspended under this 
section may request a hearing on the suspension at a time earlier than 
specified in the order to show cause under Sec. 1314.150, which request 
shall be granted by the Administrator, who shall fix a date for such 
hearing as early as reasonably possible.



PART 1315_IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE,
AND PHENYLPROPANOLAMINE--Table of Contents



                      Subpart A_General Information

Sec.
1315.01  Scope.
1315.02  Definitions.
1315.03  Personal use exemption.
1315.05  Applicability.

                  Subpart B_Assessment of Annual Needs

1315.11  Assessment of annual needs.
1315.13  Adjustments of assessment of annual needs.

                Subpart C_Individual Manufacturing Quotas

1315.21  Individual manufacturing quotas.

[[Page 238]]

1315.22  Procedure for applying for individual manufacturing quotas.
1315.23  Procedure for fixing individual manufacturing quotas.
1315.24  Inventory allowance.
1315.25  Increase in individual manufacturing quotas.
1315.26  Reduction in individual manufacturing quotas.
1315.27  Abandonment of quota.

                 Subpart D_Procurement and Import Quotas

1315.30  Procurement and import quotas.
1315.32  Obtaining a procurement quota.
1315.33  Power of attorney.
1315.34  Obtaining an import quota.
1315.36  Amending an import quota.

                           Subpart E_Hearings

1315.50  Hearings generally.
1315.52  Purpose of hearing.
1315.54  Waiver or modification of rules.
1315.56  Request for hearing or appearance; waiver.
1315.58  Burden of proof.
1315.60  Time and place of hearing.
1315.62  Final order.

    Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.

    Source: 72 FR 37448, July 10, 2007, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 1315 appear at 81 FR 
97041, Dec. 30, 2016.



                      Subpart A_General Information



Sec. 1315.01  Scope.

    This part specifies procedures governing the establishment of an 
assessment of annual needs, procurement and manufacturing quotas 
pursuant to section 306 of the Act (21 U.S.C. 826), and import quotas 
pursuant to section 1002 of the Act (21 U.S.C. 952) for ephedrine, 
pseudoephedrine, and phenylpropanolamine.



Sec. 1315.02  Definitions.

    (a) Except as specified in paragraphs (b) and (c) of this section, 
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.
    (b) The term net disposal means, for a stated period, the sum of 
paragraphs (b)(1) through (b)(3) of this section minus the sum of 
paragraphs (b)(4) and (b)(5) of this section:
    (1) The quantity of ephedrine, pseudoephedrine, or 
phenylpropanolamine distributed by the registrant to another person.
    (2) The quantity of that chemical used by the registrant in the 
production of (or converted by the registrant into) another chemical or 
product.
    (3) The quantity of that chemical otherwise disposed of by the 
registrant.
    (4) The quantity of that chemical returned to the registrant by any 
purchaser.
    (5) The quantity of that chemical distributed by the registrant to a 
registered manufacturer of that chemical for purposes other than use in 
the production of, or conversion into, another chemical or in the 
manufacture of dosage forms of that chemical.
    (c) Ephedrine, pseudoephedrine, and phenylpropanolamine include 
their salts, optical isomers, and salts of optical isomers.



Sec. 1315.03  Personal use exemption.

    A person need not register as an importer, file an import 
declaration, and obtain an import quota if both of the following 
conditions are met:
    (a) The person purchases scheduled listed chemical products at 
retail and imports them for personal use, by means of shipping through 
any private or commercial carrier or the Postal Service.
    (b) In any 30-day period, the person imports no more than 7.5 grams 
of ephedrine base, 7.5 grams of pseudoephedrine base, and 7.5 grams of 
phenylpropanolamine base in scheduled listed chemical products.



Sec. 1315.05  Applicability.

    This part applies to all of the following:
    (a) Persons registered to manufacture (including repackaging or 
relabeling) or to import ephedrine, pseudoephedrine, or 
phenylpropanolamine as bulk chemicals.
    (b) Persons reg