[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2006 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
21
Part 1300 to End
Revised as of April 1, 2006
Food and Drugs
________________________
Containing a codification of documents of general
applicability and future effect
As of April 1, 2006
With Ancillaries
Published by
Office of the Federal Register
National Archives and Records
Administration
A Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter II--Drug Enforcement Administration,
Department of Justice 3
Chapter III--Office of National Drug Control Policy 191
Finding Aids:
Material Approved for Incorporation by Reference........ 263
Table of CFR Titles and Chapters........................ 265
Alphabetical List of Agencies Appearing in the CFR...... 283
List of CFR Sections Affected........................... 293
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 1300.01
refers to title 21, part
1300, section 01.
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[[Page v]]
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
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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
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collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
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the revision dates of the 50 CFR titles.
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REPUBLICATION OF MATERIAL
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Raymond A. Mosley,
Director,
Office of the Federal Register.
April 1, 2006.
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The
first eight volumes, containing parts 1-1299, comprise Chapter I--Food
and Drug Administration, Department of Health and Human Services. The
ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2006.
For this volume, Elmer Barksdale was Chief Editor. The Code of
Federal Regulations publication program is under the direction of
Frances D. McDonald, assisted by Alomha S. Morris.
[[Page 1]]
TITLE 21-FOOD AND DRUGS
(This book contains part 1300 to End)
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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
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Part Page
1300 Definitions................................. 5
1301 Registration of manufacturers, distributors,
and dispensers of controlled substances. 14
1302 Labeling and packaging requirements for
controlled substances................... 46
1303 Quotas...................................... 48
1304 Records and reports of registrants.......... 56
1305 Orders for schedule I and II controlled
substances.............................. 71
1306 Prescriptions............................... 78
1307 Miscellaneous............................... 89
1308 Schedules of controlled substances.......... 92
1309 Registration of manufacturers, distributors,
importers and exporters of list I
chemicals............................... 110
1310 Records and reports of listed chemicals and
certain machines........................ 121
1311 Digital certificates........................ 142
1312 Importation and exportation of controlled
substances.............................. 147
1313 Importation and exportation of precursors
and essential chemicals................. 160
1314-1315 [Reserved]
1316 Administrative functions, practices, and
procedures.............................. 167
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PART 1300_DEFINITIONS--Table of Contents
Sec.
1300.01 Definitions relating to controlled substances.
1300.02 Definitions relating to listed chemicals.
Authority: 21 U.S.C. 802, 871(b), 951, 958(f)
Source: 62 FR 13941, Mar. 24, 1997, unless otherwise noted.
Sec. 1300.01 Definitions relating to controlled substances.
(a) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802), except that certain
terms used in part 1316 of this chapter are defined at the beginning of
each subpart of that part.
(b) As used in parts 1301 through 1308 and part 1312 of this
chapter, the following terms shall have the meanings specified:
(1) The term Act means the Controlled Substances Act, as amended (84
Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and
Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).
(2) The term Administration means the Drug Enforcement
Administration.
(3) The term Administrator means the Administrator of the Drug
Enforcement Administration. The Administrator has been delegated
authority under the Act by the Attorney General (28 CFR 0.100).
(4) The term anabolic steroid means any drug or hormonal substance,
chemically and pharmacologically related to testosterone (other than
estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and
includes:
(i) 3[beta],17-dihydroxy-5a-androstane
(ii) 3[alpha],17[beta]-dihydroxy-5a-androstane
(iii) 5[alpha]-androstan-3,17-dione
(iv) 1-androstenediol (3[beta],17[beta]-dihydroxy-5[alpha]-androst-
1-ene)
(v) 1-androstenediol (3[alpha],17[beta]-dihydroxy-5[alpha]-androst-
1-ene)
(vi) 4-androstenediol (3[beta],17[beta]-dihydroxy-androst-4-ene)
(vii) 5-androstenediol (3[beta],17[beta]-dihydroxy-androst-5-ene)
(viii) 1-androstenedione ([5[alpha]]-androst-1-en-3,17-dione)
(ix) 4-androstenedione (androst-4-en-3,17-dione)
(x) 5-androstenedione (androst-5-en-3,17-dione)
(xi) bolasterone (7[alpha],17[alpha]-dimethyl-17[beta]-
hydroxyandrost-4-en-3-one)
(xii) boldenone (17[beta]-hydroxyandrost-1,4,-diene-3-one)
(xiii) calusterone (7[beta],17[alpha]-dimethyl-17[beta]-
hydroxyandrost-4-en-3-one)
(xiv) clostebol (4-chloro-17[beta]-hydroxyandrost-4-en-3-one)
(xv) dehydrochloromethyltestosterone (4-chloro-17[beta]-hydroxy-
17[alpha]-methyl-androst-1,4-dien-3-one)
(xvi) [Delta]1-dihydrotestosterone (a.k.a. `1-testosterone')
(17[beta]-hydroxy-5[alpha]-androst-1-en-3-one)
(xvii) 4-dihydrotestosterone (17[beta]-hydroxy-androstan-3-one)
(xviii) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-5[alpha]-
androstan-3-one)
(xix) ethylestrenol (17[alpha]-ethyl-17[beta]-hydroxyestr-4-ene)
(xx) fluoxymesterone (9-fluoro-17[alpha]-methyl-11[beta],17[beta]-
dihydroxyandrost-4-en-3-one)
(xxi) formebolone (2-formyl-17[alpha]-methyl-11[alpha],17[beta]-
dihydroxyandrost-1,4-dien-3-one)
(xxii) furazabol (17[alpha]-methyl-17[beta]-hydroxyandrostano[2,3-
c]-furazan)
(xxiii) 13[beta]-ethyl-17[alpha]-hydroxygon-4-en-3-one
(xxiv) 4-hydroxytestosterone (4,17[beta]-dihydroxy-androst-4-en-3-
one)
(xxv) 4-hydroxy-19-nortestosterone (4,17[beta]-dihydroxy-estr-4-en-
3-one)
(xxvi) mestanolone (17[alpha]-methyl-17[beta]-hydroxy-5-androstan-3-
one)
(xxvii) mesterolone (1[alpha]methyl-17[beta]-hydroxy-[5[alpha]]-
androstan-3-one)
(xxviii) methandienone (17[alpha]-methyl-17[beta]-hydroxyandrost-
1,4-dien-3-one)
(xxix) methandriol (17[alpha]-methyl-3[beta],17[beta]-
dihydroxyandrost-5-ene)
(xxx) methenolone (1-methyl-17[beta]-hydroxy-5[alpha]-androst-1-en-
3-one)
(xxxi) 17[alpha]-methyl-3[beta], 17[beta]-dihydroxy-5a-androstane
(xxxii) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy-5a-androstane
(xxxiii) 17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-4-ene
(xxxiv) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-methyl-4-
hydroxy-17[beta]-hydroxyestr-4-en-3-one)
(xxxv) methyldienolone (17[alpha]-methyl-17[beta]-hydroxyestra-
4,9(10)-dien-3-one)
[[Page 6]]
(xxxvi) methyltrienolone (17[alpha]-methyl-17[beta]-hydroxyestra-
4,9-11-trien-3-one)
(xxxvii) methyltestosterone (17[alpha]-methyl-17[beta]-
hydroxyandrost-4-en-3-one)
(xxxviii) mibolerone (7[alpha],17[alpha]-dimethyl-17[beta]-
hydroxyestr-4-en-3-one)
(xxxix) 17[alpha]-methyl-[Delta]1-dihydrotestosterone (17b[beta]-
hydroxy-17[alpha]-methyl-5[alpha]-androst-1-en-3-one) (a.k.a. `17-
[alpha]-methyl-1-testosterone')
(xl) nandrolone (17[beta]-hydroxyestr-4-en-3-one)
(xli) 19-nor-4-androstenediol (3[beta], 17[beta]-dihydroxyestr-4-
ene)
(xlii) 19-nor-4-androstenediol (3[alpha], 17[beta]-dihydroxyestr-4-
ene)
(xliii) 19-nor-5-androstenediol (3[beta], 17[beta]-dihydroxyestr-5-
ene)
(xliv) 19-nor-5-androstenediol (3[alpha], 17[beta]-dihydroxyestr-5-
ene)
(xlv) 19-nor-4-androstenedione (estr-4-en-3,17-dione)
(xlvi) 19-nor-5-androstenedione (estr-5-en-3,17-dione
(xlvii) norbolethone (13[beta], 17[alpha]-diethyl-17[beta]-
hydroxygon-4-en-3-one)
(xlviii) norclostebol (4-chloro-17[beta]-hydroxyestr-4-en-3-one)
(xlix) norethandrolone (17[alpha]-ethyl-17[beta]-hydroxyestr-4-en-3-
one)
(l) normethandrolone (17[alpha]-methyl-17[beta]-hydroxyestr-4-en-3-
one)
(li) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-2-oxa-
[5[alpha]]-androstan-3-one)
(lii) oxymesterone (17[alpha]-methyl-4,17[beta]-dihydroxyandrost-4-
en-3-one)
(liii) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-17[beta]-
hydroxy-[5[alpha]]-androstan-3-one)
(liv) stanozolol (17[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-
androst-2-eno[3,2-c]-pyrazole)
(lv) stenbolone (17[beta]-hydroxy-2-methyl-[5[alpha]]-androst-1-en-
3-one)
(lvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-
oic acid lactone)
(lvii) testosterone (17[beta]-hydroxyandrost-4-en-3-one)
(lviii) tetrahydrogestrinone (13[beta], 17[alpha]-diethyl-17[beta]-
hydroxygon-4,9,11-trien-3-one)
(lix) trenbolone (17[beta]-hydroxyestr-4,9,11-trien-3-one)
(lx) 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.
(5) The term basic class means, as to controlled substances listed
in Schedules I and II:
(i) Each of the opiates, including its isomers, esters, ethers,
salts, and salts of isomers, esters, and ethers whenever the existence
of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in Sec. 1308.11(b) of this
chapter;
(ii) Each of the opium derivatives, including its salts, isomers,
and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation,
listed in Sec. 1308.11(c) of this chapter;
(iii) Each of the hallucinogenic substances, including its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific chemical
designation, listed in Sec. 1308.11(d) of this chapter;
(iv) Each of the following substances, whether produced directly or
indirectly by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis:
(A) Opium, including raw opium, opium extracts, opium fluid
extracts, powdered opium, granulated opium, deodorized opium and
tincture of opium;
(B) Apomorphine;
(C) Codeine;
(D) Etorphine hydrochloride;
(E) Ethylmorphine;
(F) Hydrocodone;
(G) Hydromorphone;
(H) Metopon;
(I) Morphine;
(J) Oxycodone;
(K) Oxymorphone;
(L) Thebaine;
(M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of this
chapter;
(N) Cocaine; and
[[Page 7]]
(O) Ecgonine;
(v) Each of the opiates, including its isomers, esters, ethers,
salts, and salts of isomers, esters, and ethers whenever the existence
of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in Sec. 1308.12(c) of this
chapter; and
(vi) Methamphetamine, its salts, isomers, and salts of its isomers;
(vii) Amphetamine, its salts, optical isomers, and salts of its
optical isomers;
(viii) Phenmetrazine and its salts;
(ix) Methylphenidate;
(x) Each of the substances having a depressant effect on the central
nervous system, including its salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation, listed in Sec.
1308.12(e) of this chapter.
(6) The term commercial container means any bottle, jar, tube,
ampule, or other receptacle in which a substance is held for
distribution or dispensing to an ultimate user, and in addition, any box
or package in which the receptacle is held for distribution or
dispensing to an ultimate user. The term commercial container does not
include any package liner, package insert or other material kept with or
within a commercial container, nor any carton, crate, drum, or other
package in which commercial containers are stored or are used for
shipment of controlled substances.
(7) The term compounder means any person engaging in maintenance or
detoxification treatment who also mixes, prepares, packages or changes
the dosage form of a narcotic drug listed in Schedules II, III, IV or V
for use in maintenance or detoxification treatment by another narcotic
treatment program.
(8) The term controlled substance has the meaning given in section
802(6) of Title 21, United States Code (U.S.C.).
(9) The term customs territory of the United States means the
several States, the District of Columbia, and Puerto Rico.
(10) The term detoxification treatment means the dispensing, for a
period of time as specified below, of a narcotic drug or narcotic drugs
in decreasing doses to an individual to alleviate adverse physiological
or psychological effects incident to withdrawal from the continuous or
sustained use of a narcotic drug and as a method of bringing the
individual to a narcotic drug-free state within such period of time.
There are two types of detoxification treatment: Short-term
detoxification treatment and long-term detoxification treatment.
(i) Short-term detoxification treatment is for a period not in
excess of 30 days.
(ii) Long-term detoxification treatment is for a period more than 30
days but not in excess of 180 days.
(11) The term dispenser means an individual practitioner,
institutional practitioner, pharmacy or pharmacist who dispenses a
controlled substance.
(12) The term export means, with respect to any article, any taking
out or removal of such article from the jurisdiction of the United
States (whether or not such taking out or removal constitutes an
exportation within the meaning of the customs and related laws of the
United States).
(13) The term exporter includes every person who exports, or who
acts as an export broker for exportation of, controlled substances
listed in any schedule.
(14) The term hearing means:
(i) In part 1301 of this chapter, any hearing held for the granting,
denial, revocation, or suspension of a registration pursuant to sections
303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
(ii) In part 1303 of this chapter, any hearing held regarding the
determination of aggregate production quota or the issuance, adjustment,
suspension, or denial of a procurement quota or an individual
manufacturing quota.
(iii) In part 1308 of this chapter, any hearing held for the
issuance, amendment, or repeal of any rule issuable pursuant to section
201 of the Act (21 U.S.C. 811).
(15) The term import means, with respect to any article, any
bringing in or introduction of such article into either the jurisdiction
of the United States or the customs territory of the United States, and
from the jurisdiction of the United States into the customs territory of
the United States (whether or
[[Page 8]]
not such bringing in or introduction constitutes an importation within
the meaning of the tariff laws of the United States).
(16) The term importer includes every person who imports, or who
acts as an import broker for importation of, controlled substances
listed in any schedule.
(17) The term individual practitioner means a physician, dentist,
veterinarian, or other individual licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he/she
practices, to dispense a controlled substance in the course of
professional practice, but does not include a pharmacist, a pharmacy, or
an institutional practitioner.
(18) The term institutional practitioner means a hospital or other
person (other than an individual) licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which it
practices, to dispense a controlled substance in the course of
professional practice, but does not include a pharmacy.
(19) The term interested person means any person adversely affected
or aggrieved by any rule or proposed rule issuable pursuant to section
201 of the Act (21 U.S.C. 811).
(20) The term inventory means all factory and branch stocks in
finished form of a basic class of controlled substance manufactured or
otherwise acquired by a registrant, whether in bulk, commercial
containers, or contained in pharmaceutical preparations in the
possession of the registrant (including stocks held by the registrant
under separate registration as a manufacturer, importer, exporter, or
distributor).
(21) The term isomer means the optical isomer, except as used in
Sec. 1308.11(d) and Sec. 1308.12(b)(4) of this chapter. As used in
Sec. 1308.11(d) of this chapter, the term isomer means the optical,
positional, or geometric isomer. As used in Sec. 1308.12(b)(4) of this
chapter, the term isomer means the optical or geometric isomer.
(22) The term jurisdiction of the United States means the customs
territory of the United States, the Virgin Islands, the Canal Zone,
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
(23) The term label means any display of written, printed, or
graphic matter placed upon the commercial container of any controlled
substance by any manufacturer of such substance.
(24) The term labeling means all labels and other written, printed,
or graphic matter:
(i) Upon any controlled substance or any of its commercial
containers or wrappers, or
(ii) Accompanying such controlled substance.
(25) The term Long Term Care Facility (LTCF) means a nursing home,
retirement care, mental care or other facility or institution which
provides extended health care to resident patients.
(26) The term maintenance treatment means the dispensing for a
period in excess of twenty-one days, of a narcotic drug or narcotic
drugs in the treatment of an individual for dependence upon heroin or
other morphine-like drug.
(27) The term manufacture means the producing, preparation,
propagation, compounding, or processing of a drug or other substance or
the packaging or repackaging of such substance, or the labeling or
relabeling of the commercial container of such substance, but does not
include the activities of a practitioner who, as an incident to his/her
administration or dispensing such substance in the course of his/her
professional practice, prepares, compounds, packages or labels such
substance. The term manufacturer means a person who manufactures a drug
or other substance, whether under a registration as a manufacturer or
under authority of registration as a researcher or chemical analyst.
(28) The term mid-level practitioner means an individual
practitioner, other than a physician, dentist, veterinarian, or
podiatrist, who is licensed, registered, or otherwise permitted by the
United States or the jurisdiction in which he/she practices, to dispense
a controlled substance in the course of professional practice. Examples
of mid-level practitioners include, but are not limited to, health care
providers such as nurse practitioners, nurse midwives, nurse
anesthetists, clinical nurse specialists and physician assistants who
are authorized to dispense controlled
[[Page 9]]
substances by the state in which they practice.
(29) The term name means the official name, common or usual name,
chemical name, or brand name of a substance.
(30) The term narcotic drug means any of the following whether
produced directly or indirectly by extraction from substances of
vegetable origin or independently by means of chemical synthesis or by a
combination of extraction and chemical synthesis:
(i) Opium, opiates, derivatives of opium and opiates, including
their isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers whenever the existence of such isomers, esters, ethers and salts
is possible within the specific chemical designation. Such term does not
include the isoquinoline alkaloids of opium.
(ii) Poppy straw and concentrate of poppy straw.
(iii) Coca leaves, except coca leaves and extracts of coca leaves
from which cocaine, ecgonine and derivatives of ecgonine or their salts
have been removed.
(iv) Cocaine, its salts, optical and geometric isomers, and salts of
isomers.
(v) Ecgonine, its derivatives, their salts, isomers and salts of
isomers.
(vi) Any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in paragraphs (b)(31)(i)
through (v) of this section.
(31) The term narcotic treatment program means a program engaged in
maintenance and/or detoxification treatment with narcotic drugs.
(32) The term net disposal means, for a stated period, the quantity
of a basic class of controlled substance distributed by the registrant
to another person, plus the quantity of that basic class used by the
registrant in the production of (or converted by the registrant into)
another basic class of controlled substance or a noncontrolled
substance, plus the quantity of that basic class otherwise disposed of
by the registrant, less the quantity of that basic class returned to the
registrant by any purchaser, and less the quantity of that basic class
distributed by the registrant to another registered manufacturer of that
basic class for purposes other than use in the production of, or
conversion into, another basic class of controlled substance or a
noncontrolled substance or in the manufacture of dosage forms of that
basic class.
(33) The term pharmacist means any pharmacist licensed by a State to
dispense controlled substances, and shall include any other person
(e.g., pharmacist intern) authorized by a State to dispense controlled
substances under the supervision of a pharmacist licensed by such State.
(34) The term person includes any individual, corporation,
government or governmental subdivision or agency, business trust,
partnership, association, or other legal entity.
(35) The term prescription means an order for medication which is
dispensed to or for an ultimate user but does not include an order for
medication which is dispensed for immediate administration to the
ultimate user. (e.g., an order to dispense a drug to a bed patient for
immediate administration in a hospital is not a prescription.)
(36) The term proceeding means all actions taken for the issuance,
amendment, or repeal of any rule issued pursuant to section 201 of the
Act (21 U.S.C. 811), commencing with the publication by the
Administrator of the proposed rule, amended rule, or repeal in the
Federal Register.
(37) The term purchaser means any registered person entitled to
obtain and execute order forms pursuant to Sec. Sec. 1305.04 and
1305.06.
(38) The term readily retrievable means that certain records are
kept by automatic data processing systems or other electronic or
mechanized recordkeeping systems in such a manner that they can be
separated out from all other records in a reasonable time and/or records
are kept on which certain items are asterisked, redlined, or in some
other manner visually identifiable apart from other items appearing on
the records.
(39) The terms register and registration refer only to registration
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823
or 957).
[[Page 10]]
(40) The term registrant means any person who is registered pursuant
to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
(41) The term reverse distributor means a registrant who receives
controlled substances acquired from another DEA registrant for the
purpose of--
(i) Returning unwanted, unusable, or outdated controlled substances
to the manufacturer or the manufacturer's agent; or
(ii) Where necessary, processing such substances or arranging for
processing such substances for disposal.
(42) The term supplier means any registered person entitled to fill
order forms pursuant to Sec. 1305.08 of this chapter.
(43) The term freight forwarding facility means a separate facility
operated by a distributing registrant through which sealed, packaged
controlled substances in unmarked shipping containers (i.e., the
containers do not indicate that the contents include controlled
substances) are, in the course of delivery to, or return from,
customers, transferred in less than 24 hours. A distributing registrant
who operates a freight forwarding facility may use the facility to
transfer controlled substances from any location the distributing
registrant operates that is registered with the Administration to
manufacture, distribute, or import controlled substances, or, with
respect to returns, registered to dispense controlled substances,
provided that the notice required by Sec. 1301.12(b)(4) of Part 1301 of
this chapter has been submitted and approved. For purposes of this
definition, a distributing registrant is a person who is registered with
the Administration as a manufacturer, distributor, and/or importer.
(44) The term central fill pharmacy means a pharmacy which is
permitted by the state in which it is located to prepare controlled
substances orders for dispensing pursuant to a valid prescription
transmitted to it by a registered retail pharmacy and to return the
labeled and filled prescriptions to the retail pharmacy for delivery to
the ultimate user. Such central fill pharmacy shall be deemed
``authorized'' to fill prescriptions on behalf of a retail pharmacy only
if the retail pharmacy and central fill pharmacy have a contractual
relationship providing for such activities or share a common owner.
(45) The term 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.
[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]
Sec. 1300.02 Definitions relating to listed chemicals.
(a) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802), except that certain
terms used in part 1316 of this chapter are defined at the beginning of
each subpart of that part.
(b) As used in parts 1309, 1310, and 1313 of this chapter, the
following terms shall have the meaning specified:
(1) The term Act means the Controlled Substances Act, as amended (84
Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and
Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951) as amended.
(2) The term Administration means the Drug Enforcement
Administration.
(3) The term Administrator means the Administrator of the Drug
Enforcement Administration. The Administrator has been delegated
authority under the Act by the Attorney General (28 CFR 0.100).
(4) The terms broker and trader mean any individual, corporation,
corporate division, partnership, association, or other legal entity
which assists in arranging an international transaction in a listed
chemical by--
(i) Negotiating contracts;
(ii) Serving as an agent or intermediary; or
(iii) Fulfilling a formal obligation to complete the transaction by
bringing together a buyer and seller, a buyer and transporter, or a
seller and transporter, or by receiving any form of compensation for so
doing.
[[Page 11]]
(5) The term chemical export means transferring ownership or
control, or the sending or taking of threshold quantities of listed
chemicals out of the United States (whether or not such sending or
taking out constitutes an exportation within the meaning of the Customs
and related laws of the United States).
(6) The term chemical exporter is a regulated person who, as the
principal party in interest in the export transaction, has the power and
responsibility for determining and controlling the sending of the listed
chemical out of the United States.
(7) The term chemical import means with respect to a listed
chemical, any bringing in or introduction of such listed chemical into
either the jurisdiction of the United States or into the Customs
territory of the United States (whether or not such bringing in or
introduction constitutes an importation within the meaning of the tariff
laws of the United States).
(8) The term chemical importer is a regulated person who, as the
principal party in interest in the import transaction, has the power and
responsibility for determining and controlling the bringing in or
introduction of the listed chemical into the United States.
(9) The term chemical mixture means a combination of two or more
chemical substances, at least one of which is not a listed chemical,
except that such term does not include any combination of a listed
chemical with another chemical that is present solely as an impurity or
which has been created to evade the requirements of the Act.
(10) The term customs territory of the United States means the
several States, the District of Columbia, and Puerto Rico.
(11) The term encapsulating machine means any manual, semi-
automatic, or fully automatic equipment which may be used to fill shells
or capsules with any powdered, granular, semi-solid, or liquid material.
(12) The term established business relationship with a foreign
customer means the regulated person has exported a listed chemical at
least once within the past six months, or twice within the past twelve
months to a foreign manufacturer, distributor, or end user of the
chemical that has an established business in the foreign country with a
fixed street address. A person or business which functions as a broker
or intermediary is not a customer for purposes of this definition. The
term also means that the regulated person has provided the
Administration with the following information in accordance with the
waiver of 15-day advance notice requirements of Sec. 1313.24 of this
chapter:
(i) The name and street address of the chemical exporter and of each
regular customer;
(ii) The telephone number, telex number, contact person, and where
available, the facsimile number for the chemical exporter and for each
regular customer;
(iii) The nature of the regular customer's business (i.e., importer,
exporter, distributor, manufacturer, etc.), and if known, the use to
which the listed chemical or chemicals will be applied;
(iv) The duration of the business relationship;
(v) The frequency and number of transactions occurring during the
preceding 12-month period;
(vi) the amounts and the listed chemical or chemicals involved in
regulated transactions between the chemical exporter and regular
customer;
(vii) The method of delivery (direct shipment or through a broker or
forwarding agent); and
(viii) Other information that the chemical exporter considers
relevant for determining whether a customer is a regular customer.
(13) The term established record as an importer means that the
regulated person has imported a listed chemical at least once within the
past six months, or twice within the past twelve months from a foreign
supplier. The term also means that the regulated person has provided the
Administration with the following information in accordance with the
waiver of the 15-day advance notice requirements of Sec. 1313.15 of
this chapter:
(i) The name, DEA registration number (where applicable), street
address, telephone number, telex number, and, where available, the
facsimile number
[[Page 12]]
of the regulated person and of each foreign supplier; and
(ii) The frequency and number of transactions occurring during the
preceding 12 month period.
(14) The term hearing means any hearing held for the granting,
denial, revocation, or suspension of a registration pursuant to sections
303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
(15) The term international transaction means a transaction
involving the shipment of a listed chemical across an international
border (other than a United States border) in which a broker or trader
located in the United States participates.
(16) The term jurisdiction of the United States means the customs
territory of the United States, the Virgin Islands, the Canal Zone,
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
(17) The term listed chemical means any List I chemical or List II
chemical.
(18) The term List I chemical means a chemical specifically
designated by the Administrator in Sec. 1310.02(a) of this chapter
that, in addition to legitimate uses, is used in manufacturing a
controlled substance in violation of the Act and is important to the
manufacture of a controlled substance.
(19) The term List II chemical means a chemical, other than a List I
chemical, specifically designated by the Administrator in Sec.
1310.02(b) of this chapter that, in addition to legitimate uses, is used
in manufacturing a controlled substance in violation of the Act.
(20) The term name means the official name, common or usual name,
chemical name, or brand name of a substance.
(21) The term person includes any individual, corporation,
government or governmental subdivision or agency, business trust,
partnership, association, or other legal entity.
(22) The term readily retrievable means that certain records are
kept by automatic data processing systems or other electronic or
mechanized recordkeeping systems in such a manner that they can be
separated out from all other records in a reasonable time and/or records
are kept on which certain items are asterisked, redlined, or in some
other manner visually identifiable apart from other items appearing on
the records.
(23) The terms register and registration refer only to registration
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823
or 957).
(24) The term registrant means any person who is registered pursuant
to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
(25) The term regular customer means a person with whom the
regulated person has an established business relationship for a
specified listed chemical or chemicals that has been reported to the
Administration subject to the criteria established in Sec.
1300.02(b)(12).
(26) The term regular importer means, with respect to a listed
chemical, a person that has an established record as an importer of that
listed chemical that is reported to the Administrator.
(27) The term regulated person means any individual, corporation,
partnership, association, or other legal entity who manufactures,
distributes, imports, or exports a listed chemical, a tableting machine,
or an encapsulating machine, or who acts as a broker or trader for an
international transaction involving a listed chemical, tableting
machine, or encapsulating machine.
(28) The term regulated transaction means:
(i) A distribution, receipt, sale, importation, or exportation of a
listed chemical, or an international transaction involving shipment of a
listed chemical, or if the Administrator establishes a threshold amount
for a specific listed chemical, a threshold amount as determined by the
Administrator, which includes a cumulative threshold amount for multiple
transactions, of a listed chemical, except that such term does not
include:
(A) A domestic lawful distribution in the usual course of business
between agents or employees of a single regulated person; in this
context, agents or employees means individuals under the direct
management and control of the regulated person;
(B) A delivery of a listed chemical to or by a common or contract
carrier for carriage in the lawful and usual course
[[Page 13]]
of the business of the common or contract carrier, or to or by a
warehouseman for storage in the lawful and usual course of the business
of the warehouseman, except that if the carriage or storage is in
connection with the distribution, importation, or exportation of a
listed chemical to a third person, this paragraph does not relieve a
distributor, importer, or exporter from compliance with parts 1309,
1310, and 1313 of this chapter;
(C) Any category of transaction or any category of transaction for a
specific listed chemical or chemicals specified by regulation of the
Administrator as excluded from this definition as unnecessary for
enforcement of the Act;
(D) Any transaction in a listed chemical that is contained in a drug
that may be marketed or distributed lawfully in the United States under
the Federal Food, Drug, and Cosmetic Act unless--
(1)(i) the drug contains ephedrine or its salts, optical isomers, or
salts of optical isomers, pseudoephedrine or its salts, optical isomers,
or salts of optical isomers, or phenylpropanolamine or its salts,
optical isomers, or salts of optical isomers unless otherwise exempted
under Sec. 1310.11 of this chapter, except that any sale of ordinary
over-the-counter pseudoephedrine or phenylpropanolamine products by
retail distributors shall not be a regulated transaction; or
(ii) The Administrator has determined pursuant to the criteria in
Sec. 1310.10 of this chapter that the drug or group of drugs is being
diverted to obtain the listed chemical for use in the illicit production
of a controlled substance; and
(2) The quantity of ephedrine, pseudoephedrine, phenylpropanolamine,
or other listed chemical contained in the drug included in the
transaction or multiple transactions equals or exceeds the threshold
established for that chemical, except that the threshold for any sale of
products containing pseudoephedrine or phenylpropanolamine by retail
distributors or by distributors required to submit reports by Sec.
1310.03(c) shall be 9 grams of pseudoephedrine or 9 grams of
phenylpropanolamine in a single transaction and sold in package sizes of
not more than 3 grams of pseudoephedrine base or 3 grams of
phenylpropanolamine base. For combination ephedrine products the
threshold for any sale by retail distributors or by distributors
required to submit reports by Sec. 1310.03(c) shall be 24 grams of
ephedrine in a single transaction.
(E) Any transaction in a chemical mixture designated in Sec.
1310.12 and Sec. 1310.13 that the Administrator has exempted from
regulation.
(ii) A distribution, importation, or exportation of a tableting
machine or encapsulating machine except that such term does not include
a domestic lawful distribution in the usual course of business between
agents and employees of a single regulated person; in this context,
agents or employees means individuals under the direct management and
control of the regulated person.
(29) The term retail distributor means a grocery store, general
merchandise store, drug store, or other entity or person whose
activities as a distributor relating to drug products containing
pseudoephedrine, phenylpropanolamine, or ephedrine are limited almost
exclusively to sales for personal use, both in number of sales and
volume of sales, either directly to walk-in customers or in face-to-face
transactions by direct sales. For the purposes of this paragraph, sale
for personal use means the distribution of below-threshold quantities in
a single transaction to an individual for legitimate medical use. Also
for the purposes of this paragraph, a grocery store is an entity within
Standard Industrial Classification (SIC) code 5411, a general
merchandise store is an entity within SIC codes 5300 through 5399 and
5499, and a drug store is an entity within SIC code 5912.
(30) The term tableting machine means any manual, semi-automatic, or
fully automatic equipment which may be used for the compaction or
molding of powdered or granular solids, or semi-solid material, to
produce coherent solid tablets.
(31) The term ordinary over-the-counter pseudoephedrine or
phenylpropanolamine product means any product containing pseudoephedrine
or phenylpropanolamine that is--
[[Page 14]]
(i) Regulated pursuant to the Act; and
(ii)(A) Except for liquids, sold in package sizes of not more than
3.0 grams of pseudoephedrine base or 3.0 grams of phenylpropanolamine
base, and that is packaged in blister packs, each blister containing not
more than two dosage units, or where the use of blister packs is
technically infeasible, that is packaged in unit dose packets or
pouches, and
(B) For liquids, sold in package sizes of not more than 3.0 grams of
pseudoephedrine base or 3.0 grams of phenylpropanolamine base.
(32) The term combination ephedrine product means a drug product
containing ephedrine or its salts, optical isomers, or salts of optical
isomers, and therapeutically significant quantities of another active
medicinal ingredient.
(33) The term drug product means an active ingredient in dosage form
that has been approved or otherwise may be lawfully marketed under the
Food, Drug, and Cosmetic Act for distribution in the United States.
(34) The term valid prescription means a prescription that is issued
for a legitimate medical purpose by an individual practitioner licensed
by law to administer and prescribe the drugs concerned and acting in the
usual course of the practitioner's professional practice.
[62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. 1, 1997; 67 FR 14859,
Mar. 28, 2002, as amended at 68 FR 23203, May 1, 2003; 68 FR 57803, Oct.
7, 2003]
PART 1301_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF
CONTROLLED SUBSTANCES--Table of Contents
General Information
Sec.
1301.01 Scope of this part 1301.
1301.02 Definitions.
1301.03 Information; special instructions.
Registration
1301.11 Persons required to register.
1301.12 Separate registrations for separate locations.
1301.13 Application for registration; time for application; expiration
date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
1301.14 Filing of application; acceptance for filing; defective
applications.
1301.15 Additional information.
1301.16 Amendments to and withdrawal of applications.
1301.17 Special procedures for certain applications.
1301.18 Research protocols.
Exceptions to Registration and Fees
1301.21 Exception from fees.
1301.22 Exemption of agents and employees; affiliated practitioners.
1301.23 Exemption of certain military and other personnel.
1301.24 Exemption of law enforcement officials.
1301.25 Registration regarding ocean vessels, aircraft, and other
entities.
1301.26 Exemptions from import or export requirements for personal
medical use.
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.
Action on Application for Registration: Revocation or Suspension of
Registration
1301.31 Administrative review generally.
1301.32 Action on applications for research in Schedule I substances.
1301.33 Application for bulk manufacture of Schedule I and II
substances.
1301.34 Application for importation of Schedule I and II substances.
1301.35 Certificate of registration; denial of registration.
1301.36 Suspension or revocation of registration; suspension of
registration pending final order; extension of registration
pending final order.
1301.37 Order to show cause.
Hearings
1301.41 Hearings generally.
1301.42 Purpose of hearing.
1301.43 Request for hearing or appearance; waiver.
1301.44 Burden of proof.
1301.45 Time and place of hearing.
1301.46 Final order.
Modification, Transfer, and Termination of Registration
1301.51 Modification in registration.
[[Page 15]]
1301.52 Termination of registration; transfer of registration;
distribution upon discontinuance of business.
Security Requirements
1301.71 Security requirements generally.
1301.72 Physical security controls for nonpractitioners; narcotic
treatment programs and compounders for narcotic treatment
programs; storage areas.
1301.73 Physical security controls for nonpractitioners; compounders for
narcotic treatment programs; manufacturing and compounding
areas.
1301.74 Other security controls for nonpractitioners; narcotic treatment
programs and compounders for narcotic treatment programs.
1301.75 Physical security controls for practitioners.
1301.76 Other security controls for practitioners.
1301.77 Security controls for freight forwarding facilities.
Employee Screening--Non-Practitioners
1301.90 Employee screening procedures.
1301.91 Employee responsibility to report drug diversion.
1301.92 Illicit activities by employees.
1301.93 Sources of information for employee checks.
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 951, 952,
953, 956, 957.
Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
General Information
Sec. 1301.01 Scope of this part 1301.
Procedures governing the registration of manufacturers,
distributors, dispensers, importers, and exporters of controlled
substances pursuant to sections 301-304 and 1007-1008 of the Act (21
U.S.C. 821-824 and 957-958) are set forth generally by those sections
and specifically by the sections of this part.
[62 FR 13945, Mar. 24, 1997]
Sec. 1301.02 Definitions.
Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13945, Mar. 24, 1997]
Sec. 1301.03 Information; special instructions.
Information regarding procedures under these rules and instructions
supplementing these rules will be furnished upon request by writing to
the Registration Unit, Drug Enforcement Administration, Department of
Justice, Post Office Box 28083, Central Station, Washington, DC 20005.
[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 23, 1973,
and amended at 51 FR 5319, Feb. 13, 1986]
Registration
Sec. 1301.11 Persons required to register.
(a) Every person who manufactures, distributes, dispenses, imports,
or exports any controlled substance or who proposes to engage in the
manufacture, distribution, dispensing, importation or exportation of any
controlled substance shall obtain a registration unless exempted by law
or pursuant to Sec. Sec. 1301.22-1301.26. Only persons actually engaged
in such activities are required to obtain a registration; related or
affiliated persons who are not engaged in such activities are not
required to be registered. (For example, a stockholder or parent
corporation of a corporation manufacturing controlled substances is not
required to obtain a registration.)
(b) [Reserved]
[62 FR 13945, Mar. 24, 1997]
Sec. 1301.12 Separate registrations for separate locations.
(a) A separate registration is required for each principal place of
business or professional practice at one general physical location where
controlled substances are manufactured, distributed, imported, exported,
or dispensed by a person.
(b) The following locations shall be deemed not to be places where
controlled substances are manufactured, distributed, or dispensed:
(1) A warehouse where controlled substances are stored by or on
behalf of a registered person, unless such substances are distributed
directly from such warehouse to registered locations other than the
registered location from which the substances were delivered or to
persons not required to register by
[[Page 16]]
virtue of subsection 302(c)(2) or subsection 1007(b)(1)(B) of the Act
(21 U.S.C. 822(c)(2) or 957(b)(1)(B));
(2) An office used by agents of a registrant where sales of
controlled substances are solicited, made, or supervised but which
neither contains such substances (other than substances for display
purposes or lawful distribution as samples only) nor serves as a
distribution point for filling sales orders; and
(3) An office used by a practitioner (who is registered at another
location) where controlled substances are prescribed but neither
administered nor otherwise dispensed as a regular part of the
professional practice of the practitioner at such office, and where no
supplies of controlled substances are maintained.
(4) A freight forwarding facility, as defined in Sec. 1300.01 of
this part, provided that the distributing registrant operating the
facility has submitted written notice of intent to operate the facility
by registered mail, return receipt requested (or other suitable means of
documented delivery) and such notice has been approved. The notice shall
be submitted to the Special Agent in Charge of the Administration's
offices in both the area in which the facility is located and each area
in which the distributing registrant maintains a registered location
that will transfer controlled substances through the facility. The
notice shall detail the registered locations that will utilize the
facility, the location of the facility, the hours of operation, the
individual(s) responsible for the controlled substances, the security
and recordkeeping procedures that will be employed, and whether
controlled substances returns will be processed through the facility.
The notice must also detail what state licensing requirements apply to
the facility and the registrant's actions to comply with any such
requirements. The Special Agent in Charge of the DEA Office in the area
where the freight forwarding facility will be operated will provide
written notice of approval or disapproval to the person within thirty
days after confirmed receipt of the notice. Registrants that are
currently operating freight forwarding facilities under a memorandum of
understanding with the Administration must provide notice as required by
this section no later than September 18, 2000 and receive written
approval from the Special Agent in Charge of the DEA Office in the area
in which the freight forwarding facility is operated in order to
continue operation of the facility.
[62 FR 13945, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000;
65 FR 45829, July 25, 2000]
Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
(a) Any person who is required to be registered and who is not so
registered may apply for registration at any time. No person required to
be registered shall engage in any activity for which registration is
required until the application for registration is granted and a
Certificate of Registration is issued by the Administrator to such
person.
(b) Any person who is registered may apply to be reregistered not
more than 60 days before the expiration date of his/her registration,
except that a bulk manufacturer of Schedule I or II controlled
substances or an importer of Schedule I or II controlled substances may
apply to be reregistered no more than 120 days before the expiration
date of their registration.
(c) At the time a manufacturer, distributor, reverse distributor,
researcher, analytical lab, importer, exporter or narcotic treatment
program is first registered, that business activity shall be assigned to
one of twelve groups, which shall correspond to the months of the year.
The expiration date of the registrations of all registrants within any
group will be the last date of the month designated for that group. In
assigning any of these business activities to a group, the
Administration may select a group the expiration date of which is less
than one year from the date such business activity was registered. If
the business activity is assigned to a group which has an expiration
date less than three months from the date of which the
[[Page 17]]
business activity is registered, the registration shall not expire until
one year from that expiration date; in all other cases, the registration
shall expire on the expiration date following the date on which the
business activity is registered.
(d) At the time a retail pharmacy, hospital/clinic, practitioner or
teaching institution is first registered, that business activity shall
be assigned to one of twelve groups, which shall correspond to the
months of the year. The expiration date of the registrations of all
registrants within any group will be the last day of the month
designated for that group. In assigning any of the above business
activities to a group, the Administration may select a group the
expiration date of which is not less than 28 months nor more than 39
months from the date such business activity was registered. After the
initial registration period, the registration shall expire 36 months
from the initial expiration date.
(e) Any person who is required to be registered and who is not so
registered, shall make application for registration for one of the
following groups of controlled substances activities, which are deemed
to be independent of each other. Application for each registration shall
be made on the indicated form, and shall be accompanied by the indicated
fee. Fee payments shall be made in the form of a personal, certified, or
cashier's check or money order made payable to the ``Drug Enforcement
Administration''. The application fees are not refundable. Any person,
when registered to engage in the activities described in each
subparagraph in this paragraph, shall be authorized to engage in the
coincident activities described without obtaining a registration to
engage in such coincident activities, provided that, unless specifically
exempted, he/she complies with all requirements and duties prescribed by
law for persons registered to engage in such coincident activities. Any
person who engages in more than one group of independent activities
shall obtain a separate registration for each group of activities,
except as provided in this paragraph under coincident activities. A
single registration to engage in any group of independent activities
listed below may include one or more controlled substances listed in the
schedules authorized in that group of independent activities. A person
registered to conduct research with controlled substances listed in
Schedule I may conduct research with any substances listed in Schedule I
for which he/she has filed and had approved a research protocol.
(1)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Registration
Business activity Controlled substances DEA application forms Application period Coincident activities
fee ($) (years) allowed
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(i) Manufacturing Schedules I-V............................................ New--225............................................ 1,625 1 Schedules I-V:May
Renewal--225a....................................... 1,625 distribute that
substance or class for
which registration was
issued; may not
distribute or dispose
any substance or class
for which not
registered. Schedules
II-V: except a person
registered to dispose
of any controlled
substance may conduct
chemical analysis and
preclinical research
(including quality
control analysis) with
substances listed in
those schedules for
which authorization as
a mfg. Was issued.
(ii) Distributing Schedules I-V............................................ New--225............................................ 813 1 .......................
Renewal--225a....................................... 813
(iii) Reverse distributing Schedules I-V............................................ New--225............................................ 813 1 .......................
Renewal 225a........................................ 813
[[Page 18]]
(iv) Dispensing or Schedules II-V........................................... New--224............................................ 390 3 May conduct research
instructing (includes Renewal--224a....................................... 390 and instructional
Practitioner, Hospital/ activities with those
Clinic, Retail Pharmacy, substances for which
Central Fill Pharmacy, registration was
Teaching Institution) granted, except that a
mid-level practitioner
may conduct such
research only to the
extent expressly
authorized under state
statute. A pharmacist
may manufacture an
aqueous or oleaginous
solution or solid
dosage form containing
a narcotic controlled
substance in Schedule
II-V in a proportion
not exceeding 20% of
the complete solution,
compound or mixture. A
retail pharmacy may
perform central fill
pharmacy activities.
(v) Research Schedule I............................................... New--225............................................ 130 1 A researcher may
Renewal--225a....................................... 130 manufacture or import
the basic class of
substance or
substances for which
registration was
issued, provided that
such manufacture or
import is set forth in
the protocol required
in Section 1301.18 and
to distribute such
class to persons
registered or
authorized to conduct
research with such
class of substance or
registered or
authorized to conduct
chemical analysis with
controlled substances.
(vi) Research Schedules II-V........................................... New--225............................................ 130 1 May conduct chemical
Renewal--225a....................................... 130 analysis with
controlled substances
in those schedules for
which registration was
issued; manufacture
such substances if and
to the extent that
such manufacture is
set forth in a
statement filed with
the application for
registration or
reregistration and
provided that the
manufacture is not for
the purposes of dosage
form development;
import such substances
for research purposes;
distribute such
substances to persons
registered or
authorized to conduct
chemical analysis,
instructional
activities or research
with such substances,
and to persons
exempted from
registration pursuant
to Section 1301.24;
and conduct
instructional
activities with
controlled substances.
(vii) Narcotic Treatment Narcotic Drugs in Schedules II-V......................... New--363............................................ 130 1 .......................
Program (including Renewal 363a........................................ 130
compounder)
(viii) Importing Schedules I-V............................................ New--225............................................ 813 1 May distribute that
Renewal--225a....................................... 813 substance or class for
which registration was
issued; may not
distribute any
substance or class for
which not registered.
(ix) Exporting Schedules I-V............................................ New--225............................................ 813 1
Renewal--225a....................................... 813
[[Page 19]]
(x) Chemical Analysis Schedules I-V............................................ New--225............................................ 130 1 May manufacture and
Renewal--225a....................................... 130 import controlled
substances for
analytical or
instructional
activities; may
distribute such
substances to persons
registered or
authorized to conduct
chemical analysis,
instructional
activities, or
research with such
substances and to
persons exempted from
registration pursuant
to section 1301.24;
may export such
substances to persons
in other countries
performing chemical
analysis or enforcing
laws related to
controlled substances
or drugs in those
countries; and may
conduct instructional
activities with
controlled substances.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(2) DEA Forms 224, 225, and 363 may be obtained at any area office
of the Administration or by writing to the Registration Unit, Drug
Enforcement Administration, Department of Justice, Post Office Box
28083, Central Station, Washington, DC 20005.
(3) DEA Forms 224a, 225a, and 363a will be mailed, as applicable, to
each registered person approximately 60 days before the expiration date
of his/her registration; if any registered person does not receive such
forms within 45 days before the expiration date of his/her registration,
he/she must promptly give notice of such fact and request such forms by
writing to the Registration Unit of the Administration at the foregoing
address.
(f) Each application for registration to handle any basic class of
controlled substance listed in Schedule I (except to conduct chemical
analysis with such classes), and each application for registration to
manufacture a basic class of controlled substance listed in Schedule II
shall include the Administration Controlled Substances Code Number, as
set forth in part 1308 of this chapter, for each basic class to be
covered by such registration.
(g) Each application for registration to import or export controlled
substances shall include the Administration Controlled Substances Code
Number, as set forth in part 1308 of this chapter, for each controlled
substance whose importation or exportation is to be authorized by such
registration. Registration as an importer or exporter shall not entitle
a registrant to import or export any controlled substance not specified
in such registration.
(h) Each application for registration to conduct research with any
basic class of controlled substance listed in Schedule II shall include
the Administration Controlled Substances Code Number, as set forth in
part 1308 of this chapter, for each such basic class to be manufactured
or imported as a coincident activity of that registration. A statement
listing the quantity of each such basic class of controlled substance to
be imported or manufactured during the registration period for which
application is being made shall be included with each such application.
For purposes of this paragraph only, manufacturing is defined as the
production of a controlled substance by synthesis, extraction or by
agricultural/horticultural means.
(i) Each application shall include all information called for in the
form, unless the item is not applicable, in which case this fact shall
be indicated.
(j) Each application, attachment, or other document filed as part of
an application, shall be signed by the applicant, if an individual; by a
partner of the applicant, if a partnership; or by an officer of the
applicant, if a corporation, corporate division, association, trust or
other entity. An applicant may authorize one or more individuals, who
would not otherwise be authorized to
[[Page 20]]
do so, to sign applications for the applicant by filing with the
Registration Unit of the Administration a power of attorney for each
such individual. The power of attorney shall be signed by a person who
is authorized to sign applications under this paragraph and shall
contain the signature of the individual being authorized to sign
applications. The power of attorney shall be valid until revoked by the
applicant.
[62 FR 13946, Mar. 24, 1997, as amended at 68 FR 37409, June 24, 2003;
68 FR 41228, July 11, 2003; 68 FR 58598, Oct. 10, 2003]
Sec. 1301.14 Filing of application; acceptance for filing; defective
applications.
(a) All applications for registration shall be submitted for filing
to the Registration Unit, Drug Enforcement Administration, Department of
Justice, Post Office Box 28083, Central Station, Washington, DC 20005.
The appropriate registration fee and any required attachments must
accompany the application.
(b) Any person required to obtain more than one registration may
submit all applications in one package. Each application must be
complete and should not refer to any accompanying application for
required information.
(c) Applications submitted for filing are dated upon receipt. If
found to be complete, the application will be accepted for filing.
Applications failing to comply with the requirements of this part will
not generally be accepted for filing. In the case of minor defects as to
completeness, the Administrator may accept the application for filing
with a request to the applicant for additional information. A defective
application will be returned to the applicant within 10 days following
its receipt with a statement of the reason for not accepting the
application for filing. A defective application may be corrected and
resubmitted for filing at any time; the Administrator shall accept for
filing any application upon resubmission by the applicant, whether
complete or not.
(d) Accepting an application for filing does not preclude any
subsequent request for additional information pursuant to Sec. 1301.15
and has no bearing on whether the application will be granted.
[62 FR 13948, Mar. 24, 1997]
Sec. 1301.15 Additional information.
The Administrator may require an applicant to submit such documents
or written statements of fact relevant to the application as he/she
deems necessary to determine whether the application should be granted.
The failure of the applicant to provide such documents or statements
within a reasonable time after being requested to do so shall be deemed
to be a waiver by the applicant of an opportunity to present such
documents or facts for consideration by the Administrator in granting or
denying the application.
[62 FR 13948, Mar. 24, 1997]
Sec. 1301.16 Amendments to and withdrawal of applications.
(a) An application may be amended or withdrawn without permission of
the Administrator at any time before the date on which the applicant
receives an order to show cause pursuant to Sec. 1301.37. An
application may be amended or withdrawn with permission of the
Administrator at any time where good cause is shown by the applicant or
where the amendment or withdrawal is in the public interest.
(b) After an application has been accepted for filing, the request
by the applicant that it be returned or the failure of the applicant to
respond to official correspondence regarding the application, when sent
by registered or certified mail, return receipt requested, shall be
deemed to be a withdrawal of the application.
[62 FR 13949, Mar. 24, 1997]
Sec. 1301.17 Special procedures for certain applications.
(a) If, at the time of application for registration of a new
pharmacy, the pharmacy has been issued a license from the appropriate
State licensing agency, the applicant may include with his/her
application an affidavit as to the existence of the State license in the
following form:
[[Page 21]]
Affidavit for New Pharmacy
I, --------------------, the -------------------- (Title of officer,
official, partner, or other position) of --------------------
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) at -------------------- (Number and Street),
-------------------- (City) ------------ (State) ------------ (Zip
code), hereby certify that said store was issued a pharmacy permit No.
-------- by the ---------------- (Board of Pharmacy or Licensing Agency)
of the State of ------------ on ------------ (Date).
This statement is submitted in order to obtain a Drug Enforcement
Administration registration number. I understand that if any information
is false, the Administration may immediately suspend the registration
for this store and commence proceedings to revoke under 21 U.S.C. 824(a)
because of the danger to public health and safety. I further understand
that any false information contained in this affidavit may subject me
personally and the above-named corporation/partnership/business to
prosecution under 21 U.S.C. 843, the penalties for conviction of which
include imprisonment for up to 4 years, a fine of not more than $30,000
or both.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
Subscribed to and sworn before me this -------------- day of ------
--------, 19----.
________________________________________________________________________
Notary Public
(b) Whenever the ownership of a pharmacy is being transferred from
one person to another, if the transferee owns at least one other
pharmacy licensed in the same State as the one the ownership of which is
being transferred, the transferee may apply for registration prior to
the date of transfer. The Administrator may register the applicant and
authorize him to obtain controlled substances at the time of transfer.
Such registration shall not authorize the transferee to dispense
controlled substances until the pharmacy has been issued a valid State
license. The transferee shall include with his/her application the
following affidavit:
Affidavit for Transfer of Pharmacy
I, --------------------, the -------------------- (Title of officer,
official, partner or other position) of --------------------
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) hereby certify:
(1) That said company was issued a pharmacy permit No.------------by
the -------------------- (Board of Pharmacy of Licensing Agency) of the
State of ------------ and a DEA Registration Number --------------------
for a pharmacy located at -------------------- (Number and Street) ----
-------- (City) ------------ (State) ------------ (Zip Code); and
(2) That said company is acquiring the pharmacy business of --------
------------ (Name of Seller) doing business as--------------------with
DEA Registration Number ------------ on or about ------------ (Date of
Transfer) and that said company has applied (or will apply on ----------
-- (Date) for a pharmacy permit from the board of pharmacy (or licensing
agency) of the State of ------------ to do business as ----------------
---- (Store name) at -------------------- (Number and Street) ----------
---------- (City) ------------ (State) ------------ (Zip Code).
This statement is submitted in order to obtain a Drug Enforcement
Administration registration number.
I understand that if a DEA registration number is issued, the
pharmacy may acquire controlled substances but may not dispense them
until a pharmacy permit or license is issued by the State board of
pharmacy or licensing agency.
I understand that if any information is false, the Administration
may immediately suspend the registration for this store and commence
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to
public health and safety. I further understand that any false
information contained in this affidavit may subject me personally to
prosecution under 21 U.S.C. 843, the penalties for conviction of which
include imprisonment for up to 4 years, a fine of not more than $30,000
or both.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
Subscribed to and sworn before me this ---------------- day of ----
--------------, 19----.
________________________________________________________________________
Notary Public
(c) 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
[[Page 22]]
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 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.
[[Page 23]]
(vii) If the investigator desires to manufacture or import any
controlled substance listed in paragraph (a)(2)(iii) of this section, a
statement of the quantity to be manufactured or imported and the sources
of the chemicals to be used or the substance to be imported.
(3) Authority:
(i) Institutional approval.
(ii) Approval of a Human Research Committee for human studies.
(iii) Indication of an approved active Notice of Claimed
Investigational Exemption for a New Drug (number).
(iv) Indication of an approved funded grant (number), if any.
(b) In the case of a clinical investigation with controlled
substances listed in Schedule I, the applicant shall submit three copies
of a Notice of Claimed Investigational Exemption for a New Drug (IND)
together with a statement of the security provisions (as proscribed in
paragraph (a)(2)(vi) of this section for a research protocol) to, and
have such submission approved by, the Food and Drug Administration as
required in 21 U.S.C. 355(i) and Sec. 130.3 of this title. Submission
of this Notice and statement to the Food and Drug Administration shall
be in lieu of a research protocol to the Administration as required in
paragraph (a) of this section. The applicant, when applying for
registration with the Administration, shall indicate that such notice
has been submitted to the Food and Drug Administration by submitting to
the Administration with his/her DEA Form 225 three copies of the
following certificate:
I hereby certify that on -------------------- (Date), pursuant to 21
U.S.C. 355(i) and 21 CFR 130.3, I, -------------------- (Name and
Address of IND Sponsor) submitted a Notice of Claimed Investigational
Exemption for a New Drug (IND) to the Food and Drug Administration for:
________________________________________________________________________
(Name of Investigational Drug).
________________________________________________________________________
(Date)
________________________________________________________________________
(Signature of Applicant).
(c) In the event that the registrant desires to increase the
quantity of a controlled substance used for an approved research
project, he/she shall submit a request to the Registration Unit, Drug
Enforcement Administration, Post Office Box 28083, Central Station,
Washington, DC 20005, by registered mail, return receipt requested. The
request shall contain the following information: DEA registration
number; name of the controlled substance or substances and the quantity
of each authorized in the approved protocol; and the additional quantity
of each desired. Upon return of the receipt, the registrant shall be
authorized to purchase the additional quantity of the controlled
substance or substances specified in the request. The Administration
shall review the letter and forward it to the Food and Drug
Administration together with the Administration comments. The Food and
Drug Administration shall approve or deny the request as an amendment to
the protocol and so notify the registrant. Approval of the letter by the
Food and Drug Administration shall authorize the registrant to use the
additional quantity of the controlled substance in the research project.
(d) In the event the registrant desires to conduct research beyond
the variations provided in the registrant's approved protocol (excluding
any increase in the quantity of the controlled substance requested for
his/her research project as outlined in paragraph (c) of this section),
he/she shall submit three copies of a supplemental protocol in
accordance with paragraph (a) of this section describing the new
research and omitting information in the supplemental protocol which has
been stated in the original protocol. Supplemental protocols shall be
processed and approved or denied in the same manner as original research
protocols.
[62 FR 13949, Mar. 24, 1997]
Exceptions to Registration and Fees
Sec. 1301.21 Exemption from fees.
(a) The Administrator shall exempt from payment of an application
fee for registration or reregistration:
(1) Any hospital or other institution which is operated by an agency
of the United States (including the U.S. Army, Navy, Marine Corps., Air
Force, and Coast Guard), of any State, or any political subdivision or
agency thereof.
[[Page 24]]
(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. 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
[[Page 25]]
Health Service'') and the service identification number of the issuing
official in lieu of the registration number required on prescription
forms. The service identification number for a Public Health Service
employee is his/her Social Security identification number.
(b) The requirement of registration is waived for any official or
agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or
Public Health Service who or which is authorized to import or export
controlled substances in the course of his/her official duties.
(c) If any official exempted by this section also engages as a
private individual in any activity or group of activities for which
registration is required, such official shall obtain a registration for
such private activities.
[62 FR 13951, Mar. 24, 1997]
Sec. 1301.24 Exemption of law enforcement officials.
(a) The requirement of registration is waived for the following
persons in the circumstances described in this section:
(1) Any officer or employee of the Administration, any officer of
the U.S. Customs Service, any officer or employee of the United States
Food and Drug Administration, and any other Federal officer who is
lawfully engaged in the enforcement of any Federal law relating to
controlled substances, drugs or customs, and is duly authorized to
possess or to import or export controlled substances in the course of
his/her official duties; and
(2) Any officer or employee of any State, or any political
subdivision or agency thereof, who is engaged in the enforcement of any
State or local law relating to controlled substances and is duly
authorized to possess controlled substances in the course of his/her
official duties.
(b) Any official exempted by this section may, when acting in the
course of his/her official duties, procure any controlled substance in
the course of an inspection, in accordance with Sec. 1316.03(d) of this
chapter, or in the course of any criminal investigation involving the
person from whom the substance was procured, and may possess any
controlled substance and distribute any such substance to any other
official who is also exempted by this section and acting in the course
of his/her official duties.
(c) In order to enable law enforcement agency laboratories,
including laboratories of the Administration, to obtain and transfer
controlled substances for use as standards in chemical analysis, such
laboratories shall obtain annually a registration to conduct chemical
analysis. Such laboratories shall be exempted from payment of a fee for
registration. Laboratory personnel, when acting in the scope of their
official duties, are deemed to be officials exempted by this section and
within the activity described in section 515(d) of the Act (21 U.S.C.
885(d)). For purposes of this paragraph, laboratory activities shall not
include field or other preliminary chemical tests by officials exempted
by this section.
(d) In addition to the activities authorized under a registration to
conduct chemical analysis pursuant to Sec. 1301.13(e)(1)(ix),
laboratories of the Administration shall be authorized to manufacture or
import controlled substances for any lawful purpose, to distribute or
export such substances to any person, and to import and export such
substances in emergencies without regard to the requirements of part
1312 of this chapter if a report concerning the importation or
exportation is made to the Drug Operations Section of the Administration
within 30 days of such importation or exportation.
[62 FR 13951, Mar. 24, 1997]
Sec. 1301.25 Registration regarding ocean vessels, aircraft, and other
entities.
(a) If acquired by and dispensed under the general supervision of a
medical officer described in paragraph (b) of this section, or the
master or first officer of the vessel under the circumstances described
in paragraph (d) of this section, controlled substances may be held for
stocking, be maintained in, and dispensed from medicine chests, first
aid packets, or dispensaries:
(1) On board any vessel engaged in international trade or in trade
between ports of the United States and any merchant vessel belonging to
the U.S. Government;
[[Page 26]]
(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)_______________________________________________
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
[[Page 27]]
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 not be distributed to persons not under the general
supervision of the medical officer employed by the owner or operator of
the vessel, aircraft, or other entity, except in accordance with Sec.
1307.21 of this chapter.
[62 FR 13951, Mar. 24, 1997]
Sec. 1301.26 Exemptions from import or export requirements for personal
medical use.
Any individual who has in his/her possession a controlled substance
listed in schedules II, III, IV, or V, which he/she has lawfully
obtained for his/her personal medical use, or for administration to an
animal accompanying him/her, may enter or depart the United States with
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C.
952-955), provided the following conditions are met:
(a) The controlled substance is in the original container in which
it was dispensed to the individual; and
(b) The individual makes a declaration to an appropriate official of
the Bureau of Customs and Border Protection stating:
(1) That the controlled substance is possessed for his/her personal
use, or
[[Page 28]]
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]
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 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) Where the individual practitioner is not a member of a group
practice, the total number of such patients of the individual
practitioner will not
[[Page 29]]
exceed 30 at any one time, unless regulations promulgated by the
Secretary of Health and Human Services are modified.
(iv) Where the individual practitioner is a member of a group
practice, the total number of such patients of the group practice will
not exceed 30 at any one time, unless regulations promulgated by the
Secretary of Health and Human Services are modified.
(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 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
[[Page 30]]
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]
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 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.
[[Page 31]]
(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 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
[[Page 32]]
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
Sec. Sec. 1301.71-1301.76; and
(2) Employment of security procedures to guard against in-transit
losses within and without the jurisdiction of the United States.
(d) In determining whether competition among the domestic
manufacturers of a controlled substance is adequate within the meaning
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as section
1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator
shall consider:
(1) The extent of price rigidity in the light of changes in:
(i) raw materials and other costs and
(ii) conditions of supply and demand;
(2) The extent of service and quality competition among the domestic
manufacturers for shares of the domestic market including:
(i) Shifts in market shares and
(ii) Shifts in individual customers among domestic manufacturers;
(3) The existence of substantial differentials between domestic
prices and the higher of prices generally prevailing in foreign markets
or the prices at which the applicant for registration to import is
committed to undertake to provide such products in the domestic market
in conformity with the Act. In determining the existence of substantial
differentials hereunder, appropriate consideration should be given to
any additional costs imposed on domestic manufacturers by the
requirements of the Act and such other cost-related and other factors as
the Administrator may deem relevant. In no event shall an importer's
offering prices in the United States be considered if they are lower
than those prevailing in the foreign market or markets from which the
importer is obtaining his/her supply;
[[Page 33]]
(4) The existence of competitive restraints imposed upon domestic
manufacturers by governmental regulations; and
(5) Such other factors as may be relevant to the determinations
required under this paragraph.
(e) In considering the scope of the domestic market, consideration
shall be given to substitute products which are reasonably
interchangeable in terms of price, quality and use.
(f) The fact that the number of existing manufacturers is small
shall not demonstrate, in and of itself, that adequate competition among
them does not exist.
[62 FR 13953, Mar. 24, 1997]
Sec. 1301.35 Certificate of registration; denial of registration.
(a) The Administrator shall issue a Certificate of Registration (DEA
Form 223) to an applicant if the issuance of registration or
reregistration is required under the applicable provisions of sections
303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the
issuance of registration or reregistration is not required, the
Administrator shall deny the application. Before denying any
application, the Administrator shall issue an order to show cause
pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold
a hearing on the application pursuant to Sec. 1301.41.
(b) If in response to a show cause order a hearing is requested by
an applicant for registration or reregistration to manufacture in bulk a
basic class of controlled substance listed in Schedule I or II, notice
that a hearing has been requested shall be published in the Federal
Register and shall be mailed simultaneously to the applicant and to all
persons to whom notice of the application was mailed. Any person
entitled to file comments or objections to the issuance of the proposed
registration pursuant to Sec. 1301.33(a) may participate in the hearing
by filing notice of appearance in accordance with Sec. 1301.43. Such
persons shall have 30 days to file a notice of appearance after the date
of publication of the notice of a request for a hearing in the Federal
Register.
(c) The Certificate of Registration (DEA Form 223) shall contain the
name, address, and registration number of the registrant, the activity
authorized by the registration, the schedules and/or Administration
Controlled Substances Code Number (as set forth in part 1308 of this
chapter) of the controlled substances which the registrant is authorized
to handle, the amount of fee paid (or exemption), and the expiration
date of the registration. The registrant shall maintain the certificate
of registration at the registered location in a readily retrievable
manner and shall permit inspection of the certificate by any official,
agent or employee of the Administration or of any Federal, State, or
local agency engaged in enforcement of laws relating to controlled
substances.
[62 FR 13954, Mar. 24, 1997]
Sec. 1301.36 Suspension or revocation of registration; suspension of
registration pending final order; extension of registration pending
final order.
(a) For any registration issued under section 303 of the Act (21
U.S.C. 823), the Administrator may:
(1) Suspend the registration pursuant to section 304(a) of the Act
(21 U.S.C. 824(a)) for any period of time.
(2) Revoke the registration pursuant to section 304(a) of the Act
(21 U.S.C. 824(a)).
(b) For any registration issued under section 1008 of the Act (21
U.S.C. 958), the Administrator may:
(1) Suspend the registration pursuant to section 1008(d) of the Act
(21 U.S.C. 958(d)) for any period of time.
(2) Revoke the registration pursuant to section 1008(d) of the Act
(21 U.S.C. 958(d)) if he/she determines that such registration is
inconsistent with the public interest as defined in section 1008 or with
the United States obligations under international treaties, conventions,
or protocols in effect on October 12, 1984.
(c) The Administrator may limit the revocation or suspension of a
registration to the particular controlled substance, or substances, with
respect to which grounds for revocation or suspension exist.
(d) Before revoking or suspending any registration, the
Administrator
[[Page 34]]
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 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
[[Page 35]]
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
Sec. Sec. 1301.42-1301.46 of this part, and by the procedures for
administrative hearings under the Act set forth in Sec. Sec. 1316.41-
1316.67 of this chapter.
(b) Any hearing under this part shall be independent of, and not in
lieu of, criminal prosecutions or other proceedings under the Act or any
other law of the United States.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.42 Purpose of hearing.
If requested by a person entitled to a hearing, the Administrator
shall hold a hearing for the purpose of receiving factual evidence
regarding the issues involved in the denial, revocation, or suspension
of any registration, and the granting of any application for
registration to import or to manufacture in bulk a basic class of
controlled substance listed in Schedule I or II. Extensive argument
should not be offered into evidence but rather presented in opening or
closing statements of counsel or in memoranda or proposed findings of
fact and conclusions of law.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.43 Request for hearing or appearance; waiver.
(a) Any person entitled to a hearing pursuant to Sec. 1301.32 or
Sec. Sec. 1301.34-1301.36 and desiring a hearing shall, within 30 days
after the date of receipt of the order to show cause (or the date of
publication of notice of the application for registration in the Federal
Register in the case of Sec. 1301.34), file with the Administrator a
written request for a
[[Page 36]]
hearing in the form prescribed in Sec. 1316.47 of this chapter.
(b) Any person entitled to participate in a hearing pursuant to
Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30
days of the date of publication of notice of the request for a hearing
in the Federal Register, file with the Administrator a written notice of
intent to participate in such hearing in the form prescribed in Sec.
1316.48 of this chapter. Any person filing a request for a hearing need
not also file a notice of appearance.
(c) Any person entitled to a hearing or to participate in a hearing
pursuant to Sec. 1301.32 or Sec. Sec. 1301.34-1301.36 may, within the
period permitted for filing a request for a hearing or a notice of
appearance, file with the Administrator a waiver of an opportunity for a
hearing or to participate in a hearing, together with a written
statement regarding such person's position on the matters of fact and
law involved in such hearing. Such statement, if admissible, shall be
made a part of the record and shall be considered in light of the lack
of opportunity for cross-examination in determining the weight to be
attached to matters of fact asserted therein.
(d) If any person entitled to a hearing or to participate in a
hearing pursuant to Sec. 1301.32 or Sec. Sec. 1301.34-1301.36 fails to
file a request for a hearing or a notice of appearance, or if such
person so files and fails to appear at the hearing, such person shall be
deemed to have waived the opportunity for a hearing or to participate in
the hearing, unless such person shows good cause for such failure.
(e) If all persons entitled to a hearing or to participate in a
hearing waive or are deemed to waive their opportunity for the hearing
or to participate in the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his/her final order pursuant to Sec.
1301.46 without a hearing.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.44 Burden of proof.
(a) At any hearing on an application to manufacture any controlled
substance listed in Schedule I or II, the applicant shall have the
burden of proving that the requirements for such registration pursuant
to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any other
person participating in the hearing pursuant to Sec. 1301.35(b) shall
have the burden of proving any propositions of fact or law asserted by
such person in the hearing.
(b) At any hearing on the granting or denial of an applicant to be
registered to conduct a narcotic treatment program or as a compounder,
the applicant shall have the burden of proving that the requirements for
each registration pursuant to section 303(g) of the Act (21 U.S.C.
823(g)) are satisfied.
(c) At any hearing on the granting or denial of an application to be
registered to import or export any controlled substance listed in
Schedule I or II, the applicant shall have the burden of proving that
the requirements for such registration pursuant to sections 1008(a) and
(d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other
person participating in the hearing pursuant to Sec. 1301.34 shall have
the burden of proving any propositions of fact or law asserted by him/
her in the hearings.
(d) At any other hearing for the denial of a registration, the
Administration shall have the burden of proving that the requirements
for such registration pursuant to section 303 or section 1008(c) and (d)
of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.
(e) At any hearing for the revocation or suspension of a
registration, the Administration shall have the burden of proving that
the requirements for such revocation or suspension pursuant to section
304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are
satisfied.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.45 Time and place of hearing.
The hearing will commence at the place and time designated in the
order to show cause or notice of hearing published in the Federal
Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter
it may be moved to a different place and may be continued from day to
day or recessed to a later day without notice other than announcement
thereof by the presiding officer at the hearing.
[62 FR 13956, Mar. 24, 1997]
[[Page 37]]
Sec. 1301.46 Final order.
As soon as practicable after the presiding officer has certified the
record to the Administrator, the Administrator shall issue his/her order
on the granting, denial, revocation, or suspension of registration. In
the event that an application for registration to import or to
manufacture in bulk a basic class of any controlled substance listed in
Schedule I or II is granted, or any application for registration is
denied, or any registration is revoked or suspended, the order shall
include the findings of fact and conclusions of law upon which the order
is based. The order shall specify the date on which it shall take
effect. The Administrator shall serve one copy of his/her order upon
each party in the hearing.
[62 FR 13956, Mar. 24, 1997]
Modification, Transfer and Termination of Registration
Sec. 1301.51 Modification in registration.
Any registrant may apply to modify his/her registration to authorize
the handling of additional controlled substances or to change his/her
name or address, by submitting a letter of request to the Registration
Unit, Drug Enforcement Administration, Department of Justice, Post
Office Box 28083, Central Station, Washington, DC 20005. The letter
shall contain the registrant's name, address, and registration number as
printed on the certificate of registration, and the substances and/or
schedules to be added to his/her registration or the new name or address
and shall be signed in accordance with Sec. 1301.13(j). If the
registrant is seeking to handle additional controlled substances listed
in Schedule I for the purpose of research or instructional activities,
he/she shall attach three copies of a research protocol describing each
research project involving the additional substances, or two copies of a
statement describing the nature, extent, and duration of such
instructional activities, as appropriate. No fee shall be required to be
paid for the modification. The request for modification shall be handled
in the same manner as an application for registration. If the
modification in registration is approved, the Administrator shall issue
a new certificate of registration (DEA Form 223) to the registrant, who
shall maintain it with the old certificate of registration until
expiration.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.52 Termination of registration; transfer of registration;
distribution upon discontinuance of business.
(a) Except as provided in paragraph (b) of this section, the
registration of any person shall terminate if and when such person dies,
ceases legal existence, or discontinues business or professional
practice. Any registrant who ceases legal existence or discontinues
business or professional practice shall notify the Administrator
promptly of such fact.
(b) No registration or any authority conferred thereby shall be
assigned or otherwise transferred except upon such conditions as the
Administration may specifically designate and then only pursuant to
written consent. Any person seeking authority to transfer a registration
shall submit a written request, providing full details regarding the
proposed transfer of registration, to the Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement
Administration, Department of Justice, Washington, DC 20537.
(c) Any registrant desiring to discontinue business activities
altogether or with respect to controlled substances (without
transferring such business activities to another person) shall return
for cancellation his/her certificate of registration, and any unexecuted
order forms in his/her possession, to the Registration Unit, Drug
Enforcement Administration, Department of Justice, Post Office Box
28083, Central Station, Washington, DC 20005. Any controlled substances
in his/her possession may be disposed of in accordance with Sec.
1307.21 of this chapter.
(d) Any registrant desiring to discontinue business activities
altogether or with respect to controlled substance (by transferring such
business activities to another person) shall submit in person or by
registered or certified mail, return receipt requested, to the Special
Agent in Charge in his/her area, at least 14 days in advance of the date
of the proposed transfer (unless
[[Page 38]]
the Special Agent in Charge waives this time limitation in individual
instances), the following information:
(1) The name, address, registration number, and authorized business
activity of the registrant discontinuing the business (registrant-
transferor);
(2) The name, address, registration number, and authorized business
activity of the person acquiring the business (registrant-transferee);
(3) Whether the business activities will be continued at the
location registered by the person discontinuing business, or moved to
another location (if the latter, the address of the new location should
be listed);
(4) Whether the registrant-transferor has a quota to manufacture or
procure any controlled substance listed in Schedule I or II (if so, the
basic class or class of the substance should be indicated); and
(5) The date on which the transfer of controlled substances will
occur.
(e) Unless the registrant-transferor is informed by the Special
Agent in Charge, before the date on which the transfer was stated to
occur, that the transfer may not occur, the registrant-transferor may
distribute (without being registered to distribute) controlled
substances in his/her possession to the registrant-transferee in
accordance with the following:
(1) On the date of transfer of the controlled substances, a complete
inventory of all controlled substances being transferred shall be taken
in accordance with Sec. 1304.11 of this chapter. This inventory shall
serve as the final inventory of the registrant-transferor and the
initial inventory of the registrant-transferee, and a copy of the
inventory shall be included in the records of each person. It shall not
be necessary to file a copy of the inventory with the Administration
unless requested by the Special Agent in Charge. Transfers of any
substances listed in Schedule I or II shall require the use of order
forms in accordance with part 1305 of this chapter.
(2) On the date of transfer of the controlled substances, all
records required to be kept by the registrant-transferor with reference
to the controlled substances being transferred, under part 1304 of this
chapter, shall be transferred to the registrant-transferee.
Responsibility for the accuracy of records prior to the date of transfer
remains with the transferor, but responsibility for custody and
maintenance shall be upon the transferee.
(3) In the case of registrants required to make reports pursuant to
part 1304 of this chapter, a report marked ``Final'' will be prepared
and submitted by the registrant-transferor showing the disposition of
all the controlled substances for which a report is required; no
additional report will be required from him, if no further transactions
involving controlled substances are consummated by him. The initial
report of the registrant-transferee shall account for transactions
beginning with the day next succeeding the date of discontinuance or
transfer of business by the transferor-registrant and the substances
transferred to him shall be reported as receipts in his/her initial
report.
[62 FR 13957, Mar. 24, 1997]
Security Requirements
Sec. 1301.71 Security requirements generally.
(a) All applicants and registrants shall provide effective controls
and procedures to guard against theft and diversion of controlled
substances. In order to determine whether a registrant has provided
effective controls against diversion, the Administrator shall use the
security requirements set forth in Sec. Sec. 1301.72-1301.76 as
standards for the physical security controls and operating procedures
necessary to prevent diversion. Materials and construction which will
provide a structural equivalent to the physical security controls set
forth in Sec. Sec. 1301.72, 1301.73 and 1301.75 may be used in lieu of
the materials and construction described in those sections.
(b) Substantial compliance with the standards set forth in
Sec. Sec. 1301.72-1301.76 may be deemed sufficient by the Administrator
after evaluation of the overall security system and needs of the
applicant or registrant. In evaluating the overall security system of a
registrant or applicant, the Administrator may consider any of the
following factors as he may deem relevant
[[Page 39]]
to the need for strict compliance with security requirements:
(1) The type of activity conducted (e.g., processing of bulk
chemicals, preparing dosage forms, packaging, labeling, cooperative
buying, etc.);
(2) The type and form of controlled substances handled (e.g., bulk
liquids or dosage units, usable powders or nonusable powders);
(3) The quantity of controlled substances handled;
(4) The location of the premises and the relationship such location
bears on security needs;
(5) The type of building construction comprising the facility and
the general characteristics of the building or buildings;
(6) The type of vault, safe, and secure enclosures or other storage
system (e.g., automatic storage and retrieval system) used;
(7) The type of closures on vaults, safes, and secure enclosures;
(8) The adequacy of key control systems and/or combination lock
control systems;
(9) The adequacy of electric detection and alarm systems, if any
including use of supervised transmittal lines and standby power sources;
(10) The extent of unsupervised public access to the facility,
including the presence and characteristics of perimeter fencing, if any;
(11) The adequacy of supervision over employees having access to
manufacturing and storage areas;
(12) The procedures for handling business guests, visitors,
maintenance personnel, and nonemployee service personnel;
(13) The availability of local police protection or of the
registrant's or applicant's security personnel;
(14) The adequacy of the registrant's or applicant's system for
monitoring the receipt, manufacture, distribution, and disposition of
controlled substances in its operations; and
(15) The applicability of the security requirements contained in all
Federal, State, and local laws and regulations governing the management
of waste.
(c) When physical security controls become inadequate as a result of
a controlled substance being transferred to a different schedule, or as
a result of a noncontrolled substance being listed on any schedule, or
as a result of a significant increase in the quantity of controlled
substances in the possession of the registrant during normal business
operations, the physical security controls shall be expanded and
extended accordingly. A registrant may adjust physical security controls
within the requirements set forth in Sec. Sec. 1301.72-1301.76 when the
need for such controls decreases as a result of a controlled substance
being transferred to a different schedule, or a result of a controlled
substance being removed from control, or as a result of a significant
decrease in the quantity of controlled substances in the possession of
the registrant during normal business operations.
(d) Any registrant or applicant desiring to determine whether a
proposed security system substantially complies with, or is the
structural equivalent of, the requirements set forth in Sec. Sec.
1301.72-1301.76 may submit any plans, blueprints, sketches or other
materials regarding the proposed security system either to the Special
Agent in Charge in the region in which the system will be used, or to
the Diversion Operations Section, Drug Enforcement Administration,
Department of Justice, Washington, DC 20537.
(e) Physical security controls of locations registered under the
Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on
April 30, 1971, shall be deemed to comply substantially with the
standards set forth in Sec. Sec. 1301.72, 1301.73 and 1301.75. Any new
facilities or work or storage areas constructed or utilized for
controlled substances, which facilities or work or storage areas have
not been previously approved by the Administration, shall not
necessarily be deemed to comply substantially with the standards set
forth in Sec. Sec. 1301.72, 1301.73 and 1301.75, notwithstanding that
such facilities or work or storage areas have physical security controls
similar to those previously approved by the Administration.
[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
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]
[[Page 40]]
Sec. 1301.72 Physical security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs; storage
areas.
(a) Schedules I and II. Raw material, bulk materials awaiting
further processing, and finished products which are controlled
substances listed in Schedule I or II (except GHB that is manufactured
or distributed in accordance with an exemption under section 505(i) of
the FFDCA which shall be subject to the requirements of paragraph (b) of
this section) shall be stored in one of the following secured areas:
(1) Where small quantities permit, a safe or steel cabinet;
(i) Which safe or steel cabinet shall have the following
specifications or the equivalent: 30 man-minutes against surreptitious
entry, 10 man-minutes against forced entry, 20 man-hours against lock
manipulation, and 20 man-hours against radiological techniques;
(ii) Which safe or steel cabinet, if it weighs less than 750 pounds,
is bolted or cemented to the floor or wall in such a way that it cannot
be readily removed; and
(iii) Which safe or steel cabinet, if necessary, depending upon the
quantities and type of controlled substances stored, is equipped with an
alarm system which, upon attempted unauthorized entry, shall transmit a
signal directly to a central protection company or a local or State
police agency which has a legal duty to respond, or a 24-hour control
station operated by the registrant, or such other protection as the
Administrator may approve.
(2) A vault constructed before, or under construction on, September
1, 1971, which is of substantial construction with a steel door,
combination or key lock, and an alarm system; or
(3) A vault constructed after September 1, 1971:
(i) The walls, floors, and ceilings of which vault are constructed
of at least 8 inches of reinforced concrete or other substantial
masonry, reinforced vertically and horizontally with \1/2\-inch steel
rods tied 6 inches on center, or the structural equivalent to such
reinforced walls, floors, and ceilings;
(ii) The door and frame unit of which vault shall conform to the
following specifications or the equivalent: 30 man-minutes against
surreptitious entry, 10 man-minutes against forced entry, 20 man-hours
against lock manipulation, and 20 man-hours against radiological
techniques;
(iii) Which vault, if operations require it to remain open for
frequent access, is equipped with a ``day-gate'' which is self-closing
and self-locking, or the equivalent, for use during the hours of
operation in which the vault door is open;
(iv) The walls or perimeter of which vault are equipped with an
alarm, which upon unauthorized entry shall transmit a signal directly to
a central station protection company, or a local or State police agency
which has a legal duty to respond, or a 24-hour control station operated
by the registrant, or such other protection as the Administrator may
approve, and, if necessary, holdup buttons at strategic points of entry
to the perimeter area of the vault;
(v) The door of which vault is equipped with contact switches; and
(vi) Which vault has one of the following: Complete electrical
lacing of the walls, floor and ceilings; sensitive ultrasonic equipment
within the vault; a sensitive sound accumulator system; or such other
device designed to detect illegal entry as may be approved by the
Administration.
(b) Schedules III, IV and V. Raw material, bulk materials awaiting
further processing, and finished products which are controlled
substances listed in Schedules III, IV, and V, and GHB when it is
manufactured or distributed in accordance with an exemption under
section 505(i) of the FFDCA, shall be stored in the following secure
storage areas:
(1) A safe or steel cabinet as described in paragraph (a)(1) of this
section;
(2) A vault as described in paragraph (a)(2) or (3) of this section
equipped with an alarm system as described in paragraph (b)(4)(v) of
this section;
(3) A building used for storage of Schedules III through V
controlled substances with perimeter security which limits access during
working hours and provides security after working hours and meets the
following specifications:
[[Page 41]]
(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 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
[[Page 42]]
may be stored separately, provided that each storage area complies with
the requirements set forth in this section.
(d) Accessibility to storage areas. The controlled substances
storage areas shall be accessible only to an absolute minimum number of
specifically authorized employees. When it is necessary for employee
maintenance personnel, nonemployee maintenance personnel, business
guests, or visitors to be present in or pass through controlled
substances storage areas, the registrant shall provide for adequate
observation of the area by an employee specifically authorized in
writing.
[36 FR 18730, Sept. 21, 1971, as amended at 37 FR 15919, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 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 on GPO Access.
Sec. 1301.73 Physical security controls for non-practitioners;
compounders for narcotic treatment programs; manufacturing and
compounding areas.
All manufacturing activities (including processing, packaging and
labeling) involving controlled substances listed in any schedule and all
activities of compounders shall be conducted in accordance with the
following:
(a) All in-process substances shall be returned to the controlled
substances storage area at the termination of the process. If the
process is not terminated at the end of a workday (except where a
continuous process or other normal manufacturing operation should not be
interrupted), the processing area or tanks, vessels, bins or bulk
containers containing such substances shall be securely locked, with
adequate security for the area or building. If such security requires an
alarm, such alarm, upon unauthorized entry, shall transmit a signal
directly to a 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 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.
[[Page 43]]
(c) The registrant shall notify the Field Division Office of the
Administration in his area, in writing, of any theft or significant loss
of any controlled substances within one business day of discovery of the
theft or loss. The supplier is responsible for reporting all in-transit
losses of controlled substances by the common or contract carrier
selected pursuant to paragraph (e) of this section, within one business
day of discovery of such theft or loss. The registrant shall also
complete, and submit to the Field Division Office in his 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 storing controlled
substances in a public warehouse, a registrant is responsible for
selecting a warehouseman which will provide adequate security to guard
against storage losses; wherever possible, the registrant shall store
controlled substances in a public warehouse which complies with the
requirements set forth in Sec. 1301.72. In addition, the registrant
shall employ precautions (e.g., assuring that shipping containers do not
indicate that contents are controlled substances) to guard against
storage or in-transit losses.
(f) When distributing controlled substances through agents (e.g.,
detailmen), a registrant is responsible for providing and requiring
adequate security to guard against theft and diversion while the
substances are being stored or handled by the agent or agents.
(g) Before the initial distribution of carfentanil etorphine
hydrochloride and/or diprenorphine to any person, the registrant must
verify that the person is authorized to handle the substances(s) by
contacting the Drug Enforcement Administration.
(h) The acceptance of delivery of narcotic substances by a narcotic
treatment program shall be made only by a licensed practitioner employed
at the facility or other authorized individuals designated in writing.
At the time of delivery, the licensed practitioner or other authorized
individual designated in writing (excluding persons currently
[[Page 44]]
or previously dependent on narcotic drugs), shall sign for the narcotics
and place his specific title (if any) on any invoice. Copies of these
signed invoices shall be kept by the distributor.
(i) Narcotics dispensed or administered at a narcotic treatment
program will be dispensed or administered directly to the patient by
either (1) the licensed practitioner, (2) a registered nurse under the
direction of the licensed practitioner, (3) a licensed practical nurse
under the direction of the licensed practitioner, or (4) a pharmacist
under the direction of the licensed practitioner.
(j) Persons enrolled in a narcotic treatment program will be
required to wait in an area physically separated from the narcotic
storage and dispensing area. This requirement will be enforced by the
program physician and employees.
(k) All narcotic treatment programs must comply with standards
established by the Secretary of Health and Human Services (after
consultation with the Administration) respecting the quantities of
narcotic drugs which may be provided to persons enrolled in a narcotic
treatment program for unsupervised use.
(l) DEA may exercise discretion regarding the degree of security
required in narcotic treatment programs based on such factors as the
location of a program, the number of patients enrolled in a program and
the number of physicians, staff members and security guards. Similarly,
such factors will be taken into consideration when evaluating existing
security or requiring new security at a narcotic treatment program.
[36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, 1971, as amended at 36
FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 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 on GPO Access.
Sec. 1301.75 Physical security controls for practitioners.
(a) Controlled substances listed in Schedule I shall be stored in a
securely locked, substantially constructed cabinet.
(b) Controlled substances listed in Schedules II, III, IV, and V
shall be stored in a securely locked, substantially constructed cabinet.
However, pharmacies and institutional practitioners may disperse such
substances throughout the stock of noncontrolled substances in such a
manner as to obstruct the theft or diversion of the controlled
substances.
(c) This section shall also apply to nonpractitioners authorized to
conduct research or chemical analysis under another registration.
(d) Carfentanil etorphine hydrochloride and diprenorphine shall be
stored in a safe or steel cabinet equivalent to a U.S. Government Class
V security container.
[39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54
FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997]
Sec. 1301.76 Other security controls for practitioners.
(a) The registrant shall not employ, as an agent or employee who has
access to controlled substances, any person who has been convicted of a
felony offense relating to controlled substances or who, at any time,
had an application for registration with the DEA denied, had a DEA
registration revoked or has surrendered a DEA registration for cause.
For purposes of this subsection, the term ``for cause'' means a
surrender in lieu of, or as a consequence of, any federal or state
administrative, civil or criminal action resulting from an investigation
of the individual's handling of controlled substances.
(b) The registrant shall notify the Field Division Office of the
Administration in his area, 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;
[[Page 45]]
(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 Sec.
1301.13(e)(1) and/or Sec. Sec. 1307.11-1307.12) he/she shall comply
with the requirements imposed on nonpractitioners in Sec. 1301.74 (a),
(b), and (e).
(d) Central fill pharmacies must comply with Sec. 1301.74(e) when
selecting private, common or contract carriers to transport filled
prescriptions to a retail pharmacy for delivery to the ultimate user.
When central fill pharmacies contract with private, common or contract
carriers to transport filled prescriptions to a retail pharmacy, the
central fill pharmacy is responsible for reporting in-transit losses
upon discovery of such loss by use of a DEA Form 106. Retail pharmacies
must comply with Sec. 1301.74(e) when selecting private, common or
contract carriers to retrieve filled prescriptions from a central fill
pharmacy. When retail pharmacies contract with private, common or
contract carriers to retrieve filled prescriptions from a central fill
pharmacy, the retail pharmacy is responsible for reporting in-transit
losses upon discovery of such loss by use of a DEA Form 106.
[36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971;
37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 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]
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:
[[Page 46]]
Question. Within the past five years, have you been convicted of a
felony, or within the past two years, of any misdemeanor or are you
presently formally charged with committing a criminal offense? (Do not
include any traffic violations, juvenile offenses or military
convictions, except by general court-martial.) If the answer is yes,
furnish details of conviction, offense, location, date and sentence.
Question. In the past three years, have you ever knowingly used any
narcotics, amphetamines or barbiturates, other than those prescribed to
you by a physician? If the answer is yes, furnish details.
Advice. An authorization, in writing, that allows inquiries to be
made of courts and law enforcement agencies for possible pending charges
or convictions must be executed by a person who is allowed to work in an
area where access to controlled substances clearly exists. A person must
be advised that any false information or omission of information will
jeopardize his or her position with respect to employment. The
application for employment should inform a person that information
furnished or recovered as a result of any inquiry will not necessarily
preclude employment, but will be considered as part of an overall
evaluation of the person's qualifications. The maintaining of fair
employment practices, the protection of the person's right of privacy,
and the assurance that the results of such inquiries will be treated by
the employer in confidence will be explained to the employee.
[40 FR 17143, Apr. 17, 1975]
Sec. 1301.91 Employee responsibility to report drug diversion.
Reports of drug diversion by fellow employees is not only a
necessary part of an overall employee security program but also serves
the public interest at large. It is, therefore, the position of DEA that
an employee who has knowledge of drug diversion from his employer by a
fellow employee has an obligation to report such information to a
responsible security official of the employer. The employer shall treat
such information as confidential and shall take all reasonable steps to
protect the confidentiality of the information and the identity of the
employee furnishing information. A failure to report information of drug
diversion will be considered in determining the feasibility of
continuing to allow an employee to work in a drug security area. The
employer shall inform all employees concerning this policy.
[40 FR 17143, Apr. 17, 1975]
Sec. 1301.92 Illicit activities by employees.
It is the position of DEA that employees who possess, sell, use or
divert controlled substances will subject themselves not only to State
or Federal prosecution for any illicit activity, but shall also
immediately become the subject of independent action regarding their
continued employment. The employer will assess the seriousness of the
employee's violation, the position of responsibility held by the
employee, past record of employment, etc., in determining whether to
suspend, transfer, terminate or take other action against the employee.
[40 FR 17143, Apr. 17, 1975]
Sec. 1301.93 Sources of information for employee checks.
DEA recommends that inquiries concerning employees' criminal records
be made as follows:
Local inquiries. Inquiries should be made by name, date and place of
birth, and other identifying information, to local courts and law
enforcement agencies for records of pending charges and convictions.
Local practice may require such inquiries to be made in person, rather
than by mail, and a copy of an authorization from the employee may be
required by certain law enforcement agencies.
DEA inquiries. Inquiries supplying identifying information should
also be furnished to DEA Field Division Offices along with written
consent from the concerned individual for a check of DEA files for
records of convictions. The Regional check will result in a national
check being made by the Field Division Office.
[40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22, 1982]
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.
[[Page 47]]
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:
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
[[Page 48]]
a seal to disclose upon inspection any tampering or opening of the
container.
[62 FR 13958, Mar. 24, 1997]
Sec. 1302.07 Labeling and packaging requirements for imported and
exported substances.
(a) The symbol requirements of Sec. Sec. 1302.03-1302.05 apply to
every commercial container containing, and to all labeling of,
controlled substances imported into the jurisdiction of and/or the
customs territory of the United States.
(b) The symbol requirements of Sec. Sec. 1302.03-1302.05 do not
apply to any commercial containers containing, or any labeling of, a
controlled substance intended for export from the jurisdiction of the
United States.
(c) The sealing requirements of Sec. 1302.06 apply to every bottle,
multiple dose vial, or other commercial container of any controlled
substance listed in schedule I or II, or any narcotic controlled
substance listed in schedule III or IV, imported into, exported from, or
intended for export from, the jurisdiction of and/or the customs
territory of the United States.
[62 FR 13958, Mar. 24, 1997]
PART 1303_QUOTAS--Table of Contents
General Information
Sec.
1303.01 Scope of part 1303.
1303.02 Definitions.
Aggregate Production and Procurement Quotas
1303.11 Aggregate production quotas.
1303.12 Procurement quotas.
1303.13 Adjustments of aggregate production quotas.
Individual Manufacturing Quotas
1303.21 Individual manufacturing quotas.
1303.22 Procedure for applying for individual manufacturing quotas.
1303.23 Procedure for fixing individual manufacturing quotas.
1303.24 Inventory allowance.
1303.25 Increase in individual manufacturing quotas.
1303.26 Reduction in individual manufacturing quotas.
1303.27 Abandonment of quota.
Hearings
1303.31 Hearings generally.
1303.32 Purpose of hearing.
1303.33 Waiver or modification of rules.
1303.34 Request for hearing or appearance; waiver.
1303.35 Burden of proof.
1303.36 Time and place of hearing.
1303.37 Final order.
Authority: 21 U.S.C. 821, 826, 871(b).
General Information
Sec. 1303.01 Scope of part 1303.
Procedures governing the establishment of production and
manufacturing quotas on basic classes of controlled substances listed in
schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826)
are governed generally by that section and specifically by the sections
of this part.
[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13958, Mar. 24, 1997]
Aggregate Production and Procurement Quotas
Sec. 1303.11 Aggregate production quotas.
(a) The Administrator shall determine the total quantity of each
basic class of controlled substance listed in Schedule I or II necessary
to be manufactured during the following calendar year to provide for the
estimated medical, scientific, research and industrial needs of the
United States, for lawful export requirements, and for the establishment
and maintenance of reserve stocks.
(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;
[[Page 49]]
(4) Projected demand for such class as indicated by procurement
quotas requested pursuant to Sec. 1303.12; and
(5) Other factors affecting medical, scientific, research, and
industrial needs in the United States and lawful export requirements, as
the Administrator finds relevant, including changes in the currently
accepted medical use in treatment with the class or the substances which
are manufactured from it, the economic and physical availability of raw
materials for use in manufacturing and for inventory purposes, yield and
stability problems, potential disruptions to production (including
possible labor strikes), and recent unforeseen emergencies such as
floods and fires.
(c) The Administrator shall, on or before May 1 of each year,
publish in the Federal Register, general notice of an aggregate
production quota for any basic class determined by him under this
section. A copy of said notice shall be mailed simultaneously to each
person registered as a bulk manufacturer of the basic class. The
Administrator shall permit any interested person to file written
comments on or objections to the proposal and shall designate in the
notice the time during which such filings may be made. The Administrator
may, but shall not be required to, hold a public hearing on one or more
issues raised by the comments and objections filed with him. In the
event the Administrator decides to hold such a hearing, he shall publish
notice of the hearing in the Federal Register, which notice shall
summarize the issues to be heard and shall set the time for the hearing
which shall nnt be less than 30 days after the date of publication of
the notice. After consideration of any comments or objections, or after
a hearing if one is ordered by the Administrator, the Administrator
shall issue and publish in the Federal Register his final order
determining the aggregate production quota for the basic class of
controlled substance. The order shall include the findings of fact and
conclusions of law upon which the order is based. The order shall
specify the date on which it shall take effect. A copy of said order
shall be mailed simultaneously to each person registered as a bulk
manufacturer of the basic class.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.12 Procurement quotas.
(a) In order to determine the estimated needs for, and to insure an
adequate and uninterrupted supply of, basic classes of controlled
substances listed in Schedules I and II (except raw opium being imported
by the registrant pursuant to an import permit) the Administrator shall
issue procurement quotas authorizing persons to procure and use
quantities of each basic class of such substances for the purpose of
manufacturing such class into dosage forms or into other substances.
(b) Any person who is registered to manufacture controlled
substances listed in any schedule and who desires to use during the next
calendar year any basic class of controlled substances listed in
Schedule I or II (except raw opium being imported by the registrant
pursuant to an import permit) for purposes of manufacturing, shall apply
on DEA Form 250 for a procurement quota for such basic class. A separate
application must be made for each basic class desired to be procured or
used. The applicant shall state whether he intends to manufacture the
basic class himself or purchase it from another manufacturer. The
applicant shall state separately each purpose for which the basic class
is desired, the quantity desired for that purpose during the next
calendar year, and the quantities used and estimated to be used, if any,
for that purpose during the current and preceding 2 calendar years. If
the purpose is to manufacture the basic class into dosage form, the
applicant shall state the official name, common or usual name, chemical
name, or brand name 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
[[Page 50]]
basic class of controlled substance listed in Schedule I or II, the
applicant shall also state the quantity of the other basic class which
the applicant has applied to manufacture pursuant to Sec. 1303.22 and
the quantity of the first basic class necessary to manufacture a
specified unit of the second basic class. DEA Form 250 shall be filed on
or before April 1 of the year preceding the calendar year for which the
procurement quota is being applied. Copies of DEA Form 250 may be
obtained from, and shall be filed with, the Drug & Chemical Evaluation
Section, Drug Enforcement Administration, Department of Justice,
Washington, DC 20537.
(c) The Administrator shall, on or before July 1 of the year
preceding the calendar year during which the quota shall be effective,
issue to each qualified applicant a procurement quota authorizing him to
procure and use:
(1) All quantities of such class necessary to manufacture all
quantities of other basic classes of controlled substances listed in
Schedules I and II which the applicant is authorized to manufacture
pursuant to Sec. 1303.23; and
(2) Such other quantities of such class as the applicant has applied
to procure and use and are consistent with his past use, his estimated
needs, and the total quantity of such class that will be produced.
(d) Any person to whom a procurement quota has been issued may at
any time request an adjustment in the quota by applying to the
Administrator with a statement showing the need for the adjustment. Such
application shall be filed with the Drug & Chemical Evaluation Section,
Drug Enforcement Administration, Department of Justice, Washington, DC
20537. The Administrator shall increase or decrease the procurement
quota of such person if and to the extent that he finds, after
considering the factors enumerated in paragraph (c) of this section and
any occurrences since the issuance of the procurement quota, that the
need justifies an adjustment.
(e) The following persons need not obtain a procurement quota:
(1) Any person who is registered to manufacture a basic class of
controlled substance listed in Schedule I or II and who uses all of the
quantity he manufactures in the manufacture of a substance not
controlled under the Act;
(2) Any person who is registered or authorized to conduct chemical
analysis with controlled substances (for controlled substances to be
used in such analysis only); and
(3) Any person who is registered to conduct research with a basic
class of controlled substance listed in Schedule I or II and who is
authorized to manufacture a quantity of such class pursuant to Sec.
1301.13 of this chapter.
(f) Any person to whom a procurement quota has been issued,
authorizing that person to procure and use a quantity of a basic class
of controlled substances listed in Schedules I or II during the current
calendar year, shall, at or before the time of giving an order to
another manufacturer requiring the distribution of a quantity of such
basic class, certify in writing to such other manufacturer that the
quantity of such basic class ordered does not exceed the person's unused
and available procurement quota of such basic class for the current
calendar year. The written certification shall be executed by the same
individual who signed the DEA Form 222 transmitting the order.
Manufacturers shall not fill an order from persons required to apply for
a procurement quota under paragraph (b) of this section unless the order
is accompanied by a certification as required under this section. The
certification required by this section shall contain the following: The
date of the certification; the name and address of the bulk manufacturer
to whom the certification is directed; a reference to the number of the
DEA Form 222 to which the certification applies; the name of the person
giving the order to which the certification applies; the name of the
basic class specified in the DEA Form 222 to 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
[[Page 51]]
current calendar year; and the signature of the individual who signed
the DEA Form 222 to which the certification applies.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36
FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, 1972. Redesignated at 38
FR 26609, Sept. 24, 1973]
Editorial Note: For Federal Register citations affecting Sec.
1303.12, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Sec. 1303.13 Adjustments of aggregate production quotas.
(a) The Administrator may at any time increase or reduce the
aggregate production quota for a basic class of controlled substance
listed in Schedule I or II which he has previously fixed pursuant to
Sec. 1303.11.
(b) In determining to adjust the aggregate production quota, the
Administrator shall consider the following factors:
(1) Changes in the demand for that class, changes in the national
rate of net disposal of the class, and changes in the rate of net
disposal of the class by registrants holding individual manufacturing
quotas for that class;
(2) Whether any increased demand for that class, the national and/or
individual rates of net disposal of that class are temporary, short
term, or long term;
(3) Whether any increased demand for that class can be met through
existing inventories, increased individual manufacturing quotas, or
increased importation, without increasing the aggregate production
quota, taking into account production delays and the probability that
other individual manufacturing quotas may be suspended pursuant to Sec.
1303.24(b);
(4) Whether any decreased demand for that class will result in
excessive inventory accumulation by all persons registered to handle
that class (including manufacturers, distributors, practitioners,
importers, and exporters), notwithstanding the possibility that
individual manufacturing quotas may be suspended pursuant to Sec.
1303.24(b) or abandoned pursuant to Sec. 1303.27;
(5) Other factors affecting medical, scientific, research, and
industrial needs in the United States and lawful export requirements, as
the Administrator finds relevant, including changes in the currently
accepted medical use in treatment with the class or the substances which
are manufactured from it, the economic and physical availability of raw
materials for use in manufacturing and for inventory purposes, yield and
stability problems, potential disruptions to production (including
possible labor strikes), and recent unforeseen emergencies such as
floods and fires.
(c) The Administrator in the event he determines to increase or
reduce the aggregate production quota for a basic class of controlled
substance, shall publish in the Federal Register general notice of an
adjustment in the aggregate production quota for that class determined
by him under this section. A copy of said notice shall be mailed
simultaneously to each person registered as a bulk manufacturer of the
basic class. The Administrator shall permit any interested person to
file written comments on or objections to the proposal and shall
designate in the notice the time during which such filings may be made.
The Administrator may, but shall not be required to, hold a public
hearing on one or more issues raised by the comments and objections
filed with him. In the event the Administrator decides to hold such a
hearing, he shall publish notice of the hearing in the Federal Register,
which notice shall summarize the issues to be heard and shall set the
time for the hearing, which shall not be less than 10 days after the
date of publication of the notice. After consideration of any comments
or objections, or after a hearing if one is ordered by the
Administrator, the Administrator shall issue and publish in the Federal
Register his final 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]
[[Page 52]]
Individual Manufacturing Quotas
Sec. 1303.21 Individual manufacturing quotas.
(a) The Administrator shall, on or before July 1 of each year, fix
for and issue to each person who is registered to manufacture a basic
class of controlled substance listed in Schedule I or II, and who
applies for a manufacturing quota, an individual manufacturing quota
authorizing that person to manufacture during the next calendar year a
quantity of that basic class. Any manufacturing quota fixed and issued
by the Administrator shall be subject to his authority to reduce or
limit it at a later date pursuant to Sec. 1303.26 and to his authority
to revoke or suspend it at any time pursuant to Sec. Sec. 1301.36 of
this chapter.
(b) No individual manufacturing quota shall be required for
registrants listed in Sec. 1303.12(e).
[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
as amended at 62 FR 13958, Mar. 24, 1997]
Sec. 1303.22 Procedure for applying for individual manufacturing quotas.
Any person who is registered to manufacture any basic class of
controlled substance listed in Schedule I or II and who desires to
manufacture a quantity of such class shall apply on DEA Form 189 for a
manufacturing quota for such quantity of such class. Copies of DEA Form
189 may be obtained from, and shall be filed (on or before May 1 of the
year preceding the calendar year for which the manufacturing quota is
being applied) with, the Drug & Chemical Evaluation Section, Drug
Enforcement Administration, Department of Justice, Washington, D.C.
20537. A separate application must be made for each basic class desired
to be manufactured. The applicant shall state:
(a) The name and Administration Controlled Substances Code Number,
as set forth in part 1308 of this chapter, of the basic class.
(b) For the basic class in each of the current and preceding 2
calendar years,
(1) The authorized individual manufacturing quota, if any;
(2) The actual or estimated quantity manufactured;
(3) The actual or estimated net disposal;
(4) The actual or estimated inventory allowance pursuant to Sec.
1303.24; and
(5) The actual or estimated inventory as of December 31;
(c) For the basic class in the next calendar year,
(1) The desired individual manufacturing quota; and
(2) Any additional factors which the applicant finds relevant to the
fixing of his individual manufacturing quota, including the trend of
(and recent changes in) his and the national rates of net disposal, his
production cycle and current inventory position, the econolic and
physical availability of raw materials for use in manufacturing and for
inventory purposes, yield and stability problems, potential disruptions
to production (including possible labor strikes) and recent unforeseen
emergencies such as floods and fires.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 37
FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and
amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR
13958, Mar. 24, 1997]
Sec. 1303.23 Procedure for fixing individual manufacturing quotas.
(a) In fixing individual manufacturing quotas for a basic class of
controlled substance listed in Schedule I or II, the Administrator shall
allocate to each applicant who is currently manufacturing such class a
quota equal to 100 percent of the estimated net disposal of that
applicant for the next calendar year, adjusted--
(1) By the amount necessary to increase or reduce the estimated
inventory of the applicant on December 31 of 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
[[Page 53]]
manufacturing and for inventory purposes, yield and stability problems,
potential disruptions to production (including possible labor strikes),
and recent unforeseen emergencies such as floods and fires.
(b) In fixing individual manufacturing quotas for a basic class of
controlled substance listed in Schedule I or II, the Administrator shall
allocate to each applicant who is not currently manufacturing such class
a quota equal to 100 percent of the reasonably estimated net disposal of
that applicant for the next calendar year, as determined by the
Administrator, adjusted--
(1) By the amount necessary to provide the applicant his estimated
inventory allowance for the next calendar year, pursuant to Sec.
1303.24, and
(2) By any other factors which the Administrator deems relevant to
the fixing of the individual manufacturing quota of the applicant,
including the trend of (and recent changes in) the national rate of net
disposal, his production cycle and current inventory position, the
economic and physical availability of raw materials for use in
manufacturing and for inventory purposes, yield and stability problems,
potential disruptions to production (including possible labor strikes),
and recent unforeseen emergencies such as floods and fires.
(c) The Administrator shall, on or before March 1 of each year,
adjust the individual manufacturing quota allocated for that year to
each applicant in paragraph (a) of this section by the amount necessary
to increase or reduce the actual inventory of the applicant to December
31 of the preceding year to his estimated inventory allowance for the
current calendar year, pursuant to Sec. 1303.24.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.24 Inventory allowance.
(a) For the purpose of determining individual manufacturing quotas
pursuant to Sec. 1303.23, each registered manufacturer shall be allowed
as a part of such quota an amount sufficient to maintain an inventory
equal to,
(1) For current manufacturers, 50 percent of his average estimated
net disposal for the current calendar year and the last preceding
calendar year; or
(2) For new manufacturers, 50 percent of his reasonably estimated
net disposal for the next calendar year as determined by the
Administrator.
(b) During each calendar year each registered manufacturer shall be
allowed to maintain an inventory of a basic class not exceeding 65
percent of his estimated net disposal of that class for that year, as
determined at the time his quota for that year was determined. At any
time the inventory of a basic class held by a manufacturer exceeds 65
percent of his estimated net disposal, his quota for that class is
automatically suspended and shall remain suspended until his inventory
is less than 60 percent of his estimated net disposal. The Administrator
may, upon application and for good cause shown, permit a manufacturer
whose quota is, or is likely to be, suspended pursuant to this paragraph
to continue manufacturing and to accumulate an inventory in excess of 65
percent of his estimated net disposal, upon such conditions and within
such limitations as the Administrator may find necessary or desirable.
(c) If, during a calendar year, a registrant has manufactured the
entire quantity of a basic class allocated to him under an individual
manufacturing quota, and his inventory of that class is less than 40
percent of his estimated net disposal of that class for that year, the
Administrator may, upon application pursuant to Sec. 1303.25, increase
the quota of such registrant sufficiently to allow restoration of the
inventory to 50 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
[[Page 54]]
estimated net disposal, inventory and other requirements during the
remainder of such calendar year.
(b) The Administrator, in passing upon a registrant's application
for an increase in his individual manufacturing quota, shall take into
consideration any occurrences since the filing of such registrant's
initial quota application that may require an increased manufacturing
rate by such registrant during the balance of the calendar year. In
passing upon such application the Administrator may also take into
consideration the amount, if any, by which his determination of the
total quantity for the basic class of controlled substance to be
manufactured under Sec. 1303.11 exceeds the aggregate of all the
individual manufacturing quotas for the basic class of controlled
substance, and the equitable distribution of such excess among other
registrants.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.26 Reduction in individual manufacturing quotas.
The Administrator may at any time reduce an individual manufacturing
quota for a basic class of controlled substance listed in Schedule I or
II which he has previously fixed in order to prevent the aggregate of
the individual manufacturing quotas and import permits outstanding or to
be granted from exceeding the aggregate production quota which has been
established for that class pursuant of Sec. 1303.11, as adjusted
pursuant to Sec. 1303.13. If a quota assigned to a new manufacturer
pursuant to Sec. 1303.23(b), or if a quota assigned to any manufacturer
is increased pursuant to Sec. 1303.24(c), or if an import permit issued
to an importer pursuant to part 1312 of this chapter, causes the total
quantity of a basic class to be manufactured and imported during the
year to exceed the aggregate production quota which has been established
for that class pursuant to Sec. 1303.11, as adjusted pursuant to Sec.
1303.13, the Administrator may proportionately reduce the individual
manufacturing quotas and import permits of all other registrants to keep
the aggregate production quota within the limits originally established,
or, alternatively, the Administrator may reduce the individual
manufacturing quota of any registrant whose quota is suspended pursuant
to Sec. 1303.24(b) or Sec. 1301.36 of this chapter, or is abandoned
pursuant to Sec. 1303.27.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958,
Mar. 24, 1997]
Sec. 1303.27 Abandonment of quota.
Any manufacturer assigned an individual manufacturing quota for any
basic class pursuant to Sec. 1303.23 may at any time abandon his right
to manufacture all or any part of such quota by filing with the Drug &
Chemical Evaluation Section a written notice of such abandonment,
stating the name and Administration Controlled Substances Code Number,
as set forth in part 1308 of this chapter, of the substance and the
amount which he has chosen not to manufacture. The Administrator may, in
his discretion, allocate such amount among the other manufacturers in
proportion to their respective quotas.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841,
May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Mar. 24, 1997]
Hearings
Sec. 1303.31 Hearings generally.
(a) In any case where the Administrator shall hold a hearing
regarding the determination of an aggregate production quota pursuant to
Sec. 1303.11(c), or regarding the adjustment of an aggregate production
quota pursuant to Sec. 1303.13(c), the procedures for such hearing
shall be governed generally by the rule making procedures set forth in
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
section 306 of the Act (21 U.S.C. 826), by Sec. Sec. 1303.32-1303.37,
and by the procedures for administrative hearings under the Act set
forth in Sec. Sec. 1316.41-1316.67 of this chapter.
(b) In any case where the Administrator shall hold a hearing
regarding the issuance, adjustment, suspension,
[[Page 55]]
or denial of a procurement quota pursuant to Sec. 1303.12, or the
issuance, adjustment, suspension, or denial of an individual
manufacturing quota pursuant to Sec. Sec. 1303.21-1303.27, the
procedures for such hearing shall be governed generally by the
adjudication procedures set forth in the Administrative Procedures Act
(5 U.S.C. 551-559) and specifically by section 306 of the Act (21 U.S.C.
826), by Sec. Sec. 1303.32-1303.37, and by the procedures for
administrative hearings under the Act set forth in Sec. Sec. 1316.41-
1316.67 of this chapter.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.32 Purpose of hearing.
(a) The Administrator may, in his sole discretion, hold a hearing
for the purpose of receiving factual evidence regarding any one or more
issues (to be specified by him) involved in the determination or
adjustment of any aggregate production quota.
(b) If requested by a person applying for or holding a procurement
quota or an individual manufacturing quota, the Administrator shall hold
a hearing for the purpose of receiving factual evidence regarding the
issues involved in the issuance, adjustment, suspension, or denial of
such quota to such person, but the Administrator need not hold a hearing
on the suspension of a quota pursuant to Sec. 1301.36 of this chapter
separate from a hearing on the suspension of registration pursuant to
those sections.
(c) Extensive argument should not be offered into evidence but
rather presented in opening or closing statements of counsel or in
memoranda or proposed findings of fact and conclusions of law.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958,
Mar. 24, 1997]
Sec. 1303.33 Waiver or modification of rules.
The Administrator or the presiding officer (with respect to matters
pending before him) may modify or waive any rule in this part by notice
in advance of the hearing, if he determines that no party in the hearing
will be unduly prejudiced and the ends of justice will thereby be
served. Such notice of modification or waiver shall be made a part of
the record of the hearing.
[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.34 Request for hearing or appearance; waiver.
(a) Any applicant or registrant who desires a hearing on the
issuance, adjustment, suspension, or denial of his procurement and/or
individual manufacturing quota shall, within 30 days after the date of
receipt of the issuance, adjustment, suspension, or denial of such
quota, file with the Administrator a written request for a hearing in
the form prescribed in Sec. 1316.47 of this chapter. Any interested
person who desires a hearing on the determination of an aggregate
production quota shall, within the time prescribed in Sec. 1303.11(c),
file with the Administrator a written request for a hearing in the form
prescribed in Sec. 1316.47 of this chapter, including in the request a
statement of the grounds for a hearing.
(b) Any interested person who desires to participate in a hearing on
the determination or adjustment of an aggregate production quota, which
hearing is ordered by the Administrator pursuant to Sec. 1303.11(c) or
Sec. 1303.13(c) may do so by filing with the Administrator, within 30
days of the date of publication of notice of the hearing in the Federal
Register, a written notice of his intention to participate in such
hearing in the form prescribed in Sec. 1316.48 of this chapter.
(c) Any person entitled to a hearing or to participate in a hearing
pursuant to paragraph (b) of this section, may, 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.
[[Page 56]]
(d) If any person entitled to a hearing or to participate in a
hearing pursuant to paragraph (b) of this section, fails to file a
request for a hearing or notice of appearance, or if he so files and
fails to appear at the hearing, he shall be deemed to have waived his
opportunity for the hearing or to participate in the hearing, unless he
shows good cause for such failure.
(e) If all persons entitled to a hearing or to participate in a
hearing waive or are deemed to waive their opportunity for the hearing
or to participate in the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his final order pursuant to Sec.
1303.37 without a hearing.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971;
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.35 Burden of proof.
(a) At any hearing regarding the determination or adjustment of an
aggregate production quota, each interested person participating in the
hearing shall have the burden of proving any propositions of fact or law
asserted by him in the hearing.
(b) At any hearing regarding the issuance, adjustment, suspension,
or denial of a procurement or individual manufacturing quota, the
Administration shall have the burden of proving that the requirements of
this part for such issuance, adjustment, suspension, or denial are
satisfied.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958,
Mar. 24, 1997]
Sec. 1303.36 Time and place of hearing.
(a) If any applicant or registrant requests a hearing on the
issuance, adjustment, suspension, or denial of his procurement and/or
individual manufacturing quota pursuant to Sec. 1303.34, the
Administrator shall hold such hearing. Notice of the hearing shall be
given to the applicant or registrant of the time and place at least 30
days prior to the hearing, unless the applicant or registrant waives
such notice and requests the hearing be held at an earlier time, in
which case the Administrator shall fix a date for such hearing as early
as reasonably possible.
(b) The hearing will commence at the place and time designated in
the notice given pursuant to paragraph (a) of this section or in the
notice of hearing published in the Federal Register pursuant to Sec.
1303.11(c) or Sec. 1303.13 (c), but thereafter it may be moved to a
different place and may be continued from day to day or recessed to a
later day without notice other than announcement thereof by the
presiding officer at the hearing.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.37 Final order.
As soon as practicable after the presiding officer has certified the
record to the Administrator, the Administrator shall issue his order on
the determination or adjustment of the aggregate production quota or on
the issuance, adjustment, suspension, or denial of the procurement quota
or individual manufacturing quota, as case may be. The order shall
include the findings of fact and conclusions of law upon which the order
is based. The order shall specify the date on which it shall take
effect. The Administrator shall serve one copy of his order upon each
party in the hearing.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973]
PART 1304_RECORDS AND REPORTS OF REGISTRANTS--Table of Contents
General Information
Sec.
1304.01 Scope of part 1304.
1304.02 Definitions.
1304.03 Persons required to keep records and file reports.
1304.04 Maintenance of records and inventories.
1304.05 Records of authorized central fill pharmacies and retail
pharmacies.
Inventory Requirements
1304.11 Inventory requirements.
Continuing Records
1304.21 General requirements for continuing records.
[[Page 57]]
1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers, and exporters.
1304.23 Records for chemical analysts.
1304.24 Records for maintenance treatment programs and detoxification
treatment programs.
1304.25 Records for treatment programs which compound narcotics for
treatment programs and other locations.
1304.26 Additional recordkeeping requirements applicable to drug
products containing gamma-hydroxybutyric acid.
Reports
1304.31 Reports from manufacturers importing narcotic raw material.
1304.32 Reports of manufacturers importing coca leaves.
1304.33 Reports to ARCOS.
Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965, unless otherwise
noted.
General Information
Sec. 1304.01 Scope of part 1304.
Inventory and other records and reports required under section 307
or section 1008(d) of the Act (21 U.S.C. 827 and 958(d)) shall be in
accordance with, and contain the information required by, those sections
and by the sections of this part.
[36 FR 7789, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1304.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13958, Mar. 24, 1997]
Sec. 1304.03 Persons required to keep records and file reports.
(a) Each registrant shall maintain the records and inventories and
shall file the reports required by this part, except as exempted by this
section. Any registrant who is authorized to conduct other activities
without being registered to conduct those activities, either pursuant to
Sec. 1301.22(b) of this chapter or pursuant to Sec. Sec. 1307.11-
1307.15 of this chapter, shall maintain the records and inventories and
shall file the reports required by this part for persons registered to
conduct such activities. This latter requirement should not be construed
as requiring stocks of controlled substances being used in various
activities under one registration to be stored separately, nor that
separate records are required for each activity. The intent of the
Administration is to permit the registrant to keep one set of records
which are adapted by the registrant to account for controlled substances
used in any activity. Also, the Administration does not wish to acquire
separate stocks of the same substance to be purchased and stored for
separate activities. Otherwise, there is no advantage gained by
permitting several activities under one registration. Thus, when a
researcher manufactures a controlled item, he must keep a record of the
quantity manufactured; when he distributes a quantity of the item, he
must use and keep invoices or order forms to document the transfer; when
he imports a substance, he keeps as part of his records the
documentation required of an importer; and when substances are used in
chemical analysis, he need not keep a record of this because such a
record would not be required of him under a registration to do chemical
analysis. All of these records may be maintained in one consolidated
record system. Similarly, the researcher may store all of his controlled
items in one place, and every two years take inventory of all items on
hand, regardless of whether the substances were manufactured by him,
imported by him, or purchased domestically by him, of whether the
substances will be administered to subjects, distributed to other
researchers, or destroyed during chemical analysis.
(b) A registered individual practitioner is required to keep
records, as described in Sec. 1304.04, of controlled substances in
Schedules II, III, IV, and V which are dispensed, other than by
prescribing or administering in the lawful course of professional
practice.
(c) A registered individual practitioner is not required to keep
records of controlled substances in Schedules II, III, IV, and V which
are prescribed in the lawful course of professional practice, unless
such substances are prescribed in the course of maintenance or
detoxification treatment of an individual.
[[Page 58]]
(d) A registered individual practitioner is not required to keep
records of controlled substances listed in Schedules II, III, IV and V
which are administered in the lawful course of professional practice
unless the practitioner regularly engages in the dispensing or
administering of controlled substances and charges patients, either
separately or together with charges for other professional services, for
substances so dispensed or administered. Records are required to be kept
for controlled substances administered in the course of maintenance or
detoxification treatment of an individual.
(e) Each registered mid-level practitioner shall maintain in a
readily retrievable manner those documents required by the state in
which he/she practices which describe the conditions and extent of his/
her authorization to dispense controlled substances and shall make such
documents available for inspection and copying by authorized employees
of the Administration. Examples of such documentation include protocols,
practice guidelines or practice agreements.
(f) Registered persons using any controlled substances while
conducting preclinical research, in teaching at a registered
establishment which maintains records with respect to such substances or
conducting research in conformity with an exemption granted under
section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i) or 360b(j)) at a registered establishment which maintains
records in accordance with either of those sections, are not required to
keep records if he/she notifies the Administration of the name, address,
and registration number of the establishment maintaining such records.
This notification shall be given at the time the person applies for
registration or reregistration and shall be made in the form of an
attachment to the application, which shall be filed with the
application.
(g) A distributing registrant who utilizes a freight forwarding
facility shall maintain records to reflect transfer of controlled
substances through the facility. These records must contain the date,
time of transfer, number of cartons, crates, drums or other packages in
which commercial containers of controlled substances are shipped and
authorized signatures for each transfer. A distributing registrant may,
as part of the initial request to operate a freight forwarding facility,
request permission to store records at a central location. Approval of
the request to maintain central records would be implicit in the
approval of the request to operate the facility. Otherwise, a request to
maintain records at a central location must be submitted in accordance
with Sec. 1304.04 of this part. These records must be maintained for a
period of two years.
[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971;
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 50 FR 40523, Oct. 4, 1985; 51 FR 5320, Feb. 13, 1986; 51
FR 26154, July 21, 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, Mar.
24, 1997; 65 FR 44679, July 19, 2000]
Sec. 1304.04 Maintenance of records and inventories.
(a) 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 Sec. Sec. 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 59]]
(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.
(b) All registrants that are authorized to maintain a central
recordkeeping system shall be subject to the following conditions:
(1) The records to be maintained at the central record location
shall not include executed order forms, prescriptions and/or inventories
which shall be maintained at each registered location.
(2) If the records are kept on microfilm, computer media or in any
form requiring special equipment to render the records easily readable,
the registrant shall provide access to such equipment with the records.
If any code system is used (other than pricing information), a key to
the code shall be provided to make the records understandable.
(3) The registrant agrees to deliver all or any part of such records
to the registered location within two business days upon receipt of a
written request from the Administration for such records, and if the
Administration chooses to do so in lieu of requiring delivery of such
records to the registered location, to allow authorized employees of the
Administration to inspect such records at the central location upon
request by such employees without a warrant of any kind.
(4) In the event that a registrant fails to comply with these
conditions, the Special Agent in Charge may cancel such central
recordkeeping authorization, and all other central recordkeeping
authorizations held by the registrant without a hearing or other
procedures. In the event of a cancellation of central recordkeeping
authorizations under this paragraph the registrant shall, within the
time specified by the Special Agent in Charge, comply with the
requirements of this section that all records be kept at the registered
location.
(c) Registrants need not notify the Special Agent in Charge or
obtain central recordkeeping approval in order to maintain records on an
in-house computer system.
(d) ARCOS participants who desire authorization to report from other
than their registered locations must obtain a separate central reporting
identifier. Request for central reporting identifiers will be submitted
to: ARCOS Unit, P.O. Box 28293, Central Station, Washington, DC 20005.
(e) All central recordkeeping permits previously issued by the
Administration expired September 30, 1980.
(f) Each registered manufacturer, distributor, importer, exporter,
narcotic treatment program and compounder for narcotic treatment program
shall maintain inventories and records of controlled substances as
follows:
(1) Inventories and records of controlled substances listed in
Schedules I and II shall be maintained separately from all of the
records of the registrant; and
(2) Inventories and records of controlled substances listed in
Schedules III, IV, and V shall be maintained either separately from all
other records of the registrant or in such form that the information
required is readily retrievable from the ordinary business records of
the registrant.
(g) Each registered individual practitioner required to keep records
and institutional practitioner shall maintain inventories and records of
controlled substances in the manner prescribed in paragraph (f) of this
section.
(h) Each registered pharmacy shall maintain the inventories and
records of controlled substances as follows:
(1) Inventories and records of all controlled substances listed in
Schedules I and II shall be maintained separately from all other records
of the pharmacy, and prescriptions for such substances shall be
maintained in a separate prescription file; and
(2) Inventories and records of controlled substances listed in
Schedules
[[Page 60]]
III, IV, and V shall be maintained either separately from all other
records of the pharmacy or in such form that the information required is
readily retrievable from ordinary business records of the pharmacy, and
prescriptions for such substances shall be maintained either in a
separate prescription file for controlled substances listed in Schedules
III, IV, and V only or in such form that they are readily retrievable
from the other prescription records of the pharmacy. Prescriptions will
be deemed readily retrievable if, at the time they are initially filed,
the face of the prescription is stamped in red ink in the lower right
corner with the letter ``C'' no less than 1 inch high and filed either
in the prescription file for controlled substances listed in Schedules I
and II or in the usual consecutively numbered prescription file for non-
controlled substances. However, if a pharmacy employs an ADP system or
other electronic recordkeeping system for prescriptions which permits
identification by prescription number and retrieval of original
documents by prescriber's name, patient's name, drug dispensed, and date
filled, then the requirement to mark the hard copy prescription with a
red ``C'' is waived.
(Authority: 21 U.S.C. 821 and 871(b); 28 CFR 0.100)
[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 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]
Sec. 1304.05 Records of authorized central fill pharmacies and retail
pharmacies.
(a) Every retail pharmacy that utilizes the services of a central
fill pharmacy must keep a record of all central fill pharmacies,
including name, address and DEA number, that are authorized to fill
prescriptions on its behalf. The retail pharmacy must also verify the
registration for each central fill pharmacy authorized to fill
prescriptions on its behalf. These records must be made available upon
request for inspection by DEA.
(b) Every central fill pharmacy must keep a record of all retail
pharmacies, including name, address and DEA number, for which it is
authorized to fill prescriptions. The central fill pharmacy must also
verify the registration for all retail pharmacies for which it is
authorized to fill prescriptions. These records must be made available
upon request for inspection by DEA.
[68 FR 37410, June 24, 2003]
Inventory Requirements
Sec. 1304.11 Inventory requirements.
(a) General requirements. Each inventory shall contain a complete
and accurate record of all controlled substances on hand on the date the
inventory is taken, and shall be maintained in written, typewritten, or
printed form at the registered location. An inventory taken by use of an
oral recording device must be promptly transcribed. Controlled
substances shall be deemed to be ``on hand'' if they are in the
possession of or under the control of the registrant, including
substances returned by a customer, ordered by a customer but not yet
invoiced, stored in a warehouse on behalf of the registrant, and
substances in the possession of employees of the registrant and intended
for distribution as complimentary samples. A separate inventory shall be
made for each registered location and each independent activity
registered, except as provided in paragraph (e)(4) of this section. In
the event controlled substances in the possession or under the control
of the registrant are stored at a location for which he/she is not
registered, the substances shall be included in the inventory of the
registered location to which they are subject to control or to which the
person possessing the substance is responsible. The inventory may be
taken either as of opening of business or as of the close of business on
the inventory date and it shall be indicated on the inventory.
(b) Initial inventory date. Every person required to keep records
shall take an inventory of all stocks of controlled substances on hand
on the date he/she first engages in the manufacture, distribution, or
dispensing of controlled substances, in accordance with paragraph (e) of
this section as applicable.
[[Page 61]]
In the event a person commences business with no controlled substances
on hand, he/she shall record this fact as the initial inventory.
(c) Biennial inventory date. After the initial inventory is taken,
the registrant shall take a new inventory of all stocks of controlled
substances on hand at least every two years. The biennial inventory may
be taken on any date which is within two years of the previous biennial
inventory date.
(d) Inventory date for newly controlled substances. On the effective
date of a rule by the Administrator pursuant to Sec. Sec. 1308.45,
1308.46, or 1308.47 of this chapter adding a substance to any schedule
of controlled substances, which substance was, immediately prior to that
date, not listed on any such schedule, every registrant required to keep
records who possesses that substance shall take an inventory of all
stocks of the substance on hand. Thereafter, such substance shall be
included in each inventory made by the registrant pursuant to paragraph
(c) of this section.
(e) Inventories of manufacturers, distributors, dispensers,
researchers, importers, exporters and chemical analysts. Each person
registered or authorized (by Sec. 1301.13 or Sec. Sec. 1307.11-1307.13
of this chapter) to manufacture, distribute, dispense, import, export,
conduct research or chemical analysis with controlled substances and
required to keep records pursuant to Sec. 1304.03 shall include in the
inventory the information listed below.
(1) Inventories of manufacturers. Each person registered or
authorized to manufacture controlled substances shall include the
following information in the inventory:
(i) For each controlled substance in bulk form to be used in (or
capable of use in) the manufacture of the same or other controlled or
non-controlled substances in finished form, the inventory shall include:
(A) The name of the substance and
(B) The total quantity of the substance to the nearest metric unit
weight consistent with unit size.
(ii) For each controlled substance in the process of manufacture on
the inventory date, the inventory shall include:
(A) The name of the substance;
(B) The quantity of the substance in each batch and/or stage of
manufacture, identified by the batch number or other appropriate
identifying number; and
(C) The physical form which the substance is to take upon completion
of the manufacturing process (e.g., granulations, tablets, capsules, or
solutions), identified by the batch number or other appropriate
identifying number, and if possible the finished form of the substance
(e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce
or milliliter) and the number or volume thereof.
(iii) For each controlled substance in finished form the inventory
shall include:
(A) The name of the substance;
(B) Each finished form of the substance (e.g., 10-milligram tablet
or 10-milligram concentration per fluid ounce or milliliter);
(C) The number of units or volume of each finished form in each
commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
(D) The number of commercial containers of each such finished form
(e.g. four 100-tablet bottles or six 3-milliliter vials).
(iv) For each controlled substance not included in paragraphs (e)(1)
(i), (ii) or (iii) of this section (e.g., damaged, defective or impure
substances awaiting disposal, substances held for quality control
purposes, or substances maintained for extemporaneous compoundings) the
inventories shall include:
(A) The name of the substance;
(B) The total quantity of the substance to the nearest metric unit
weight or the total number of units of finished form; and
(C) The reason for the substance being maintained by the registrant
and whether such substance is capable of use in the manufacture of any
controlled substance in finished form.
(2) Inventories of distributors. Except for reverse distributors
covered by paragraph (e)(3) of this section, each
[[Page 62]]
person registered or authorized to distribute controlled substances
shall include in the inventory the same information required of
manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this
section.
(3) Inventories of dispensers, researchers, and reverse
distributors. Each person registered or authorized to dispense, conduct
research, or act as a reverse distributor with controlled substances
shall include in the inventory the same information required of
manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this
section. In determining the number of units of each finished form of a
controlled substance in a commercial container which has been opened,
the dispenser, researcher, or reverse distributor shall do as follows:
(i) If the substance is listed in Schedule I or II, make an exact
count or measure of the contents, or
(ii) If the substance is listed in Schedule III, IV or V, make an
estimated count or measure of the contents, unless the container holds
more than 1,000 tablets or capsules in which case he/she must make an
exact count of the contents.
(4) Inventories of importers and exporters. Each person registered
or authorized to import or export controlled substances shall include in
the inventory the same information required of manufacturers pursuant to
paragraphs (e)(1) (iii) and (iv) of this section. Each such person who
is also registered as a manufacturer or as a distributor shall include
in his/her inventory as an importer or exporter only those stocks of
controlled substances that are actually separated from his stocks as a
manufacturer or as a distributor (e.g., in transit or in storage for
shipment).
(5) Inventories of chemical analysts. Each person registered or
authorized to conduct chemical analysis with controlled substances shall
include in his inventory the same information required of manufacturers
pursuant to paragraphs (e)(1) (iii) and (iv) of this section as to
substances which have been manufactured, imported, or received by such
person. If less than 1 kilogram of any controlled substance (other than
a hallucinogenic controlled substance listed in Schedule I), or less
than 20 grams of a hallucinogenic substance listed in Schedule I (other
than lysergic acid diethylamide), or less than 0.5 gram of lysergic acid
diethylamide, is on hand at the time of inventory, that substance need
not be included in the inventory. Laboratories of the Administration may
possess up to 150 grams of any hallucinogenic substance in Schedule I
without regard to a need for an inventory of those substances. No
inventory is required of known or suspected controlled substances
received as evidentiary materials for analysis.
[62 FR 13959, Mar. 24, 1997, as amended at 68 FR 41228, July 11, 2003]
Continuing Records
Sec. 1304.21 General requirements for continuing records.
(a) Every registrant required to keep records pursuant to Sec.
1304.03 shall maintain on a current basis a complete and accurate record
of each such substance manufactured, imported, received, sold,
delivered, exported, or otherwise disposed of by him/her, except that no
registrant shall be required to maintain a perpetual inventory.
(b) Separate records shall be maintained by a registrant for each
registered location except as provided in Sec. 1304.04 (a). In the
event controlled substances are in the possession or under the control
of a registrant at a location for which he is not registered, the
substances shall be included in the records of the registered location
to which they are subject to control or to which the person possessing
the substance is responsible.
(c) Separate records shall be maintained by a registrant for each
independent activity for which he/she is registered, except as provided
in Sec. 1304.22(d).
(d) In recording dates of receipt, importation, distribution,
exportation, or other transfers, the date on which the controlled
substances are actually received, imported, distributed, exported, or
otherwise transferred shall be used as the date of receipt or
distribution of
[[Page 63]]
any documents of transfer (e.g., invoices or packing slips).
[36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13960,
Mar. 24, 1997]
Sec. 1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers and exporters.
Each person registered or authorized (by Sec. 1301.13(e) or
Sec. Sec. 1307.11-1307.13 of this chapter) to manufacture, distribute,
dispense, import, export or conduct research with controlled substances
shall maintain records with the information listed below.
(a) Records for manufacturers. Each person registered or authorized
to manufacture controlled substances shall maintain records with the
following information:
(1) For each controlled substance in bulk form to be used in, or
capable of use in, or being used in, the manufacture of the same or
other controlled or noncontrolled substances in finished form,
(i) The name of the substance;
(ii) The quantity manufactured in bulk form by the registrant,
including the date, quantity and batch or other identifying number of
each batch manufactured;
(iii) The quantity received from other persons, including the date
and quantity of each receipt and the name, address, and registration
number of the other person from whom the substance was received;
(iv) The quantity imported directly by the registrant (under a
registration as an importer) for use in manufacture by him/her,
including the date, quantity, and import permit or declaration number
for each importation;
(v) The quantity used to manufacture the same substance in finished
form, including:
(A) The date and batch or other identifying number of each
manufacture;
(B) The quantity used in the manufacture;
(C) The finished form (e.g., 10-milligram tablets or 10-milligram
concentration per fluid ounce or milliliter);
(D) The number of units of finished form manufactured;
(E) The quantity used in quality control;
(F) The quantity lost during manufacturing and the causes therefore,
if known;
(G) The total quantity of the substance contained in the finished
form;
(H) The theoretical and actual yields; and
(I) Such other information as is necessary to account for all
controlled substances used in the manufacturing process;
(vi) The quantity used to manufacture other controlled and
noncontrolled substances, including the name of each substance
manufactured and the information required in paragraph (a)(1)(v) of this
section;
(vii) The quantity distributed in bulk form to other persons,
including the date and quantity of each distribution and the name,
address, and registration number of each person to whom a distribution
was made;
(viii) The quantity exported directly by the registrant (under a
registration as an exporter), including the date, quantity, and export
permit or declaration number of each exportation;
(ix) The quantity distributed or disposed of in any other manner by
the registrant (e.g., by distribution of complimentary samples or by
destruction), including the date and manner of distribution or disposal,
the name, address, and registration number of the person to whom
distributed, and the quantity distributed or disposed; and
(x) The originals of all written certifications of available
procurement quotas submitted by other persons (as required by Sec.
1303.12(f) of this chapter) relating to each order requiring the
distribution of a basic class of controlled substance listed in Schedule
I or II.
(2) For each controlled substance in finished form,
(i) The name of the substance;
(ii) Each finished form (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter) and the number of units or
volume of finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial);
(iii) The number of containers of each such commercial finished form
[[Page 64]]
manufactured from bulk form by the registrant, including the information
required pursuant to paragraph (a)(1)(v) of this section;
(iv) The number of units of finished forms and/or commercial
containers acquired from other persons, including the date of and number
of units and/or commercial containers in each acquisition to inventory
and the name, address, and registration number of the person from whom
the units were acquired;
(v) The number of units of finished forms and/or commercial
containers imported directly by the person (under a registration or
authorization to import), including the date of, the number of units
and/or commercial containers in, and the import permit or declaration
number for, each importation;
(vi) The number of units and/or commercial containers manufactured
by the registrant from units in finished form received from others or
imported, including:
(A) The date and batch or other identifying number of each
manufacture;
(B) The operation performed (e.g., repackaging or relabeling);
(C) The number of units of finished form used in the manufacture,
the number manufactured and the number lost during manufacture, with the
causes for such losses, if known; and
(D) Such other information as is necessary to account for all
controlled substances used in the manufacturing process;
(vii) The number of commercial containers distributed to other
persons, including the date of and number of containers in each
reduction from inventory, and the name, address, and registration number
of the person to whom the containers were distributed; (viii) The number
of commercial containers exported directly by the registrant (under a
registration as an exporter), including the date, number of containers
and export permit or declaration number for each exportation; and
(ix) The number of units of finished forms and/or commercial
containers distributed or disposed of in any other manner by the
registrant (e.g., by distribution of complimentary samples or by
destruction), including the date and manner of distribution or disposal,
the name, address, and registration number of the person to whom
distributed, and the quantity in finished form distributed or disposed.
(b) Records for distributors. Except as provided in paragraph (e) of
this section, each person registered or authorized to distribute
controlled substances shall maintain records with the same information
required of manufacturers pursuant to paragraphs (a)(2)(i), (ii), (iv),
(v), (vii), (viii) and (ix) of this section.
(c) Records for dispensers and researchers. Each person registered
or authorized to dispense or conduct research with controlled substances
shall maintain records with the same information required of
manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and
(ix) of this section. In addition, records shall be maintained of the
number of units or volume of such finished form dispensed, including the
name and address of the person to whom it was dispensed, the date of
dispensing, the number of units or volume dispensed, and the written or
typewritten name or initials of the individual who dispensed or
administered the substance on behalf of the dispenser. In addition to
the requirements of this paragraph, practitioners dispensing gamma-
hydroxybutyric acid under a prescription must also comply with Sec.
1304.26.
(d) Records for importers and exporters. Each person registered or
authorized to import or export controlled substances shall maintain
records with the same information required of manufacturers pursuant to
paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In addition,
the quantity disposed of in any other manner by the registrant (except
quantities used in manufacturing by an importer under a registration as
a manufacturer), which quantities are to be recorded pursuant to
paragraphs (a)(1) (iv) and (v) of this section; and the quantity (or
number of units or volume in finished form) exported, including the
date, quantity (or number of units or volume), and the export permit or
declaration number for each exportation, but excluding all quantities
(and number of units and volumes) manufactured by an exporter under a
[[Page 65]]
registration as a manufacturer, which quantities (and numbers of units
and volumes) are to be recorded pursuant to paragraphs (a)(1)(xiii) or
(a)(2)(xiii) of this section.
(e) Records for reverse distributors. Each person registered to
distribute controlled substances as a reverse distributor shall maintain
records with the following information for each controlled substance:
(1) For each controlled substance in bulk form the following:
(i) The name of the controlled substance.
(ii) The total quantity of the controlled substance to the nearest
metric unit weight consistent with unit size.
(iii) The quantity received from other persons, including the date
and quantity of each receipt and the name, address, and registration
number of the other person from whom the controlled substance was
received.
(iv) The quantity returned to the original manufacturer of the
controlled substance or the manufacturer's agent, including the date of
and quantity of each distribution and the name, address and registration
number of the manufacturer or manufacturer's agent to whom the
controlled substance was distributed.
(v) The quantity disposed of including the date and manner of
disposal and the signatures of two responsible employees of the
registrant who witnessed the disposal.
(2) For each controlled substance in finished form the following:
(i) The name of the substance.
(ii) Each finished form (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter) and the number of units or
volume of finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial).
(iii) The number of commercial containers of each such finished form
received from other persons, including the date of and number of
containers in each receipt and the name, address, and registration
number of the person from whom the containers were received.
(iv) The number of commercial containers of each such finished form
distributed back to the original manufacturer of the substance or the
manufacturer's agent, including the date of and number of containers in
each distribution and the name, address, and registration number of the
manufacturer or manufacturer's agent to whom the containers were
distributed.
(v) The number of units or volume of finished forms and/or
commercial containers disposed of including the date and manner of
disposal, the quantity of the substance in finished form disposed, and
the signatures of two responsible employees of the registrant who
witnessed the disposal.
[62 FR 13960, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003;
70 FR 293, Jan. 4, 2005]
Sec. 1304.23 Records for chemical analysts.
(a) Each person registered or authorized (by Sec. 1301.22(b) of
this chapter) to conduct chemical analysis with controlled substances
shall maintain records with the following information (to the extent
known and reasonably ascertainable by him) for each controlled
substance:
(1) The name of the substance;
(2) The form or forms in which the substance is received, imported,
or manufactured by the registrant (e.g., powder, granulation, tablet,
capsule, or solution) and the concentration of the substance in such
form (e.g., C.P., U.S.P., N.F., 10-milligram tablet or 10-milligram
concentration per milliliter);
(3) The total number of the forms received, imported or manufactured
(e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder),
including the date and quantity of each receipt, importation, or
manufacture and the name, address, and registration number, if any, of
the person from whom the substance was received;
(4) The quantity distributed, exported, or destroyed in any manner
by the registrant (except quantities used in chemical analysis or other
laboratory work), including the date and manner of distribution,
exportation, or destruction, and the name, address, and registration
number, if any, of each person to whom the substance was distributed or
exported.
[[Page 66]]
(b) Records of controlled substances used in chemical analysis or
other laboratory work are not required.
(c) Records relating to known or suspected controlled substances
received as evidentiary material for analysis are not required under
paragraph (a) of this section.
[36 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36
FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated at 62 FR 13961, Mar. 24, 1997]
Sec. 1304.24 Records for maintenance treatment programs and
detoxification treatment programs.
(a) Each person registered or authorized (by Sec. 1301.22 of this
chapter) to maintain and/or detoxify controlled substance users in a
narcotic treatment program shall maintain records with the following
information for each narcotic controlled substance:
(1) Name of substance;
(2) Strength of substance;
(3) Dosage form;
(4) Date dispensed;
(5) Adequate identification of patient (consumer);
(6) Amount consumed;
(7) Amount and dosage form taken home by patient; and
(8) Dispenser's initials.
(b) The records required by paragraph (a) of this section will be
maintained in a dispensing log at the narcotic treatment program site
and will be maintained in compliance with Sec. 1304.22 without
reference to Sec. 1304.03.
(c) All sites which compound a bulk narcotic solution from bulk
narcotic powder to liquid for on-site use must keep a separate batch
record of the compounding.
(d) Records of identity, diagnosis, prognosis, or treatment of any
patients which are maintained in connection with the performance of a
narcotic treatment program shall be confidential, except that such
records may be disclosed for purposes and under the circumstances
authorized by part 310 and 42 CFR part 2.
[39 FR 37985, Oct. 25, 1974. Redesignated and amended at 62 FR 13961,
Mar. 24, 1997]
Sec. 1304.25 Records for treatment programs which compound narcotics
for treatment programs and other locations.
Each person registered or authorized by Sec. 1301.22 of this
chapter to compound narcotic drugs for off-site use in a narcotic
treatment program shall maintain records which include the following
information for each narcotic drug:
(a) For each narcotic controlled substance in bulk form to be used
in, or capable of use in, or being used in, the compounding of the same
or other noncontrolled substances in finished form:
(1) The name of the substance;
(2) The quantity compounded in bulk form by the registrant,
including the date, quantity and batch or other identifying number of
each batch compounded;
(3) The quantity received from other persons, including the date and
quantity of each receipt and the name, address and registration number
of the other person from whom the substance was received;
(4) The quantity imported directly by the registrant (under a
registration as an importer) for use in compounding by him, including
the date, quantity and import permit or declaration number of each
importation;
(5) The quantity used to compound the same substance in finished
form, including:
(i) The date and batch or other identifying number of each
compounding;
(ii) The quantity used in the compound;
(iii) The finished form (e.g., 10-milligram tablets or 10-milligram
concentration per fluid ounce or milliliter;
(iv) The number of units of finished form compounded;
(v) The quantity used in quality control;
(vi) The quantity lost during compounding and the causes therefore,
if known;
(vii) The total quantity of the substance contained in the finished
form;
(viii) The theoretical and actual yields; and
(ix) Such other information as is necessary to account for all
controlled substances used in the compounding process;
[[Page 67]]
(6) The quantity used to manufacture other controlled and non-
controlled substances; including the name of each substance manufactured
and the information required in paragraph (a)(5) of this section;
(7) The quantity distributed in bulk form to other programs,
including the date and quantity of each distribution and the name,
address and registration number of each program to whom a distribution
was made;
(8) The quantity exported directly by the registrant (under a
registration as an exporter), including the date, quantity, and export
permit or declaration number of each exploration; and
(9) The quantity disposed of by destruction, including the reason,
date and manner of destruction. All other destruction of narcotic
controlled substances will comply with Sec. 1307.22.
(b) For each narcotic controlled substance in finished form:
(1) The name of the substance;
(2) Each finished form (e.g., 10-milligram tablet or 10 milligram
concentration per fluid ounce or milliliter) and the number of units or
volume or finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial);
(3) The number of containers of each such commercial finished form
compounded from bulk form by the registrant, including the information
required pursuant to paragraph (a)(5) of this section;
(4) The number of units of finished forms and/or commercial
containers received from other persons, including the date of and number
of units and/or commercial containers in each receipt and the name,
address and registration number of the person from whom the units were
received;
(5) The number of units of finished forms and/or commercial
containers imported directly by the person (under a registration or
authorization to import), including the date of, the number of units
and/or commercial containers in, and the import permit or declaration
number for, each importation;
(6) The number of units and/or commercial containers compounded by
the registrant from units in finished form received from others or
imported, including:
(i) The date and batch or other identifying number of each
compounding;
(ii) The operation performed (e.g., repackaging or relabeling);
(iii) The number of units of finished form used in the compound, the
number compounded and the number lost during compounding, with the
causes for such losses, if known; and
(iv) Such other information as is necessary to account for all
controlled substances used in the compounding process;
(7) The number of containers distributed to other programs,
including the date, the number of containers in each distribution, and
the name, address and registration number of the program to whom the
containers were distributed;
(8) The number of commercial containers exported directly by the
registrant (under a registration as an exporter), including the date,
number of containers and export permit or declaration number for each
exportation; and
(9) The number of units of finished forms and/or commercial
containers destroyed in any manner by the registrant, including the
reason, the date and manner of destruction. All other destruction of
narcotic controlled substances will comply with Sec. 1307.22.
[39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997]
Sec. 1304.26 Additional recordkeeping requirements applicable to drug
products containing gamma-hydroxybutyric acid.
In addition to the recordkeeping requirements for dispensers and
researchers provided in Sec. 1304.22, practitioners dispensing gamma-
hydroxybutyric acid that is manufactured or distributed in accordance
with an application under section 505 of the Federal Food, Drug, and
Cosmetic Act must maintain and make available for inspection and copying
by the Attorney General, all of the following information for each
prescription:
(a) Name of the prescribing practitioner.
(b) Prescribing practitioner's Federal and State registration
numbers, with
[[Page 68]]
the expiration dates of these registrations.
(c) Verification that the prescribing practitioner possesses the
appropriate registration to prescribe this controlled substance.
(d) Patient's name and address.
(e) Patient's insurance provider, if available.
[70 FR 293, Jan. 4, 2005]
Reports
Sec. 1304.31 Reports from manufacturers importing narcotic raw material.
(a) Every manufacturer which imports or manufactures from narcotic
raw material (opium, poppy straw, and concentrate of poppy straw) shall
submit information which accounts for the importation and for all
manufacturing operations performed between importation and the
production in bulk or finished marketable products, standardized in
accordance with the U.S. Pharmacopeia, National Formulary or other
recognized medical standards. Reports shall be signed by the authorized
official and submitted quarterly on company letterhead to the Drug
Enforcement Administration, Drug and Chemical Evaluation Section,
Washington, D.C. 20537, on or before the 15th day of the month
immediately following the period for which it is submitted.
(b) The following information shall be submitted for each type of
narcotic raw material (quantities are expressed as grams of anhydrous
morphine alkaloid):
(1) Beginning inventory;
(2) Gains on reweighing;
(3) Imports;
(4) Other receipts;
(5) Quantity put into process;
(6) Losses on reweighing;
(7) Other dispositions and
(8) Ending inventory.
(c) The following information shall be submitted for each narcotic
raw material derivative including morphine, codeine, thebaine,
oxycodone, hydrocodone, medicinal opium, manufacturing opium, crude
alkaloids and other derivatives (quantities are expressed as grams of
anhydrous base or anhydrous morphine alkaloid for manufacturing opium
and medicinal opium):
(1) Beginning inventory;
(2) Gains on reweighing;
(3) Quantity extracted from narcotic raw material;
(4) Quantity produced/manufactured/synthesized;
(5) Quantity sold;
(6) Quantity returned to conversion processes for reworking;
(7) Quantity used for conversion;
(8) Quantity placed in process;
(9) Other dispositions;
(10) Losses on reweighing and
(11) Ending inventory.
(d) The following information shall be submitted for importation of
each narcotic raw material:
(1) Import permit number;
(2) Date shipment arrived at the United States port of entry;
(3) Actual quantity shipped;
(4) Assay (percent) of morphine, codeine and thebaine and
(5) Quantity shipped, expressed as anhydrous morphine alkaloid.
(e) Upon importation of crude opium, samples will be selected and
assays made by the importing manufacturer in the manner and according to
the method specified in the U.S. Pharmacopoeia. Where final assay data
is not determined at the time of rendering report, the report shall be
made on the basis of the best data available, subject to adjustment, and
the necessary adjusting entries shall be made on the next report.
(f) Where factory procedure is such that partial withdrawals of
opium are made from individual containers, there shall be attached to
each container a stock record card on which shall be kept a complete
record of all withdrawals therefrom.
(g) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed or
placed into process for the manufacture of a specified end-product, it
must no longer be accounted for as precursor stocks available for
conversion or use, but rather as end-product in-process inventories.
[62 FR 13961, Mar. 24, 1997]
[[Page 69]]
Sec. 1304.32 Reports of manufacturers importing coca leaves.
(a) Every manufacturer importing or manufacturing from raw coca
leaves shall submit information accounting for the importation and for
all manufacturing operations performed between the importation and the
manufacture of bulk or finished products standardized in accordance with
U.S. Pharmacopoeia, National Formulary, or other recognized standards.
The reports shall be submitted quarterly on company letterhead to the
Drug Enforcement Administration, Drug and Chemical Evaluation Section,
Washington, DC 20537, on or before the 15th day of the month immediately
following the period for which it is submitted.
(b) The following information shall be submitted for raw coca leaf,
ecgonine, ecgonine for conversion or further manufacture,
benzoylecgonine, manufacturing coca extracts (list for tinctures and
extracts; and others separately), other crude alkaloids and other
derivatives (quantities should be reported as grams of actual quantity
involved and the cocaine alkaloid content or equivalency):
(1) Beginning inventory;
(2) Imports;
(3) Gains on reweighing;
(4) Quantity purchased;
(5) Quantity produced;
(6) Other receipts;
(7) Quantity returned to processes for reworking;
(8) Material used in purification for sale;
(9) Material used for manufacture or production;
(10) Losses on reweighing;
(11) Material used for conversion;
(12) Other dispositions and
(13) Ending inventory.
(c) The following information shall be submitted for importation of
coca leaves:
(1) Import permit number;
(2) Date the shipment arrived at the United States port of entry;
(3) Actual quantity shipped;
(4) Assay (percent) of cocaine alkaloid and
(5) Total cocaine alkaloid content.
(d) Upon importation of coca leaves, samples will be selected and
assays made by the importing manufacturer in accordance with recognized
chemical procedures. These assays shall form the basis of accounting for
such coca leaves, which shall be accounted for in terms of their cocaine
alkaloid content or equivalency or their total anhydrous coca alkaloid
content. Where final assay data is not determined at the time of
submission, the report shall be made on the basis of the best data
available, subject to adjustment, and the necessary adjusting entries
shall be made on the next report.
(e) Where factory procedure is such that partial withdrawals of
medicinal coca leaves are made from individual containers, there shall
be attached to the container a stock record card on which shall be kept
a complete record of withdrawals therefrom.
(f) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed or
placed into process for the manufacture of a specified end-product, it
must no longer be accounted for as precursor stocks available for
conversion or use, but rather as end-product in-process inventories.
[62 FR 13962, Mar. 24, 1997]
Sec. 1304.33 Reports to ARCOS.
(a) Reports generally. All reports required by this section shall be
filed with the ARCOS Unit, PO 28293, Central Station, Washington, DC
20005 on DEA Form 333, or on media which contains the data required by
DEA Form 333 and which is acceptable to the ARCOS Unit.
(b) Frequency of reports. Acquisition/Distribution transaction
reports shall be filed every quarter not later than the 15th day of the
month succeeding the quarter for which it is submitted; except that a
registrant may be given permission to file more frequently (but not more
frequently than monthly), depending on the number of transactions being
reported each time by that registrant. Inventories shall provide data on
the stocks of each reported controlled substance on hand as of the close
of business on December 31 of each year, indicating whether the
substance is in storage or in process of manufacturing. These reports
shall be
[[Page 70]]
filed not later than January 15 of the following year. Manufacturing
transaction reports shall be filed annually for each calendar year not
later than January 15 of the following year, except that a registrant
may be given permission to file more frequently (but not more frequently
than quarterly).
(c) Persons reporting. For controlled substances in Schedules I, II,
narcotic controlled substances in Schedule III, and gamma-hydroxybutyric
acid drug product controlled substances in Schedule III, each person who
is registered to manufacture in bulk or dosage form, or to package,
repackage, label or relabel, and each person who is registered to
distribute, including each person who is registered to reverse
distribute, shall report acquisition/distribution transactions. In
addition to reporting acquisition/distribution transactions, each person
who is registered to manufacture controlled substances in bulk or dosage
form shall report manufacturing transactions on controlled substances in
Schedules I and II, each narcotic controlled substance listed in
Schedules III, IV, and V, gamma-hydroxybutyric acid drug product
controlled substances in Schedule III, and on each psychotropic
controlled substance listed in Schedules III and IV as identified in
paragraph (d) of this section.
(d) Substances covered. (1) Manufacturing and acquisition/
distribution transaction reports shall include data on each controlled
substance listed in Schedules I and II, on each narcotic controlled
substance listed in Schedule III (but not on any material, compound,
mixture or preparation containing a quantity of a substance having a
stimulant effect on the central nervous system, which material,
compound, mixture or preparation is listed in Schedule III or on any
narcotic controlled substance listed in Schedule V), and on gamma-
hydroxybutyric acid drug products listed in Schedule III. Additionally,
reports on manufacturing transactions shall include the following
psychotropic controlled substances listed in Schedules III and IV:
(i) Schedule III
(A) Benzphetamine;
(B) Cyclobarbital;
(C) Methyprylon; and
(D) Phendimetrazine.
(ii) Schedule IV
(A) Barbital;
(B) Diethylpropion (Amfepramone);
(C) Ethchlorvynol;
(D) Ethinamate;
(E) Lefetamine (SPA);
(F) Mazindol;
(G) Meprobamate;
(H) Methylphenobarbital;
(I) Phenobarbital;
(J) Phentermine; and
(K) Pipradrol.
(2) Data shall be presented in such a manner as to identify the
particular form, strength, and trade name, if any, of the product
containing the controlled substance for which the report is being made.
For this purpose, persons filing reports shall utilize the National Drug
Code Number assigned to the product under the National Drug Code System
of the Food and Drug Administration.
(e) Transactions reported. Acquisition/distribution transaction
reports shall provide data on each acquisition to inventory (identifying
whether it is, e.g., by purchase or transfer, return from a customer, or
supply by the Federal Government) and each reduction from inventory
(identifying whether it is, e.g., by sale or transfer, theft,
destruction or seizure by Government agencies). Manufacturing reports
shall provide data on material manufactured, manufacture from other
material, use in manufacturing other material and use in producing
dosage forms.
(f) Exceptions. A registered institutional practitioner who
repackages or relabels exclusively for distribution or who distributes
exclusively to (for dispensing by) agents, employees, or affiliated
institutional practitioners of the registrant may be exempted from
filing reports under this section by applying to the ARCOS Unit of the
Administration.
(Approved by the Office of Management and Budget under control number
1117-0003)
[62 FR 13962, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003;
70 FR 294, Jan. 4, 2005]
[[Page 71]]
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.
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(b)(44) of this chapter, to a retail pharmacy.
Sec. 1305.04 Persons entitled to order Schedule I and II controlled
substances.
(a) Only persons who are registered with DEA under section 303 of
the Act (21 U.S.C. 823) to handle Schedule I or II controlled
substances, and persons who are registered with DEA under section 1008
of the Act (21 U.S.C. 958) to export these substances may obtain and use
DEA Form 222 (order forms) or issue electronic orders for these
substances. Persons not registered to handle Schedule I or II controlled
substances and persons registered only to import controlled substances
are not entitled to obtain Form 222 or issue electronic orders for these
substances.
(b) An order for Schedule I or II controlled substances may be
executed only on behalf of the registrant named on the order and only if
his or her registration for the substances being purchased has not
expired or been revoked or suspended.
Sec. 1305.05 Power of attorney.
(a) A registrant may authorize one or more individuals, whether or
not located at his or her registered location, to issue orders for
Schedule I and II
[[Page 72]]
controlled substances on the registrant's behalf by executing a power of
attorney for each such individual, if the power of attorney is retained
in the files, with executed Forms 222 where applicable, for the same
period as any order bearing the signature of the attorney. The power of
attorney must be available for inspection together with other order
records.
(b) A registrant may revoke any power of attorney at any time by
executing a notice of revocation.
(c) The power of attorney and notice of revocation must be similar
to the following format:
Power of Attorney for DEA Forms 222 and Electronic Orders
________________________________________________________________________
(Name of registrant)
________________________________________________________________________
(Address of registrant)
________________________________________________________________________
(DEA registration number)
I, -------- (name of person granting power), the undersigned, who am
authorized to sign the current application for registration of the
above-named registrant under the Controlled Substances Act or Controlled
Substances Import and Export Act, have made, constituted, and appointed,
and by these presents, do make, constitute, and appoint -------- (name
of attorney-in-fact), my true and lawful attorney for me in my name,
place, and stead, to execute applications for Forms 222 and to sign
orders for Schedule I and II controlled substances, whether these orders
be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part
1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and
confirm all that said attorney must lawfully do or cause to be done by
virtue hereof.
________________________________________________________________________
(Signature of person granting power)
I, -------- (name of attorney-in-fact), hereby affirm that I am the
person named herein as attorney-in-fact and that the signature affixed
hereto is my signature.
(signature of attorney-in-fact)
Witnesses:
1. ------------
2. ------------
Signed and dated on the -------- day of --------, (year), at -------- .
Notice of Revocation
The foregoing power of attorney is hereby revoked by the
undersigned, who is authorized to sign the current application for
registration of the above-named registrant under the Controlled
Substances Act or the Controlled Substances Import and Export Act.
Written notice of this revocation has been given to the attorney-in-fact
-------- this same day.
________________________________________________________________________
(Signature of person revoking power)
Witnesses:
1. ------------
2. ------------
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.
[[Page 73]]
(b) A purchaser who has obtained any Schedule I or II controlled
substance by either a DEA Form 222 or an electronic order may return the
substance to the supplier of the substance with either a DEA Form 222 or
an electronic order from the supplier.
(c) A person registered to dispense Schedule II substances may
distribute the substances to another dispenser with either a DEA Form
222 or an electronic order only in the circumstances described in Sec.
1307.11 of this chapter.
(d) A person registered or authorized to conduct chemical analysis
or research with controlled substances may distribute a Schedule I or II
controlled substance to another person registered or authorized to
conduct chemical analysis, instructional activities, or research with
the substances with either a DEA Form 222 or an electronic order, if the
distribution is for the purpose of furthering the chemical analysis,
instructional activities, or research.
(e) A person registered as a compounder of narcotic substances for
use at off-site locations in conjunction with a narcotic treatment
program at the compounding location, who is authorized to handle
Schedule II narcotics, is authorized to fill either a DEA Form 222 or an
electronic order for distribution of narcotic drugs to off-site narcotic
treatment programs only.
Sec. 1305.07 Special procedure for filling certain orders.
A supplier of carfentanil, etorphine hydrochloride, or
diprenorphine, if he or she determines that the purchaser is a
veterinarian engaged in zoo and exotic animal practice, wildlife
management programs, or research, and is authorized by the Administrator
to handle these substances, may fill the order in accordance with the
procedures set forth in Sec. 1305.17 except that:
(a) A DEA Form 222 or an electronic order for carfentanil, etorphine
hydrochloride, and diprenorphine must contain only these substances in
reasonable quantities.
(b) The substances must be shipped, under secure conditions using
substantial packaging material with no markings on the outside that
would indicate the content, only to the purchaser's registered location.
Subpart B_DEA Form 222
Sec. 1305.11 Procedure for obtaining DEA Forms 222.
(a) DEA Forms 222 are issued in mailing envelopes containing either
seven or fourteen forms, each form containing an original, duplicate,
and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit,
which is based on the business activity of the registrant, will be
imposed on the number of DEA Forms 222, which will be furnished on any
requisition unless additional forms are specifically requested and a
reasonable need for such additional forms is shown.
(b) Any person applying for a registration that would entitle him or
her to obtain a DEA Form 222 may requisition the forms by so indicating
on the application form; a DEA Form 222 will be supplied upon the
registration of the applicant. Any person holding a registration
entitling him or her to obtain a DEA Form 222 may requisition the forms
for the first time by contacting any Division Office or the Registration
Section of the Administration. Any person already holding a DEA Form 222
may requisition additional forms on DEA Form 222a, which is mailed to a
registrant approximately 30 days after each shipment of DEA Forms 222 to
that registrant, or by contacting any Division Office or the
Registration Section of the Administration. All requisition forms (DEA
Form 222a) must be submitted to the DEA Registration Section.
(c) Each requisition must show the name, address, and registration
number of the registrant and the number of books of DEA Forms 222
desired. Each requisition must be signed and dated by the same person
who signed the most recent application for registration or for
reregistration, or by any person authorized to obtain and execute DEA
Forms 222 by a power of attorney under Sec. 1305.05.
(d) DEA Forms 222 will be serially numbered and issued with the
name, address, and registration number of the registrant, the authorized
activity, and
[[Page 74]]
schedules of the registrant. This information cannot be altered or
changed by the registrant; any errors must be corrected by the
Registration Section of the Administration by returning the forms with
notification of the error.
Sec. 1305.12 Procedure for executing DEA Forms 222.
(a) A purchaser must prepare and execute a DEA Form 222
simultaneously in triplicate by means of interleaved carbon sheets that
are part of the DEA Form 222. DEA Form 222 must be prepared by use of a
typewriter, pen, or indelible pencil.
(b) Only one item may be entered on each numbered line. An item must
consist of one or more commercial or bulk containers of the same
finished or bulk form and quantity of the same substance. The number of
lines completed must be noted on that form at the bottom of the form, in
the space provided. DEA Forms 222 for carfentanil, etorphine
hydrochloride, and diprenorphine must contain only these substances.
(c) The name and address of the supplier from whom the controlled
substances are being ordered must be entered on the form. Only one
supplier may be listed on any form.
(d) Each DEA Form 222 must be signed and dated by a person
authorized to sign an application for registration or a person granted
power of attorney to sign a Form 222 under Sec. 1305.05. The name of
the purchaser, if different from the individual signing the DEA Form
222, must also be inserted in the signature space.
(e) Unexecuted DEA Forms 222 may be kept and may be executed at a
location other than the registered location printed on the form,
provided that all unexecuted forms are delivered promptly to the
registered location upon an inspection of the location by any officer
authorized to make inspections, or to enforce, any Federal, State, or
local law regarding controlled substances.
Sec. 1305.13 Procedure for filling DEA Forms 222.
(a) A purchaser must submit Copy 1 and Copy 2 of the DEA Form 222 to
the supplier and retain Copy 3 in the purchaser's files.
(b) A supplier may fill the order, if possible and if the supplier
desires to do so, and must record on Copies 1 and 2 the number of
commercial or bulk containers furnished on each item and the date on
which the containers are shipped to the purchaser. If an order cannot be
filled in its entirety, it may be filled in part and the balance
supplied by additional shipments within 60 days following the date of
the DEA Form 222. No DEA Form 222 is valid more than 60 days after its
execution by the purchaser, except as specified in paragraph (f) of this
section.
(c) The controlled substances must be shipped only to the purchaser
and the location printed by the Administration on the DEA Form 222,
except as specified in paragraph (f) of this section.
(d) The supplier must retain Copy 1 of the DEA Form 222 for his or
her files and forward Copy 2 to the Special Agent in Charge of the Drug
Enforcement Administration in the area in which the supplier is located.
Copy 2 must be forwarded at the close of the month during which the
order is filled. If an order is filled by partial shipments, Copy 2 must
be forwarded at the close of the month during which the final shipment
is made or the 60-day validity period expires.
(e) The purchaser must record on Copy 3 of the DEA Form 222 the
number of commercial or bulk containers furnished on each item and the
dates on which the containers are received by the purchaser.
(f) DEA Forms 222 submitted by registered procurement officers of
the Defense Supply Center of the Defense Logistics Agency for delivery
to armed services establishments within the United States may be shipped
to locations other than the location printed on the DEA Form 222, and in
partial shipments at different times not to exceed six months from the
date of the order, as designated by the procurement officer when
submitting the order.
Sec. 1305.14 Procedure for endorsing DEA Forms 222.
(a) A DEA Form 222, made out to any supplier who cannot fill all or
a part of
[[Page 75]]
the order within the time limitation set forth in Sec. 1305.13, may be
endorsed to another supplier for filling. The endorsement must be made
only by the supplier to whom the DEA Form 222 was first made, must state
(in the spaces provided on the reverse sides of Copies 1 and 2 of the
DEA Form 222) the name and address of the second supplier, and must be
signed by a person authorized to obtain and execute DEA Forms 222 on
behalf of the first supplier. The first supplier may not fill any part
of an order on an endorsed form. The second supplier may fill the order,
if possible and if the supplier desires to do so, in accordance with
Sec. 1305.13(b), (c), and (d), including shipping all substances
directly to the purchaser.
(b) Distributions made on endorsed DEA Forms 222 must be reported by
the second supplier in the same manner as all other distributions except
that where the name of the supplier is requested on the reporting form,
the second supplier must record the name, address, and registration
number of the first supplier.
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
[[Page 76]]
registrant is located must immediately be notified.
Sec. 1305.17 Preservation of DEA Forms 222.
(a) The purchaser must retain Copy 3 of each executed DEA Form 222
and all copies of unaccepted or defective forms with each statement
attached.
(b) The supplier must retain Copy 1 of each DEA Form 222 that it has
filled.
(c) DEA Forms 222 must be maintained separately from all other
records of the registrant. DEA Forms 222 are required to be kept
available for inspection for a period of two years. If a purchaser has
several registered locations, the purchaser must retain Copy 3 of the
executed DEA Form 222 and any attached statements or other related
documents (not including unexecuted DEA Forms 222, which may be kept
elsewhere under Sec. 1305.12(e)), at the registered location printed on
the DEA Form 222.
(d) The supplier of carfentanil, etorphine hydrochloride, and
diprenorphine must maintain DEA Forms 222 for these substances
separately from all other DEA Forms 222 and records required to be
maintained by the registrant.
Sec. 1305.18 Return of unused DEA Forms 222.
If the registration of any purchaser terminates (because the
purchaser dies, ceases legal existence, discontinues business or
professional practice, or changes the name or address as shown on the
purchaser's registration) or is suspended or revoked under Sec. 1301.36
of this chapter for all Schedule I and II controlled substances for
which the purchaser is registered, the purchaser must return all unused
DEA Forms 222 to the nearest office of the Administration.
Sec. 1305.19 Cancellation and voiding of DEA Forms 222.
(a) A purchaser may cancel part or all of an order on a DEA Form 222
by notifying the supplier in writing of the cancellation. The supplier
must indicate the cancellation on Copies 1 and 2 of the DEA Form 222 by
drawing a line through the canceled items and printing ``canceled'' in
the space provided for number of items shipped.
(b) A supplier may void part or all of an order on a DEA Form 222 by
notifying the 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.
[[Page 77]]
Sec. 1305.22 Procedure for filling electronic orders.
(a) A purchaser must submit the order to a specific supplier. The
supplier may initially process the order (e.g., entry of the order into
the computer system, billing functions, inventory identification, etc.)
centrally at any location, regardless of the location's registration
with DEA. Following centralized processing, the supplier may distribute
the order to one or more registered locations maintained by the supplier
for filling. The registrant must maintain control of the processing of
the order at all times.
(b) A supplier may fill the order for a Schedule I or II controlled
substance, if possible and if the supplier desires to do so and is
authorized to do so under Sec. 1305.06.
(c) A supplier must do the following before filling the order:
(1) Verify the integrity of the signature and the order by using
software that complies with Part 1311 of this chapter to validate the
order.
(2) Verify that the digital certificate has not expired.
(3) Check the validity of the certificate holder's certificate by
checking the Certificate Revocation List. The supplier may cache the
Certificate Revocation List until it expires.
(4) Verify the registrant's eligibility to order the controlled
substances by checking the certificate extension data.
(d) The supplier must retain an electronic record of every order,
and, linked to each order, a record of the number of commercial or bulk
containers furnished on each item and the date on which the supplier
shipped the containers to the purchaser. The linked record must also
include any data on the original order that the supplier completes.
Software used to handle digitally signed orders must comply with part
1311 of this chapter.
(e) If an order cannot be filled in its entirety, a supplier may
fill it in part and supply the balance by additional shipments within 60
days following the date of the order. No order is valid more than 60
days after its execution by the purchaser, except as specified in
paragraph (h) of this section.
(f) A supplier must ship the controlled substances to the registered
location associated with the digital certificate used to sign the order,
except as specified in paragraph (h) of this section.
(g) When a purchaser receives a shipment, the purchaser must create
a record of the quantity of each item received and the date received.
The record must be electronically linked to the original order and
archived.
(h) Registered procurement officers of the Defense Supply Center of
the Defense Logistics Agency may order controlled substances for
delivery to armed services establishments within the United States.
These orders may be shipped to locations other than the registered
location, and in partial shipments at different times not to exceed six
months from the date of the order, as designated by the procurement
officer when submitting the order.
Sec. 1305.23 Endorsing electronic orders.
A supplier may not endorse an electronic order to another supplier
to fill.
Sec. 1305.24 Central processing of orders.
(a) A supplier that has one or more registered locations and
maintains a central processing computer system in which orders are
stored may have one or more of the supplier's registered locations fill
an electronic order if the supplier does the following:
(1) Assigns each item on the order to a specific registered location
for filling.
(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:
[[Page 78]]
(1) The required data fields have not been completed.
(2) The order is not signed using a digital certificate issued by
DEA.
(3) The digital certificate used had expired or had been revoked
prior to signature.
(4) The purchaser's public key will not validate the digital
signature.
(5) The validation of the order shows that the order is invalid for
any reason.
(b) If an order cannot be filled for any reason under this section,
the supplier must notify the purchaser and provide a statement as to the
reason (e.g., improperly prepared or altered). A supplier may, for any
reason, refuse to accept any order, and if a supplier refuses to accept
the order, a statement that the order is not accepted is sufficient for
purposes of this paragraph.
(c) When a purchaser receives an unaccepted electronic order from
the supplier, the purchaser must electronically link the statement of
nonacceptance to the original order. The original order and the
statement must be retained in accordance with Sec. 1305.27.
(d) Neither a purchaser nor a supplier may correct a defective
order; the purchaser must issue a new order for the order to be filled.
Sec. 1305.26 Lost electronic orders.
(a) If a purchaser determines that an unfilled electronic order has
been lost before or after receipt, the purchaser must provide, to the
supplier, a signed statement containing the unique tracking number and
date of the lost order and stating that the goods covered by the first
order were not received through loss of that order.
(b) If the purchaser executes an order to replace the lost order,
the purchaser must electronically link an electronic record of the
second order and a copy of the statement with the record of the first
order and retain them.
(c) If the supplier to whom the order was directed subsequently
receives the first order, the supplier must indicate that it is ``Not
Accepted'' and return it to the purchaser. The purchaser must link the
returned order to the record of that order and the statement.
Sec. 1305.27 Preservation of electronic orders.
(a) A purchaser must, for each order filled, retain the original
signed order and all linked records for that order for two years. The
purchaser must also retain all copies of each unaccepted or defective
order and each linked statement.
(b) A supplier must retain each original order filled and the linked
records for two years.
(c) If electronic order records are maintained on a central server,
the records must be readily retrievable at the registered location.
Sec. 1305.28 Canceling and voiding electronic orders.
(a) A supplier may void all or part of an electronic order by
notifying the purchaser of the voiding. If the entire order is voided,
the supplier must make an electronic copy of the order, indicate on the
copy ``Void,'' and return it to the purchaser. The supplier is not
required to retain a record of orders that are not filled.
(b) The purchaser must retain an electronic copy of the voided
order.
(c) To partially void an order, the supplier must indicate in the
linked record that nothing was shipped for each item voided.
Sec. 1305.29 Reporting to DEA.
A supplier must, for each electronic order filled, forward either a
copy of the electronic order or an electronic report of the order in a
format that DEA specifies to DEA within two business days.
PART 1306_PRESCRIPTIONS--Table of Contents
General Information
Sec.
1306.01 Scope of part 1306.
1306.02 Definitions.
1306.03 Persons entitled to issue prescriptions.
1306.04 Purpose of issue of prescription.
1306.05 Manner of issuance of prescriptions.
1306.06 Persons entitled to fill prescriptions.
1306.07 Administering or dispensing of narcotic drugs.
Controlled Substances Listed in Schedule II
1306.11 Requirement of prescription.
[[Page 79]]
1306.12 Refilling prescriptions.
1306.13 Partial filling of prescriptions.
1306.14 Labeling of substances and filling of prescriptions.
1306.15 Provision of prescription information between retail pharmacies
and central fill pharmacies for prescriptions of Schedule II
controlled substances.
Controlled Substances Listed in Schedules III, IV, and V
1306.21 Requirement of prescription.
1306.22 Refilling of prescriptions.
1306.23 Partial filling of prescriptions.
1306.24 Labeling of substances and filling of prescriptions.
1306.25 Transfer between pharmacies of presription information for
Schedules III, IV, and V controlled substances for refill
purposes.
1306.26 Dispensing without prescription.
1306.27 Provision of prescription information between retail pharmacies
and central fill pharmacies for initial and refill
prescriptions of Schedule III, IV, or V controlled substances.
Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.
Source: 36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971,
unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.
General Information
Sec. 1306.01 Scope of part 1306.
Rules governing the issuance, filling and filing of prescriptions
pursuant to section 309 of the Act (21 U.S.C. 829) are set forth
generally in that section and specifically by the sections of this part.
Sec. 1306.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13964, Mar. 24, 1997]
Sec. 1306.03 Persons entitled to issue prescriptions.
(a) A prescription for a controlled substance may be issued only by
an individual practitioner who is:
(1) Authorized to prescribe controlled substances by the
jurisdiction in which he is licensed to practice his profession and
(2) Either registered or exempted from registration pursuant to
Sec. Sec. 1301.22(c) and 1301.23 of this chapter.
(b) A prescription issued by an individual practitioner may be
communicated to a pharmacist by an employee or agent of the individual
practitioner.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966,
Mar. 24, 1997]
Sec. 1306.04 Purpose of issue of prescription.
(a) A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice. The
responsibility for the proper prescribing and dispensing of controlled
substances is upon the prescribing practitioner, but a corresponding
responsibility rests with the pharmacist who fills the prescription. An
order purporting to be a prescription issued not in the usual course of
professional treatment or in legitimate and authorized research is not a
prescription within the meaning and intent of section 309 of the Act (21
U.S.C. 829) and the person knowingly filling such a purported
prescription, as well as the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to
controlled substances.
(b) A prescription may not be issued in order for an individual
practitioner to obtain controlled substances for supplying the
individual practitioner for the purpose of general dispensing to
patients.
(c) A prescription may not be issued for ``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]
[[Page 80]]
Sec. 1306.05 Manner of issuance of prescriptions.
(a) All prescriptions for controlled substances shall be dated as
of, and signed on, the day when issued and shall bear the full name and
address of the patient, the drug name, strength, dosage form, quantity
prescribed, directions for use and the name, address and registration
number of the practitioner. In addition, 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). Where a prescription is for gamma-hydroxybutyric acid, the
practitioner shall note on the face of the prescription the medical need
of the patient for the prescription. A practitioner may sign a
prescription in the same manner as he would sign a check or legal
document (e.g., J.H. Smith or John H. Smith). Where an oral order is not
permitted, prescriptions shall be written with ink or indelible pencil
or typewriter and shall be manually signed by the practitioner. The
prescriptions may be prepared by the secretary or agent for the
signature of a practitioner, but the prescribing practitioner is
responsible in case the prescription does not conform in all essential
respects to the law and regulations. A corresponding liability rests
upon the pharmacist, including a pharmacist employed by a central fill
pharmacy, who fills a prescription not prepared in the form prescribed
by DEA regulations.
(b) An individual practitioner exempted from registration under
Sec. 1301.22(c) of this chapter shall include on all prescriptions
issued by him or her the registration number of the hospital or other
institution and the special internal code number assigned to him or her
by the hospital or other institution as provided in Sec. 1301.22(c) of
this chapter, in lieu of the registration number of the practitioner
required by this section. Each written prescription shall have the name
of the physician stamped, typed, or handprinted on it, as well as the
signature of the physician.
(c) An official exempted from registration under Sec. 1301.22(c)
shall include on all prescriptions issued by him his branch of service
or agency (e.g., ``U.S. Army'' or ``Public Health Service'') and his
service identification number, in lieu of the registration number of the
practitioner required by this section. The service identification number
for a Public Health Service employee is his Social Security
identification number. Each prescription shall have the name of the
officer stamped, typed, or handprinted on it, as well as the signature
of the officer.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 60 FR 36641,
July 18, 1995; 62 FR 13966, Mar. 24, 1997; 70 FR 36343, June, 23, 2005]
Sec. 1306.06 Persons entitled to fill prescriptions.
A prescription for a controlled substance may only be filled by a
pharmacist, acting in the usual course of his professional practice and
either registered individually or employed in a registered pharmacy, a
registered central fill pharmacy, or registered institutional
practitioner.
[68 FR 37410, June 24, 2003, 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 (but not prescribing) narcotic drugs to a person for the
purpose of relieving
[[Page 81]]
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]
Controlled Substances Listed in Schedule II
Sec. 1306.11 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed
in Schedule II, which is a prescription drug as determined under the
Federal Food, Drug, and Cosmetic Act, only pursuant to a written
prescription signed by the practitioner, except as provided in paragraph
(d) of this section. A prescription for a Schedule II controlled
substance may be transmitted by the practitioner or the practitioner's
agent to a pharmacy via facsimile equipment, provided that the original
written, signed prescription is presented to the pharmacist for review
prior to the actual dispensing of the controlled substance, except as
noted in paragraph (e), (f), or (g) of this section. The original
prescription shall be maintained in accordance with Sec. 1304.04(h) of
this chapter.
(b) An individual practitioner may administer or dispense directly a
controlled substance listed in Schedule II in the course of his
professional practice without a prescription, subject to Sec. 1306.07.
(c) An institutional practitioner may administer or dispense
directly (but not prescribe) a controlled substance listed in Schedule
II only pursuant to a written prescription signed by the prescribing
individual practitioner or to an order for medication made by an
individual practitioner which is dispensed for immediate administration
to the ultimate user.
(d) In the case of an emergency situation, as defined by the
Secretary in Sec. 290.10 of this title, a pharmacist may dispense a
controlled substance listed in Schedule II upon receiving oral
authorization of a prescribing individual practitioner, provided that:
(1) The quantity prescribed and dispensed is limited to the amount
adequate to treat the patient during the emergency period (dispensing
beyond the emergency period must be pursuant to a written prescription
signed by the prescribing individual practitioner);
(2) The prescription shall be immediately reduced to writing by the
pharmacist and shall contain all information required in Sec. 1306.05,
except for the signature of the prescribing individual practitioner;
(3) If the prescribing individual practitioner is not known to the
pharmacist, he must make a reasonable effort to determine that the oral
authorization came from a registered individual practitioner, which may
include a callback to the prescribing individual practitioner using his
phone number as listed in the telephone directory and/or other good
faith efforts to insure his identity; and
(4) Within 7 days after authorizing an emergency oral prescription,
the prescribing individual practitioner shall cause a written
prescription for the emergency quantity prescribed to be delivered to
the dispensing pharmacist. In addition to conforming to the requirements
of Sec. 1306.05, the prescription shall have written on its face
``Authorization for Emergency Dispensing,'' and the date of the oral
order. The written prescription may be delivered
[[Page 82]]
to the pharmacist in person or by mail, but if delivered by mail it must
be postmarked within the 7 day period. Upon receipt, the dispensing
pharmacist shall attach this prescription to the oral emergency
prescription which had earlier been reduced to writing. The pharmacist
shall notify the nearest office of the Administration if the prescribing
individual practitioner fails to deliver a written prescription to him;
failure of the pharmacist to do so shall void the authority conferred by
this paragraph to dispense without a written prescription of a
prescribing individual practitioner.
(5) Central fill pharmacies shall not be authorized under this
paragraph to prepare prescriptions for a controlled substance listed in
Schedule II upon receiving an oral authorization from a retail
pharmacist or an individual practitioner.
(e) A prescription prepared in accordance with Sec. 1306.05 written
for a Schedule II narcotic substance to be compounded for the direct
administration to a patient by parenteral, intravenous, intramuscular,
subcutaneous or intraspinal infusion may be transmitted by the
practitioner or the practitioner's agent to the pharmacy by facsimile.
The facsimile serves as the original written prescription for purposes
of this paragraph (e) and it shall be maintained in accordance with
Sec. 1304.04(h) of this chapter.
(f) A prescription prepared in accordance with Sec. 1306.05 written
for Schedule II substance for a resident of a Long Term Care Facility
may be transmitted by the practitioner or the practitioner's agent to
the dispensing pharmacy by facsimile. The facsimile serves as the
original written prescription for purposes of this paragraph (f) and it
shall be maintained in accordance with Sec. 1304.04(h).
(g) A prescription prepared in accordance with Sec. 1306.05 written
for a Schedule II narcotic substance for a patient enrolled in a hospice
care program certified and/or paid for by Medicare under Title XVIII or
a hospice program which is licensed by the state may be transmitted by
the practitioner or the practitioner's agent to the dispensing pharmacy
by facsimile. The practitioner or the practitioner's agent will note on
the prescription that the patient is a hospice patient. The facsimile
serves as the original written prescription for purposes of this
paragraph (g) and it shall be maintained in accordance with Sec.
1304.04(h).
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 53 FR 4964,
Feb. 19, 1988; 59 FR 26111, May 19, 1994; 59 FR 30832, June 15, 1994; 62
FR 13964, Mar. 24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410, June
24, 2003]
Sec. 1306.12 Refilling prescriptions.
The refilling of a prescription for a controlled substance listed in
Schedule II is prohibited.
Sec. 1306.13 Partial filling of prescriptions.
(a) The partial filling of a prescription for a controlled substance
listed in Schedule II is permissible, if the pharmacist is unable to
supply the full quantity called for in a written or emergency oral
prescription and he makes a notation of the quantity supplied on the
face of the written prescription (or written record of the emergency
oral prescription). The remaining portion of the prescription may be
filled within 72 hours of the first partial filling; however, if the
remaining portion is not or cannot be filled within the 72-hour period,
the pharmacist shall so notify the prescribing individual practitioner.
No further quantity may be supplied beyond 72 hours without a new
prescription.
(b) A prescription for a Schedule II controlled substance written
for a patient in a Long Term Care Facility (LTCF) or for a patient with
a medical diagnosis documenting a terminal illness may be filled in
partial quantities to include individual dosage units. If there is any
question whether a patient may be classified as having a terminal
illness, the pharmacist must contact the practitioner prior to partially
filling the prescription. Both the pharmacist and the prescribing
practitioner have a corresponding responsibility to assure that the
controlled substance is for a terminally ill patient. The pharmacist
must record on the prescription whether the patient is ``terminally
ill''
[[Page 83]]
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]
Sec. 1306.14 Labeling of substances and filling of prescriptions.
(a) The pharmacist filling a written or emergency oral prescription
for a controlled substance listed in Schedule II shall affix to the
package a label showing date of filling, the pharmacy name and address,
the serial number of the prescription, the name of the patient, the name
of the prescribing practitioner, and directions for use and cautionary
statements, if any, contained in such prescription or required by law.
(b) If the prescription is filled at a central fill pharmacy, the
central fill pharmacy shall affix to the package a label showing the
retail pharmacy name and address and a unique identifier, (i.e. the
central fill pharmacy's DEA registration number) indicating that the
prescription was filled at the central fill pharmacy, in addition to the
information required under paragraph (a) of this section.
(c) The requirements of paragraph (a) of this section do not apply
when a controlled substance listed in Schedule II is prescribed for
administration to an ultimate user who is institutionalized: Provided,
That:
(1) Not more than 7-day supply of the controlled substance listed in
Schedule II is dispensed at one time;
(2) The controlled substance listed in Schedule II is not in the
possession of the ultimate user prior to the administration;
(3) The institution maintains appropriate safeguards and records
regarding the proper administration, control, dispensing, and storage of
the controlled substance listed in Schedule II; and
(4) The system employed by the pharmacist in filling a prescription
is adequate to identify the supplier, the product, and the patient, and
to set forth the directions for use and cautionary statements, if any,
contained in the prescription or required by law.
(d) All written prescriptions and written records of emergency oral
prescriptions shall be kept in accordance with requirements of Sec.
1304.04(h) of this chapter.
[36 FR 13368, July 21, 1971, as amended at 37 FR 15921, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13965,
Mar. 24, 1997; 68 FR 37410, June 24, 2003]
[[Page 84]]
Sec. 1306.15 Provision of prescription information between retail
pharmacies and central fill pharmacies for prescriptions of Schedule
II controlled substances.
Prescription information may be provided to an authorized central
fill pharmacy by a retail pharmacy for dispensing purposes. The
following requirements shall also apply:
(a) Prescriptions for controlled substances listed in Schedule II
may be transmitted electronically from a retail pharmacy to a central
fill pharmacy including via facsimile. The retail pharmacy transmitting
the prescription information must:
(1) Write the word ``CENTRAL FILL'' on the face of the original
prescription and record the name, address, and DEA registration number
of the central fill pharmacy to which the prescription has been
transmitted and, the name of the retail pharmacy pharmacist transmitting
the prescription, and the date of transmittal;
(2) Ensure that all information required to be on a prescription
pursuant to Section 1306.05 of this part is transmitted to the central
fill pharmacy (either on the face of the prescription or in the
electronic transmission of information);
(3) Maintain the original prescription for a period of two years
from the date the prescription was filled;
(4) Keep a record of receipt of the filled prescription, including
the date of receipt, the method of delivery (private, common or contract
carrier) and the name of the retail pharmacy employee accepting
delivery.
(b) The central fill pharmacy receiving the transmitted prescription
must:
(1) Keep a copy of the prescription (if sent via facsimile) or an
electronic record of all the information transmitted by the retail
pharmacy, including the name, address, and DEA registration number of
the retail pharmacy transmitting the prescription;
(2) Keep a record of the date of receipt of the transmitted
prescription, the name of the pharmacist filling the prescription, and
the date of filling of the prescription;
(3) Keep a record of the date the filled prescription was delivered
to the retail pharmacy and the method of delivery (i.e. private, common
or contract carrier).
[68 FR 37410, June 24, 2003]
Controlled Substances Listed in Schedules III, IV, and V
Sec. 1306.21 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed
in Schedule III, IV, or V which is a prescription drug as determined
under the Federal Food, Drug, and Cosmetic Act, only pursuant to either
a written prescription signed by a practitioner or a facsimile of a
written, signed prescription transmitted by the practitioner or the
practitioner's agent to the pharmacy or pursuant to an oral prescription
made by an individual practitioner and promptly reduced to writing by
the pharmacist containing all information required in Sec. 1306.05,
except for the signature of the practitioner.
(b) An individual practitioner may administer or dispense directly a
controlled substance listed in Schedule III, IV, or V in the course of
his/her professional practice without a prescription, subject to Sec.
1306.07.
(c) An institutional practitioner may administer or dispense
directly (but not prescribe) a controlled substance listed in Schedule
III, IV, or V only pursuant to a written prescription signed by an
individual practitioner, or pursuant to a facsimile of a written
prescription or order for medication transmitted by the practitioner or
the practitioner's agent to the institutional practitioner-pharmacist,
or pursuant to an oral prescription made by an individual practitioner
and promptly reduced to writing by the pharmacist (containing all
information required in Section 1306.05 except for the signature of the
individual practitioner), or pursuant to an order for medication made by
an individual practitioner which is dispensed for immediate
administration to the ultimate user, subject to Sec. 1306.07.
[62 FR 13965, Mar. 24, 1997]
Sec. 1306.22 Refilling of prescriptions.
(a) No prescription for a controlled substance listed in Schedule
III or IV shall be filled or refilled more than six
[[Page 85]]
months after the date on which such prescription was issued and no such
prescription authorized to be refilled may be refilled more than five
times. Each refilling of a prescription shall be entered on the back of
the prescription or on another appropriate document. If entered on
another document, such as a medication record, the document must be
uniformly maintained and readily retrievable. The following information
must be retrievable by the prescription number consisting of the name
and dosage form of the controlled substance, the date filled or
refilled, the quantity dispensed, initials of the dispensing pharmacist
for each refill, and the total number of refills for that prescription.
If the pharmacist merely initials and dates the back of the prescription
it shall be deemed that the full face amount of the prescription has
been dispensed. The prescribing practitioner may authorize additional
refills of Schedule III or IV controlled substances on the original
prescription through an oral refill authorization transmitted to the
pharmacist provided the following conditions are met:
(1) The total quantity authorized, including the amount of the
original prescription, does not exceed five refills nor extend beyond
six months from the date of issue of the original prescription.
(2) The pharmacist obtaining the oral authorization records on the
reverse of the original prescription the date, quantity of refill,
number of additional refills authorized, and initials the prescription
showing who received the authorization from the prescribing practitioner
who issued the original prescription.
(3) The quantity of each additional refill authorized is equal to or
less than the quantity authorized for the initial filling of the
original prescription.
(4) The prescribing practitioner must execute a new and separate
prescription for any additional quantities beyond the five refill, six-
month limitation.
(b) As an alternative to the procedures provided by subsection (a),
an automated data processing system may be used for the storage and
retrieval of refill information for prescription orders for controlled
substances in Schedule III and IV, subject to the following conditions:
(1) Any such proposed computerized system must provide on-line
retrieval (via CRT display or hard-copy printout) of original
prescription order information for those prescription orders which are
currently authorized for refilling. This shall include, but is not
limited to, data such as the original prescription number, date of
issuance of the original prescription order by the practitioner, full
name and address of the patient, name, address, and DEA registration
number of the practitioner, and the name, strength, dosage form,
quantity of the controlled substance prescribed (and quantity dispensed
if different from the quantity prescribed), and the total number of
refills authorized by the prescribing practitioner.
(2) Any such proposed computerized system must also provide on-line
retrieval (via CRT display or hard-copy printout) of the current refill
history for Schedule III or IV controlled substance prescription orders
(those authorized for refill during the past six months.) This refill
history shall include, but is not limited to, the name of the controlled
substance, the date of refill, the quantity dispensed, the
identification code, or name or initials of the dispensing pharmacist
for each refill and the total number of refills dispensed to date for
that prescription order.
(3) Documentation of the fact that the refill information entered
into the computer each time a pharmacist refills an original
prescription order for a Schedule III or IV controlled substance is
correct must be provided by the individual pharmacist who makes use of
such a system. If such a system provides a hard-copy printout of each
day's controlled substance prescription order refill data, that printout
shall be verified, dated, and signed by the individual pharmacist who
refilled such a prescription order. The individual pharmacist must
verify that the data indicated is correct and then sign this document in
the same manner as he would sign a check or legal document (e.g., J. H.
Smith, or John H. Smith). This document shall be maintained in a
[[Page 86]]
separate file at that pharmacy for a period of two years from the
dispensing date. This printout of the day's controlled substance
prescription order refill data must be provided to each pharmacy using
such a computerized system within 72 hours of the date on which the
refill was dispensed. It must be verified and signed by each pharmacist
who is involved with such dispensing. In lieu of such a printout, the
pharmacy shall maintain a bound log book, or separate file, in which
each individual pharmacist involved in such dispensing shall sign a
statement (in the manner previously described) each day, attesting to
the fact that the refill information entered into the computer that day
has been reviewed by him and is correct as shown. Such a book or file
must be maintained at the pharmacy employing such a system for a period
of two years after the date of dispensing the appropriately authorized
refill.
(4) Any such computerized system shall have the capability of
producing a printout of any refill data which the user pharmacy is
responsible for maintaining under the Act and its implementing
regulations. For example, this would include a refill-by-refill audit
trail for any specified strength and dosage form of any controlled
substance (by either brand or generic name or both). Such a printout
must include name of the prescribing practitioner, name and address of
the patient, quantity dispensed on each refill, date of dispensing for
each refill, name or identification code of the dispensing pharmacist,
and the number of the original prescription order. In any computerized
system employed by a user pharmacy the central recordkeeping location
must be capable of sending the printout to the pharmacy within 48 hours,
and if a DEA Special Agent or Diversion Investigator requests a copy of
such printout from the user pharmacy, it must, if requested to do so by
the Agent or Investigator, verify the printout transmittal capability of
its system by documentation (e.g., postmark).
(5) In the event that a pharmacy which employs such a computerized
system experiences system down-time, the pharmacy must have an auxiliary
procedure which will be used for documentation of refills os Schedule
III and IV controlled substance prescription orders. This auxiliary
procedure must insure that refills are authorized by the original
prescription order, that the maximum number of refills has not been
exceeded, and that all of the appropriate data is retained for on-line
data entry as soon as the computer system is available for use again.
(c) When filing refill information for original prescription orders
for Schedule III or IV controlled substances, a pharmacy may use only
one of the two systems described in paragraphs (a) or (b) of this
section.
[36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971. Redesignated at
38 FR 26609, Sept. 24, 1973, and amended at 42 FR 28878, June 6, 1977;
45 FR 44266, July 1, 1980; 52 FR 3605, Feb. 5, 1987; 62 FR 13966, Mar.
24, 1997]
Sec. 1306.23 Partial filling of prescriptions.
The partial filling of a prescription for a controlled substance
listed in Schedule III, IV, or V is permissible, provided that:
(a) Each partial filling is recorded in the same manner as a
refilling,
(b) The total quantity dispensed in all partial fillings does not
exceed the total quantity prescribed, and
(c) No dispensing occurs after 6 months after the date on which the
prescription was issued.
[36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 51 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24,
1997]
Sec. 1306.24 Labeling of substances and filing of prescriptions.
(a) The pharmacist filling a prescription for a controlled substance
listed in Schedule III, IV, or V shall affix to the package a label
showing the pharmacy name and address, the serial number and date of
initial filling, the name of the patient, the name of the practitioner
issuing the prescription, and directions for use and cautionary
statements, if any, contained in such prescription as required by law.
(b) If the prescription is filled at a central fill pharmacy, the
central fill pharmacy shall affix to the package a label showing the
retail pharmacy
[[Page 87]]
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 Schedules III, IV or V for the purpose of
refill dispensing is permissible between pharmacies on a one time basis
only. However, pharmacies electronically sharing a real-time, on-line
database may transfer up to the maximum refills permitted by law and the
prescriber's authorization. Transfers are subject to the following
requirements:
(1) The transfer is communicated directly between two licensed
pharmacists and the transferring pharmacist records the following
information:
(i) Write the word ``VOID'' on the face of the invalidated
prescription.
(ii) Record on the reverse of the invalidated prescription the name,
address and DEA registration number of the pharmacy to which it was
transferred and the name of the pharmacist receiving the prescription
information.
(iii) Record the date of the transfer and the name of the pharmacist
transferring the information.
(b) The pharmacist receiving the transferred prescription
information shall reduce to writing the following:
(1) Write the word ``transfer'' on the face of the transferred
prescription.
(2) Provide all information required to be on a prescription
pursuant to 21 CFR 1306.05 and include:
(i) Date of issuance of original prescription;
(ii) Original number of refills authorized on original prescription;
(iii) Date of original dispensing;
(iv) Number of valid refills remaining and date(s) and locations of
previous refill(s);
(v) Pharmacy's name, address, DEA registration number and
prescription number from which the prescription information was
transferred;
(vi) Name of pharmacist who transferred the prescription.
(vii) Pharmacy's name, address, DEA registration number and
prescription number from which the prescription was originally filled;
(3) The original and transferred prescription(s) must be maintained
for a period of two years from the date of last refill.
(c) Pharmacies electronically accessing the same prescription record
must satisfy all information requirements of a manual mode for
prescription transferral.
(d) The procedure allowing the transfer of prescription information
for refill purposes is permissible only if allowable under existing
state or other applicable law.
[46 FR 48919, Oct. 5, 1981. Redesignated and amended at 62 FR 13966,
Mar. 24, 1997]
[[Page 88]]
Sec. 1306.26 Dispensing without prescription.
A controlled substance listed in Schedules II, III, IV, or V which
is not a prescription drug as determined under the Federal Food, Drug,
and Cosmetic Act, may be dispensed by a pharmacist without a
prescription to a purchaser at retail, provided that:
(a) Such dispensing is made only by a pharmacist (as defined in part
1300 of this chapter), and not by a nonpharmacist employee even if under
the supervision of a pharmacist (although after the pharmacist has
fulfilled his professional and legal responsibilities set forth in this
section, the actual cash, credit transaction, or delivery, may be
completed by a nonpharmacist);
(b) Not more than 240 cc. (8 ounces) of any such controlled
substance containing opium, nor more than 120 cc. (4 ounces) of any
other such controlled substance nor more than 48 dosage units of any
such controlled substance containing opium, nor more than 24 dosage
units of any other such controlled substance may be dispensed at retail
to the same purchaser in any given 48-hour period;
(c) The purchaser is at least 18 years of age;
(d) The pharmacist requires every purchaser of a controlled
substance under this section not known to him to furnish suitable
identification (including proof of age where appropriate);
(e) A bound record book for dispensing of controlled substances
under this section is maintained by the pharmacist, which book shall
contain the name and address of the purchaser, the name and quantity of
controlled substance purchased, the date of each purchase, and the name
or initials of the pharmacist who dispensed the substance to the
purchaser (the book shall be maintained in accordance with the
recordkeeping requirement of Sec. 1304.04 of this chapter); and
(f) A prescription is not required for distribution or dispensing of
the substance pursuant to any other Federal, State or local law.
(g) Central fill pharmacies may not dispense controlled substances
to a purchaser at retail pursuant to this section.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesigated and
amended at 62 FR 13966, Mar. 24, 1997; 68 FR 37411, June 24, 2003]
Sec. 1306.27 Provision of prescription information between retail
pharmacies and central fill pharmacies for initial and refill
prescriptions of Schedule III, IV, or V controlled substances.
Prescription information may be provided to an authorized central
fill pharmacy by a retail pharmacy for dispensing purposes. The
following requirements shall also apply:
(a) Prescriptions for controlled substances listed in Schedule III,
IV or V may be transmitted electronically from a retail pharmacy to a
central fill pharmacy including via facsimile. The retail pharmacy
transmitting the prescription information must:
(1) Write the word ``CENTRAL FILL'' on the face of the original
prescription and record the name, address, and DEA registration number
of the central fill pharmacy to which the prescription has been
transmitted and the name of the retail pharmacy pharmacist transmitting
the prescription, and the date of transmittal;
(2) Ensure that all information required to be on a prescription
pursuant to Sec. 1306.05 of this part is transmitted to the central
fill pharmacy (either on the face of the prescription or in the
electronic transmission of information);
(3) Indicate in the information transmitted the number of refills
already dispensed and the number of refills remaining;
(4) Maintain the original prescription for a period of two years
from the date the prescription was last refilled;
(5) Keep a record of receipt of the filled prescription, including
the date of receipt, the method of delivery (private, common or contract
carrier) and the name of the retail pharmacy employee accepting
delivery.
(b) The central fill pharmacy receiving the transmitted prescription
must:
(1) Keep a copy of the prescription (if sent via facsimile) or an
electronic
[[Page 89]]
record of all the information transmitted by the retail pharmacy,
including the name, address, and DEA registration number of the retail
pharmacy transmitting the prescription;
(2) Keep a record of the date of receipt of the transmitted
prescription, the name of the licensed pharmacist filling the
prescription, and dates of filling or refilling of the prescription;
(3) Keep a record of the date the filled prescription was delivered
to the retail pharmacy and the method of delivery (i.e. private, common
or contract carrier).
[68 FR 37411, June 24, 2003]
PART 1307_MISCELLANEOUS--Table of Contents
General Information
Sec.
1307.01 Definitions.
1307.02 Application of State law and other Federal law.
1307.03 Exceptions to regulations.
Special Exceptions for Manufacture and Distribution of Controlled
Substances
1307.11 Distribution by dispenser to another practitioner or reverse
distributor.
1307.12 Distribution to supplier or manufacturer.
1307.13 Incidental manufacture of controlled substances.
Disposal of Controlled Substances
1307.21 Procedure for disposing of controlled substances.
1307.22 Disposal of controlled substances by the Administration.
Special Exempt Persons
1307.31 Native American Church.
Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise noted.
Source: 36 FR 7801, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
General Information
Sec. 1307.01 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13966, Mar. 24, 1997]
Sec. 1307.02 Application of State law and other Federal law.
Nothing in this chapter shall be construed as authorizing or
permitting any person to do any act which such person is not authorized
or permitted to do under other Federal laws or obligations under
international treaties, conventions or protocols, or under the law of
the State in which he/she desires to do such act nor shall compliance
with such parts be construed as compliance with other Federal or State
laws unless expressly provided in such other laws.
[62 FR 13966, Mar. 24, 1997]
Sec. 1307.03 Exceptions to regulations.
Any person may apply for an exception to the application of any
provision of this chapter by filing a written request stating the
reasons for such exception. Requests shall be filed with the
Administrator, Drug Enforcement Administration, Department of Justice,
Washington, DC 20537. The Administrator may grant an exception in his
discretion, but in no case shall he/she be required to grant an
exception to any person which is otherwise required by law or the
regulations cited in this section.
[62 FR 13966, Mar. 24, 1997]
Special Exceptions for Manufacture and Distribution of Controlled
Substances
Sec. 1307.11 Distribution by dispenser to another practitioner or
reverse distributor.
(a) A practitioner who is registered to dispense a controlled
substance may distribute (without being registered to distribute) a
quantity of such substance to--
(1) Another practitioner for the purpose of general dispensing by
the practitioner to patients, provided that--
(i) The practitioner to whom the controlled substance is to be
distributed is registered under the Act to dispense that controlled
substance;
(ii) The distribution is recorded by the distributing practitioner
in accordance with Sec. 1304.22(c) of this chapter
[[Page 90]]
and by the receiving practitioner in accordance with Sec. 1304.22(c) of
this chapter;
(iii) If the substance is listed in Schedule I or II, an order form
is used as required in part 1305 of this chapter; and
(iv) The total number of dosage units of all controlled substances
distributed by the practitioner pursuant to this section and Sec.
1301.25 of this chapter during each calendar year in which the
practitioner is registered to dispense does not exceed 5 percent of the
total number of dosage units of all controlled substances distributed
and dispensed by the practitioner during the same calendar year.
(2) A reverse distributor who is registered to receive such
controlled substances.
(b) If, during any calendar year in which the practitioner is
registered to dispense, the practitioner has reason to believe that the
total number of dosage units of all controlled substances which will be
distributed by him pursuant to paragraph (a)(1) of this section and
Sec. 1301.25 of this chapter will exceed 5 percent of this total number
of dosage units of all controlled substances distributed and dispensed
by him during that calendar year, the practitioner shall obtain a
registration to distribute controlled substances.
(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 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]
Sec. 1307.12 Distribution to supplier or manufacturer.
(a) Any person lawfully in possession of a controlled substance
listed in any schedule may distribute (without being registered to
distribute) that substance to the person from whom he/she obtained it or
to the manufacturer of the substance, or, if designated, to the
manufacturer's registered agent for accepting returns, provided that a
written record is maintained which indicates the date of the
transaction, the name, form and quantity of the substance, the name,
address, and registration number, if any, of the person making the
distribution, and the name, address, and registration number, if known,
of the supplier or manufacturer. In the case of returning a controlled
substance in Schedule I or II, an order form shall be used in the manner
prescribed in part 1305 of this chapter and be maintained as the written
record of the transaction. Any person not required to register pursuant
to sections 302(c) or 1007(b)(1) of the Act (21 U.S.C. 822(c) or
957(b)(1)) shall be exempt from maintaining the records required by this
section.
(b) Distributions referred to in paragraph (a) may be made through a
freight forwarding facility operated by the person to whom the
controlled substance is being returned provided that prior arrangement
has been made for the return and the person making the distribution
delivers the controlled substance directly to an agent or employee of
the person to whom the controlled substance is being returned.
[65 FR 44679, July 19, 2000; 65 FR 45829, July 25, 2000, as amended at
68 FR 41229, July 11, 2003]
Sec. 1307.13 Incidental manufacture of controlled substances.
Any registered manufacturer who, incidentally but necessarily,
manufactures a controlled substance as a result of the manufacture of a
controlled substance or basic class of controlled substance for which he
is registered and has been issued an individual manufacturing quota
pursuant to part 1303 of this chapter (if such substance or class is
listed in Schedule I or II) shall be exempt from the requirement of
registration pursuant to part 1301 of this chapter and, if such
incidentally manufactured substance is listed in Schedule I or II, shall
be exempt from the requirement of an individual manufacturing quota
pursuant to part 1303 of this chapter, if such substances are disposed
of in accordance with Sec. 1307.21.
[36 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated at 62 FR 13967, Mar. 24, 1997]
[[Page 91]]
Disposal of Controlled Substances
Sec. 1307.21 Procedure for disposing of controlled substances.
(a) Any person in possession of any controlled substance and
desiring or required to dispose of such substance may request assistance
from the Special Agent in Charge of the Administration in the area in
which the person is located for authority and instructions to dispose of
such substance. The request should be made as follows:
(1) If the person is a registrant, he/she shall list the controlled
substance or substances which he/she desires to dispose of on DEA Form
41, and submit three copies of that form to the Special Agent in Charge
in his/her area; or
(2) If the person is not a registrant, he/she shall submit to the
Special Agent in Charge a letter stating:
(i) The name and address of the person;
(ii) The name and quantity of each controlled substance to be
disposed of;
(iii) How the applicant obtained the substance, if known; and
(iv) The name, address, and registration number, if known, of the
person who possessed the controlled substances prior to the applicant,
if known.
(b) The Special Agent in Charge shall authorize and instruct the
applicant to dispose of the controlled substance in one of the following
manners:
(1) By transfer to person registered under the Act and authorized to
possess the substance;
(2) By delivery to an agent of the Administration or to the nearest
office of the Administration;
(3) By destruction in the presence of an agent of the Administration
or other authorized person; or
(4) By such other means as the Special Agent in Charge may determine
to assure that the substance does not become available to unauthorized
persons.
(c) In the event that a registrant is required regularly to dispose
of controlled substances, the Special Agent in Charge may authorize the
registrant to dispose of such substances, in accordance with paragraph
(b) of this section, without prior approval of the Administration in
each instance, on the condition that the registrant keep records of such
disposals and file periodic reports with the Special Agent in Charge
summarizing the disposals made by the registrant. In granting such
authority, the Special Agent in Charge may place such conditions as he
deems proper on the disposal of controlled substances, including the
method of disposal and the frequency and detail of reports.
(d) This section shall not be construed as affecting or altering in
any way the disposal of controlled substances through procedures
provided in laws and regulations adopted by any State.
[36 FR 7801, Apr. 24, 1971, as amended at 37 FR 15922, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735,
Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997]
Sec. 1307.22 Disposal of controlled substances by the Administration.
Any controlled substance delivered to the Administration under Sec.
1307.21 or forfeited pursuant to section 511 of the Act (21 U.S.C. 881)
may be delivered to any department, bureau, or other agency of the
United States or of any State upon proper application addressed to the
Administrator, Drug Enforcement Administration, Department of Justice,
Washington, DC 20537 The application shall show the name, address, and
official title of the person or agency to whom the controlled drugs are
to be delivered, including the name and quantity of the substances
desired and the purpose for which intended. The delivery of such
controlled drugs shall be ordered by the Administrator, if, in his
opinion, there exists a medical or scientific need therefor.
[38 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
as amended at 62 FR 13967, Mar. 24, 1997]
Special Exempt Persons
Sec. 1307.31 Native American Church.
The listing of peyote as a controlled substance in Schedule I does
not apply to the nondrug use of peyote in bona fide religious ceremonies
of the Native American Church, and members of the Native American Church
so using peyote are exempt from registration. Any person who
manufactures peyote for or
[[Page 92]]
distributes peyote to the Native American Church, however, is required
to obtain registration annually and to comply with all other
requirements of law.
PART 1308_SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents
General Information
Sec.
1308.01 Scope of part 1308.
1308.02 Definitions.
1308.03 Administration Controlled Substances Code Number.
Schedules
1308.11 Schedule I.
1308.12 Schedule II.
1308.13 Schedule III.
1308.14 Schedule IV.
1308.15 Schedule V.
Excluded Nonnarcotic Substances
1308.21 Application for exclusion of a nonnarcotic substance.
1308.22 Excluded substances.
Exempt Chemical Preparations
1308.23 Exemption of certain chemical preparations; application.
1308.24 Exemption chemical preparations.
Excluded Veterinary Anabolic Steroid Implant Products
1308.25 Exclusion of a veterinary anabolic steroid implant product;
application.
1308.26 Excluded veterinary anabolic steroid implant products.
Exempted Prescription Products
1308.31 Application for exemption of a nonnarcotic prescription product.
1308.32 Exempted prescription products.
Exempt Anabolic Steroid Products
1308.33 Exemption of certain anabolic steroid products; application.
1308.34 Exempt anabolic steroid products.
Exempt cannabis plant material, and products made therefrom, that
contain tetrahydrocannabinols
1308.35 Exemption of certain cannabis plant material, and products made
therefrom, that contain tetrahydrocannabinols.
Hearings
1308.41 Hearings generally.
1308.42 Purpose of hearing.
1308.43 Initiation of proceedings for rule-making.
1308.44 Request for hearing or appearance; waiver.
1308.45 Final order.
1308.46 Control required under international treaty.
1308.47 Control of immediate precursors.
1308.49 Emergency scheduling.
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
Source: 38 FR 8254, Mar. 30, 1973, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
General Information
Sec. 1308.01 Scope of part 1308.
Schedules of controlled substances established by section 202 of the
Act (21 U.S.C. 812), as they are changed, updated, and republished from
time to time, are set forth in this part.
Sec. 1308.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13967, Mar. 24, 1997]
Sec. 1308.03 Administration Controlled Substances Code Number.
(a) Each controlled substance, or basic class thereof, has been
assigned an ``Administration Controlled Substances Code Number'' for
purposes of identification of the substances or class on certain
Certificates of Registration issued by the Administration pursuant to
Sec. Sec. 1301.35 of this chapter and on certain order forms issued by
the Administration pursuant to Sec. 1305.05(d) of this chapter.
Applicants for procurement and/or individual manufacturing quotas must
include the appropriate code number on the application as required in
Sec. Sec. 1303.12(b) and 1303.22(a) of this chapter. Applicants for
import and export permits must include the appropriate code number on
the application as required in Sec. Sec. 1312.12(a) and 1312.22(a) of
this chapter. Authorized registrants who desire to import or export a
controlled substance for which an import or export permit is not
required must include the appropriate Administration Controlled
Substances Code Number beneath or beside the name of each controlled
substance listed on the DEA Form 236
[[Page 93]]
(Controlled Substance Import/Export Declaration) which is executed for
such importation or exportation as required in Sec. Sec. 1312.18(c) and
1312.27(b) of this chapter.
(b) Except as stated in paragraph (a) of this section, no applicant
or registrant is required to use the Administration Controlled
Substances Code Number for any purpose.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973
and amended at 51 FR 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997]
Schedules
Sec. 1308.11 Schedule I.
(a) Schedule I shall consist of the drugs and other substances, by
whatever official name, common or usual name, chemical name, or brand
name designated, listed in this section. Each drug or substance has been
assigned the DEA Controlled Substances Code Number set forth opposite
it.
(b) Opiates. Unless specifically excepted or unless listed in
another schedule, any of the following opiates, including their isomers,
esters, ethers, salts, and salts of isomers, esters and ethers, whenever
the existence of such isomers, esters, ethers and salts is possible
within the specific chemical designation (for purposes of paragraph
(b)(34) only, the term isomer includes the optical and geometric
isomers):
(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4- 9815
piperidinyl]-N-phenylacetamide).................................
(2) Acetylmethadol............................................... 9601
(3) Allylprodine................................................. 9602
(4) Alphacetylmethadol (except levo-alphacetylmethadol also known 9603
as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM)....
(5) Alphameprodine............................................... 9604
(6) Alphamethadol................................................ 9605
(7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4- 9814
piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-
propanilido) piperidine)........................................
(8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4- 9832
piperidinyl]-N-phenylpropanamide)...............................
(9) Benzethidine................................................. 9606
(10) Betacetylmethadol........................................... 9607
(11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4- 9830
piperidinyl]-N-phenylpropanamide)...............................
(12) Beta-hydroxy-3-methylfentanyl (other name: N-[1-(2-hydroxy-2- 9831
phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide..........
(13) Betameprodine............................................... 9608
(14) Betamethadol................................................ 9609
(15) Betaprodine................................................. 9611
(16) Clonitazene................................................. 9612
(17) Dextromoramide.............................................. 9613
(18) Diampromide................................................. 9615
(19) Diethylthiambutene.......................................... 9616
(20) Difenoxin................................................... 9168
(21) Dimenoxadol................................................. 9617
(22) Dimepheptanol............................................... 9618
(23) Dimethylthiambutene......................................... 9619
(24) Dioxaphetyl butyrate........................................ 9621
(25) Dipipanone.................................................. 9622
(26) Ethylmethylthiambutene...................................... 9623
(27) Etonitazene................................................. 9624
(28) Etoxeridine................................................. 9625
(29) Furethidine................................................. 9626
(30) Hydroxypethidine............................................ 9627
(31) Ketobemidone................................................ 9628
(32) Levomoramide................................................ 9629
(33) Levophenacylmorphan......................................... 9631
(34) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4-piperidyl]- 9813
N-phenylpropanamide)............................................
(35) 3-methylthiofentanyl (N-[(3-methyl-1-(2-thienyl)ethyl-4- 9833
piperidinyl]-N-phenylpropanamide)...............................
(36) Morpheridine................................................ 9632
(37) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine)............. 9661
(38) Noracymethadol.............................................. 9633
(39) Norlevorphanol.............................................. 9634
(40) Normethadone................................................ 9635
(41) Norpipanone................................................. 9636
(42) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenethyl)-4- 9812
piperidinyl] propanamide........................................
(43) PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine........ 9663
(44) Phenadoxone................................................. 9637
(45) Phenampromide............................................... 9638
(46) Phenomorphan................................................ 9647
(47) Phenoperidine............................................... 9641
(48) Piritramide................................................. 9642
(49) Proheptazine................................................ 9643
(50) Properidine................................................. 9644
(51) Propiram.................................................... 9649
(52) Racemoramide................................................ 9645
(53) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]- 9835
propanamide.....................................................
(54) Tilidine.................................................... 9750
(55) Trimeperidine............................................... 9646
(c) Opium derivatives. Unless specifically excepted or unless listed
in another schedule, any of the following opium derivatives, its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific chemical
designation:
(1) Acetorphine.................................................. 9319
(2) Acetyldihydrocodeine......................................... 9051
(3) Benzylmorphine............................................... 9052
(4) Codeine methylbromide........................................ 9070
(5) Codeine-N-Oxide.............................................. 9053
(6) Cyprenorphine................................................ 9054
(7) Desomorphine................................................. 9055
(8) Dihydromorphine.............................................. 9145
(9) Drotebanol................................................... 9335
(10) Etorphine (except hydrochloride salt)....................... 9056
(11) Heroin...................................................... 9200
(12) Hydromorphinol.............................................. 9301
(13) Methyldesorphine............................................ 9302
(14) Methyldihydromorphine....................................... 9304
(15) Morphine methylbromide...................................... 9305
(16) Morphine methylsulfonate.................................... 9306
(17) Morphine-N-Oxide............................................ 9307
(18) Myrophine................................................... 9308
(19) Nicocodeine................................................. 9309
(20) Nicomorphine................................................ 9312
(21) Normorphine................................................. 9313
(22) Pholcodine.................................................. 9314
(23) Thebacon.................................................... 9315
(d) Hallucinogenic substances. Unless specifically excepted or
unless listed in
[[Page 94]]
another schedule, any material, compound, mixture, or preparation, which
contains any quantity of the following hallucinogenic substances, or
which contains any of its salts, isomers, and salts of isomers whenever
the existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation (for purposes of this paragraph
only, the term ``isomer'' includes the optical, position and geometric
isomers):
(1) Alpha-ethyltryptamine........................................ 7249
Some trade or other names: etryptamine; Monase; [alpha]-ethyl-
1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; [alpha]-ET;
and AET.
(2) 4-bromo-2,5-dimethoxy-amphetamine............................ 7391
Some trade or other names: 4-bromo-2,5-dimethoxy-[alpha]-
methylphenethylamine; 4-bromo-2,5-DMA
(3) 4-Bromo-2,5-dimethoxyphenethylamine.......................... 7392
Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)-1-
aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.
(4) 2,5-dimethoxyamphetamine..................................... 7396
Some trade or other names: 2,5-dimethoxy-[alpha]-
methylphenethylamine; 2,5-DMA
(5) 2,5-dimethoxy-4-ethylamphet-amine............................ 7399
Some trade or other names: DOET
(6) 2,5-dimethoxy-4-(n)-propylthiophenethylamine (other name: 2C- 7348
T-7)............................................................
(7) 4-methoxyamphetamine......................................... 7411
Some trade or other names: 4-methoxy-[alpha]-
methylphenethylamine; paramethoxyamphetamine, PMA
(8) 5-methoxy-3,4-mdthylenedioxy-amphetamine..................... 7401
(9) 4-methyl-2,5-dimethoxy-amphetamine........................... 7395
Some trade and other names: 4-methyl-2,5-dimethoxy-[alpha]-
methylphenethylamine; ``DOM''; and ``STP''
(10) 3,4-methylenedioxy amphetamine.............................. 7400
(11) 3,4-methylenedioxymethamphetamine (MDMA).................... 7405
(12) 3,4-methylenedioxy-N-ethylamphetamine (also known as N-ethyl- 7404
alpha-methyl-3,4(methylenedioxy)phenethylamine, N-ethyl MDA,
MDE, MDEA.......................................................
(13) N-hydroxy-3,4-methylenedioxyamphetamine (also known as N- 7402
hydroxy-alpha-methyl-3,4(methylenedioxy)phenethylamine, and N-
hydroxy MDA.....................................................
(14) 3,4,5-trimethoxy amphetamine................................ 7390
(15) Alpha-methyltryptamine (other name: AMT).................... 7432
(16) Bufotenine.................................................. 7433
Some trade and other names: 3-([beta]-Dimethylaminoethyl)-5-
hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-
dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine
(17) Diethyltryptamine........................................... 7434
Some trade and other names: N,N-Diethyltryptamine; DET
(18) Dimethyltryptamine.......................................... 7435
Some trade or other names: DMT
(19) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT) 7439
(20) Ibogaine.................................................... 7260
Some trade and other names: 7-Ethyl-6,6[beta],7,8,9,10,12,13-
octahydro-2-methoxy-6,9-methano-5H-pyrido [1', 2':1,2] azepino
[5,4-b] indole; Tabernanthe iboga
(21) Lysergic acid diethylamide.................................. 7315
(22) Marihuana................................................... 7360
(23) Mescaline................................................... 7381
(24) Parahexyl--7374; some trade or other names: 3-Hexyl-1-
hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-
dibenzo[b,d]pyran; Synhexyl.
(25) Peyote...................................................... 7415
Meaning all parts of the plant presently classified botanically
as Lophophora williamsii Lemaire, whether growing or not, the
seeds thereof, any extract from any part of such plant, and
every compound, manufacture, salts, derivative, mixture, or
preparation of such plant, its seeds or extracts
(Interprets 21 USC 812(c), Schedule I(c) (12))
(26) N-ethyl-3-piperidyl benzilate............................... 7482
(27) N-methyl-3-piperidyl benzilate.............................. 7484
(28) Psilocybin.................................................. 7437
(29) Psilocyn.................................................... 7438
(30) Tetrahydrocannabinols....................................... 7370
Meaning tetrahydrocannabinols naturally contained in a plant of
the genus Cannabis (cannabis plant), as well as synthetic
equivalents of the substances contained in the cannabis plant,
or in the resinous extractives of such plant, and/or synthetic
substances, derivatives, and their isomers with similar
chemical structure and pharmacological activity to those
substances contained in the plant, such as the following:
1 cis or trans tetrahydrocannabinol, and their optical isomers
6 cis or trans tetrahydrocannabinol, and their optical isomers
3, 4 cis or trans tetrahydrocannabinol, and its optical isomers
(Since nomenclature of these substances is not internationally
standardized, compounds of these structures, regardless of
numerical designation of atomic positions covered.)
(31) Ethylamine analog of phencyclidine.......................... 7455
Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-
phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)ethylamine,
cyclohexamine, PCE
(32) Pyrrolidine analog of phencyclidine......................... 7458
Some trade or other names: 1-(1-phenylcyclohexyl)-pyrrolidine,
PCPy, PHP
(33) Thiophene analog of phencyclidine........................... 7470
Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]-
piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP
(34) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine...................... 7473
Some other names: TCPy
(e) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a depressant
effect on the central nervous system, including its salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation:
(1) gamma-hydroxybutyric acid (some other names include GHB; 2010
gamma-hydroxybutyrate; 4-hydroxybutyrate; 4-hydroxybutanoic
acid; sodium oxybate; sodium oxybutyrate).......................
(2) Mecloqualone................................................. 2572
(3) Methaqualone................................................. 2565
(f) Stimulants. Unless specifically excepted or unless listed in
another
[[Page 95]]
schedule, any material, compound, mixture, or preparation which contains
any quantity of the following substances having a stimulant effect on
the central nervous system, including its salts, isomers, and salts of
isomers:
(1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2- 1585
oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine)...............
(2) N-Benzylpiperazine (some other names: BZP, 1- 7493
benzylpiperazine)...............................................
(3) Cathinone.................................................... 1235
Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-
aminopropiophenone, 2-aminopropiophenone, and norephedrone
(4) Fenethylline................................................. 1503
(5) Methcathinone (Some other names: 2-(methylamino)- 1237
propiophenone; alpha-(methylamino)propiophenone; 2-(methylamino)-
1-phenylpropan-1-one; alpha-N-methylaminopropiophenone;
monomethylpropion; ephedrone; N-methylcathinone;
methylcathinone; AL-464; AL-422; AL-463 and UR1432), its salts,
optical isomers and salts of optical isomers....................
(6) ()cis-4-methylaminorex (()cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine)........
(7) N-ethylamphetamine........................................... 1475
(8) N,N-dimethylamphetamine (also known as N,N-alpha-trimethyl- 1480
benzeneethanamine; N,N-alpha-trimethylphenethylamine)...........
(g) Temporary listing of substances subject to emergency scheduling.
Any material, compound, mixture or preparation which contains any
quantity of the following substances:
(1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide 9818
(benzylfentanyl), its optical isomers, salts and salts of
isomers.........................................................
(2) N-[1-(2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide 9834
(thenylfentanyl), its optical isolers, salts and salts of
isomers.........................................................
[39 FR 22141, June 20, 1974]
Editorial Note: For Federal Register citations affecting Sec.
1308.11, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Sec. 1308.12 Schedule II.
(a) Schedule II shall consist of the drugs and other substances, by
whatever official name, common or usual name, chemical name, or brand
name designated, listed in this section. Each drug or substance has been
assigned the Controlled Substances Code Number set forth opposite it.
(b) Substances, vegetable origin or chemical synthesis. Unless
specifically excepted or unless listed in another schedule, any of the
following substances whether produced directly or indirectly by
extraction from substances of vegetable origin, or independently by
means of chemical synthesis, or by a combination of extraction and
chemical synthesis:
(1) Opium and opiate, and any salt, compound, derivative, or
preparation of opium or opiate excluding apomorphine, thebaine-derived
butorphanol, dextrorphan, nalbuphine, nalmefene, naloxone, and
naltrexone, and their respective salts, but including the following:
(1) Raw opium.................................................... 9600
(2) Opium extracts............................................... 9610
(3) Opium fluid.................................................. 9620
(4) Powdered opium............................................... 9639
(5) Granulated opium............................................. 9640
(6) Tincture of opium............................................ 9630
(7) Codeine...................................................... 9050
(8) Dihydroetorphine............................................. 9334
(9) Ethylmorphine................................................ 9190
(10) Etorphine hydrochloride..................................... 9059
(11) Hydrocodone................................................. 9193
(12) Hydromorphone............................................... 9150
(13) Metopon..................................................... 9260
(14) Morphine.................................................... 9300
(15) Oxycodone................................................... 9143
(16) Oxymorphone................................................. 9652
(17) Thebaine.................................................... 9333
(2) Any salt, compound, derivative, or preparation thereof which is
chemically equivalent or identical with any of the substances referred
to in paragraph (b) (1) of this section, except that these substances
shall not include the isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4) Coca leaves (9040) and any salt, compound, derivative or
preparation of coca leaves (including cocaine (9041) and ecgonine (9180)
and their salts, isomers, derivatives and salts of isomers and
derivatives), and any salt, compound, derivative, or preparation thereof
which is chemically equivalent or identical with any of these
substances, except that the substances shall not include decocainized
coca leaves or extraction of coca leaves, whhch extractions do not
contain cocaine or ecgonine.
(5) Concentrate of poppy straw (the crude extract of poppy straw in
either liquid, solid or powder form which contains the phenanthrene
alkaloids of the opium poppy), 9670.
(c) Opiates. Unless specifically excepted or unless in another
schedule any of the following opiates, including its isomers, esters,
ethers, salts and salts of isomers, esters and ethers
[[Page 96]]
whenever the existence of such isomers, esters, ethers, and salts is
possible within the specific chemical designation, dextrorphan and
levopropoxyphene excepted:
(1) Alfentanil................................................... 9737
(2) Alphaprodine................................................. 9010
(3) Anileridine.................................................. 9020
(4) Bezitramide.................................................. 9800
(5) Bulk dextropropoxyphene (non-dosage forms)................... 9273
(6) Carfentanil.................................................. 9743
(7) Dihydrocodeine............................................... 9120
(8) Diphenoxylate................................................ 9170
(9) Fentanyl..................................................... 9801
(10) Isomethadone................................................ 9226
(11) Levo-alphacetylmethadol..................................... 9648
[Some other names: levo-alpha-acetylmethadol, levomethadyl
acetate, LAAM]
(12) Levomethorphan.............................................. 9210
(13) Levorphanol................................................. 9220
(14) Metazocine.................................................. 9240
(15) Methadone................................................... 9250
(16) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl 9254
butane..........................................................
(17) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1- 9802
diphenylpropane-carboxylic acid.................................
(18) Pethidine (meperidine)...................................... 9230
(19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4- 9232
phenylpiperidine................................................
(20) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4- 9233
carboxylate.....................................................
(21) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4- 9234
carboxylic acid.................................................
(22) Phenazocine................................................. 9715
(23) Piminodine.................................................. 9730
(24) Racemethorphan.............................................. 9732
(25) Racemorphan................................................. 9733
(26) Remifentanil................................................ 9739
(27) Sufentanil.................................................. 9740
(d) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a stimulant
effect on the central nervous system:
(1) Amphetamine, its salts, optical isomers, and salts of its 1100
optical isomers.................................................
(2) Methamphetamine, its salts, isomers, and salts of its isomers 1105
(3) Phenmetrazine and its salts.................................. 1631
(4) Methylphenidate.............................................. 1724
(e) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a depressant
effect on the central nervous system, including its salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation:
(1) Amobarbital.................................................. 2125
(2) Glutethimide................................................. 2550
(3) Pentobarbital................................................ 2270
(4) Phencyclidine................................................ 7471
(5) Secobarbital................................................. 2315
(f) Hallucinogenic substances.
(1) Nabilone..................................................... 7379
[Another name for nabilone: ()-trans-3-
(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-
dimethyl-9H-dibenzo[b,d]pyran-9-one]
(g) Immediate precursors. Unless specifically excepted or unless
listed in another schedule, any material, compound, mixture, or
preparation which contains any quantity of the following substances:
(1) Immediate precursor to amphetamine and methamphetamine:
(i) Phenylacetone................................................ 8501
Some trade or other names: phenyl-2-propanone; P2P; benzyl
methyl ketone; methyl benzyl ketone;
(2) Immediate precursors to phencyclidine (PCP):
(i) 1-phenylcyclohexylamine...................................... 7460
(ii) 1-piperidinocyclohexanecarbonitrile (PCC)................... 8603
[39 FR 22142, June 20, 1974]
Editorial Note: For Federal Register citations affecting Sec.
1308.12, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Sec. 1308.13 Schedule III.
(a) Schedule III shall consist of the drugs and other substances, by
whatever official name, common or usual name, chemical name, or brand
name designated, listed in this section. Each drug or substance has been
assigned the DEA Controlled Substances Code Number set forth opposite
it.
(b) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a stimulant
effect on the central nervous sxstem, including its salts, isomers
(whether optical, position, or geometric), and salts of such isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation:
(1) Those compounds, mixtures, or preparations in dosage unit 1405
form containing any stimulant substances listed in schedule II
which compounds, mixtures, or preparations were listed on August
25, 1971, as excepted compounds under Sec. 1308.32, and any
other drug of the quantitative composition shown in that list
for those drugs or which is the same except that it contains a
lesser quantity of controlled substances........................
(2) Benzphetamine................................................ 1228
[[Page 97]]
(3) Chlorphentermine............................................. 1645
(4) Clortermine.................................................. 1647
(5) Phendimetrazine.............................................. 1615
(c) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a depressant
effect on the central nervous system:
(1) Any compound, mixture or preparation containing:
(i) Amobarbital.............................................. 2126
(ii) Secobarbital............................................ 2316
(iii) Pentobarbital.......................................... 2271
or any salt thereof and one or more other active medicinal
ingredients which are not listed in any schedule.
(2) Any suppository dosage form containing:
(i) Amobarbital.............................................. 2126
(ii) Secobarbital............................................ 2316
(iii) Pentobarbital.......................................... 2271
or any salt of any of these drugs and approved by the Food and
Drug Administration for marketing only as a suppository.
(3) Any substance which contains any quantity of a derivative of 2100
barbituric acid or any salt thereof.............................
(4) Chlorhexadol................................................. 2510
(5) Any drug product containing gamma hydroxybutyric acid, 2012
including its salts, isomers, and salts of isomers, for which an
application is approved under section 505 of the Federal Food,
Drug, and Cosmetic Act..........................................
(6) Ketamine, its salts, isomers, and salts of isomers........... 7285
[Some other names for ketamine: ()-2-(2-
chlorophenyl)-2-(methylamino)-cyclohexanone]
(7) Lysergic acid................................................ 7300
(8) Lysergic acid amide.......................................... 7310
(9) Methyprylon.................................................. 2575
(10) Sulfondiethylmethane........................................ 2600
(11) Sulfonethylmethane.......................................... 2605
(12) Sulfonmethane............................................... 2610
(13) Tiletamine and zolazepam or any salt thereof................ 7295
Some trade or other names for a tiletamine-zolazepam
combination product:
Telazol......................................................
Some trade or other names for tiletamine:
2-(ethylamino)-2-(2-thienyl)-cyclohexanone...................
Some trade or other names for zolazepam:
4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-
e] [1,4]-diazepin-7(1H)-one, flupyrazapon...................
(d) Nalorphine 9400.
(e) Narcotic drugs. Unless specifically excepted or unless listed in
another schedule:
(1) Any material, compound, mixture, or preparation containing
any of the following narcotic drugs, or their salts calculated
as the free anhydrous base or alkaloid, in limited quantities as
set forth below:
(i) Not more than 1.8 grams of codeine per 100 milliliters or 9803
not more than 90 milligrams per dosage unit, with an equal
or greater quantity of an isoquinoline alkaloid of opium....
(ii) Not more than 1.8 grams of codeine per 100 milliliters 9804
or not more than 90 milligrams per dosage unit, with one or
more active, nonnarcotic ingredients in recognized
therapeutic amounts.........................................
(iii) Not more than 300 milligrams of dihydrocodeinone 9805
(hydrocodone) per 100 milliliters or not more than 15
milligrams per dosage unit, with a fourfold or greater
quantity of an isoquinoline alkaloid of opium...............
(iv) Not more than 300 milligrams of dihydrocodeinone 9806
(hydrocodone) per 100 milliliters or not more than 15
milligrams per dosage unit, with one or more active
nonnarcotic ingredients in recognized therapeutic amounts...
(v) Not more than 1.8 grams of dihydrocodeine per 100 9807
milliliters or not more than 90 milligrams per dosage unit,
with one or more active nonnarcotic ingredients in
recognized therapeutic amounts..............................
(vi) Not more than 300 milligrams of ethylmorphine per 100 9808
milliliters or not more than 15 milligrams per dosage unit,
with one or more active, nonnarcotic ingredients in
recognized therapeutic amounts..............................
(vii) Not more than 500 milligrams of opium per 100 9809
milliliters or per 100 grams or not more than 25 milligrams
per dosage unit, with one or more active, nonnarcotic
ingredients in recognized therapeutic amounts...............
(viii) Not more than 50 milligrams of morphine per 100 9810
milliliters or per 100 grams, with one or more active,
nonnarcotic ingredients in recognized therapeutic amounts...
(2) Any material, compound, mixture, or preparation containing
any of the following narcotic drugs or their salts, as set forth
below:
(i) Buprenorphine............................................ 9064
(ii) [Reserved]..............................................
(f) Anabolic Steroids. Unless specifically excepted or unless listed
in another schedule, any material, compound, mixture or preparation
containing any quantity of the following substances, including its
salts, 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, as amended at 41 FR 43401, Oct. 1, 1976; 43
FR 3359, Jan. 25, 1978; 44 FR 40888, July 13, 1979; 46 FR 52334, Oct.
27, 1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan. 21, 1987; 52 FR
5952, Feb. 27, 1987; 56 FR 5754, Feb. 13, 1991; 56 FR 11932, Mar. 21,
1991; 62 FR 13968, Mar. 24, 1997; 64 FR 35930, July 2, 1999; 64 FR
37675, July 13, 1999; 65 FR 13238, Mar. 13, 2000; 65 FR 17440, Apr. 3,
2000; 67 FR 62370, Oct. 7, 2002; 70 FR 74657, Dec. 16, 2005]
[[Page 98]]
Sec. 1308.14 Schedule IV.
(a) Schedule IV shall consist of the drugs and other substances, by
whatever official name, common or usual name, chemical name, or brand
name designated, listed in this section. Each drug or substance has been
assigned the DEA Controlled Substances Code Number set forth opposite
it.
(b) Narcotic drugs. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
containing any of the following narcotic drugs, or their salts
calculated as the free anhydrous base or alkaloid, in limited quantities
as set forth below:
(1) Not more than 1 milligram of difenoxin and not less than 25 9167
micrograms of atropine sulfate per dosage unit..................
(2) Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3- 9278
methyl-2-propionoxybutane)......................................
(c) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances, including its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific chemical
designation:
(1) Alprazolam.................................................. 2882
(2) Barbital.................................................... 2145
(3) Bromazepam.................................................. 2748
(4) Camazepam................................................... 2749
(5) Chloral betaine............................................. 2460
(6) Chloral hydrate............................................. 2465
(7) Chlordiazepoxide............................................ 2744
(8) Clobazam.................................................... 2751
(9) Clonazepam.................................................. 2737
(10) Clorazepate................................................ 2768
(11) Clotiazepam................................................ 2752
(12) Cloxazolam................................................. 2753
(13) Delorazepam................................................ 2754
(14) Diazepam................................................... 2765
(15) Dichloralphenazone......................................... 2467
(16) Estazolam.................................................. 2756
(17) Ethchlorvynol.............................................. 2540
(18) Ethinamate................................................. 2545
(19) Ethyl loflazepate.......................................... 2758
(20) Fludiazepam................................................ 2759
(21) Flunitrazepam.............................................. 2763
(22) Flurazepam................................................. 2767
(23) Halazepam.................................................. 2762
(24) Haloxazolam................................................ 2771
(25) Ketazolam.................................................. 2772
(26) Loprazolam................................................. 2773
(27) Lorazepam.................................................. 2885
(28) Lormetazepam............................................... 2774
(29) Mebutamate................................................. 2800
(30) Medazepam.................................................. 2836
(31) Meprobamate................................................ 2820
(32) Methohexital............................................... 2264
(33) Methylphenobarbital (mephobarbital)........................ 2250
(34) Midazolam.................................................. 2884
(35) Nimetazepam................................................ 2837
(36) Nitrazepam................................................. 2834
(37) Nordiazepam................................................ 2838
(38) Oxazepam................................................... 2835
(39) Oxazolam................................................... 2839
(40) Paraldehyde................................................ 2585
(41) Petrichloral............................................... 2591
(42) Phenobarbital.............................................. 2285
(43) Pinazepam.................................................. 2883
(44) Prazepam................................................... 2764
(45) Quazepam................................................... 2881
(46) Temazepam.................................................. 2925
(47) Tetrazepam................................................. 2886
(48) Triazolam.................................................. 2887
(49) Zaleplon................................................... 2781
(50) Zolpidem................................................... 2783
(51) 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) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a stimulant
effect on the central nervous system, including its salts, isomers and
salts of isomers:
(1) Cathine ((+)-norpseudoephedrine)............................. 1230
(2) Diethylpropion............................................... 1610
(3) Fencamfamin.................................................. 1760
(4) Fenproporex.................................................. 1575
(5) Mazindol..................................................... 1605
(6) Mefenorex.................................................... 1580
(7)Modafinil..................................................... 1680
(8) Pemoline (including organometallic complexes and chelates 1530
thereof)........................................................
(9) Phentermine.................................................. 1640
(10) Pipradrol................................................... 1750
(11) Sibutramine................................................. 1675
(12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane)............... 1635
(f) Other substances. Unless specifically excepted or unless listed
in another schedule, any material, compound, mixture or preparation
which contains any quantity of the following substances, including its
salts:
(1) Pentazocine.................................................. 9709
(2) Butorphanol (including its optical isomers).................. 9720
[39 FR 22143, June 20, 1974]
Editorial Note: For Federal Register citations affecting Sec.
1308.14, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
[[Page 99]]
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) Pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid] 2782
(2) [Reserved]
[39 FR 22143, June 20, 1974, as amended at 43 FR 38383, Aug. 28, 1978;
44 FR 40888, July 13, 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb.
28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, Apr. 4, 1988; 56 FR
61372, Dec. 3, 1991; 67 FR 62370, Oct. 7, 2002; 70 FR 43635, July 28,
2005]
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 Administrator, Drug Enforcement
Administration, Department of Justice, Washington, DC 20537.
(b) An application for an exclusion under this section shall contain
the following information:
(1) The name and address of the applicant;
(2) The name of the substance for which exclusion is sought; and
(3) The complete quantitative composition of the substance.
(c) Within a reasonable period of time after the receipt of an
application for an exclusion under this section, the Administrator shall
notify the applicant of his acceptance or nonacceptance of his
application, and if not accepted, the reason therefore. The
Administrator need not accept an application for filing if any of the
requirements prescribed in paragraph (b) of this section is lacking or
is not set forth as to be readily understood. If the applicant desires,
he may amend the application to meet the requirements of paragraph (b)
of this section. If the application is accepted for filing, the
Administrator shall issue and publish in the Federal Register his order
on
[[Page 100]]
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]
Sec. 1308.22 Excluded substances.
The following nonnarcotic substances which may, under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the
counter without a prescription, are excluded from all schedules pursuant
to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):
Excluded Nonnarcotic Products
----------------------------------------------------------------------------------------------------------------
Controlled (mg or mg/
Company Trade name NDC code Form substance ml)
----------------------------------------------------------------------------------------------------------------
Bioline Laboratories........... Theophed.......... 00719-1945 TB Phenobarbital..... 8.00
Goldline Laboratories.......... Guiaphed Elixir... 00182-1377 EL Phenobarbital..... 4.00
Goldline Laboratories.......... Tedrigen Tablets.. 00182-0134 TB Phenobarbital..... 8.00
Hawthorne Products Inc......... Choate's Leg .............. LQ Chloral hydrate... 246.67
Freeze.
Parke-Davis & Co............... Tedral............ 00071-0230 TB Phenobarbital..... 8.00
Parke-Davis & Co............... Tedral Elixir..... 00071-0242 EX Phenobarbital..... 40.00
Parke-Davis & Co............... Tedral S.A........ 00071-0231 TB Phenobarbital..... 8.00
Parke-Davis & Co............... Tedral Suspension. 00071-0237 SU Phenobarbital..... 80.00
Parmed Pharmacy................ Asma-Ese.......... 00349-2018 TB Phenobarbital..... 8.10
Rondex Labs.................... Azma-Aids......... 00367-3153 TB Phenobarbital..... 8.00
Smith Kline Consumer........... Benzedrex......... 49692-0928 IN Propylhexedrine... 250.00
Sterling Drug, Inc............. Bronkolixir....... 00057-1004 EL Phenobarbital..... 0.80
Sterling Drug, Inc............. Bronkotabs........ 00057-1005 TB Phenobarbital..... 8.00
Vicks Chemical Co.............. Vicks Inhaler..... 23900-0010 IN I-Desoxyephedrine. 113.00
White Hall Labs................ Primatene (P- 00573-2940 TB Phenobarbital..... 8.00
tablets).
----------------------------------------------------------------------------------------------------------------
[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 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]
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
[[Page 101]]
agents in such a manner, combination, quantity, proportion, or
concentration, that the preparation or mixture does not present any
potential for abuse. If the preparation or mixture contains a narcotic
controlled substance, the preparation or mixture must be formulated in
such a manner that it incorporates methods of denaturing or other means
so that the preparation or mixture is not liable to be abused or have
ill effects, if abused, and so that the narcotic substance cannot in
practice be removed.
(b) Any person seeking to have any preparation or mixture containing
a controlled substance and one or more noncontrolled substances exempted
from the application of all or any part of the Act, pursuant to
paragraph (a) of this section, may apply to the Administrator, Drug
Enforcement Administration, Department of Justice, Washington, DC 20537.
(c) An application for an exemption under this section shall contain
the following information:
(1) The name, address, and registration number, if any, of the
applicant;
(2) The name, address, and registration number, if any, of the
manufacturer or importer of the preparation or mixture, if not the
applicant;
(3) The exact trade name or other designation of the preparation or
mixture;
(4) The complete qualitative and quantitative composition of the
preparation or mixture (including all active and inactive ingredients
and all controlled and noncontrolled substances);
(5) The form of the immediate container in which the preparation or
mixture will be distributed with sufficient descriptive detail to
identify the preparation or mixture (e.g., bottle, packet, vial, soft
plastic pillow, agar gel plate, etc.);
(6) The dimensions or capacity of the immediate container of the
preparation or mixture;
(7) The label and labeling, as defined in part 1300 of this chapter,
of the immediate container and the commercial containers, if any, of the
preparation or mixture;
(8) A brief statement of the facts which the applicant believes
justify the granting of an exemption under this paragraph, including
information on the use to which the preparation or mixture will be put;
(9) The date of the application; and
(10) Which of the information submitted on the application, if any,
is deemed by the applicant to be a trade secret or otherwise
confidential and entitled to protection under subsection 402(a)(8) of
the Act (21 U.S.C. 842(a) (8)) or any other law restricting public
disclosure of information.
(d) The Administrator may require the applicant to submit such
documents or written statements of fact relevant to the application as
he deems necessary to determine whether the application should be
granted.
(e) Within a reasonable period of time after the receipt of an
application for an exemption under this section, the Administrator shall
notify the applicant of his acceptance or nonacceptance of his
application, and if not accepted, the reason therefor. The Administrator
need not accept an application for filing if any of the requirements
prescribed in paragraph (c) or requested pursuant to paragraph (d) is
lacking or is not set forth as to be readily understood. If the
applicant desires, he may amend the application to meet the requirements
of paragraphs (c) and (d) of this section. If the application is
accepted for filing, the Administrator shall issue and publish in the
Federal Register his order on the application, which shall include a
reference to the legal authority under which the order is based. This
order shall specify the date on which it shall take effect. The
Administrator shall permit any interested person to file written
comments on or objections to the order within 60 days of the date of
publication of his order in the Federal Register. If any such comments
or objections raise significant issues regarding any finding of fact or
conclusion of law upon which the order is based, the Administrator shall
immediately suspend the effectiveness of the order until he may
reconsider the application in light of the comments and objections
filed. Thereafter, the Administrator shall reinstate, revoke, or amend
his original order as he determines appropriate.
[[Page 102]]
(f) The Administrator may at any time revoke or modify any exemption
granted pursuant to this section by following the procedures set forth
in paragraph (e) of this section for handling an application for an
exemption which has been accepted for filing. The Administrator may also
modify or revoke the criteria by which exemptions are granted (and
thereby modify or revoke all preparations and mixtures granted under the
old criteria) and modify the scope of exemptions at any time.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 46 FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, 1997]
Sec. 1308.24 Exempt chemical preparations.
(a) The chemical preparations and mixtures approved pursuant to
Sec. 1308.23 are exempt from application of sections 302, 303, 305,
306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822-823,
825-829, 952-954) and Sec. 1301.74 of this chapter, to the extent
described in paragraphs (b) to (h) of this section. Substances set forth
in paragraph (j) of this section shall be exempt from the application of
sections 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21
U.S.C. 825-829, 952-954) and Sec. Sec. 1301.71--1301.73 and 1301.74
(a), (b), (d), (e) and (f) of this chapter to the extent as hereinafter
may be provided.
(b) Registration and security: Any person who manufactures an exempt
chemical preparation or mixture must be registered under the Act and
comply with all relevant security requirements regarding controlled
substances being used in the manufacturing process until the preparation
or mixture is in the form described in paragraph (i) of this section.
Any other person who handles an exempt chemical preparation after it is
in the form described in paragraph (i) of this section is not required
to be registered under the Act to handle that preparation, and the
preparation is not required to be stored in accordance with security
requirements regarding controlled substances.
(c) Labeling: In lieu of the requirements set forth in part 1302 of
this chapter, the label and the labeling of an exempt chemical
preparation must be prominently marked with its full trade name or other
description and the name of the manufacturer or supplier as set forth in
paragraph (i) of this section, in such a way that the product can be
readily identified as an exempt chemical preparation. The label and
labeling must also include in a prominent manner the statement ``For
industrial use only'' or ``For chemical use only'' or ``For in vitro use
only--not for human or animal use'' or ``Diagnostic reagent--for
professional use only'' or a comparable statement warning the person
reading it that human or animal use is not intended. The symbol
designating the schedule of the controlled substance is not required on
either the label or the labeling of the exempt chemical preparation, nor
is it necessary to list all ingredients of the preparation.
(d) Records and reports: Any person who manufactures an exempt
chemical preparation or mixture must keep complete and accurate records
and file all reports required under part 1304 of this chapter regarding
all controlled substances being used in the manufacturing process until
the preparation or mixture is in the form described in paragraph (i) of
this section. In lieu of records and reports required under part 1304 of
this chapter regarding exempt chemical preparations, the manufacturer
need only record the name, address, and registration number, if any, of
each person to whom the manufacturer distributes any exempt chemical
preparation. Each importer or exporter of an exempt narcotic chemical
preparation must submit a semiannual report of the total quantity of
each substance imported or exported in each calendar half-year within 30
days of the close of the period to the Drug and Chemical Evaluation
Section, Drug Enforcement Administration, Department of Justice,
Washington, DC 20537. Any other person who handles an exempt chemical
preparation after it is in the form described in paragraph (i) of this
section is not required to maintain records or file reports.
(e) Quotas, order forms, prescriptions, import, export, and
transshipment requirements: Once an exempt chemical preparation is in
the form described in paragraph (i) of this section, the requirements
regarding
[[Page 103]]
quotas, order forms, prescriptions, import permits and declarations,
export permit and declarations, and transshipment and intransit permits
and declarations do not apply. These requirements do apply, however, to
any controlled substances used in manufacturing the exempt chemical
preparation before it is in the form described in paragraph (i) of this
section.
(f) Criminal penalties: No exemption granted pursuant to Sec.
1308.23 affects the criminal liability for illegal manufacture,
distribution, or possession of controlled substances contained in the
exempt chemical preparation. Distribution, possession, and use of an
exempt chemical preparation are lawful for registrants and
nonregistrants only as long as such distribution, possession, or use is
intended for laboratory, industrial, or educational purposes and not for
immediate or subsequent administration to a human being or other animal.
(g) Bulk materials: For materials exempted in bulk quantities, the
Administrator may prescribe requirements other than those set forth in
paragraphs (b) through (e) of this section on a case-by-case basis.
(h) Changes in chemical preparations: Any change in the quantitative
or qualitative composition of the preparation or mixture after the date
of application, or change in the trade name or other designation of the
preparation or mixture, set forth in paragraph (i) of this section,
requires a new application for exemption.
(i) A listing of exempt chemical preparations may be obtained by
submitting a written request to the Drug and Chemical Evaluation
Section, Drug Enforcement Administration, Washington, DC 20537.
(j) The following substances are designated as exempt chemical
preparations for the purposes set forth in this section.
(1) Chloral. When packaged in a sealed, oxygen-free environment,
under nitrogen pressure, safeguarded against exposure to the air.
(2) Emit\R\ Phenobarbital Enzyme Reagent B. In one liter quantities
each with a 5 ml. retention sample for repackaging as an exempt chemical
preparation only.
[38 FR 8255, Mar. 30, 1973]
Editorial Note: For Federal Register citations affecting Sec.
1308.24, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.
Excluded Veterinary Anabolic Steroid Implant Products
Sec. 1308.25 Exclusion of a veterinary anabolic steroid implant
product; application.
(a) Any person seeking to have any anabolic steroid product, which
is expressly intended for administration through implants to cattle or
other nonhuman species and which has been approved by the Secretary of
Health and Human Services for such administration, identified as being
excluded from any schedule, pursuant to section 102(41)(B)(i) of the Act
(21 U.S.C. 802(41)(B)(i)), may apply to the Administrator, Drug
Enforcement Administration, Department of Justice, Washington, DC 20537.
(b) An application for any exclusion under this section shall be
submitted in triplicate and contain the following information:
(1) The name and address of the applicant;
(2) The name of the product;
(3) The chemical structural formula or description for any anabolic
steroid contained in the product;
(4) A complete description of dosage and quantitative composition of
the dosage form;.
(5) The conditions of use including whether or not Federal law
restricts this product to use by or on the order of a licensed
veterinarian;
(6) A description of the delivery system in which the dosage form
will be distributed with sufficient detail to identify the product (e.g.
20 cartridge brown plastic belt);
(7) The label and labeling of the immediate container and the
commercial containers, if any, of the product;.
(8) The name and address of the manufacturer of the dosage form if
different from that of the applicant; and
(9) Evidence that the product has been approved by the Secretary of
[[Page 104]]
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]
Sec. 1308.26 Excluded veterinary anabolic steroid implant products.
(a) Products containing an anabolic steroid, that are expressly
intended for administration through implants to cattle or other nonhuman
species and which have been approved by the Secretary of Health and
Human Services for such administration are excluded from all schedules
pursuant to section 102(41)(B)(I) of the Act (21 U.S.C. 802(41)(B)(I)).
A listing of the excluded products may be obtained by submitting a
written request to the Drug and Chemical Evaluation Section, Drug
Enforcement Administration, Washington DC 20537.
(b) In accordance with section 102(41)(B)(ii) of the Act (21 U.S.C.
802(41)(B)(ii)) if any person prescribes, dispenses, or distributes a
product listed in paragraph (a) of this section for human use, such
person shall be considered to have prescribed, dispensed, or distributed
an anabolic steroid within the meaning of section 102(41)(A) of the Act
(21 U.S.C. 802(41)(A)).
[56 FR 42936, Aug. 30, 1991, as amended at 57 FR 19534, May 7, 1992; 58
FR 15088, Mar. 19, 1993; 62 FR 13967, Mar. 24, 1997]
Exempted Prescription Products
Sec. 1308.31 Application for exemption of a nonnarcotic prescription
product.
(a) Any person seeking to have any compound, mixture, or preparation
containing any nonnarcotic controlled substance listed in Sec.
1308.12(e), or in Sec. 1308.13 (b) or (c), or in Sec. 1308.14, or in
Sec. 1308.15, exempted from application of all or any part of the Act
pursuant to section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A).
may apply to the Administrator, Drug Enforcement Administration,
Washington, DC 20537, for such exemption.
(b) An application for an exemption under this section shall contain
the following information:
(1) The complete quantitative composition of the dosage form.
(2) Description of the unit dosage form together with complete
labeling.
(3) A summary of the pharmacology of the product including animal
investigations and clinical evaluations and studies, with emphasis on
the psychic and/or physiological dependence liability (this must be done
for each of the active ingredients separately and for the combination
product).
(4) Details of synergisms and antagonisms among ingredients.
[[Page 105]]
(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 specify in the order his
findings as to such conditions.
(d) The Administrator may revoke any exemption granted pursuant to
section 201(g)(3)(A) of the Act (21 U.S.C. 811(g)(3)(A)) by following
the procedures set forth in paragraph (c) of this section for handling
an application for an exemption which has been accepted for filing.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973,
as amended at 44 FR 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987]
Sec. 1308.32 Exempted prescription products.
The compounds, mixtures, or preparations that contain a nonnarcotic
controlled substance listed in Sec. 1308.12(e) or in Sec. 1308.13 (b)
or (c) or in Sec. 1308.14 or in Sec. 1308.15 listed in the Table of
Exempted Prescription Products have been exempted by the Administrator
from the application of sections 302 through 305, 307 through 309, 1002
through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) and
Sec. Sec. 1301.13, 1301.22, and Sec. Sec. 1301.71 through 1301.76 of
this chapter for administrative purposes only. An exception to the above
is that those products containing butalbital shall not be exempt from
the requirement of 21 U.S.C. 952-954 concerning importation,
exportation, transshipment and in-transit shipment of controlled
substances. Any deviation from the quantitative composition of any of
the listed drugs shall require a petition of exemption in order for the
product to be exempted. A listing of the Exempted Prescription Products
may be obtained by submitting a written request to the Drug and Chemical
Evaluation Section, Drug Enforcement Administration, Washington, DC
20537.
[62 FR 13967, Mar. 24, 1997]
Exempt Anabolic Steroid Products
Sec. 1308.33 Exemption of certain anabolic steroid products;
application.
(a) The Administrator, upon the recommendation of 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
[[Page 106]]
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 Administrator, Drug
Enforcement Administration, Department of Justice, Washington, DC 20537.
(c) An application for an exemption under this section shall be
submitted in triplicate and contain the following information:
(1) The name and address of the applicant;
(2) The name of the product;
(3) The chemical structural formula or description for any anabolic
steroid contained in the product;
(4) The complete description of dosage and quantitative composition
of the dosage form;
(5) A description of the delivery system, if applicable;
(6) The indications and conditions for use in which species,
including whether or not this product is a prescription drug;
(7) Information to facilitate identification of the dosage form,
such as shape, color, coating, and scoring;
(8) The label and labeling of the immediate container and the
commercial containers, if any, of the product;
(9) The units in which the dosage form is ordinarily available; and
(10) The facts which the applicant believes justify:
(i) A determination that the product has no significant potential
for abuse and
(ii) a granting of an exemption under this section.
(d) Within a reasonable period of time after the receipt of the
application for an exemption under this section, the Administrator shall
notify the applicant of his acceptance or nonacceptance of the
application, and if not accepted, the reason therefor. The Administrator
need not accept an application for filing if any of the requirements
prescribed in paragraph (c) of this section is lacking or is not set
forth so as to be readily understood. The applicant may amend the
application to meet the requirements of paragraph (c) of this section.
If accepted for filing, the Administrator will request from the
Secretary for Health and Human Services his recommendation, as to
whether such product which contains an anabolic steroid should be
considered for exemption from certain portions of the Controlled
Substances Act. On receipt of the recommendation of the Secretary, the
Administrator shall make a determination as to whether the evidence
submitted or otherwise available sufficiently establishes that the
product possesses no significant potential for abuse. The Administrator
shall issue and publish in the Federal Register his order on the
application, which shall include a reference to the legal authority
under which the order is issued, and the findings of fact and
conclusions of law upon which the order is based. This order shall
specify the date on which it will take effect. The Administrator shall
permit any interested person to file written comments on or objections
to the order within 60 days of the date of publication of his order in
the Federal Register. If any such comments or objections raise
significant issues regarding any finding of fact or conclusion of law
upon which the order is based, the Administrator shall immediately
suspend the effectiveness of the order until he may reconsider the
application in light of the comments and objections filed. Thereafter,
the Administrator shall reinstate, revoke, or amend his original order
as he determines appropriate.
(e) The Administrator may revoke any exemption granted pursuant to
section 1903(a) of Public Law 101-647 by following the procedures set
forth in paragraph (d) of this section for handling an application for
an exemption which has been accepted for filing.
[56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. 31, 1992, as amended at
62 FR 13968, Mar. 24, 1997; 70 FR 74657, Dec. 16, 2005]
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
[[Page 107]]
Administrator from application of sections 302 through 309 and 1002
through 1004 of the Act (21 U.S.C. 822-829 and 952-954) and Sec. Sec.
1301.13, 1301.22, and 1301.71 through 1301.76 of this chapter for
administrative purposes only may be obtained by submitting a written
request to the Drug and Chemical Evaluation Section, Drug Enforcement
Administration, Washington, DC 20537.
[62 FR 13967, Mar. 24, 1997]
Exempt Cannabis Plant Material, and Products Made Therefrom, that
Contain Tetrahydrocannabinols
Sec. 1308.35 Exemption of certain cannabis plant material, and products
made therefrom, that contain tetrahydrocannabinols.
(a) Any processed plant material or animal feed mixture containing
any amount of tetrahydrocannabinols (THC) that is both:
(1) Made from any portion of a plant of the genus Cannabis excluded
from the definition of marijuana under the Act [i.e., the mature stalks
of such plant, fiber produced from such stalks, oil or cake made from
the seeds of such plant, any other compound, manufacture, salt,
derivative, mixture, or preparation of such mature stalks (except the
resin extracted therefrom), fiber, oil, or cake, or the sterilized seed
of such plant which is incapable of germination] and
(2) Not used, or intended for use, for human consumption, has been
exempted by the Administrator from the application of the Act and this
chapter.
(b) As used in this section, the following terms shall have the
meanings specified:
(1) The term processed plant material means cannabis plant material
that has been subject to industrial processes, or mixed with other
ingredients, such that it cannot readily be converted into any form that
can be used for human consumption.
(2) The term animal feed mixture means sterilized cannabis seeds
mixed with other ingredients (not derived from the cannabis plant) in a
formulation that is designed, marketed, and distributed for animal
consumption (and not for human consumption).
(3) The term used for human consumption means either:
(i) Ingested orally or
(ii) Applied by any means such that THC enters the human body.
(4) The term intended for use for human consumption means any of the
following:
(i) Designed by the manufacturer for human consumption;
(ii) Marketed for human consumption; or
(iii) Distributed, exported, or imported, with the intent that it be
used for human consumption.
(c) In any proceeding arising under the Act or this chapter, the
burden of going forward with the evidence that a material, compound,
mixture, or preparation containing THC is exempt from control pursuant
to this section shall be upon the person claiming such exemption, as set
forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to
meet this burden with respect to a product or plant material that has
not been expressly exempted from control by the Administrator pursuant
to Sec. 1308.23, the person claiming the exemption must present
rigorous scientific evidence, including well-documented scientific
studies by experts trained and qualified to evaluate the effects of
drugs on humans.
[66 FR 51544, Oct. 9, 2001]
Hearings
Sec. 1308.41 Hearings generally.
In any case where the Administrator shall hold a hearing on the
issuance, amendment, or repeal of rules pursuant to section 201 of the
Act, the procedures for such hearing and accompanying proceedings shall
be governed generally by the rulemaking procedures set forth in the
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
section 201 of the Act (21 U.S.C. 811), by Sec. Sec. 1308.42-1308.51,
and by Sec. Sec. 1316.41-1316.67 of this chapter.
Sec. 1308.42 Purpose of hearing.
If requested by any interested person after proceedings are
initiated pursuant to Sec. 1308.43, the Administrator shall hold a
hearing for the purpose of receiving factual evidence and expert opinion
regarding the issues involved
[[Page 108]]
in the issuance, amendment or repeal of a rule issuable pursuant to
section 201(a) of the Act (21 U.S.C. 811(a)). Extensive argument should
not be offered into evidence but rather presented in opening or closing
statements of counsel or in memoranda or proposed findings of fact and
conclusions of law. Additional information relating to hearings to
include waivers or modification of rules, request for hearing, burden of
proof, time and place, and final order are set forth in part 1316 of
this chapter.
[62 FR 13968, Mar. 24, 1997]
Sec. 1308.43 Initiation of proceedings for rulemaking.
(a) Any interested person may submit a petition to initiate
proceedings for the issuance, amendment, or repeal of any rule or
regulation issuable pursuant to the provisions of section 201 of the
Act.
(b) Petitions shall be submitted in quintuplicate to the
Administrator in the following form:
________________________________________________________________________
(Date)
Administrator, Drug Enforcement
Administration
Department of Justice,
Washington, DC 20537.
Dear Sir: The undersigned ---------------------------------- hereby
petitions the Administrator to initiate proceedings for the issuance
(amendment or repeal) of a rule or regulation pursuant to section 201 of
the Controlled Substances Act.
Attached hereto and constituting a part of this petition are the
following:
(A) The proposed rule in the form proposed by the petitioner. (If
the petitioner seeks the amendment or repeal of an existing rule, the
existing rule, together with a reference to the section in the Code of
Federal Regulations where it appears, should be included.)
(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
[[Page 109]]
or other substance, or substantial evidence that the drug or other
substances should be subjected to lesser control or removed entirely
from the schedules, he shall initiate proceedings for control, transfer,
or removal as the case may be.
(f) If and when the Administrator determines to initiate
proceedings, he shall publish in the Federal Register general notice of
any proposed rule making to issue, amend, or repeal any rule pursuant to
section 201 of the Act. Such published notice shall include a statement
of the time, place, and nature of any hearings on the proposal in the
event a hearing is requested pursuant to Sec. 1308.44. Such hearings
may not be commenced until after the expiration of at least 30 days from
the date the general notice is published in the Federal Register. Such
published notice shall also include a reference to the legal authority
under which the rule is proposed, a statement of the proposed rule, and,
in the discretion of the Administrator, a summary of the subjects and
issues involved.
(g) The Administrator may permit any interested persons to file
written comments on or objections to the proposal and shall designate in
the notice of proposed rule making the time during which such filings
may be made.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]
Sec. 1308.44 Request for hearing or appearance; waiver.
(a) Any interested person desiring a hearing on a proposed
rulemaking, shall, within 30 days after the date of publication of
notice of the proposed rulemaking in the Federal Register, file with the
Administrator a written request for a hearing in the form prescribed in
Sec. 1316.47 of this chapter.
(b) Any interested person desiring to participate in a hearing
pursuant to Sec. 1308.41 shall, within 30 days after the date of
publication of the notice of hearing in the Federal Register, file with
the Administrator a written notice of his intention to participate in
such hearing in the form prescribed in Sec. 1316.48 of this chapter.
Any person filing a request for a hearing need not also file a notice of
appearance; the request for a hearing shall be deemed to be a notice of
appearance.
(c) Any interested person may, within the period permitted for
filing a request for a hearing, file with the Administrator a waiver of
an opportunity for a hearing or to participate in a hearing, together
with a written statement regarding his position on the matters of fact
and law involved in such hearing. Such statement, if admissible, shall
be made a part of the record and shall be considered in light of the
lack of opportunity for cross-examination in determining the weight to
be attached to matters of fact asserted therein.
(d) If any interested person fails to file a request for a hearing;
or if he so files and fails to appear at the hearing, he shall be deemed
to have waived his opportunity for the hearing or to participate in the
hearing, unless he shows good cause for such failure.
(e) If all interested persons waive or are deemed to waive their
opportunity for the hearing or to participate in the hearing, the
Administrator may cancel the hearing, if scheduled, and issue his final
order pursuant to Sec. 1308.45 without a hearing.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]
Sec. 1308.45 Final order.
As soon as practicable after the presiding officer has certified the
record to the Administrator, the Administrator shall cause to be
published in the Federal Register his order in the proceeding, which
shall set forth the final rule and the findings of fact and conclusions
of law upon which the rule is based. This order shall specify the date
on which it shall take effect, which shall not be less than 30 days from
the date of publication in the Federal Register unless the Administrator
finds that conditions of public health or safety necessitate an earlier
effective date, in which event the Administrator shall specify in the
order his findings as to such conditions.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated at 62 FR 13968, Mar. 24, 1997]
[[Page 110]]
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 which the controlled
substance of which it is an immediate precursor is placed or any other
schedule with a higher numerical designation. An order controlling an
immediate precursor shall become effective 30 days from the date of
publication in the Federal Register, unless the Administrator finds that
conditions of public health or safety necessitate an earlier effective
date, in which event the Administrator shall specify in the order his
findings as to such conditions.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated at 62 FR 13968, Mar. 24, 1997]
Sec. 1308.49 Emergency scheduling.
Pursuant to 21 U.S.C. 811(h) and without regard to the requirements
of 21 U.S.C. 811(b) relating to the scientific and medical evaluation of
the Secretary of Health and Human Services, the Administrator may place
a substance into Schedule I on a temporary basis, if he determines that
such action is necessary to avoid an imminent hazard to the public
safety. An order issued under this section may not be effective before
the expiration of 30 days from:
(a) The date of publication by the Administrator of a notice in the
Federal Register of his intention to issue such order and the grounds
upon which such order is to be issued, and
(b) The date the Administrator has transmitted notification to the
Secretary of Health and Human Services of his intention to issue such
order. An order issued under this section shall be vacated upon the
conclusion of a subsequent rulemaking proceeding initiated under section
201(a) (21 U.S.C. 811(a)) with respect to such substance or at the end
of one year from the effective date of the order scheduling the
substance, except that during the pendency of proceedings under section
201(a) (21 U.S.C. 811(a)) with respect to the substance, the
Administrator may extend the temporary scheduling for up to six months.
[51 FR 15318, Apr. 23, 1986. Redesignated and amended at 62 FR 13968,
Mar. 24, 1997]
PART 1309_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND
EXPORTERS OF LIST I CHEMICALS--Table of Contents
General Information
Sec.
1309.01 Scope of part 1309.
1309.02 Definitions.
1309.03 Information; special instructions.
Fees for Registration and Reregistration
1309.11 Fee amounts.
[[Page 111]]
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.
Modification, Transfer and Termination of Registration
1309.61 Modification in registration.
1309.62 Termination of registration.
1309.63 Transfer of registration.
Security Requirements
1309.71 General security requirements.
1309.72 Felony conviction; employer responsibilities.
1309.73 Employee responsibility to report diversion.
Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877, 958.
Source: 60 FR 32454, June 22, 1995, unless otherwise noted.
General Information
Sec. 1309.01 Scope of part 1309.
Procedures governing the registration of manufacturers,
distributors, importers and exporters of List I chemicals pursuant to
Sections 102, 302, 303, 1007 and 1008 of the Act (21 U.S.C. 802, 822,
823, 957 and 958) are set forth generally by those sections and
specifically by the sections of this part.
Sec. 1309.02 Definitions.
Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13968, Mar. 24, 1997]
Sec. 1309.03 Information; special instructions.
Information regarding procedures under these rules and instructions
supplementing these rules will be furnished upon request by writing to
the Drug Enforcement Administration, Chemical Operations Section, Office
of Diversion Control, Washington, D.C. 20537.
Fees for Registration and Reregistration
Sec. 1309.11 Fee amounts.
(a) For each initial registration to manufacture for distribution,
distribute, import, or export, the applicant shall pay a fee of $595 for
an annual registration.
(b) For each reregistration to manufacture for distribution,
distribute, import, or export, the registrant shall pay a fee of $477
for an annual registration.
(c) For each initial registration to conduct business as a retail
distributor the applicant shall pay an application processing fee of $7
and an investigation fee of $248, for an annual registration.
(d) For each reregistration to conduct business as a retail
distributor the registrant shall pay a fee of $116.
Sec. 1309.12 Time and method of payment; refund.
(a) For each application for registration or reregistration to
manufacture for distribution, distribute, import, or export, the
applicant shall pay the fee
[[Page 112]]
when the application for registration or reregistration is submitted for
filing.
(b) For retail the distributor initial applications, the applicant
shall pay the application processing fee when the application for
registration is submitted for filing. The investigation fee shall be
paid within 30 days after DEA notifies the applicant that the
preregistration investigation has been scheduled.
(c) For retail distributor reregistration applications, the
registrant shall pay the fee when the application for reregistration is
submitted for filing.
(d) Payments should be made in the form of a personal, certified, or
cashier's check or money order made payable to ``Drug Enforcement
Administration.'' Payments made in the form of stamps, foreign currency,
or third party endorsed checks will not be accepted. These application
fees are not refundable.
[60 FR 32454, June 22, 1995; 60 FR 35264, July 6, 1995]
Requirements for Registration
Sec. 1309.21 Persons required to register.
(a) Every person who distributes, imports, or exports any List I
chemical, other than those List I chemicals contained in a product
exempted under Sec. 1300.02(b)(28)(i)(D) of this chapter (irrespective
of the threshold provisions under Sec. 1300.02(b)(28)(i)(D)(2) of this
chapter), or who proposes to engage in the distribution, importation, or
exportation of any List I chemical, shall obtain annually a registration
specific to the List I chemicals to be handled, unless exempted by law
or pursuant to Sec. Sec. 1309.24 through 1309.26 of this part. Only
persons actually engaged in such activities are required to obtain a
registration; related or affiliated persons who are not engaged in such
activities are not required to be registered. (For example, a
stockholder or parent corporation of a corporation distributing List I
chemicals is not required to obtain a registration.)
(b) Every person who distributes or exports a List I chemical they
have manufactured, other than a List I chemical contained in a product
exempted under Sec. 1300.02(b)(28)(i)(D) of this chapter, or proposes
to distribute or export a List I chemical they have manufactured, shall
obtain annually a registration specific to the List I chemicals to be
handled, unless exempted by law or pursuant to Sec. Sec. 1309.24
through 1309.26 of this part.
[67 FR 14860, Mar. 28, 2002]
Sec. 1309.22 Separate registration for independent activities.
(a) The following groups of activities are deemed to be independent
of each other:
(1) Retail distributing of List I chemicals;
(2) Non-Retail distributing of List I chemicals;
(3) Importing List I chemicals; and
(4) Exporting List I chemicals.
(b) Every person who engages in more than one group of independent
activities shall obtain a separate registration for each group of
activities, unless otherwise exempted by the Act or Sec. Sec. 1309.24
through 1309.26, except that a person registered to import any List I
chemical shall be authorized to distribute that List I chemical after
importation, but no other chemical that the person is not registered to
import.
[60 FR 32454, June 22, 1995, as amended at 61 FR 32926, June 26, 1996;
67 FR 14860, Mar. 28, 2002]
Sec. 1309.23 Separate registration for separate locations.
(a) A separate registration is required for each principal place of
business at one general physical location where List I chemicals are
distributed, imported, or exported by a person.
(b) The following locations shall be deemed to be places not subject
to the registration requirement:
(1) A warehouse where List I chemicals are stored by or on behalf of
a registered person, unless such chemicals are distributed directly from
such warehouse to locations other than the registered location from
which the chemicals were originally delivered; and
(2) An office used by agents of a registrant where sales of List I
chemicals are solicited, made, or supervised but which neither contains
such chemicals
[[Page 113]]
(other than chemicals for display purposes) nor serves as a distribution
point for filling sales orders.
Sec. 1309.24 Waiver of registration requirement for certain activities.
(a) The requirement of registration is waived for any agent or
employee of a person who is registered to engage in any group of
independent activities, if such agent or employee is acting in the usual
course of his or her business or employment.
(b) The requirement of registration is waived for any person who
distributes a product containing a List I chemical that is regulated
pursuant to Sec. 1300.02(b)(28)(i)(D), if that person is registered
with the Administration to manufacture, distribute or dispense a
controlled substance.
(c) The requirement of registration is waived for any person who
imports or exports a product containing a List I chemical that is
regulated pursuant to Sec. 1300.02(b)(28)(i)(D), if that person is
registered with the Administration to engage in the same activity with a
controlled substance.
(d) The requirement of registration is waived for any person who
distributes a prescription drug product containing a List I chemical
that is regulated pursuant to Sec. 1300.02(b)(28)(i)(D) of this
chapter.
(e) The requirement of registration is waived for any retail
distributor whose activities with respect to List I chemicals are
limited to the distribution of below-threshold quantities of a
pseudoephedrine, phenylpropanolamine, or combination ephedrine product
that is regulated pursuant to Sec. 1300.02(b)(28)(i)(D) of this
chapter, in a single transaction to an individual for legitimate medical
use, irrespective of whether the form of packaging of the product meets
the definition of ``ordinary over-the-counter pseudoephedrine or
phenylpropanolamine product'' under Sec. 1300.02(b)(31) of this
chapter.
(f) The requirement of registration is waived for any person whose
activities with respect to List I chemicals are limited to the
distribution of red phosphorus, white phosphorus, or hypophosphorous
acid (and its salts) to: another location operated by the same firm
solely for internal end-use; or an EPA or State licensed waste treatment
or disposal firm for the purpose of waste disposal.
(g) The requirement of registration is waived for any person whose
distribution of red phosphorus or white phosphorus is limited solely to
residual quantities of chemical returned to the producer, in reusable
rail cars and intermodal tank containers which conform to International
Standards Organization specifications (with capacities greater than or
equal to 2,500 gallons in a single container).
(h) The requirement of registration is waived for any manufacturer
of a List I chemical, if that chemical is produced solely for internal
consumption by the manufacturer and there is no subsequent distribution
or exportation of the List I chemical.
(i) If any person exempted under paragraph (b), (c), (d), (e), (f)
or (g) of this section also engages in the distribution, importation or
exportation of a List I chemical, other than as described in such
paragraph, the person shall obtain a registration for such activities,
as required by Sec. 1309.21 of this part.
(j) The Administrator may, upon finding that continuation of the
waiver would not be in the public interest, suspend or revoke a waiver
granted under paragraph (b), (c), (d), (e), (f) or (g) of this section
pursuant to the procedures set forth in Sec. Sec. 1309.43 through
1309.46 and 1309.51 through 1309.55 of this part. In considering the
revocation or suspension of a person's waiver granted pursuant to
paragraph (b) or (c) of this section, the Administrator shall also
consider whether action to revoke or suspend the person's controlled
substance registration pursuant to 21 U.S.C. 824 is warranted.
(k) Any person exempted from the registration requirement under this
section shall comply with the security requirements set forth in
Sec. Sec. 1309.71-1309.73 of this part and the recordkeeping and
reporting requirements set forth under parts 1310 and 1313 of this
chapter.
[67 FR 14860, Mar. 28, 2002, as amended at 68 FR 37414, June 24, 2003;
68 FR 57803, Oct. 7, 2003]
[[Page 114]]
Sec. 1309.25 Temporary exemption from registration for chemical
registration applicants.
(a) Each person required by section 302 of the Act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export a combination
ephedrine product is temporarily exempted from the registration
requirement, provided that the person submits a proper application for
registration on or before July 12, 1997. The exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in this part 1309 and parts 1310, and 1313 of this chapter
remain in full force and effect.
(b) Each person required by section 302 of the Act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export a
pseudoephedrine or phenylpropanolamine drug product is temporarily
exempted from the registration requirement, provided that the person
submits a proper application for registration on or before October 3,
1997. The exemption will remain in effect for each person who has made
such application until the Administration has approved or denied that
application. This exemption applies only to registration; all other
chemical control requirements set forth in this part 1309 and parts 1310
and 1313 of this chapter remain in full force and effect.
[67 FR 14860, Mar. 28, 2002]
Sec. 1309.26 Exemption of law enforcement officials.
(a) The requirement of registration is waived for the following
persons in the circumstances described in this section:
(1) Any officer or employee of the Administration, any officer of
the U.S. Customs Service, any officer or employee of the United States
Food and Drug Administration, any other Federal officer who is lawfully
engaged in the enforcement of any Federal law relating to listed
chemicals, controlled substances, drugs or customs, and is duly
authorized to possess and distribute List I chemicals in the course of
official duties; and
(2) Any officer or employee of any State, or any political
subdivision or agency thereof, who is engaged in the enforcement of any
State or local law relating to listed chemicals and controlled
substances and is duly authorized to possess and distribute List I
chemicals in the course of his official duties.
(b) Any official exempted by this section may, when acting in the
course of official duties, possess any List I chemical and distribute
any such chemical to any other official who is also exempted by this
section and acting in the course of official duties.
Application for Registration
Sec. 1309.31 Time for application for registration; expiration date.
(a) Any person who is required to be registered and who is not so
registered may apply for registration at any time. No person required to
be registered shall engage in any activity for which registration is
required until the application for registration is approved and a
Certificate of Registration is issued by the Administrator to such
person.
(b) Any person who is registered may apply to be reregistered not
more than 60 days before the expiration date of his registration.
(c) At the time a person is first registered, that person shall be
assigned to one of twelve groups, which shall correspond to the months
of the year. The expiration date of the registrations of all registrants
within any group will be the last day of the month designated for that
group. In assigning any of the above persons to a group, the
Administration may select a group the expiration date of which is less
than one year from the date such business activity was registered. If
the person is assigned to a group which has an expiration date less than
eleven months from the date of which the person is registered, the
registration shall not expire until one year from that expiration date;
in all other cases, the registration shall expire on the expiration date
following the date on which the person is registered.
[[Page 115]]
Sec. 1309.32 Application forms; contents; signature.
(a) Any person who is required to be registered pursuant to Sec.
1309.21 and is not so registered, shall apply on DEA Form 510.
(b) Any person who is registered pursuant to Section 1309.21, shall
apply for reregistration on DEA Form 510a.
(c) DEA Form 510 may be obtained at any divisional office of the
Administration or by writing to the Registration Unit, Drug Enforcement
Administration, Department of Justice, Post Office Box 28083, Central
Station, Washington, DC 20005. DEA Form 510a will be mailed to each List
I chemical registrant approximately 60 days before the expiration date
of his or her registration; if any registered person does not receive
such forms within 45 days before the expiration date of the
registration, notice must be promptly given of such fact and DEA Form
510a must be requested by writing to the Registration Unit of the
Administration at the foregoing address.
(d) Each application for registration shall include the
Administration Chemical Code Number, as set forth in Sec. 1310.02 of
this chapter, for each List I chemical to be distributed, imported, or
exported.
(e) Registration shall not entitle a person to engage in any
activity with any List I chemical not specified in his or her
application.
(f) Each application shall include all information called for in the
form, unless the item is not applicable, in which case this fact shall
be indicated.
(g) Each application, attachment, or other document filed as part of
an application, shall be signed by the applicant, if an individual; by a
partner of the applicant, if a partnership; or by an officer of the
applicant, if a corporation, corporate division, association, trust or
other entity. An applicant may authorize one or more individuals, who
would not otherwise be authorized to do so, to sign applications for the
applicant by filing with the application or other document a power of
attorney for each such individual. The power of attorney shall be signed
by a person who is authorized to sign applications under this paragraph
and shall contain the signature of the individual being authorized to
sign the application or other document. The power of attorney shall be
valid until revoked by the applicant.
Sec. 1309.33 Filing of application; joint filings.
(a) All applications for registration shall be submitted for filing
to the Registration Unit, Drug Enforcement Administration, Chemical
Registration/ODC, Post Office Box 2427, Arlington, Virginia 22202-2427.
The appropriate registration fee and any required attachments must
accompany the application.
(b) Any person required to obtain more than one registration may
submit all applications in one package. Each application must be
complete and must not refer to any accompanying application for required
information.
Sec. 1309.34 Acceptance for filing; defective applications.
(a) Applications submitted for filing are dated upon receipt. If
found to be complete, the application will be accepted for filing.
Applications failing to comply with the requirements of this part will
not generally be accepted for filing. In the case of minor defects as to
completeness, the Administrator may accept the application for filing
with a request to the applicant for additional information. A defective
application will be returned to the applicant within 10 days of receipt
with a statement of the reason for not accepting the application for
filing. A defective application may be corrected and resubmitted for
filing at any time.
(b) Accepting an application for filing does not preclude any
subsequent request for additional information pursuant to Sec. 1309.35
and has no bearing on whether the application will be granted.
Sec. 1309.35 Additional information.
The Administrator may require an applicant to submit such documents
or written statements of fact relevant to the application as he deems
necessary to determine whether the application should be granted. The
failure of the applicant to provide such documents or statements within
a reasonable time after being requested to do so shall be
[[Page 116]]
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.
(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,
[[Page 117]]
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, 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
[[Page 118]]
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. 1309.54. If a hearing is requested, the Administrator
shall hold a hearing at the time and place stated in the order, pursuant
to Sec. 1309.51.
(e) When authorized by the Administrator, any agent of the
Administration may serve the order to show cause.
Hearings
Sec. 1309.51 Hearings generally.
(a) In any case where the Administrator shall hold a hearing on any
registration or application therefore, the procedures for such hearing
shall be governed generally by the adjudication procedures set forth in
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
sections 303 and 304 of the Act (21 U.S.C. 823-824), by Sec. Sec.
1309.52 through 1309.57, and by the procedures for administrative
hearings under the Act set forth in Sec. Sec. 1316.41 through 1316.67
of this chapter.
(b) Any hearing under this part shall be independent of, and not in
lieu of, criminal prosecutions or other proceedings under the Act or any
other law of the United States.
Sec. 1309.52 Purpose of hearing.
If requested by a person entitled to a hearing, the Administrator
shall hold a hearing for the purpose of receiving factual evidence
regarding the issues involved in the denial, revocation, or suspension
of any registration. Extensive argument should not be offered into
evidence but rather presented in opening or closing statements of
counsel or in memoranda or proposed findings of fact and conclusions of
law.
Sec. 1309.53 Request for hearing or appearance; waiver.
(a) Any person entitled to a hearing pursuant to Sec. Sec. 1309.42
and 1309.43 and desiring a hearing shall, within 30 days after the date
of receipt of the order to show cause, file with the Administrator a
written request for a hearing in the form prescribed in Sec. 1316.47 of
this chapter.
(b) Any person entitled to a hearing pursuant to Sec. Sec. 1309.42
and 1309.43 may, within the period permitted for filing a request for a
hearing, file with the Administrator a waiver of an opportunity for a
hearing, together with a written statement regarding his position on the
matters of fact and law involved in such hearing. Such statement, if
admissible, shall be made a part of the record and shall be considered
in light of the lack of opportunity for cross-examination in determining
the weight
[[Page 119]]
to be attached to matters of fact asserted therein.
(c) If any person entitled to a hearing pursuant to Sec. Sec.
1309.42 and 1309.43 fails to file a request for a hearing, or if he so
files and fails to appear at the hearing, he shall be deemed to have
waived his opportunity for the hearing, unless he shows good cause for
such failure.
(d) If any person entitled to a hearing waives or is deemed to waive
his or her opportunity for the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his final order pursuant to Sec.
1309.57 without a hearing.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]
Sec. 1309.54 Burden of proof.
(a) At any hearing for the denial of a registration, the
Administration shall have the burden of proving that the requirements
for such registration pursuant to section 303 of the Act (21 U.S.C. 823)
are not satisfied.
(b) At any hearing for the revocation or suspension of a
registration, the Administration shall have the burden of proving that
the requirements for such revocation or suspension pursuant to section
304(a) of the Act (21 U.S.C. 824(a)) are satisfied.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]
Sec. 1309.55 Time and place of hearing.
The hearing will commence at the place and time designated in the
order to show cause or notice of hearing published in the Federal
Register (unless expedited pursuant to Section 1309.44(c)) but
thereafter it may be moved to a different place and may be continued
from day to day or recessed to a later day without notice other than
announcement thereof by the presiding officer at the hearing.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]
Modification, Transfer and Termination of Registration
Sec. 1309.61 Modification in registration.
Any registrant may apply to modify his or her registration to
authorize the handling of additional List I chemicals or to change his
or her name or address, by submitting a letter of request to the Drug
Enforcement Administration, Chemical Registration/ODC, Post Office Box
2427, Arlington, Virginia 22202-2427. The letter shall contain the
registrant's name, address, and registration number as printed on the
certificate of registration, and the List I chemicals to be added to his
registration or the new name or address and shall be signed in
accordance with Sec. 1309.32(g). No fee shall be required to be paid
for the modification. The request for modification shall be handled in
the same manner as an application for registration. If the modification
in registration is approved, the Administrator shall issue a new
certificate of registration (DEA Form 511) to the registrant, who shall
maintain it with the old certificate of registration until expiration.
Sec. 1309.62 Termination of registration.
(a) The registration of any person shall terminate if and when such
person dies, ceases legal existence, or discontinues business or
professional practice. Any registrant who cases legal existence or
discontinues business or professional practice shall promptly notify the
Special Agent in Charge of the Administration in the area in which the
person is located of such fact and seek authority and instructions to
dispose of any List I chemicals obtained under the authority of that
registration.
(b) The Special Agent in Charge shall authorize and instruct the
person to dispose of the List I chemical in one of the following
manners:
(1) By transfer to person registered under the Act and authorized to
possess the substances;
(2) By delivery to an agent of the Administration or to the nearest
office of the Administration;
(3) By such other means as the Special Agent in Charge may determine
to assure that the substance does not become available to unauthorized
persons.
[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]
[[Page 120]]
Sec. 1309.63 Transfer of registration.
No registration or any authority conferred thereby shall be assigned
or otherwise transferred except upon such conditions as the
Administrator may specifically designate and then only pursuant to his
written consent.
Security Requirements
Sec. 1309.71 General security requirements.
(a) All applicants and registrants shall provide effective controls
and procedures to guard against theft and diversion of List I chemicals.
Specific attention shall be paid to storage of and controlling access to
List I chemicals as follows:
(1) Chemicals shall be stored in containers sealed in such a manner
as to indicate any attempts at tampering with the container. Where
chemicals cannot be stored in sealed containers, access to the chemicals
should be controlled through physical means or through human or
electronic monitoring.
(2) In retail settings open to the public where drugs containing
ephedrine as the sole active medicinal ingredient are distributed, such
drugs will be stocked behind a counter where only employees have access.
(b) In evaluating the effectiveness of security controls and
procedures, the Administrator shall consider the following factors:
(1) The type, form, and quantity of List I chemicals handled;
(2) The location of the premises and the relationship such location
bears on the security needs;
(3) The type of building construction comprising the facility and
the general characteristics of the building or buildings;
(4) The availability of electronic detection and alarm systems;
(5) the extent of unsupervised public access to the facility;
(6) The adequacy of supervision over employees having access to List
I chemicals;
(7) The procedures for handling business guests, visitors,
maintenance personnel, and nonemployee service personnel in areas where
List I chemicals are processed or stored;
(8) The adequacy of the registrant's or applicant's systems for
monitoring the receipt, distribution, and disposition of List I
chemicals in its operations.
(c) Any registrant or applicant desiring to determine whether a
proposed system of security controls and procedures is adequate may
submit materials and plans regarding the proposed security controls and
procedures either to the Special Agent in Charge in the region in which
the security controls and procedures will be used, or to the Chemical
Operations Section Office of Diversion Control, Drug Enforcement
Administration, Washington, D.C. 20537.
[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997;
67 FR 14861, Mar. 28, 2002]
Sec. 1309.72 Felony conviction; employer responsibilities.
(a) The registrant shall exercise caution in the consideration of
employment of persons who will have access to listed chemicals, who have
been convicted of a felony offense relating to controlled substances or
listed chemicals, or who have, at any time, had an application for
registration with the DEA denied, had a DEA registration revoked, or
surrendered a DEA registration for cause. (For purposes of this
subsection, the term ``for cause'' means a surrender in lieu of, or as a
consequence of, any Federal or State administrative, civil or criminal
action resulting from an investigation of the individual's handling of
controlled substances or listed chemicals.) The registrant should be
aware of the circumstances regarding the action against the potential
employee and the rehabilitative efforts following the action. The
registrant shall assess the risks involved in employing such persons,
including the potential for action against the registrant pursuant to
Sec. 1309.43, If such person is found to have diverted listed
chemicals, and, in the event of employment, shall institute procedures
to limit the potential for diversion of List I chemicals.
(b) It is the position of DEA that employees who possess, sell, use
or divert listed chemicals or controlled substances will subject
themselves not
[[Page 121]]
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
--Table of Contents
Sec.
1310.01 Definitions.
1310.02 Substances covered.
1310.03 Persons required to keep records and file reports.
1310.04 Maintenance of records.
1310.05 Reports.
1310.06 Content of records and reports.
1310.07 Proof of identity.
1310.08 Excluded transactions.
1310.09 Temporary exemption from registration.
1310.10 Removal of the exemption of drugs distributed under the Food,
Drug and Cosmetic Act.
1310.11 Reinstatement of exemption for drug products distributed under
the Food, Drug and Cosmetic Act.
1310.12 Exempt chemical mixtures.
1310.13 Exemption of chemical mixtures; application.
1310.14 Exemption of drug products containing ephedrine and
therapeutically significant quantities of another active
medicinal ingredient.
1310.15 Exempt drug products containing ephedrine and therapeutically
significant quantities of another active medicinal ingredient.
1310.21 Sale by Federal departments or agencies of chemicals which could
be used to manufacture controlled substances.
Authority: 21 U.S.C. 802, 827(h), 830, 871(b) 890.
Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.
Sec. 1310.01 Definitions.
Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13968, Mar. 24, 1997]
Sec. 1310.02 Substances covered.
The following chemicals have been specifically designated by the
Administrator of the Drug Enforcement Administration as the listed
chemicals subject to the provisions of this part and parts 1309 and 1313
of this chapter. Each chemical has been assigned the DEA Chemical Code
Number set forth opposite it.
(a) List I chemicals
(1) Anthranilic acid, its esters, and its salts.....................8530
(2) Benzyl cyanide..................................................8735
(3) Ephedrine, its salts, optical isomers, and salts of optical isomers
8113
(4) Ergonovine and its salts........................................8675
(5) Ergotamine and its salts........................................8676
(6) N-Acetylanthranilic acid, its esters, and its salts.............8522
(7) Norpseudoephedrine, its salts, optical isomers, and salts of optical
isomers.............................................................8317
(8) Phenylacetic acid, its esters, and its salts....................8791
(9) Phenylpropanolamine, its salts, optical isomers, and salts of
optical isomers.....................................................1225
(10) Piperidine and its salts.......................................2704
(11) Pseudoephedrine, its salts, optical isomers, and salts of optical
isomers.............................................................8112
(12) 3,4-Methylenedioxyphenyl-2-propanone...........................8502
[[Page 122]]
(13) Methylamine and its salts......................................8520
(14) Ethylamine and its salts.......................................8678
(15) Propionic anhydride............................................8328
(16) Isosafrole.....................................................8704
(17) Safrole........................................................8323
(18) Piperonal......................................................8750
(19) N-Methylephedrine, its salts, optical isomers, and salts of optical
isomers (N-Methylephedrine).........................................8115
(20) N-Methylpseudoephedrine, its salts, optical isomers, and salts of
optical isomers.....................................................8119
(21) Hydriodic Acid.................................................6695
(22) Benzaldehyde...................................................8256
(23) Nitroethane....................................................6724
(24) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2 (3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid
lactone; gamma-hydroxybutyric acid lactone).........................2011
(25) Red phosphorus.................................................6795
(26) White phosphorus (Other names: Yellow Phosphorus)..............6796
(27) Hypophosphorous acid and its salts (Including ammonium
hypophosphite, calcium hypophosphite, iron hypophosphite, potassium
hypophosphite, manganese hypophosphite, magnesium hypophosphite and
sodium hypophosphite)...............................................6797
(b) List II chemicals:
(1) Acetic anhydride................................................8519
(2) Acetone.........................................................6532
(3) Benzyl chloride.................................................8570
(4) Ethyl ether.....................................................6584
(5) Potassium permanganate..........................................6579
(6) 2-Butanone (or Methyl Ethyl Ketone or MEK)......................6714
(7) Toluene.........................................................6594
(8) Hydrochloric acid (including anhydrous hydrogen chloride).......6545
(9) Sulfuric acid...................................................6552
(10) Methyl Isobutyl Ketone (MIBK)..................................6715
(11) Iodine.........................................................6699
(c) The Administrator may add or delete a substance as a listed
chemical by publishing a final rule in the Federal Register following a
proposal which shall be published at least 30 days prior to the final
rule.
(d) Any person may petition the Administrator to have any substance
added or deleted from paragraphs (a) or (b) of this section.
(e) Any petition under this section shall contain the following
information:
(1) The name and address of the petitioner;
(2) The name of the chemical to which the petition pertains;
(3) The name and address of the manufacturer(s) of the chemical (if
known);
(4) A complete statement of the facts which the petitioner believes
justifies the addition or deletion of the substance from paragraphs (a)
or (b) of this section;
(5) The date of the petition.
(f) The Administrator may require the petitioner to submit such
documents or written statements of fact relevant to the petition as he
deems necessary in making a determination.
(g) Within a reasonable period of time after the receipt of the
petition, the Administrator shall notify the petitioner of his decision
and the reason therefor. The Administrator need not accept a petition if
any of the requirements prescribed in paragraph (e) of this section or
requested pursuant to paragraph (f) of this section are lacking or are
not clearly set forth as to be readily understood. If the petitioner
desires, he may amend and resubmit the petition to meet the requirements
of paragraphs (e) and (f) of this section.
(h) If a petition is granted or the Administrator, upon his own
motion, proposes to add or delete substances as listed chemicals as set
forth in paragraph (c) of this section, he shall issue and publish in
the Federal Register a proposal to add or delete a substance as a listed
chemical. The Administrator shall permit any interested person to file
written comments regarding the proposal within 30 days of the date of
publication of his order in the Federal Register. The Administrator will
consider any comments filed by interested persons and publish a final
rule in accordance with his decision in the matter.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991;
57 FR 43615, Sept. 22, 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460,
June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65
FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001]
Sec. 1310.03 Persons required to keep records and file reports.
(a) Each regulated person who engages in a regulated transaction
involving a listed chemical, a tableting machine, or an encapsulating
machine
[[Page 123]]
shall keep a record of the transaction as specified by Sec. 1310.04 and
file reports as specified by Sec. 1310.05. However, a non-regulated
person who acquires listed chemicals for internal consumption or ``end
use'' and becomes a regulated person by virtue of infrequent or rare
distribution of a listed chemical from inventory, shall not be required
to maintain receipt records of listed chemicals under this section.
(b) Each regulated person who manufactures a List I or List II
chemical shall file reports regarding such manufacture as specified in
Section 1310.05.
(c) Each regulated person who engages in a transaction with a
nonregulated person or who engages in an export transaction that
involves ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid, including drug products containing these chemicals,
and uses or attempts to use the Postal Service or any private or
commercial carrier must file monthly reports of each such transaction as
specified in Sec. 1310.05 of this part.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 8277, Feb. 28, 1991; 61
FR 14023, Mar. 29, 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, Oct.
7, 2003; 70 FR 294, Jan. 4, 2005]
Sec. 1310.04 Maintenance of records.
(a) Every record required to be kept subject to Sec. 1310.03 for a
List I chemical, a tableting machine, or an encapsulating machine shall
be kept by the regulated person for 2 years after the date of the
transaction.
(b) Every record required to be kept subject to Section 1310.03 for
List II chemical shall be kept by the regulated person for two years
after the date of the transaction.
(c) A record under this section shall be kept at the regulated
person's place of business where the transaction occurred, except that
records may be kept at a single, central location of the regulated
person if the regulated person has notified the Administration of the
intention to do so. Written notification must be submitted by registered
or certified mail, return receipt requested, to the Special Agent in
Charge of the DEA Divisional Office for the area in which the records
are required to be kept.
(d) The records required to be kept under this section shall be
readily retrievable and available for inspection and copying by
authorized employees of the Administration under the provisions of 21
U.S.C. 880.
(e) The regulated person with more than one place of business where
records are required to be kept shall devise a system to detect any
party purchasing from several individual locations of the regulated
person thereby seeking to avoid the application of the cumulative
threshold or evading the requirements of the Act.
(f) For those listed chemicals for which thresholds have been
established, the quantitative threshold or the cumulative amount for
multiple transactions within a calendar month, to be utilized in
determining whether a receipt, sale, importation or exportation is a
regulated transaction is as follows:
(1) List I chemicals:
(i) Except as provided in paragraph (f)(1)(ii) of this section, the
following thresholds have been established for List I chemicals.
------------------------------------------------------------------------
Chemical Threshold by base weight
------------------------------------------------------------------------
(A) Anthranilic acid, its esters, and its 30 kilograms.
salts.
(B) Benzyl cyanide........................ 1 kilogram.
(C) Ergonovine and its salts.............. 10 grams.
(D) Ergotamine and its salts.............. 20 grams.
(E) N-Acetylanthranilic acid, its esters, 40 kilograms.
and its salts.
(F) Norpseudoephedrine, its salts, optical 2.5 kilograms.
isomers, and salts of optical isomers.
(G) Phenylacetic acid, its esters, and its 1 kilogram.
salts.
(H) Phenylpropanolamine, its salts, 2.5 kilograms.
optical isomers, and salts of optical
isomers.
(I) Piperidine and its salts.............. 500 grams.
(J) Pseudoephedrine, its salts, optical 1 kilogram.
isomers, and salts of optical isomers.
(K) 3,4-Methylenedioxyphenyl-2-propanone.. 4 kilograms.
(L) Methylamine and its salts............. 1 kilogram.
(M) Ethylamine and its salts.............. 1 kilogram.
(N) Propionic anhydride................... 1 gram.
(O) Isosafrole............................ 4 kilograms.
(P) Safrole............................... 4 kilograms.
(Q) Piperonal............................. 4 kilograms.
(R) N-Methylephedrine, its salts, optical 1 kilogram.
isomers, and salts of optical isomers (N-
Methylephedrine).
(S) N-Methylpseudoephedrine, its salts, 1 kilogram.
optical isomers, and salts of optical
isomers.
(T) Hydriodic Acid........................ 1.7 kilograms (or 1 liter by
volume).
(U) Benzaldehyde.......................... 4 kilograms.
(V) Nitroethane........................... 2.5 kilograms.
------------------------------------------------------------------------
(ii) Notwithstanding the thresholds established in paragraphs
(f)(1)(i) and
[[Page 124]]
(g) of this section, the following thresholds will apply for the
following List I chemicals that are contained in drug products that are
regulated pursuant to Sec. 1300.02(b)(28)(i)(D) of this chapter
(thresholds for retail distributors and distributors required to report
under Sec. 1310.03(c) of this part are for a single transaction; the
cumulative threshold provision does not apply. All other distributions
are subject to the cumulative threshold provision.):
------------------------------------------------------------------------
Chemical Threshold by weight
------------------------------------------------------------------------
(A) Ephedrine, its salts, optical isomers, No threshold. All
and salts of optical isomers as the sole transactions regulated.
therapeutically significant medicinal
ingredient.
(B) Ephedrine, its salts, optical isomers,
and salts of optical isomers in
combination with therapeutically
significant amounts of another medicinal
ingredient:
(1) Distributions by retail 24 grams.
distributors.
(2) Distributions by persons required 24 grams.
to report under Sec. 1310.03(c) of
this part.
(3) All other domestic distributions 1 kilogram.
(other than paragraphs (f)(1)(ii)(B)
(1) and (2) of this section).
(4) Imports and Exports............... 1 kilogram
(C) Pseudoephedrine, its salts, optical
isomers, and salts of optical isomers
(other than ordinary over-the-counter
products):
(1) Distributions by retail 9 grams, and sold in package
distributors. sizes of not more than 3
grams of pseudoephedrine
base.
(2) Distributions by persons required 9 grams, and sold in package
to report under Sec. 1310.03(c) of sizes of not more than 3
this part. grams of pseudoephedrine
base.
(3) All other domestic distributions, 1 kilogram.
(other than paragraphs (f)(1)(ii)(C)
(1) and (2) of this section).
(4) Imports and Exports............... 1 kilogram.
(D) Pseudoephedrine, its salts, optical
isomers, and salts of optical isomers
(ordinary over-the-counter products):
(1) Distributions by retail Exempt.
distributors.
(2) Distributions by persons required 9 grams, and sold in package
to report under Sec. 1310.03(c) of sizes of not more than 3
this part. grams of pseudoephedrine
base.
(3) All other domestic distributions 1 kilogram.
(other than paragraphs (f)(1)(ii)(D)
(1) and (2) of this section).
(4) Imports and Exports............... 1 kilogram.
(E) Phenylpropanolamine, its salts,
optical isomers, and salts of optical
isomers (other than ordinary over-the-
counter products):
(1) Distributions by retail 9 grams, and sold in package
distributors. sizes of not more than 3
grams of
phenylpropanolamine base.
(2) Distributions by persons required 9 grams, and sold in package
to report under Sec. 1310.03(c) of sizes of not more than 3
this part. grams of
phenylpropanolamine base.
(3) All other domestic distributions 2.5 kilograms.
(other than paragraphs (f)(1)(ii)(E)
(1) and (2) of this section).
(4) Imports and Exports............... 2.5 kilograms.
(F) Phenylpropanolamine, its salts,
optical isomers, and salts of optical
isomers (ordinary over-the-counter
products):
(1) Distributions by retail Exempt.
distributors.
(2) Distributions by persons required 9 grams, and sold in package
to report under Sec. 1310.03(c) of sizes of not more than 3
this part. grams of
phenylpropanolamine base.
(3) All other domestic distributions 2.5 kilograms.
(other than paragraphs (f)(1)(ii)(F)
(1) and (2) of this section).
(4) Imports and Exports............... 2.5 kilograms.
------------------------------------------------------------------------
(2) List II Chemicals:
(i) Imports and Exports
----------------------------------------------------------------------------------------------------------------
Chemical Threshold by volume Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride................... 250 gallons........................ 1,023 kilograms.
(B) Acetone............................ 500 gallons........................ 1,500 kilograms.
(C) Benzyl chloride.................... N/A................................ 4 kilograms.
(D) Ethyl ether........................ 500 gallons........................ 1,364 kilograms.
(E) Potassium permanganate............. N/A................................ 500 kilograms.
(F) 2-Butanone (MEK)................... 500 gallons........................ 1,455 kilograms.
[[Page 125]]
(G) Toluene............................ 500 gallons........................ 1,591 kilograms.
----------------------------------------------------------------------------------------------------------------
(ii) Domestic Sales
----------------------------------------------------------------------------------------------------------------
Chemical Threshold by volume Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride................... 250 gallons........................ 1,023 kilograms.
(B) Acetone............................ 50 gallons......................... 150 kilograms.
(C) Benzyl chloride.................... N/A................................ 1 kilogram.
(D) Ethyl ether........................ 50 gallons......................... 135.8 kilograms.
(E) Potassium permanganate............. N/A................................ 55 kilograms.
(F) 2-Butanone (MEK)................... 50 gallons......................... 145 kilograms.
(G) Toluene............................ 50 gallons......................... 159 kilograms.
(H) Iodine............................. N/A................................ 0.4 kilograms.
(I) Anhydrous Hydrogen chloride........ N/A................................ 0.0 kilograms.
----------------------------------------------------------------------------------------------------------------
(iii) The cumulative threshold is not applicable to domestic sales
of Acetone, 2-Butanone (MEK), and Toluene.
(iv) Exports, Transshipments and International Transactions to
Designated Countries as Set Forth in Sec. 1310.08(b).
------------------------------------------------------------------------
Threshold by
Chemical volume Threshold by weight
------------------------------------------------------------------------
(A) Hydrochloric acid.......... 50 gallons
(1) Anhydrous Hydrogen .................. 27 kilograms.
chloride.
(B) Sulfuric acid.............. 50 gallons
------------------------------------------------------------------------
(v) Export and International Transactions to Designated Countries,
and Importations for Transshipment or Transfer to Designated Countries
------------------------------------------------------------------------
Threshold by
Chemical volume Threshold by weight
------------------------------------------------------------------------
(A) Methyl Isobutyl Ketone 500 gallons....... 1523 kilograms.
(MIBK).
(B) Reserved.
------------------------------------------------------------------------
(g) For listed chemicals for which no thresholds have been
established, the size of the transaction is not a factor in determining
whether the transaction meets the definition of a regulated transaction
as set forth in Sec. 1300.02(b)(28) of this chapter. All such
transactions, regardless of size, are subject to recordkeeping and
reporting requirements as set forth in this part and notification
provisions as set forth in part 1313 of this chapter.
(1) Listed chemicals for which no thresholds have been established:
(i) Ephedrine, its salts, optical isomers and salts of optical
isomers
(ii) Red phosphorus
(iii) White phosphorus (Other names: Yellow Phosphorus)
(iv) Hypophosphorous acid and its salts
(v) gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid
lactone; gamma-hydroxybutyric acid lactone)
(2) [Reserved]
(h) The thresholds and conditions in paragraphs (f) and (g) of this
section will apply to transactions involving regulated chemical
mixtures. For purposes of determining whether the weight or volume of a
chemical mixture meets or exceeds the applicable quantitative threshold,
the following rules apply:
(1) For chemical mixtures containing List I chemicals or List II
chemicals other than those in paragraph (h)(2) of this section, the
threshold is determined by the weight of the listed chemical in the
chemical mixture.
(2) For the List II chemicals acetone, ethyl ether, 2-butanone,
toluene, and methyl isobutyl ketone, the threshold is determined by the
weight of the entire chemical mixture.
(3) If two or more listed chemicals are present in a chemical
mixture, and the quantity of any of these chemicals
[[Page 126]]
equals or exceeds the threshold applicable to that chemical, then the
transaction is regulated.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991;
57 FR 43615, Sept. 22, 1992; 59 FR 51367, Oct. 11, 1994; 60 FR 19510,
Apr. 19, 1995; 60 FR 32460, June 22, 1995; 60 FR 42436, Aug. 16, 1995;
62 FR 5917, Feb. 10, 1997; 65 FR 47316, Aug. 2, 2000; 66 FR 52675, Oct.
17, 2001; 67 FR 14861, Mar. 28, 2002; 68 FR 11472, Mar. 11, 2003; 68 FR
23203, May 1, 2003; 68 FR 53292, Sept. 10, 2003; 68 FR 57804, Oct. 7,
2003; 69 FR 74970, Dec. 15, 2004]
Sec. 1310.05 Reports.
(a) Each regulated person shall report to the Special Agent in
Charge of the DEA Divisional Office for the area in which the regulated
person making the report is located, as follows:
(1) Any regulated transaction involving an extraordinary quantity of
a listed chemical, an uncommon method of payment or delivery, or any
other circumstance that the regulated person believes may indicate that
the listed chemical will be used in violation of this part.
(2) Any proposed regulated transaction with a person whose
description or other identifying characteristic the Administration has
previously furnished to the regulated person.
(3) Any unusual or excessive loss or disappearance of a listed
chemical under the control of the regulated person. The regulated person
responsible for reporting a loss in-transit is the supplier.
(4) Any domestic regulated transaction in a tableting machine or an
encapsulating machine.
(b) Each report submitted pursuant to paragraph (a) of this section
shall, whenever possible, be made orally to the DEA Divisional Office
for the area in which the regulated person making the report is located
at the earliest practicable opportunity after the regulated person
becomes aware of the circumstances involved and as much in advance of
the conclusion of the transaction as possible. Written reports of
transactions listed in paragraphs (a)(1), (a)(3) and (a)(4) of this
section will subsequently be filed as set forth in Sec. 1310.06 within
15 days after the regulated person becomes aware of the circumstances of
the event. A transaction may not be completed with a person whose
description or identifying characteristic has previously been furnished
to the regulated person by the Administration unless the transaction is
approved by the Administration.
(c) Each regulated person who imports or exports a tableting
machine, or encapsulation machine, shall file a report (not a 486) of
such importation or exportation with the Administration at the following
address on or before the date of importation or exportation: Drug
Enforcement Administration, P.O. Box 27284, Washington, DC 20038. In
order to facilitate the importation or exportation of any tableting
machine or encapsulating machine and implement the purpose of the Act,
regulated persons may wish to report to the Administration as far in
advance as possible. A copy of the report may be transmitted directly to
the Drug Enforcement Administration through electronic facsimile media.
Any tableting machine or encapsulating machine may be imported or
exported if that machine is needed for medical, commercial, scientific,
or other legitimate uses. However, an importation or exportation of a
tableting machine or encapsulating machine may not be completed with a
person whose description or identifying characteristic has previously
been furnished to the regulated person by the Administration unless the
transaction is approved by the Administration.
(d) Each regulated bulk manufacturer of a listed chemical shall
submit manufacturing, inventory and use data on an annual basis as set
forth in Sec. 1310.06(h). This data shall be submitted annually to the
Drug and Chemical Evaluation Section, Drug Enforcement Administration
(DEA), Washington, D.C. 20537, on or before the 15th day of March of the
year immediately following the calendar year for which submitted. A
business entity which manufactures a listed chemical may elect to report
separately by individual location or report as an aggregate amount for
the entire business entity provided that they inform the DEA of which
method they will use. This reporting requirement does not apply to drug
or other products which are exempted under Sec. Sec. 1310.01(f)(1)(iv)
or 1310.01(f)(1)(v) except as set forth in
[[Page 127]]
Sec. 1310.06(h)(5). Bulk manufacturers that produce a listed chemical
solely for internal consumption shall not be required to report for that
listed chemical. For purposes of these reporting requirements, internal
consumption shall consist of any quantity of a listed chemical otherwise
not available for further resale or distribution. Internal consumption
shall include (but not be limited to) quantities used for quality
control testing, quantities consumed in-house or production losses.
Internal consumption does not include the quantities of a listed
chemical consumed in the production of exempted products. If an existing
standard industry report contains the information required in Sec.
1310.06(h) and such information is separate or readily retrievable from
the report, that report may be submitted in satisfaction of this
requirement. Each report shall be submitted to the DEA under company
letterhead and signed by an appropriate, responsible official. For
purposes of this paragraph only, the term regulated bulk manufacturer of
a listed chemical means a person who manufactures a listed chemical by
means of chemical synthesis or by extraction from other substances. The
term bulk manufacturer does not include persons whose sole activity
consists of the repackaging or relabeling of listed chemical products or
the manufacture of drug dosage form products which contain a listed
chemical.
(e) Each regulated person required to report pursuant to Sec.
1310.03(c) of this part shall either:
(1) Submit a written report, containing the information set forth in
Sec. 1310.06(i) of this part, on or before the 15th day of each month
following the month in which the distributions took place. The report
shall be submitted under company letterhead, signed by the person
authorized to sign the registration application forms on behalf of the
registrant, to the Chemical Control Section, Office of Diversion
Control, Drug Enforcement Administration, Washington, DC 20537; or
(2) Upon request to and approval by the Administration, submit the
report in electronic form, either via computer disk or direct electronic
data transmission, in such form as the Administration shall direct.
Requests to submit reports in electronic form should be submitted to the
Chemical Control Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, ATTN: Electronic Reporting.
(f) Except as provided in paragraph (g) of this section, the
following distributions to nonregulated persons, and the following
export transactions, are not subject to the reporting requirements in
Sec. 1310.03(c):
(1) Distributions of sample packages of drug products when those
packages contain not more than two solid dosage units or the equivalent
of two dosage units in liquid form, not to exceed 10 milliliters of
liquid per package, and not more than one package is distributed to an
individual or residential address in any 30-day period.
(2) Distributions of drug products by retail distributors that may
not include face-to-face transactions to the extent that such
distributions are consistent with the activities authorized for a retail
distributor as specified in Sec. 1300.02(b)(29) of this chapter.
(3) Distributions of drug products to a resident of a long term care
facility or distributions of drug products to a long term care facility
for dispensing to or for use by a resident of that facility.
(4) Distributions of drug products in accordance with a valid
prescription.
(5) Exports which have been reported to the Administrator under
Sec. Sec. 1313.31 and 1313.32 of this chapter or which are subject to a
waiver granted under Sec. 1313.21 of this chapter.
(g) The Administrator may revoke any or all of the exemptions listed
in paragraph (f) of this section for an individual regulated person if
the Administrator finds that drug products distributed by the regulated
person are being used in violation of the regulations in this chapter or
the Controlled Substances Act. The Administrator will notify the
regulated person of the revocation, as provided in Sec. 1313.41(a) of
this chapter. The revocation will be effective upon receipt of the
notice by the person. The regulated person has
[[Page 128]]
the right to an expedited hearing regarding the revocation, as provided
in Sec. 1313.56(a) of this chapter.
[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2461, Jan. 22, 1992; 61
FR 14024, Mar. 29, 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, Mar.
24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR 49569, July 31, 2002; 68 FR
57804, Oct. 7, 2003]
Sec. 1310.06 Content of records and reports.
(a) Each record required by Sec. 1310.03 shall include the
following:
(1) The name, address, and, if required, DEA registration number of
each party to the regulated transaction.
(2) The date of the regulated transaction.
(3) The name, quantity and form of packaging of the listed chemical
or a description of the tableting machine or encapsulating machine
(including make, model and serial number).
(4) The method of transfer (company truck, picked up by customer,
etc.).
(5) The type of identification used by the purchaser and any unique
number on that identification.
(b) For purposes of this section, normal business records shall be
considered adequate if they contain the information listed in paragraph
(a) of this section and are readily retrievable from other business
records of the regulated person. For prescription drug products,
prescription and hospital records kept in the normal course of medical
treatment shall be considered adequate for satisfying the requirements
of paragraph (a) of this section with respect to dispensing to patients,
and records required to be maintained pursuant to the Federal Food and
Drug Administration regulations relating to the distribution of
prescription drugs, as set forth in 21 CFR part 205, shall be considered
adequate for satisfying the requirements of paragraph (a) of this
section with respect to distributions.
(c) Each report required by Section 1310.05(a) shall include the
information as specified by Section 1310.06(a) and, where obtainable,
the registration number of the other party, if such party is registered.
A report submitted pursuant to Sec. 1310.05(a)(1) or (a)(4) must also
include a description of the circumstances leading the regulated person
to make the report, such as the reason that the method of payment was
uncommon or the loss unusual. If the report is for a loss or
disappearance under Sec. 1310.05(a)(4), the circumstances of such loss
must be provided (in-transit, theft from premises, etc.)
(d) A suggested format for the reports is provided below:
Supplier:
Registration Number_____________________________________________________
Name____________________________________________________________________
Business Address________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Business Phone__________________________________________________________
Purchaser:
Registration Number_____________________________________________________
Name____________________________________________________________________
Business Address________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Business Phone__________________________________________________________
Identification__________________________________________________________
Shipping Address (if different than purchaser Address):
Street__________________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Date of Shipment________________________________________________________
Name of Listed Chemical(s)______________________________________________
Quantity and Form of Packaging__________________________________________
Description of Machine:
Make____________________________________________________________________
Model___________________________________________________________________
Serial ________________________________________________________
Method of Transfer______________________________________________________
If Loss or Disappearance:
Date of Loss____________________________________________________________
Type of Loss____________________________________________________________
Description of Circumstances____________________________________________
Public reporting burden for this collection of information is estimated
to average ten minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to the Drug Enforcement Administration, Records
[[Page 129]]
Management Section, Washington, D.C. 20537; and to the Office of
Management and Budget, Paperwork Reduction Project No. 1117-0024,
Washington, D.C. 20503.
(e) Each report of an importation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c) shall include the
following information:
(1) The name, address, telephone number, telex number, and, where
available, the facsimile number of the regulated person; the name,
address, telephone number, telex number, and, where available, the
facsimile number of the import broker or forwarding agent, if any:
(2) The description of each machine (including make, model, and
serial number) and the number of machines being received;
(3) The proposed import date, and the first U.S. Customs Port of
Entry; and
(4) The name, address, telephone number, telex number, and, where
available, the facsimile number of the consignor in the foreign country
of exportation.
(f) Each report of an exportation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c) shall include the
following information:
(1) The name, address, telephone number, telex number, and, where
available, the facsimile number of the regulated person; the name,
address, telephone number, telex number, and, where available, the
facsimile number of the export broker, if any;
(2) The description of each machine (including make, model, and
serial number) and the number of machines being shipped;
(3) The proposed export date, the U.S. Customs Port of exportation,
and the foreign Port of Entry; and
(4) The name, address, telephone, telex, and, where available, the
facsimile number of the consignee in the country where the shipment is
destined; the name(s) and address(es) of any intermediate consignee(s).
(g) Declared exports of machines which are refused, rejected, or
otherwise deemed undeliverable may be returned to the U.S. exporter of
record. A brief written report outlining the circumstances must be sent
to the Drug Enforcement Administration, P.O. Box 27284, Washington, DC
20038, following the return within a reasonable time. This provision
does not apply to shipments that have cleared foreign customs, been
delivered, and accepted by the foreign consignee. Returns to third
parties in the United States will be regarded as imports.
(h) Each annual report required by Section 1310.05(d) shall provide
the following information for each listed chemical manufactured:
(1) The name, address and chemical registration number (if any) of
the manufacturer and person to contact for information.
(2) The aggregate quantity of each listed chemical that the company
manufactured during the preceding calendar year.
(3) The year-end inventory of each listed chemical as of the close
of business on the 31st day of December of each year. (For each listed
chemical, if the prior period's ending inventory has not previously been
reported to DEA, this report should also detail the beginning inventory
for the period.) For purposes of this requirement, inventory shall
reflect the quantity of listed chemicals, whether in bulk or non-exempt
product form, held in storage for later distribution. Inventory does not
include waste material for destruction, material stored as an in-process
intermediate or other in-process material.
(4) The aggregate quantity of each listed chemical used for internal
consumption during the preceding calendar year, unless the chemical is
produced solely for internal consumption.
(5) The aggregate quantity of each listed chemical manufactured
which becomes a component of a product exempted from Section
1310.01(f)(1)(iv) or 1310.01(f)(1)(v) during the preceding calendar
year.
(6) Data shall identify the specific isomer, salt or ester when
applicable but quantitative data shall be reported as anhydrous base or
acid in kilogram units of measure.
(i) Each monthly report required by Sec. 1310.05(e) of this part
shall provide the following information for each distribution:
(1) Supplier name and registration number.
(2) Purchaser's name and address.
[[Page 130]]
(3) Name/address shipped to (if different from purchaser's name/
address).
(4) Name of the chemical and total amount shipped (i.e.
Pseudoephedrine, 250 grams).
(5) Date of shipment.
(6) Product name (if drug product).
(7) Dosage form (if drug product) (i.e., pill, tablet, liquid).
(8) Dosage strength (if drug product) (i.e., 30mg, 60mg, per dose
etc.).
(9) Number of dosage units (if drug product) (100 doses per
package).
(10) Package type (if drug product) (bottle, blister pack, etc.).
(11) Number of packages (if drug product) (10 bottles).
(12) Lot number (if drug product).
(j) Information provided in reports required by Sec. 1310.05(e) of
this part which is exempt from disclosure under section 552(a) of Title
5, by reason of section 552(b)(6) of Title 5, will be provided the same
protections from disclosure as are provided in section 310(c) of the Act
(21 U.S.C. 830(c)) for confidential business information.
[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2462, Jan. 22, 1992; 59
FR 51364, Oct. 11, 1994; 60 FR 32461, June 22, 1995; 61 FR 14024, Mar.
29, 1996; 61 FR 32926, June 26, 1996; 67 FR 14862, Mar. 28, 2002; 67 FR
49569, July 31, 2002]
Sec. 1310.07 Proof of identity.
(a) Each regulated person who engages in a regulated transaction
must identify the other party to the transaction. For domestic
transaction, this shall be accomplished by having the other party
present documents which would verify the identity, or registration
status if a registrant, of the other party to the regulated person at
the time the order is placed. For export transactions, this shall be
accomplished by good faith inquiry through reasonably available research
documents or publicly available information which would indicate the
existence of the foreign customer. No proof of identity is required for
foreign suppliers.
(b) The regulated person must verify the existence and apparent
validity of a business entity ordering a listed chemical, tableting
machine or encapsulating machine. For domestic transactions, this may be
accomplished by such methods as checking the telephone directory, the
local credit bureau, the local Chamber of Commerce or the local Better
Business Bureau, or, if the business entity is a registrant, by
verification of the registration. For export transactions, a good faith
inquiry to verify the existence and apparent validity of a foreign
business entity may be accomplished by such methods as verifying the
business telephone listing through international telephone information,
the firm's listing in international or foreign national chemical
directories or other commerce directories or trade publications,
confirmation through foreign subsidiaries of the U.S. regulated person,
verification through the country of destination's embassy Commercial
Attache, or official documents provided by the purchaser which confirm
the existence and apparent validity of the business entity.
(c) When transacting business with a new representative of a firm,
the regulated person must verify the claimed agency status of the
representative.
(d) For sales to individuals or cash purchasers, the type of
documents and other evidence of proof must consist of at least a
signature of the purchaser, a driver's license and one other form of
identification. Any exports to individuals or exports paid in cash are
suspect and should be handled as such. For such exports, the regulated
person shall diligently obtain from the purchaser or independently seek
to confirm clear documentation which proves the person is properly
identified such as through foreign identity documents, driver's license,
passport information and photograph, etc. Any regulated person who fails
to adequately prove the identity of the other party to the transaction
may be subject to the specific penalties provided for violations of law
related to regulated transactions in listed chemicals.
(e) For a new customer who is not an individual or cash customer,
the regulated person shall establish the identity of the authorized
purchasing agent or agents and have on file that person's signature,
electronic password, or other identification. Once the authorized
purchasing agent has been established, the agent list may be updated
annually rather than on each order.
[[Page 131]]
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) Import and export transactions of iodine.
(g) Import transactions of anhydrous hydrogen chloride.
(h) Domestic distribution of anhydrous hydrogen chloride weighing
12,000 pounds (net weight) or more in a single container.
(i) Domestic distribution of anhydrous hydrogen chloride by
pipeline.
(j) Domestic and international return shipments of reusable
containers from customer to producer containing residual quantities of
red phosphorus or white phosphorus in rail cars and intermodal tank
containers which conform to International Standards Organization
specifications (with capacities greater than or equal to 2,500 gallons
in a single container).
(k) Domestic, import, and export distributions of gamma-
butyrolactone weighing 4,000 kilograms (net weight) or more in a single
container.
(l) Domestic and import transactions in chemical mixtures that
contain acetone, ethyl ether, 2-butanone, or toluene unless regulated
because of being formulated with another listed chemical above the
concentration limit.
[57 FR 43615, Sept. 22, 1992, as amended at 60 FR 19510, Apr. 19, 1995;
60 FR 32461, June 22, 1995; 62 FR 13968, Mar. 24, 1997; 65 FR 47316,
Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 37414, June 24, 2003; 68
FR 53292, Sept. 10, 2003; 69 FR 74971, Dec. 15, 2004]
Sec. 1310.09 Temporary exemption from registration.
(a) Each person required by section 302 of the act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export a combination
ephedrine product is temporarily exempted from the registration
requirement, provided that the person submits a proper application for
registration on or before July 12, 1997. The exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in parts 1309, 1310, and 1313 of this chapter remain in full
force and effect.
(b) Each person required by section 302 of the act (21 U.S.C. 822)
to obtain a registration to distribute, import, or
[[Page 132]]
export a drug product that contains pseudoephedrine or
phenylpropanolamine that is regulated pursuant to Sec.
1300.02(b)(28)(1)(D) of this chapter is temporarily exempted from the
registration requirement, provided that the person submits a proper
application for registration on or before December 3, 1997. The
exemption will remain in effect for each person who has made such
application until the Administration has approved or denied that
application. This exemption applies only to registration; all other
chemical control requirements set forth in parts 1309, 1310, and 1313 of
this chapter remain in full force and effect.
(c) Each person required by section 302 of the act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export GBL is
temporarily exempted from the registration requirement, provided that
the DEA receives a proper application for registration on or before July
24, 2000. The exemption will remain in effect for each person who has
made such application until the Administration has approved or denied
that application. This exemption applies only to registration; all other
chemical control requirements set forth in parts 1309, 1310, and 1313 of
this chapter remain in full force and effect.
(d) Each person required by section 302 of the Act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export the List I
chemicals red phosphorus, white phosphorus, and hypophosphorous acid
(and its salts), is temporarily exempted from the registration
requirement, provided that the person submits a proper application for
registration on or before December 17, 2001. The exemption will remain
in effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in parts 1309, 1310, and 1313 of this chapter remain in full
force and effect.
(e) Each person required by section 302 of the Act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export regulated
chemical mixtures which contain ephedrine, N-methylephedrine, N-
methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or
pseudoephedrine, pursuant to Sec. Sec. 1310.12 and 1310.13, is
temporarily exempted from the registration requirement, provided that
DEA receives a proper application for registration or application for
exemption on or before June 30, 2003. The exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in parts 1309, 1310, and 1313 of this chapter remain in full
force and effect. Any person who distributes, imports or exports a
chemical mixture whose application for exemption is subsequently denied
by DEA must obtain a registration with DEA. A temporary exemption from
the registration requirement will also be provided for these persons,
provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has not been approved.
The temporary exemption for such persons will remain in effect until DEA
takes final action on their registration application.
(f) Except for chemical mixtures containing the listed chemicals in
paragraph (e) of this section, each person required by section 302 of
the Act (21 U.S.C. 822) to obtain a registration to distribute, import,
or export regulated chemical mixtures, pursuant to Sec. Sec. 1310.12
and 1310.13, is temporarily exempted from the registration requirement,
provided that DEA receives a proper application for registration or
application for exemption on or before February 14, 2005. The exemption
will remain in effect for each person who has made such application
until the Administration has approved or denied that application. This
exemption applies only to registration; all other chemical control
requirements set forth in parts 1309, 1310, and 1313 of this chapter
remain in full force and effect.
(g) Any person who distributes, imports, or exports a chemical
mixture whose application for exemption is subsequently denied by DEA
must obtain a registration with DEA. A temporary
[[Page 133]]
exemption from the registration requirement will also be provided for
these persons, provided that DEA receives a properly completed
application for registration on or before 30 days following the date of
official DEA notification that the application for exemption has not
been approved. The temporary exemption for such persons will remain in
effect until DEA takes final action on their registration application.
[62 FR 27693, May 21, 1997, as amended at 62 FR 53960, Oct. 17, 1997; 65
FR 21647, Apr. 24, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, May 1,
2003; 69 FR 74971, Dec. 15, 2004]
Sec. 1310.10 Removal of the exemption of drugs distributed under the
Food, Drug and Cosmetic Act.
(a) The Administrator may remove from exemption under Sec.
1310.01(b)(28)(i)(D) any drug or group of drugs that the Administrator
finds is being diverted to obtain a listed chemical for use in the
illicit production of a controlled substance. In removing a drug or
group of drugs from the exemption the Administrator shall consider:
(1) The scope, duration, and significance of the diversion;
(2) Whether the drug or group of drugs is formulated in such a way
that it cannot be easily used in the illicit production of a controlled
substance; and
(3) Whether the listed chemical can be readily recovered from the
drug or group of drugs.
(b) Upon determining that a drug or group of drugs should be removed
from the exemption under paragraph (a) of this section, the
Administrator shall issue and publish in the Federal Register his
proposal to remove the drug or group of drugs from the exemption, which
shall include a reference to the legal authority under which the
proposal is based. The Administrator shall permit any interested person
to file written comments on or objections to the proposal. After
considering any comments or objections filed, the Administrator shall
publish in the Federal Register his final order.
(c) The Administrator shall limit the removal of a drug or group of
drugs from exemption under paragraph (a) of this section to the most
identifiable type of the drug or group of drugs for which evidence of
diversion exists unless there is evidence, based on the pattern of
diversion and other relevant factors, that the diversion will not be
limited to that particular drug or group of drugs.
(d) Any manufacturer seeking reinstatement of a particular drug
product that has been removed from an exemption may apply to the
Administrator for reinstatement of the exemption for that particular
drug product on the grounds that the particular drug product is
manufactured and distributed in a manner that prevents diversion. In
determining whether the exemption should be reinstated the Administrator
shall consider:
(1) The package sizes and manner of packaging of the drug product;
(2) The manner of distribution and advertising of the drug product;
(3) Evidence of diversion of the drug product;
(4) Any actions taken by the manufacturer to prevent diversion of
the drug product; and
(5) Such other factors as are relevant to and consistent with the
public health and safety, including the factors described in paragraph
(a) of this section as applied to the drug product.
(e) Within a reasonable period of time after receipt of the
application for reinstatement of the exemption, the Administrator shall
notify the applicant of his acceptance or non-acceptance of his
application, and if not accepted, the reason therefor. If the
application is accepted for filing, the Administrator shall issue and
publish in the Federal Register his order on the reinstatement of the
exemption for the particular drug product, which shall include a
reference to the legal authority under which the order is based. This
order shall specify the date on which it shall take effect. The
Administrator shall permit any interested person to file written
comments on or objections to the order. If any such comments raise
significant issues regarding any finding of fact or conclusion of law
upon which the order is based, the Administrator shall immediately
suspend the effectiveness of the order until he may reconsider the
application in light
[[Page 134]]
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]
Sec. 1310.11 Reinstatement of exemption for drug products distributed
under the Food, Drug and Cosmetic Act.
(a) The Administrator has reinstated the exemption for the drug
products listed in paragraph (e) of this section from application of
sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822-823,
830, and 957-958), to the extent described in paragraphs (b), (c), and
(d) of this section.
(b) No reinstated exemption granted pursuant to 1310.10 affects the
criminal liability for illegal possession or distribution of listed
chemicals contained in the exempt drug product.
(c) Changes in exempt drug product compositions: Any change in the
quantitative or qualitative composition, trade name or other designation
of an exempt drug product listed in paragraph (d) requires a new
application for reinstatement of the exemption.
(d) The following drug products, in the form and quantity listed in
the application submitted (indicated as the ``date'') are designated as
reinstated exempt drug products for the purposes set forth in this
section:
Exempt Drug Products
----------------------------------------------------------------------------------------------------------------
Supplier Product name Form Date
----------------------------------------------------------------------------------------------------------------
[Reserved]........................... ....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
[60 FR 32462, June 22, 1995]
Sec. 1310.12 Exempt chemical mixtures.
(a) The chemical mixtures meeting the criteria in paragraphs (c) or
(d) of this section are exempted by the Administrator from application
of sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822,
823, 830, 957 and 958) to the extent described in paragraphs (b) and (c)
of this section.
(b) No exemption granted pursuant to this Sec. 1310.12 or Sec.
1310.13 affects the criminal liability for illegal possession,
distribution, exportation, or importation of listed chemicals contained
in the exempt chemical mixture or the civil liability for unlawful acts
related to exempt chemical mixtures, including distribution in violation
of 21 U.S.C. 842(a)(11).
(c) Mixtures containing a listed chemical in concentrations equal to
or less than those specified in the ``Table of Concentration Limits''
are designated as exempt chemical mixtures for the purpose set forth in
this section. The concentration is determined for liquid-liquid mixtures
by using the volume or weight and for mixtures containing solids or
gases by using the unit of weight.
[[Page 135]]
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA
chemical Concentration Special conditions
code number
----------------------------------------------------------------------------------------------------------------
List I Chemicals
----------------------------------------------------------------------------------------------------------------
N-Acetylanthranilic acid, its salts and 8522 20% by Weight............. Concentration based on any
esters. combination of N-
acetylanthranilic acid and
its salts and esters.
Anthranilic acid, and its salts and 8530 50% by Weight............. Concentration is based on any
esters. combination of anthranilic
acid and its salts and
esters.
Benzaldehyde........................... 8256 50% by Weight or Volume...
Benzyl cyanide......................... 8570 20% by Weight or Volume...
Ephedrine, its salts, optical isomers, 8113 5% by Weight, net weight Concentration based on any
and salts of optical isomers. includes capsule, if any. combination of ephedrine,
pseudoephedrine, and their
salts, optical isomers and
salts of optical isomers.
Ergonovine and its salts............... 8675 Not exempt at any Chemical mixtures containing
concentration. any amount of ergonovine,
including its salts, are not
exempt.
Ergotamine and its salts............... 8676 Not exempt at any Chemical mixtures containing
concentration. amount of any ergotamine,
including its salts, are not
exempt.
Ethylamine and its salts............... 8678 20% by Weight or Volume... Ethylamine or its salts in an
inert carrier solvent is not
considered a mixture.
Concentration is based on
ethylamine in the mixture and
not the combination of
ethylamine and carrier
solvent, if any.
Hydriodic acid......................... 6695 20% by Weight or Volume...
Isosafrole............................. 8704 20% by Weight or Volume... Concentration in a mixture
cannot exceed 20% if taken
alone or in any combination
with safrole.
Methylamine and its salts.............. 8520 20% by Weight............. Methylamine or its salts in an
inert carrier solvent is not
considered a mixture. Weight
is based on methylamine in
the mixture and not the
combined weight of carrier
solvent, if any.
3,4-Methylenedioxyphenyl-2-propanone... 8502 20% by Weight.............
N-Methylephedrine, its salts, optical 8115 0.1% by Weight............ Concentration based on any
isomers, and salts of optical isomers. combination of salts N-
methylephedrine, N-
methylpseudoephedrine and
their salts, optical isomers
and salts of optical isomers.
N-Methylpseudoephedrine, its salts, 8119 0.1% by Weight............ Concentration based on any
optical isomers, and salts of optical combination of N-
isomers. methylpseudoephedrine, N-
methylephedrine, and their
salts, optical isomers and
salts of optical isomers.
Nitroethane............................ 6724 20% by Weight or Volume...
Norpseudoephedrine, its salts, optical 8317 0.6% by Weight............ Concentration based on any
isomers, and salts of optical isomers. combination of
norpseudoephedrine,
phenylpropanolamine and their
salts, optical isomers and
salts of optical isomers.
Phenylacetic acid, and its salts and 8791 40% by Weight............. Concentration is based on any
esters. combination of phenylacetic
acid and its salts and
esters.
Phenylpropanolamine, its salts, optical 1225 0.6% by Weight............ Concentration based on any
isomers, and salts of optical isomers. combination of
phenylpropanolamine,
norpseudoephedrine and their
salts, optical isomers and
salts of optical isomers.
Piperidine, and its salts.............. 2704 20% by Weight or Volume... Concentration based on any
combination of piperidine and
its salts. Concentration
based on weight if a solid,
weight or volume if a liquid.
Piperonal.............................. 8750 20% by Weight or Volume...
Propionic anhydride.................... 8328 20% by Weight or Volume...
Pseudoephedrine, its salts, optical 8112 5% by Weight, net weight Concentration based on any
isomers, and salts of optical isomers. includes capsule, if any. combination of
pseudoephedrine, ephedrine,
and their salts, optical
isomers and salts of optical
isomers.
Safrole................................ 8323 20% by Volume............. Concentration in a mixture
cannot exceed 20% if taken
alone or in any combination
with isosafrole.
----------------------------------------------------------------------------------------------------------------
List II Chemicals
----------------------------------------------------------------------------------------------------------------
Acetic Anhydride....................... 8519 20% by Weight or Volume...
Acetone................................ 6532 35% by Weight or Volume... Exports only; Limit applies to
acetone or any combination of
acetone, ethyl ether, 2-
butanone, methyl isobutyl
ketone, and toluene if
present in the mixture by
summing the concentrations
for each chemical.
Benzyl chloride........................ 8568 20% by Weight or Volume...
[[Page 136]]
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.............
Sulfuric acid.......................... 6552 20% by Weight or Volume... Sulfuric acid in an inert
carrier solvent, such as
aqueous or alcoholic
solutions, is not considered
a mixture. Weight is based on
sulfuric acid in the mixture
and not the combined weight
of the carrier solvent, if
any.
Toluene................................ 594 35% by Weight or Volume... Exports only; Limit applies to
toluene or any combination of
acetone, ethyl ether, 2-
butanone, methyl isobutyl
ketone, and toluene if
present in the mixture by
summing the concentrations
for each chemical.
----------------------------------------------------------------------------------------------------------------
(d) The following categories of chemical mixtures are automatically
exempt from the provisions of the Controlled Substances Act as described
in paragraph (a) of this section:
(1) Harvested plant material that contains ephedrine, N-
methylephedrine, N-methylpseudoephedrine, norpseudoephedrine,
phenylpropanolamine, and/or pseudoephedrine, that is in its natural
state or has been processed in a way (such as grinding, chopping,
mulching or cutting) that preserves the natural constituents in the
ratios that are found in the plant's natural state. Plant material
subjected to chemical or physical extraction, concentration, chemical
reaction, or other treatment that alters the plant's natural
constituents or the ratios of the plant constituents are not exempt.
(2) Chemical mixtures that are distributed directly to an
incinerator for destruction or directly to an authorized waste recycler
or reprocessor where such distributions are documented on United States
Environmental Protection Agency Form 8700-22; persons distributing the
mixture to the incinerator or recycler must maintain and make available
to agents of the Administration, upon request, such documentation for a
period of no less than two years.
(3) Completely formulated paints and coatings: Completely formulated
paints and coatings are only those formulations that contain all the
components of the paint or coating for use in the final application
without the need to add any additional substances except a thinner if
needed in certain cases. A completely formulated paint or coating is
defined as any clear or pigmented liquid, liquefiable or mastic
composition designed for application to a substrate in a thin layer that
is converted to a clear or opaque solid protective, decorative, or
functional adherent film after application. Included in this category
are clear coats, topcoats, primers, varnishes, sealers, adhesives,
lacquers, stains, shellacs, inks, and temporary protective coatings.
[[Page 137]]
(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]
Sec. 1310.13 Exemption of chemical mixtures; application.
(a) The Administrator may, by publication of a Final Rule in the
Federal Register, exempt from the application of all or any part of the
Act a chemical mixture consisting of two or more chemical components, at
least one of which is not a List I or List II chemical, if:
(1) The mixture is formulated in such a way that it cannot be easily
used in the illicit production of a controlled substance; and
(2) The listed chemical or chemicals contained in the chemical
mixture cannot be readily recovered.
(b) Any manufacturer seeking an exemption for a chemical mixture,
not exempt under Sec. 1310.12, from the application of all or any part
of the Act, may apply to the Administrator, Drug Enforcement
Administration, Department of Justice, Washington, DC 20537.
(c) An application for exemption under this section shall contain
the following information:
(1) The name, address, and registration number, if any, of the
applicant;
(2) The date of the application;
(3) The exact trade name(s) of the applicant's chemical mixture and:
(i) If the applicant formulates or manufactures the chemical mixture
for other entities, the exact trade names of the chemical mixtures and
the names of the entities for which the chemical mixtures were prepared;
and
(ii) If a group of mixtures (e.g. formulations having identical
function and containing the same listed chemical(s)), the information
required in paragraph (c)(3)(i) of this section and a brief narrative of
their use.
(4) (i) The complete qualitative and quantitative composition of the
chemical mixture (including all listed and all non-listed chemicals); or
(ii) If a group of mixtures, the concentration range for the listed
chemical and a listing of all non-listed chemicals with respective
concentration ranges.
(5) (i) The chemical and physical properties of the mixture and how
they differ from the properties of the listed chemical or chemicals; and
(ii) If a group of mixtures, how the group's properties differ from
the properties of the listed chemical.
(6) A statement that the applicant believes justifies an exemption
for the chemical mixture or group of mixtures. The statement must
explain how the chemical mixture(s) meets the exemption criteria set
forth in paragraph (a) of this section.
[[Page 138]]
(7) A statement that the applicant accepts the right of the
Administrator to terminate exemption from regulation for the chemical
mixture(s) granted exemption under this section.
(8) The identification of any information on the application that is
considered by the applicant to be a trade secret or confidential and
entitled to protection under U.S. laws restricting the public disclosure
of such information.
(d) The Administrator may require the applicant to submit such
additional documents or written statements of fact relevant to the
application that he deems necessary for determining if the application
should be granted.
(e) Within 30 days after the receipt of an application for an
exemption under this section, the Administrator will notify the
applicant of acceptance or rejection of the application. If the
application is not accepted, an explanation will be provided. The
Administrator is not required to accept an application if any
information required pursuant to paragraph (c) of this section or
requested pursuant to paragraph (d) of this section is lacking or not
readily understood. The applicant may, however, amend the application to
meet the requirements of paragraphs (c) and (d) of this section. If the
exemption is granted, the applicant shall be notified in writing and the
Administrator shall issue, and publish in the Federal Register, an order
on the application. This order shall specify the date on which it shall
take effect. The Administrator shall permit any interested person to
file written comments on or objections to the order. If any comments or
objections raise significant issues regarding any findings of fact or
conclusions of law upon which the order is based, the Administrator may
suspend the effectiveness of the order until he has reconsidered the
application in light of the comments and objections filed. Thereafter,
the Administrator shall reinstate, terminate, or amend the original
order as deemed appropriate.
(f) The Administrator may, at any time, terminate or modify an
exemption for any product pursuant to paragraph (e) of this section. In
terminating or modifying an exemption, the Administrator shall issue,
and publish in the Federal Register, notification of the removal of an
exempt product or group of exempt products for which evidence of
diversion has been found. This order shall specify the date on which the
termination of exemption shall take effect. The Administrator shall
permit any interested party to file written comments on or objections to
the order within 60 days of the date of publication of the order in the
Federal Register. If any such comments or objections raise significant
issues regarding any finding of fact or conclusion of law upon which the
order is based, the Administrator may suspend the effectiveness of the
order until he has reconsidered the order in light of comments and
objections filed. Thereafter, the Administrator shall reinstate,
terminate, or amend the original order as determined appropriate.
(g) A manufacturer of an exempted chemical mixture shall notify DEA
in writing, of any change in the quantitative or qualitative composition
of a chemical mixture that has been granted an exemption by application.
Changes include those greater than the range of concentration given in
the application or that remove non-listed chemical(s) given in the
application as part of the formulation. A new application will be
required only if reformulation results in a new product having a
different commercial application or can no longer be defined as part of
a group of exempted chemicals. DEA must be notified of reformulation at
least 30 days in advance of marketing the reformulated mixture. For a
change in name or other designation, code, or any identifier, a written
notification is required. DEA must be notified of any changes at least
60 days in advance of the effective date for the change.
(h) Each manufacturer seeking exemption must apply for such an
exemption. A formulation granted exemption by publication in the Federal
Register will not be exempted for all manufacturers.
(i) The following chemical mixtures, in the form and quantity listed
in the application submitted (indicated as the ``date'' ) are designated
as exempt chemical mixtures for the purposes set forth in this section
and are exempted by the Administrator from application
[[Page 139]]
of sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822,
823, 830, 957 and 958):
Exempt Chemical Mixtures
----------------------------------------------------------------------------------------------------------------
Manufacturer Product name \1\ Form Date
----------------------------------------------------------------------------------------------------------------
[Reserved]
----------------------------------------------------------------------------------------------------------------
\1\ Designate product line if a group.
[68 FR 23204, May 1, 2003]
Sec. 1310.14 Exemption of drug products containing ephedrine and
therapeutically significant quantities of another active medicinal
ingredient.
(a) Any manufacturer of a drug product containing ephedrine in
combination with another active medicinal ingredient, the product
formulation of which is not listed in the compendiums set forth in Sec.
1310.01(b)(28)(i)(D)(1), may request that the Administrator exempt the
product as one which contains ephedrine together with a therapeutically
significant quantity of another active medicinal ingredient.
(b) An application for an exemption under this section shall contain
the following information:
(1) The name and address of the applicant;
(2) The exact trade name of the drug product for which exemption is
sought;
(3) The complete quantitative and qualitative composition of the
drug product;
(4) A brief statement of the facts which the applicant believes
justify the granting of an exemption under this section; and
(5) Certification by the applicant that the product may be lawfully
marketed or distributed under the Food, Drug, and Cosmetic Act.
(6) The identification of any information on the application which
is considered by the applicant to be a trade secret or confidential and
entitled to protection under U.S. laws restricting the public disclosure
of such information by government employees.
(c) The Administrator may require the applicant to submit such
additional documents or written statements of fact relevant to the
application which he deems necessary for determining if the application
should be granted.
(d) Within a reasonable period of time after the receipt of a
completed application for an exemption under this section, the
Administrator shall notify the applicant of acceptance or non-acceptance
of the application. If the application is not accepted, an explanation
will be provided. The Administrator is not required to accept an
application if any of the information required in paragraph (b) of this
section or requested pursuant to paragraph (c) of this section is
lacking or not readily understood. The applicant may, however, amend the
application to meet the requirements of paragraphs (b) and (c) of this
section. If the application is accepted for filing, the Administrator
shall issue and publish in the Federal Register an order on the
application, which shall include a reference to the legal authority
under which the order is based. This order shall specify the date on
which it shall take effect. The Administrator shall permit any
interested person to file written comments on or objections to the
order. If any comments or objections raise significant issues regarding
any findings of fact or law upon which the order is based, the
Administrator shall immediately suspend the effectiveness of the order
until he may reconsider the application in light of the comments and
objections filed. Thereafter, the Administrator shall reinstate, revoke,
or amend the original order as deemed appropriate.
[60 FR 32462, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
[[Page 140]]
Sec. 1310.15 Exempt drug products containing ephedrine and
therapeutically significant quantities of another active medicinal
ingredient.
(a) The drug products containing ephedrine and therapeutically
significant quantities of another active medicinal ingredient listed in
paragraph (e) of this section have been exempted by the Administrator
from application of sections 302, 303, 310, 1007, and 1008 of the Act
(21 U.S.C. 822-3, 830, and 957-8) to the extent described in paragraphs
(b), (c), and (d) of this section.
(b) No exemption granted pursuant to 1310.14 affects the criminal
liability for illegal possession or distribution of listed chemicals
contained in the exempt drug product.
(c) Changes in drug product compositions: Any change in the
quantitative or qualitative composition of an exempt drug product listed
in paragraph (d) requires a new application for exemption.
(d) In addition to the drug products listed in the compendium set
forth in Sec. 1310.01(b)(28)(i)(D)(1), the following drug products, in
the form and quantity listed in the application submitted (indicated as
the ``date'') are designated as exempt drug products for the purposes
set forth in this section:
Exempt Drug Products Containing Ephedrine and Therapeutically Significant Quantities of Another Active Medicinal
Ingredient
----------------------------------------------------------------------------------------------------------------
Supplier Product name Form Date
----------------------------------------------------------------------------------------------------------------
[Reserved]...........................
----------------------------------------------------------------------------------------------------------------
[60 FR 32463, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
Sec. 1310.21 Sale by Federal departments or agencies of chemicals
which could be used to manufacture controlled substances.
(a) A Federal department or agency may not sell from the stocks of
the department or agency any chemical which, as determined by the
Administrator of the Drug Enforcement Administration, could be used in
the manufacture of a controlled substance, unless the Administrator
certifies in writing to the head of the department or agency that there
is no reasonable cause to believe that the sale of the specific chemical
to a specific person would result in the illegal manufacture of a
controlled substance. For purposes of this requirement, reasonable cause
to believe means that the Administration has knowledge of facts which
would cause a reasonable person to reasonably conclude that a chemical
would be diverted to the illegal manufacture of a controlled substance.
(b) A Federal department or agency must request certification by
submitting a written request to the Administrator, Drug Enforcement
Administration, Washington, DC 20537, Attention: Domestic Chemical
Control Unit (ODID). A request for certification may be transmitted
directly to the Drug Enforcement Administration, Domestic Chemical
Control Unit through electronic facsimile media. A request for
certification must be submitted no later than fifteen calendar days
before the proposed sale is to take place. In order to facilitate the
sale of chemicals from Federal departments' or agencies' stocks, Federal
departments or agencies may wish to submit requests as far in advance of
the fifteen calendar days as possible. The written notification of the
proposed sale must include:
(1) The name and amount of the chemical to be sold;
(2) The name and address of the prospective bidder;
(3) The name and address of the prospective end-user, in cases where
a sale is being brokered;
(4) Point(s) of contact for the prospective bidder and, where
appropriate, prospective end-user; and
(5) The end use of the chemical.
(c) Within fifteen calendar days of receipt of a request for
certification, the Administrator will certify in writing to the head of
the Federal department or agency that there is, or is not, reasonable
cause to believe that the sale of the specific chemical to the specific
bidder and end-user would result in the illegal manufacture of a
controlled substance. In making this determination, the following
factors must be considered:
(1) Past experience of the prospective bidder or end-user in the
maintenance of effective controls against diversion
[[Page 141]]
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 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
[[Page 142]]
the existing certification will constitute a final decision for purposes
of judicial review under 21 U.S.C. 877.
[68 FR 62737, Nov. 6, 2003]
PART 1311_Digital Certificates--Table of Contents
Subpart A_General
Sec.
1311.01 Scope.
1311.02 Definitions.
1311.05 Standards for technologies for electronic transmission of
orders.
1311.08 Incorporation by reference.
Subpart B_Obtaining and Using Digital Certificates for Electronic Orders
1311.10 Eligibility to obtain a CSOS digital certificate.
1311.15 Limitations on CSOS digital certificates.
1311.20 Coordinators for CSOS digital certificate holders.
1311.25 Requirements for obtaining a CSOS digital certificate.
1311.30 Requirements for storing and using a private key for digitally
signing orders.
1311.35 Number of CSOS digital certificates needed.
1311.40 Renewal of CSOS digital certificates.
1311.45 Requirements for registrants that allow powers of attorney to
obtain CSOS digital certificates under their DEA registration.
1311.50 Requirements for recipients of digitally signed orders.
1311.55 Requirements for systems used to process digitally signed
orders.
1311.60 Recordkeeping.
Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless
otherwise noted.
Source: 70 FR 16915, Apr. 1, 2005, unless otherwise noted.
Subpart A_General
Sec. 1311.01 Scope.
This part sets forth the rules governing the use of digital
signatures and the protection of private keys by registrants.
Sec. 1311.02 Definitions.
For the purposes of this chapter:
Biometric authentication means authentication based on measurement
of the individual's physical features or repeatable actions where those
features or actions are both unique to the individual and measurable.
Cache means to download and store information on a local server or
hard drive.
Certificate Policy means a named set of rules that sets forth the
applicability of the specific digital certificate to a particular
community or class of application with common security requirements.
Certificate Revocation List (CRL) means a list of revoked, but
unexpired certificates issued by a Certification Authority.
Certification Authority (CA) means an organization that is
responsible for verifying the identity of applicants, authorizing and
issuing a digital certificate, maintaining a directory of public keys,
and maintaining a Certificate Revocation List.
CSOS means controlled substance ordering system.
Digital certificate means a data record that, at a minimum:
(1) Identifies the certification authority issuing it;
(2) Names or otherwise identifies the certificate holder;
(3) Contains a public key that corresponds to a private key under
the sole control of the certificate holder;
(4) Identifies the operational period; and
(5) Contains a serial number and is digitally signed by the
Certification Authority issuing it.
Digital signature means a record created when a file is
algorithmically transformed into a fixed length digest that is then
encrypted using an asymmetric cryptographic private key associated with
a digital certificate. The combination of the encryption and algorithm
transformation ensure that the signer's identity and the integrity of
the file can be confirmed.
Electronic signature means a method of signing an electronic message
that identifies a particular person as the source of the message and
indicates the person's approval of the information contained in the
message.
FIPS means Federal Information Processing Standards. These Federal
standards, as incorporated by reference in Sec. 1311.08, prescribe
specific performance requirements, practices, formats,
[[Page 143]]
communications protocols, etc., for hardware, software, data, etc.
FIPS 140-2, as incorporated by reference in Sec. 1311.08, means a
Federal standard for security requirements for cryptographic modules.
FIPS 180-2, as incorporated by reference in Sec. 1311.08, means a
Federal secure hash standard.
FIPS 186-2, as incorporated by reference in Sec. 1311.08, means a
Federal standard for applications used to generate and rely upon digital
signatures.
Key pair means two mathematically related keys having the properties
that:
(1) One key can be used to encrypt a message that can only be
decrypted using the other key; and
(2) Even knowing one key, it is computationally infeasible to
discover the other key.
NIST means the National Institute of Standards and Technology.
Private key means the key of a key pair that is used to create a
digital signature.
Public key means the key of a key pair that is used to verify a
digital signature. The public key is made available to anyone who will
receive digitally signed messages from the holder of the key pair.
Public Key Infrastructure (PKI) means a structure under which a
Certification Authority verifies the identity of applicants, issues,
renews, and revokes digital certificates, maintains a registry of public
keys, and maintains an up-to-date Certificate Revocation List.
Sec. 1311.05 Standards for technologies for electronic transmission
of orders.
(a) A registrant or a person with power of attorney to sign orders
for Schedule I and II controlled substances may use any technology to
sign and electronically transmit orders if the technology provides all
of the following:
(1) Authentication: The system must enable a recipient to positively
verify the signer without direct communication with the signer and
subsequently demonstrate to a third party, if needed, that the sender's
identity was properly verified.
(2) Nonrepudiation: The system must ensure that strong and
substantial evidence is available to the recipient of the sender's
identity, sufficient to prevent the sender from successfully denying
having sent the data. This criterion includes the ability of a third
party to verify the origin of the document.
(3) Message integrity: The system must ensure that the recipient, or
a third party, can determine whether the contents of the document have
been altered during transmission or after receipt.
(b) DEA has identified the following means of electronically signing
and transmitting order forms as meeting all of the standards set forth
in paragraph (a) of this section.
(1) Digital signatures using Public Key Infrastructure (PKI)
technology.
(2) [Reserved]
Sec. 1311.08 Incorporation by reference.
(a) The following standards are incorporated by reference:
(1) FIPS 140-2, Security Requirements for Cryptographic Modules, May
25, 2001, as amended by Change Notices 2 through 4, December 3, 2002.
(i) Annex A: Approved Security Functions for FIPS PUB 140-2,
Security Requirements for Cryptographic Modules, September 23, 2004.
(ii) Annex B: Approved Protection Profiles for FIPS PUB 140-2,
Security Requirements for Cryptographic Modules, November 4, 2004.
(iii) Annex C: Approved Random Number Generators for FIPS PUB 140-2,
Security Requirements for Cryptographic Modules, January 31, 2005.
(iv) Annex D: Approved Key Establishment Techniques for FIPS PUB
140-2, Security Requirements for Cryptographic Modules, February 23,
2004.
(2) FIPS 180-2, Secure Hash Standard, August 1, 2002, as amended by
change notice 1, February 25, 2004.
(3) FIPS 186-2, Digital Signature Standard, January 27, 2000, as
amended by Change Notice 1, October 5, 2001.
(b) These standards are available from the National Institute of
Standards and Technology, Computer Security Division, Information
Technology Laboratory, National Institute of Standards and Technology,
100 Bureau
[[Page 144]]
Drive, Gaithersburg, MD 20899-8930 and are available at http://
csrc.nist.gov/.
(c) These incorporations by reference were approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be inspected at the Drug Enforcement Administration,
600 Army Navy Drive, Arlington, VA 22202 or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call (202) 741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
Subpart B_Obtaining and Using Digital Certificates for Electronic Orders