[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
21
Part 1300 to End
Revised as of April 1, 2002
Food and Drugs
Containing a codification of documents of general
applicability and future effect
As of April 1, 2002
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 169
Finding Aids:
Table of CFR Titles and Chapters........................ 231
Alphabetical List of Agencies Appearing in the CFR...... 249
List of CFR Sections Affected........................... 259
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 1300.01
refers to title 21, part
1300, section 01.
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EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
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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.
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Many agencies have begun publishing numerous OMB control numbers as
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[[Page vii]]
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Raymond A. Mosley,
Director,
Office of the Federal Register.
April 1, 2002.
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THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The
first eight volumes, containing parts 1-1299, comprise Chapter I--Food
and Drug Administration, Department of Health and Human Services. The
ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2002.
Redesignation tables for Chapter I--Food and Drug Administration
appear in the Finding Aids section for the volumes containing parts 170-
199 and 500-599.
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[[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
Cross References: U.S. Customs Service, Department of the Treasury: See
Customs Duties, 19 CFR chapter I.
Regulations of the Public Health Service, Department of Health and
Human Services, applying to narcotic addicts: See Public Health, 42 CFR
part 2.
Other regulations issued by the Department of Justice appear in title
4, title 8, and title 28.
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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. 13
1302 Labeling and packaging requirements for
controlled substances................... 42
1303 Quotas...................................... 43
1304 Records and reports of registrants.......... 52
1305 Order forms................................. 64
1306 Prescriptions............................... 70
1307 Miscellaneous............................... 79
1308 Schedules of controlled substances.......... 81
1309 Registration of manufacturers, distributors,
importers and exporters of list I
chemicals............................... 100
1310 Records and reports of listed chemicals and
certain machines........................ 112
1311 [Reserved]
1312 Importation and exportation of controlled
substances.............................. 126
1313 Importation and exportation of precursors
and essential chemicals................. 138
1314-1315 [Reserved]
1316 Administrative functions, practices, and
procedures.............................. 146
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PART 1300--DEFINITIONS--Table of Contents
Sec.
1300.01 Definitions relating to controlled substances.
1300.02 Definitions relating to listed chemicals.
Authority: 21 U.S.C. 802, 871(b), 951, 958(f)
Source: 62 FR 13941, Mar. 24, 1997, unless otherwise noted.
Sec. 1300.01 Definitions relating to controlled substances.
(a) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802), except that certain
terms used in part 1316 of this chapter are defined at the beginning of
each subpart of that part.
(b) As used in parts 1301 through 1308 and part 1312 of this
chapter, the following terms shall have the meanings specified:
(1) The term Act means the Controlled Substances Act, as amended (84
Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and
Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).
(2) The term Administration means the Drug Enforcement
Administration.
(3) The term Administrator means the Administrator of the Drug
Enforcement Administration. The Administrator has been delegated
authority under the Act by the Attorney General (28 CFR 0.100).
(4) The term anabolic steroid means any drug or hormonal substance,
chemically and pharmacologically related to testosterone (other than
estrogens, progestins, and corticosteroids) that promotes muscle growth,
and includes:
(i) Boldenone;
(ii) Chlorotestosterone (4-chlortestosterone);
(iii) Clostebol;
(iv) Dehydrochlormethyltestosterone;
(v) Dihydrotestosterone (4-dihydrotestosterone);
(vi) Drostanolone;
(vii) Ethylestrenol;
(viii) Fluoxymesterone;
(ix) Formebulone (formebolone);
(x) Mesterolone;
(xi) Methandienone;
(xii) Methandranone;
(xiii) Methandriol;
(xiv) Methandrostenolone;
(xv) Methenolone;
(xvi) Methyltestosterone;
(xvii) Mibolerone;
(xviii) Nandrolone;
(xix) Norethandrolone;
(xx) Oxandrolone;
(xxi) Oxymesterone;
(xxii) Oxymetholone;
(xxiii) Stanolone;
(xxiv) Stanozolol;
(xxv) Testolactone;
(xxvi) Testosterone;
(xxvii) Trenbolone; and
(xxviii) Any salt, ester, or isomer of a drug or substance described
or listed in this paragraph, if that salt, ester, or isomer promotes
muscle growth. Except such term does not include an anabolic steroid
which is expressly intended for administration through implants to
cattle or other nonhuman species and which has been approved by the
Secretary of Health and Human Services for such administration. If any
person prescribes, dispenses, or distributes such steroid for human use,
such person shall be considered to have prescribed, dispensed, or
distributed an anabolic steroid within the meaning of this paragraph.
(5) The term basic class means, as to controlled substances listed
in Schedules I and II:
(i) Each of the opiates, including its isomers, esters, ethers,
salts, and salts of isomers, esters, and ethers whenever the existence
of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in Sec. 1308.11(b) of this
chapter;
(ii) Each of the opium derivatives, including its salts, isomers,
and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation,
listed in Sec. 1308.11(c) of this chapter;
(iii) Each of the hallucinogenic substances, including its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific chemical
designation, listed in Sec. 1308.11(d) of this chapter;
(iv) Each of the following substances, whether produced directly or
indirectly
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by extraction from substances of vegetable origin, or independently by
means of chemical synthesis, or by a combination of extraction and
chemical synthesis:
(A) Opium, including raw opium, opium extracts, opium fluid
extracts, powdered opium, granulated opium, deodorized opium and
tincture of opium;
(B) Apomorphine;
(C) Codeine;
(D) Etorphine hydrochloride;
(E) Ethylmorphine;
(F) Hydrocodone;
(G) Hydromorphone;
(H) Metopon;
(I) Morphine;
(J) Oxycodone;
(K) Oxymorphone;
(L) Thebaine;
(M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of this
chapter;
(N) Cocaine; and
(O) Ecgonine;
(v) Each of the opiates, including its isomers, esters, ethers,
salts, and salts of isomers, esters, and ethers whenever the existence
of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in Sec. 1308.12(c) of this
chapter; and
(vi) Methamphetamine, its salts, isomers, and salts of its isomers;
(vii) Amphetamine, its salts, optical isomers, and salts of its
optical isomers;
(viii) Phenmetrazine and its salts;
(ix) Methylphenidate;
(x) Each of the substances having a depressant effect on the central
nervous system, including its salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation, listed in
Sec. 1308.12(e) of this chapter.
(6) The term commercial container means any bottle, jar, tube,
ampule, or other receptacle in which a substance is held for
distribution or dispensing to an ultimate user, and in addition, any box
or package in which the receptacle is held for distribution or
dispensing to an ultimate user. The term commercial container does not
include any package liner, package insert or other material kept with or
within a commercial container, nor any carton, crate, drum, or other
package in which commercial containers are stored or are used for
shipment of controlled substances.
(7) The term compounder means any person engaging in maintenance or
detoxification treatment who also mixes, prepares, packages or changes
the dosage form of a narcotic drug listed in Schedules II, III, IV or V
for use in maintenance or detoxification treatment by another narcotic
treatment program.
(8) The term controlled substance has the meaning given in section
802(6) of Title 21, United States Code (U.S.C.).
(9) The term customs territory of the United States means the
several States, the District of Columbia, and Puerto Rico.
(10) The term detoxification treatment means the dispensing, for a
period of time as specified below, of a narcotic drug or narcotic drugs
in decreasing doses to an individual to alleviate adverse physiological
or psychological effects incident to withdrawal from the continuous or
sustained use of a narcotic drug and as a method of bringing the
individual to a narcotic drug-free state within such period of time.
There are two types of detoxification treatment: Short-term
detoxification treatment and long-term detoxification treatment.
(i) Short-term detoxification treatment is for a period not in
excess of 30 days.
(ii) Long-term detoxification treatment is for a period more than 30
days but not in excess of 180 days.
(11) The term dispenser means an individual practitioner,
institutional practitioner, pharmacy or pharmacist who dispenses a
controlled substance.
(12) The term export means, with respect to any article, any taking
out or removal of such article from the jurisdiction of the United
States (whether or not such taking out or removal constitutes an
exportation within the meaning of the customs and related laws of the
United States).
(13) The term exporter includes every person who exports, or who
acts as an export broker for exportation of, controlled substances
listed in any schedule.
(14) The term hearing means:
(i) In part 1301 of this chapter, any hearing held for the granting,
denial,
[[Page 7]]
revocation, or suspension of a registration pursuant to sections 303,
304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
(ii) In part 1303 of this chapter, any hearing held regarding the
determination of aggregate production quota or the issuance, adjustment,
suspension, or denial of a procurement quota or an individual
manufacturing quota.
(iii) In part 1308 of this chapter, any hearing held for the
issuance, amendment, or repeal of any rule issuable pursuant to section
201 of the Act (21 U.S.C. 811).
(15) The term import means, with respect to any article, any
bringing in or introduction of such article into either the jurisdiction
of the United States or the customs territory of the United States, and
from the jurisdiction of the United States into the customs territory of
the United States (whether or not such bringing in or introduction
constitutes an importation within the meaning of the tariff laws of the
United States).
(16) The term importer includes every person who imports, or who
acts as an import broker for importation of, controlled substances
listed in any schedule.
(17) The term individual practitioner means a physician, dentist,
veterinarian, or other individual licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he/she
practices, to dispense a controlled substance in the course of
professional practice, but does not include a pharmacist, a pharmacy, or
an institutional practitioner.
(18) The term institutional practitioner means a hospital or other
person (other than an individual) licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which it
practices, to dispense a controlled substance in the course of
professional practice, but does not include a pharmacy.
(19) The term interested person means any person adversely affected
or aggrieved by any rule or proposed rule issuable pursuant to section
201 of the Act (21 U.S.C. 811).
(20) The term inventory means all factory and branch stocks in
finished form of a basic class of controlled substance manufactured or
otherwise acquired by a registrant, whether in bulk, commercial
containers, or contained in pharmaceutical preparations in the
possession of the registrant (including stocks held by the registrant
under separate registration as a manufacturer, importer, exporter, or
distributor).
(21) The term isomer means the optical isomer, except as used in
Sec. 1308.11(d) and Sec. 1308.12(b)(4) of this chapter. As used in
Sec. 1308.11(d) of this chapter, the term isomer means the optical,
positional, or geometric isomer. As used in Sec. 1308.12(b)(4) of this
chapter, the term isomer means the optical or geometric isomer.
(22) The term jurisdiction of the United States means the customs
territory of the United States, the Virgin Islands, the Canal Zone,
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
(23) The term label means any display of written, printed, or
graphic matter placed upon the commercial container of any controlled
substance by any manufacturer of such substance.
(24) The term labeling means all labels and other written, printed,
or graphic matter:
(i) Upon any controlled substance or any of its commercial
containers or wrappers, or
(ii) Accompanying such controlled substance.
(25) The term Long Term Care Facility (LTCF) means a nursing home,
retirement care, mental care or other facility or institution which
provides extended health care to resident patients.
(26) The term maintenance treatment means the dispensing for a
period in excess of twenty-one days, of a narcotic drug or narcotic
drugs in the treatment of an individual for dependence upon heroin or
other morphine-like drug.
(27) The term manufacture means the producing, preparation,
propagation, compounding, or processing of a drug or other substance or
the packaging or repackaging of such substance, or the labeling or
relabeling of the commercial container of such substance, but does not
include the activities of a practitioner who, as an incident to his/her
administration or dispensing such
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substance in the course of his/her professional practice, prepares,
compounds, packages or labels such substance. The term manufacturer
means a person who manufactures a drug or other substance, whether under
a registration as a manufacturer or under authority of registration as a
researcher or chemical analyst.
(28) The term mid-level practitioner means an individual
practitioner, other than a physician, dentist, veterinarian, or
podiatrist, who is licensed, registered, or otherwise permitted by the
United States or the jurisdiction in which he/she practices, to dispense
a controlled substance in the course of professional practice. Examples
of mid-level practitioners include, but are not limited to, health care
providers such as nurse practitioners, nurse midwives, nurse
anesthetists, clinical nurse specialists and physician assistants who
are authorized to dispense controlled substances by the state in which
they practice.
(29) The term name means the official name, common or usual name,
chemical name, or brand name of a substance.
(30) The term narcotic drug means any of the following whether
produced directly or indirectly by extraction from substances of
vegetable origin or independently by means of chemical synthesis or by a
combination of extraction and chemical synthesis:
(i) Opium, opiates, derivatives of opium and opiates, including
their isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers whenever the existence of such isomers, esters, ethers and salts
is possible within the specific chemical designation. Such term does not
include the isoquinoline alkaloids of opium.
(ii) Poppy straw and concentrate of poppy straw.
(iii) Coca leaves, except coca leaves and extracts of coca leaves
from which cocaine, ecgonine and derivatives of ecgonine or their salts
have been removed.
(iv) Cocaine, its salts, optical and geometric isomers, and salts of
isomers.
(v) Ecgonine, its derivatives, their salts, isomers and salts of
isomers.
(vi) Any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in paragraphs (b)(31)(i)
through (v) of this section.
(31) The term narcotic treatment program means a program engaged in
maintenance and/or detoxification treatment with narcotic drugs.
(32) The term net disposal means, for a stated period, the quantity
of a basic class of controlled substance distributed by the registrant
to another person, plus the quantity of that basic class used by the
registrant in the production of (or converted by the registrant into)
another basic class of controlled substance or a noncontrolled
substance, plus the quantity of that basic class otherwise disposed of
by the registrant, less the quantity of that basic class returned to the
registrant by any purchaser, and less the quantity of that basic class
distributed by the registrant to another registered manufacturer of that
basic class for purposes other than use in the production of, or
conversion into, another basic class of controlled substance or a
noncontrolled substance or in the manufacture of dosage forms of that
basic class.
(33) The term pharmacist means any pharmacist licensed by a State to
dispense controlled substances, and shall include any other person
(e.g., pharmacist intern) authorized by a State to dispense controlled
substances under the supervision of a pharmacist licensed by such State.
(34) The term person includes any individual, corporation,
government or governmental subdivision or agency, business trust,
partnership, association, or other legal entity.
(35) The term prescription means an order for medication which is
dispensed to or for an ultimate user but does not include an order for
medication which is dispensed for immediate administration to the
ultimate user. (e.g., an order to dispense a drug to a bed patient for
immediate administration in a hospital is not a prescription.)
(36) The term proceeding means all actions taken for the issuance,
amendment, or repeal of any rule issued pursuant to section 201 of the
Act (21 U.S.C. 811), commencing with the publication by the
Administrator of the
[[Page 9]]
proposed rule, amended rule, or repeal in the Federal Register.
(37) The term purchaser means any registered person entitled to
obtain and execute order forms pursuant to Secs. 1305.04 and 1305.06.
(38) The term readily retrievable means that certain records are
kept by automatic data processing systems or other electronic or
mechanized recordkeeping systems in such a manner that they can be
separated out from all other records in a reasonable time and/or records
are kept on which certain items are asterisked, redlined, or in some
other manner visually identifiable apart from other items appearing on
the records.
(39) The terms register and registration refer only to registration
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823
or 957).
(40) The term registrant means any person who is registered pursuant
to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
(41) The term supplier means any registered person entitled to fill
order forms pursuant to Sec. 1305.08 of this chapter.
(42) 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.
[62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000]
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.
(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
[[Page 10]]
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 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.
[[Page 11]]
(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 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;
[[Page 12]]
(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; or
(ii) The Administrator has determined pursuant to the criteria in
1310.10 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 or other listed chemical contained in
the drug included in the transaction or multiple transactions equals or
exceeds the threshold established for that chemical.
(E) Any transaction in a chemical mixture listed in Sec. 1310.13 of
this chapter.
(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.
[62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. 1, 1997]
Effective Date Note: At 67 FR 14859, Mar. 28, 2002, Sec. 1300.02 was
amended by revising paragraph (b)(28)(i)(D), and adding paragraphs
(b)(31) and (32), effective Apr. 29, 2002. For the convenience of the
user, the revised and added text follows:
Sec. 1300.02 Definitions relating to listed chemicals.
* * * * *
(b) * * *
(28) * * *
(i) * * *
(D) * * *
(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 24 grams of pseudoephedrine or 24 grams of
phenylpropanolamine in a single transaction. 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.
* * * * *
(31) The term ordinary over-the-counter pseudoephedrine or
phenylpropanolamine product means any product containing pseudoephedrine
or phenylpropanolamine that is--
[[Page 13]]
(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.
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES--Table of Contents
General Information
Sec.
1301.01 Scope of this part 1301.
1301.02 Definitions.
1301.03 Information; special instructions.
Registration
1301.11 Persons required to register.
1301.12 Separate registrations for separate locations.
1301.13 Application for registration; time for application; expiration
date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
1301.14 Filing of application; acceptance for filing; defective
applications.
1301.15 Additional information.
1301.16 Amendments to and withdrawal of applications.
1301.17 Special procedures for certain applications.
1301.18 Research protocols.
Exceptions to Registration and Fees
1301.21 Exception from fees.
1301.22 Exemption of agents and employees; affiliated practitioners.
1301.23 Exemption of certain military and other personnel.
1301.24 Exemption of law enforcement officials.
1301.25 Registration regarding ocean vessels, aircraft, and other
entities.
1301.26 Exemptions from import or export requirements for personal
medical use.
Action on Application for Registration: Revocation or Suspension of
Registration
1301.31 Administrative review generally.
1301.32 Action on applications for research in Schedule I substances.
1301.33 Application for bulk manufacture of Schedule I and II
substances.
1301.34 Application for importation of Schedule I and II substances.
1301.35 Certificate of registration; denial of registration.
1301.36 Suspension or revocation of registration; suspension of
registration pending final order; extension of registration
pending final order.
1301.37 Order to show cause.
Hearings
1301.41 Hearings generally.
1301.42 Purpose of hearing.
1301.43 Request for hearing or appearance; waiver.
1301.44 Burden of proof.
1301.45 Time and place of hearing.
1301.46 Final order.
Modification, Transfer, and Termination of Registration
1301.51 Modification in registration.
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.
[[Page 14]]
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 Secs. 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 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
[[Page 15]]
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, 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 the above business activities to a group, the Administration may
select a group the expiration date of which is less than one year from
the date such business activity was registered. If the business activity
is assigned to a group which has an expiration date less than three
months from the date of which the business activity is registered, the
registration shall not expire until one year from that expiration date;
in all other cases, the registration shall expire on the expiration date
following the date on which the business activity is registered.
(d) At the time a retail pharmacy, hospital/clinic, practitioner or
teaching institution is first registered, that business activity shall
be assigned to one of twelve groups, which shall correspond to the
months of the year. The expiration date of the registrations of all
registrants within any group will be the last day of the month
designated for that group. In assigning any of the above business
activities to a group, the Administration may select a group the
expiration date of which is not less than 28 months nor more than 39
months from the date such business activity was registered. After the
initial registration period, the registration shall expire 36 months
from the initial expiration date.
(e) Any person who is required to be registered and who is not so
registered, shall make application for registration for one of the
following groups of controlled substances activities, which are deemed
to be independent of each other. Application for each registration shall
be made on the indicated form, and shall be accompanied by the indicated
fee. Fee payments shall be made
[[Page 16]]
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)
----------------------------------------------------------------------------------------------------------------
Application Registration
Business activity Controlled DEA application fee period Coincident
substances forms (dollars) (years) activities allowed
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing Schedules I through New--225 875 1 Schedules I through
V Renewal--225a 875 V: May distribute
that substance or
class for which
registration was
issued; may not
distribute any
substance or class
for which not
registered.
Schedules II
through V: May
conduct chemical
analysis and
preclinical
research (including
quality control
analysis) with
substances listed
in those schedules
for which
authorization as a
manufacturer was
issued.
(ii) Distributing Schedules I through New--225 438 1 ....................
V Renewal--225a 438
(iii) Dispensing or Schedules II through New--224 210 3 May conduct research
Instructing (Includes V Renewal--224a 210 and instructional
Practitioner Hospital/ activities with
Clinic, Retail those substances
Pharmacy, Teaching for which
Institution) registration was
granted, except
that a mid-level
practitioner may
conduct such
research only to
the extent
expressly
authorized under
state statute. A
pharmacist may
manufacture an
aqueous or
oleaginous solution
or solid dosage
form containing a
narcotic controlled
substance in
Schedule II through
V in a proportion
not exceeding 20
percent of the
complete solution,
compound, or
mixture.
(iv) Research Schedule I New--225 70 1 A researcher may
Renewal--225a 70 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.
[[Page 17]]
(v) Research Schedules II through New--225 70 1 May conduct chemical
V Renewal--225a 70 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.
(vi) Narcotic Treatment Narcotic Drugs in New--363 70 1 ....................
Program (including Schedules II Renewal--363a 70
compounder) through V
(vii) Importing Schedules I through New--225 438 1 May distribute that
V Renewal--225a 438 substance or class
for which
registration was
issued; may not
distribute any
substance or class
for which not
registered.
(viii) Exporting Schedules I through New--225 438 1 ....................
V Renewal--225a 438
(ix) Chemical Analysis Schedules I through New--225 70 1 May manufacture and
V Renewal--225a 70 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
relating 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,
[[Page 18]]
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 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]
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
[[Page 19]]
the applicant to provide such documents or statements within a
reasonable time after being requested to do so shall be deemed to be a
waiver by the applicant of an opportunity to present such documents or
facts for consideration by the Administrator in granting or denying the
application.
[62 FR 13948, Mar. 24, 1997]
Sec. 1301.16 Amendments to and withdrawal of applications.
(a) An application may be amended or withdrawn without permission of
the Administrator at any time before the date on which the applicant
receives an order to show cause pursuant to Sec. 1301.37. An application
may be amended or withdrawn with permission of the Administrator at any
time where good cause is shown by the applicant or where the amendment
or withdrawal is in the public interest.
(b) After an application has been accepted for filing, the request
by the applicant that it be returned or the failure of the applicant to
respond to official correspondence regarding the application, when sent
by registered or certified mail, return receipt requested, shall be
deemed to be a withdrawal of the application.
[62 FR 13949, Mar. 24, 1997]
Sec. 1301.17 Special procedures for certain applications.
(a) If, at the time of application for registration of a new
pharmacy, the pharmacy has been issued a license from the appropriate
State licensing agency, the applicant may include with his/her
application an affidavit as to the existence of the State license in the
following form:
Affidavit for New Pharmacy
I, --------------------, the -------------------- (Title of officer,
official, partner, or other position) of --------------------
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) at -------------------- (Number and Street),
-------------------- (City) ------------ (State) ------------ (Zip
code), hereby certify that said store was issued a pharmacy permit No.
-------- by the ---------------- (Board of Pharmacy or Licensing Agency)
of the State of ------------ on ------------ (Date).
This statement is submitted in order to obtain a Drug Enforcement
Administration registration number. I understand that if any information
is false, the Administration may immediately suspend the registration
for this store and commence proceedings to revoke under 21 U.S.C. 824(a)
because of the danger to public health and safety. I further understand
that any false information contained in this affidavit may subject me
personally and the above-named corporation/partnership/business to
prosecution under 21 U.S.C. 843, the penalties for conviction of which
include imprisonment for up to 4 years, a fine of not more than $30,000
or both.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
Subscribed to and sworn before me this -------- day of --------,
19------.
________________________________________________________________________
Notary Public
(b) Whenever the ownership of a pharmacy is being transferred from
one person to another, if the transferee owns at least one other
pharmacy licensed in the same State as the one the ownership of which is
being transferred, the transferee may apply for registration prior to
the date of transfer. The Administrator may register the applicant and
authorize him to obtain controlled substances at the time of transfer.
Such registration shall not authorize the transferee to dispense
controlled substances until the pharmacy has been issued a valid State
license. The transferee shall include with his/her application the
following affidavit:
Affidavit for Transfer of Pharmacy
I, --------------------, the -------------------- (Title of officer,
official, partner or other position) of --------------------
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) hereby certify:
(1) That said company was issued a pharmacy permit No.------------by
the -------------------- (Board of Pharmacy of Licensing Agency) of the
State of ------------ and a DEA Registration Number --------------------
for a pharmacy located at -------------------- (Number and Street) ----
-------- (City) ------------ (State) ------------ (Zip Code); and
(2) That said company is acquiring the pharmacy business of --------
------------ (Name of Seller) doing business
[[Page 20]]
as--------------------with DEA Registration Number ------------ on or
about ------------ (Date of Transfer) and that said company has applied
(or will apply on ------------ (Date) for a pharmacy permit from the
board of pharmacy (or licensing agency) of the State of ------------ to
do business as -------------------- (Store name) at --------------------
(Number and Street) -------------------- (City) ------------ (State) --
---------- (Zip Code).
This statement is submitted in order to obtain a Drug Enforcement
Administration registration number.
I understand that if a DEA registration number is issued, the
pharmacy may acquire controlled substances but may not dispense them
until a pharmacy permit or license is issued by the State board of
pharmacy or licensing agency.
I understand that if any information is false, the Administration
may immediately suspend the registration for this store and commence
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to
public health and safety. I further understand that any false
information contained in this affidavit may subject me personally to
prosecution under 21 U.S.C. 843, the penalties for conviction of which
include imprisonment for up to 4 years, a fine of not more than $30,000
or both.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
Subscribed to and sworn before me this----day of------------, 19--
--.
________________________________________________________________________
Notary Public
(c) The Administrator shall follow the normal procedures for
approving an application to verify the statements in the affidavit. If
the statements prove to be false, the Administrator may revoke the
registration on the basis of section 304(a)(1) of the Act (21 U.S.C.
824(a)(1)) and suspend the registration immediately by pending
revocation on the basis of section 304(d) of the Act (21 U.S.C. 824(d)).
At the same time, the Administrator may seize and place under seal all
controlled substances possessed by the applicant under section 304(f) of
the Act (21 U.S.C. 824(f)). Intentional misuse of the affidavit
procedure may subject the applicant to prosecution for fraud under
section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining
controlled substances through registration by fraudulent means may
subject the applicant to prosecution under section 403(a)(3) of the Act
(21 U.S.C. 843(a)(3)). The penalties for conviction of either offense
include imprisonment for up to 4 years, a fine not exceeding $30,000 or
both.
[62 FR 13949, Mar. 24, 1997]
Sec. 1301.18 Research protocols.
(a) A protocol to conduct research with controlled substances listed
in Schedule I shall be in the following form and contain the following
information where applicable:
(1) Investigator:
(i) Name, address, and DEA registration number; if any.
(ii) Institutional affiliation.
(iii) Qualifications, including a curriculum vitae and an
appropriate bibliography (list of publications).
(2) Research project:
(i) Title of project.
(ii) Statement of the purpose.
(iii) Name of the controlled substances or substances involved and
the amount of each needed.
(iv) Description of the research to be conducted, including the
number and species of research subjects, the dosage to be administered,
the route and method of administration, and the duration of the project.
(v) Location where the research will be conducted.
(vi) Statement of the security provisions for storing the controlled
substances (in accordance with Sec. 1301.75) and for dispensing the
controlled substances in order to prevent diversion.
(vii) If the investigator desires to manufacture or import any
controlled substance listed in paragraph (a)(2)(iii) of this section, a
statement of the quantity to be manufactured or imported and the sources
of the chemicals to be used or the substance to be imported.
(3) Authority:
(i) Institutional approval.
(ii) Approval of a Human Research Committee for human studies.
(iii) Indication of an approved active Notice of Claimed
Investigational Exemption for a New Drug (number).
(iv) Indication of an approved funded grant (number), if any.
(b) In the case of a clinical investigation with controlled
substances listed
[[Page 21]]
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.
(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
[[Page 22]]
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 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.
[[Page 23]]
(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;
(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
[[Page 24]]
(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.
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 --------
[[Page 25]]
(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), providing 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 U.S. Customs Service stating:
(1) That the controlled substance is possessed for his/her personal
use, or for an animal accompanying him/her; and
(2) The trade or chemical name and the symbol designating the
schedule of the controlled substance if it appears on the container
label, or, if such name does not appear on the label, the name
[[Page 26]]
and address of the pharmacy or practitioner who dispensed the substance
and the prescription number, if any; and
(c) The importation of the controlled substance for personal medical
use is authorized or permitted under other Federal laws and state law.
[62 FR 13952, Mar. 24, 1997]
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.
(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
[[Page 27]]
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
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;
[[Page 28]]
(5) Past experience in the manufacture of controlled substances, and
the existence in the establishment of effective control against
diversion;
(6) That the applicant will be permitted to import only:
(i) Such amounts of crude opium, poppy straw, concentrate of poppy
straw, and coca leaves as the Administrator finds to be necessary to
provide for medical, scientific, or other legitimate purposes; or
(ii) Such amounts of any controlled substances listed in Schedule I
or II as the Administrator shall find to be necessary to provide for the
medical, scientific, or other legitimate needs of the United States
during an emergency in which domestic supplies of such substances are
found by the Administrator to be inadequate; or
(iii) Such amounts of any controlled substance listed in Schedule I
or II as the Administrator shall find to be necessary to provide for the
medical, scientific, or other legitimate needs of the United States in
any case in which the Administrator finds that competition among
domestic manufacturers of the controlled substance is inadequate and
will not be rendered adequate by the registration of additional
manufacturers under section 303 of the Act (21 U.S.C. 823); or
(iv) Such limited quantities of any controlled substance listed in
Schedule I or II as the Administrator shall find to be necessary for
scientific, analytical or research uses; and
(7) Such other factors as may be relevant to and consistent with the
public health and safety.
(c) In determining whether the applicant can and will maintain
effective controls against diversion within the meaning of paragraph (b)
of this section, the Administrator shall consider among other factors:
(1) Compliance with the security requirements set forth in
Secs. 1301.71-1301.76; and
(2) Employment of security procedures to guard against in-transit
losses within and without the jurisdiction of the United States.
(d) In determining whether competition among the domestic
manufacturers of a controlled substance is adequate within the meaning
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as section
1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator
shall consider:
(1) The extent of price rigidity in the light of changes in:
(i) raw materials and other costs and
(ii) conditions of supply and demand;
(2) The extent of service and quality competition among the domestic
manufacturers for shares of the domestic market including:
(i) Shifts in market shares and
(ii) Shifts in individual customers among domestic manufacturers;
(3) The existence of substantial differentials between domestic
prices and the higher of prices generally prevailing in foreign markets
or the prices at which the applicant for registration to import is
committed to undertake to provide such products in the domestic market
in conformity with the Act. In determining the existence of substantial
differentials hereunder, appropriate consideration should be given to
any additional costs imposed on domestic manufacturers by the
requirements of the Act and such other cost-related and other factors as
the Administrator may deem relevant. In no event shall an importer's
offering prices in the United States be considered if they are lower
than those prevailing in the foreign market or markets from which the
importer is obtaining his/her supply;
(4) The existence of competitive restraints imposed upon domestic
manufacturers by governmental regulations; and
(5) Such other factors as may be relevant to the determinations
required under this paragraph.
(e) In considering the scope of the domestic market, consideration
shall be given to substitute products which are reasonably
interchangeable in terms of price, quality and use.
(f) The fact that the number of existing manufacturers is small
shall not demonstrate, in and of itself, that adequate competition among
them does not exist.
[62 FR 13953, Mar. 24, 1997]
[[Page 29]]
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 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.
[[Page 30]]
(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 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
[[Page 31]]
by the applicable provisions of section 303 and/or section 1008 of the
Act (21 U.S.C. 823 and 958) to register the applicant, the Administrator
shall serve upon the applicant an order to show cause why the
registration should not be denied.
(b) If, upon information gathered by the Administration regarding
any registrant, the Administrator determines that the registration of
such registrant is subject to suspension or revocation pursuant to
section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the
Administrator shall serve upon the registrant an order to show cause why
the registration should not be revoked or suspended.
(c) The order to show cause shall call upon the applicant or
registrant to appear before the Administrator at a time and place stated
in the order, which shall not be less than 30 days after the date of
receipt of the order. The order to show cause shall also contain a
statement of the legal basis for such hearing and for the denial,
revocation, or suspension of registration and a summary of the matters
of fact and law asserted.
(d) Upon receipt of an order to show cause, the applicant or
registrant must, if he/she desires a hearing, file a request for a
hearing pursuant to Sec. 1301.43. If a hearing is requested, the
Administrator shall hold a hearing at the time and place stated in the
order, pursuant to Sec. 1301.41.
(e) When authorized by the Administrator, any agent of the
Administration may serve the order to show cause.
[62 FR 13955, Mar. 24, 1997]
Hearings
Sec. 1301.41 Hearings generally.
(a) In any case where the Administrator shall hold a hearing on any
registration or application therefor, the procedures for such hearing
shall be governed generally by the adjudication procedures set forth in
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
sections 303, 304, and 1008 of the Act (21 U.S.C. 823-824 and 958), by
Secs. 1301.42-1301.46 of this part, and by the procedures for
administrative hearings under the Act set forth in Secs. 1316.41-1316.67
of this chapter.
(b) Any hearing under this part shall be independent of, and not in
lieu of, criminal prosecutions or other proceedings under the Act or any
other law of the United States.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.42 Purpose of hearing.
If requested by a person entitled to a hearing, the Administrator
shall hold a hearing for the purpose of receiving factual evidence
regarding the issues involved in the denial, revocation, or suspension
of any registration, and the granting of any application for
registration to import or to manufacture in bulk a basic class of
controlled substance listed in Schedule I or II. Extensive argument
should not be offered into evidence but rather presented in opening or
closing statements of counsel or in memoranda or proposed findings of
fact and conclusions of law.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.43 Request for hearing or appearance; waiver.
(a) Any person entitled to a hearing pursuant to Sec. 1301.32 or
Secs. 1301.34-1301.36 and desiring a hearing shall, within 30 days after
the date of receipt of the order to show cause (or the date of
publication of notice of the application for registration in the Federal
Register in the case of Sec. 1301.34), file with the Administrator a
written request for a hearing in the form prescribed in Sec. 1316.47 of
this chapter.
(b) Any person entitled to participate in a hearing pursuant to
Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30
days of the date of publication of notice of the request for a hearing
in the Federal Register, file with the Administrator a written notice of
intent to participate in such hearing in the form prescribed in
Sec. 1316.48 of this chapter. Any person filing a request for a hearing
need not also file a notice of appearance.
(c) Any person entitled to a hearing or to participate in a hearing
pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 may, within the period
permitted for filing a request for a hearing or a notice of appearance,
file with the Administrator a
[[Page 32]]
waiver of an opportunity for a hearing or to participate in a hearing,
together with a written statement regarding such person's position on
the matters of fact and law involved in such hearing. Such statement, if
admissible, shall be made a part of the record and shall be considered
in light of the lack of opportunity for cross-examination in determining
the weight to be attached to matters of fact asserted therein.
(d) If any person entitled to a hearing or to participate in a
hearing pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 fails to file
a request for a hearing or a notice of appearance, or if such person so
files and fails to appear at the hearing, such person shall be deemed to
have waived the opportunity for a hearing or to participate in the
hearing, unless such person shows good cause for such failure.
(e) If all persons entitled to a hearing or to participate in a
hearing waive or are deemed to waive their opportunity for the hearing
or to participate in the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his/her final order pursuant to
Sec. 1301.46 without a hearing.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.44 Burden of proof.
(a) At any hearing on an application to manufacture any controlled
substance listed in Schedule I or II, the applicant shall have the
burden of proving that the requirements for such registration pursuant
to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any other
person participating in the hearing pursuant to Sec. 1301.35(b) shall
have the burden of proving any propositions of fact or law asserted by
such person in the hearing.
(b) At any hearing on the granting or denial of an applicant to be
registered to conduct a narcotic treatment program or as a compounder,
the applicant shall have the burden of proving that the requirements for
each registration pursuant to section 303(g) of the Act (21 U.S.C.
823(g)) are satisfied.
(c) At any hearing on the granting or denial of an application to be
registered to import or export any controlled substance listed in
Schedule I or II, the applicant shall have the burden of proving that
the requirements for such registration pursuant to sections 1008(a) and
(d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other
person participating in the hearing pursuant to Sec. 1301.34 shall have
the burden of proving any propositions of fact or law asserted by him/
her in the hearings.
(d) At any other hearing for the denial of a registration, the
Administration shall have the burden of proving that the requirements
for such registration pursuant to section 303 or section 1008(c) and (d)
of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.
(e) At any hearing for the revocation or suspension of a
registration, the Administration shall have the burden of proving that
the requirements for such revocation or suspension pursuant to section
304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are
satisfied.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.45 Time and place of hearing.
The hearing will commence at the place and time designated in the
order to show cause or notice of hearing published in the Federal
Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter
it may be moved to a different place and may be continued from day to
day or recessed to a later day without notice other than announcement
thereof by the presiding officer at the hearing.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.46 Final order.
As soon as practicable after the presiding officer has certified the
record to the Administrator, the Administrator shall issue his/her order
on the granting, denial, revocation, or suspension of registration. In
the event that an application for registration to import or to
manufacture in bulk a basic class of any controlled substance listed in
Schedule I or II is granted, or any application for registration is
denied, or any registration is revoked or suspended, the order shall
include the findings of fact and conclusions of law upon which the order
is based. The order shall specify the date on which it shall take
effect. The Administrator
[[Page 33]]
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 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);
[[Page 34]]
(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 Secs. 1301.72-1301.76 as standards
for the physical security controls and operating procedures necessary to
prevent diversion. Materials and construction which will provide a
structural equivalent to the physical security controls set forth in
Secs. 1301.72, 1301.73 and 1301.75 may be used in lieu of the materials
and construction described in those sections.
(b) Substantial compliance with the standards set forth in
Secs. 1301.72-1301.76 may be deemed sufficient by the Administrator
after evaluation of the overall security system and needs of the
applicant or registrant. In evaluating the overall security system of a
registrant or applicant, the Administrator may consider any of the
following factors as he may deem relevant to the need for strict
compliance with security requirements:
(1) The type of activity conducted (e.g., processing of bulk
chemicals, preparing dosage forms, packaging, labeling, cooperative
buying, etc.);
(2) The type and form of controlled substances handled (e.g., bulk
liquids or dosage units, usable powders or nonusable powders);
(3) The quantity of controlled substances handled;
(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
[[Page 35]]
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, and;
(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.
(c) When physical security controls become inadequate as a result of
a controlled substance being transferred to a different schedule, or as
a result of a noncontrolled substance being listed on any schedule, or
as a result of a significant increase in the quantity of controlled
substances in the possession of the registrant during normal business
operations, the physical security controls shall be expanded and
extended accordingly. A registrant may adjust physical security controls
within the requirements set forth in Secs. 1301.72-1301.76 when the need
for such controls decreases as a result of a controlled substance being
transferred to a different schedule, or a result of a controlled
substance being removed from control, or as a result of a significant
decrease in the quantity of controlled substances in the possession of
the registrant during normal business operations.
(d) Any registrant or applicant desiring to determine whether a
proposed security system substantially complies with, or is the
structural equivalent of, the requirements set forth in Secs. 1301.72-
1301.76 may submit any plans, blueprints, sketches or other materials
regarding the proposed security system either to the Special Agent in
Charge in the region in which the system will be used, or to the
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 Secs. 1301.72, 1301.73 and 1301.75. Any new
facilities or work or storage areas constructed or utilized for
controlled substances, which facilities or work or storage areas have
not been previously approved by the Administration, shall not
necessarily be deemed to comply substantially with the standards set
forth in Secs. 1301.72, 1301.73 and 1301.75, notwithstanding that such
facilities or work or storage areas have physical security controls
similar to those previously approved by the Administration.
[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22,
1982; 51 FR 5319, Feb. 13, 1986]
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
[[Page 36]]
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:
(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
[[Page 37]]
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),
(1) through (14);
(8)(i) Schedule III through V controlled substances may be stored
with Schedules I and II controlled substances under security measures
provided by 21 CFR 1301.72(a);
(ii) Non-controlled drugs, substances and other materials may be
stored with Schedule III through V controlled substances in any of the
secure storage areas required by 21 CFR 1301.72(b), provided that
permission for such storage of non-controlled items is obtained in
advance, in writing, from the Special Agent in Charge of DEA for the
area in which such storage area is situated. Any such permission
tendered must be upon the Special Agent in Charge's written
determination that such non-segregated storage does not diminish
security effectiveness for Schedules III through V controlled
substances.
(c) Multiple storage areas. Where several types or classes of
controlled substances are handled separately by the registrant or
applicant for different purposes (e.g., returned goods, or goods in
process), the controlled substances may be stored separately, provided
that each storage area complies with the requirements set forth in this
section.
(d) Accessibility to storage areas. The controlled substances
storage areas shall be accessible only to an absolute minimum number of
specifically authorized employees. When it is necessary for employee
maintenance personnel, nonemployee maintenance personnel, business
guests, or visitors to be present in or pass through controlled
substances storage areas, the registrant shall provide for adequate
[[Page 38]]
observation of the area by an employee specifically authorized in
writing.
[36 FR 18730, Sept. 21, 1971, as amended at 37 FR 15919, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, l973]
Editorial Note: For Federal Register citations affecting
Sec. 1301.72, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
Sec. 1301.73 Physical security controls for non-practitioners;
compounders for narcotic treatment programs; manufacturing and
compounding areas.
All manufacturing activities (including processing, packaging and
labeling) involving controlled substances listed in any schedule and all
activities of compounders shall be conducted in accordance with the
following:
(a) All in-process substances shall be returned to the controlled
substances storage area at the termination of the process. If the
process is not terminated at the end of a workday (except where a
continuous process or other normal manufacturing operation should not be
interrupted), the processing area or tanks, vessels, bins or bulk
containers containing such substances shall be securely locked, with
adequate security for the area or building. If such security requires an
alarm, such alarm, upon unauthorized entry, shall transmit a signal
directly to a central station protection company, or local or state
police agency which has a legal duty to respond, or a 24-hour control
station operated by the registrant.
(b) Manufacturing activities with controlled substances shall be
conducted in an area or areas of clearly defined limited access which is
under surveillance by an employee or employees designated in writing as
responsible for the area. ``Limited access'' may be provided, in the
absence of physical dividers such as walls or partitions, by traffic
control lines or restricted space designation. The employee designated
as responsible for the area may be engaged in the particular
manufacturing operation being conducted: Provided, That he is able to
provide continuous surveillance of the area in order that unauthorized
persons may not enter or leave the area without his knowledge.
(c) During the production of controlled substances, the
manufacturing areas shall be accessible to only those employees required
for efficient operation. When it is necessary for employee maintenance
personnel, nonemployee maintenance personnel, business guests, or
visitors to be present in or pass through manufacturing areas during
production of controlled substances, the registrant shall provide for
adequate observation of the area by an employee specifically authorized
in writing.
[36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973 and amended at 39 FR 37984, Oct. 25, 1974]
Sec. 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs.
(a) Before distributing a controlled substance to any person who the
registrant does not know to be registered to possess the controlled
substance, the registrant shall make a good faith inquiry either with
the Administration or with the appropriate State controlled substances
registration agency, if any, to determine that the person is registered
to possess the controlled substance.
(b) The registrant shall design and operate a system to disclose to
the registrant suspicious orders of controlled substances. The
registrant shall inform the Field Division Office of the Administration
in his area of suspicious orders when discovered by the registrant.
Suspicious orders include orders of unusual size, orders deviating
substantially from a normal pattern, and orders of unusual frequency.
(c) The registrant shall notify the Field Division Office of the
Administration in his area of any theft or significant loss of any
controlled substances upon discovery of such theft or loss. The supplier
shall be responsible for reporting in-transit losses of controlled
substances by the common or contract carrier selected pursuant to
Sec. 1301.74(e), upon discovery of such theft or loss. The registrant
shall also complete DEA Form 106 regarding such theft or loss. Thefts
must be reported whether or not the controlled substances are
subsequently recovered
[[Page 39]]
and/or the responsible parties are identified and action taken against
them.
(d) The registrant shall not distribute any controlled substance
listed in Schedules II through V as a complimentary sample to any
potential or current customer (1) without the prior written request of
the customer, (2) to be used only for satisfying the legitimate medical
needs of patients of the customer, and (3) only in reasonable
quantities. Such request must contain the name, address, and
registration number of the customer and the name and quantity of the
specific controlled substance desired. The request shall be preserved by
the registrant with other records of distribution of controlled
substances. In addition, the requirements of part 1305 of the chapter
shall be complied with for any distribution of a controlled substance
listed in Schedule II. For purposes of this paragraph, the term
``customer'' includes a person to whom a complimentary sample of a
substance is given in order to encourage the prescribing or recommending
of the substance by the person.
(e) When shipping controlled substances, a registrant is responsible
for selecting common or contract carriers which provide adequate
security to guard against in-transit losses. When storing controlled
substances in a public warehouse, a registrant is responsible for
selecting a warehouseman which will provide adequate security to guard
against storage losses; wherever possible, the registrant shall store
controlled substances in a public warehouse which complies with the
requirements set forth in Sec. 1301.72. In addition, the registrant
shall employ precautions (e.g., assuring that shipping containers do not
indicate that contents are controlled substances) to guard against
storage or in-transit losses.
(f) When distributing controlled substances through agents (e.g.,
detailmen), a registrant is responsible for providing and requiring
adequate security to guard against theft and diversion while the
substances are being stored or handled by the agent or agents.
(g) Before the initial distribution of carfentanil etorphine
hydrochloride and/or diprenorphine to any person, the registrant must
verify that the person is authorized to handle the substances(s) by
contacting the Drug Enforcement Administration.
(h) The acceptance of delivery of narcotic substances by a narcotic
treatment program shall be made only by a licensed practitioner employed
at the facility or other authorized individuals designated in writing.
At the time of delivery, the licensed practitioner or other authorized
individual designated in writing (excluding persons currently or
previously dependent on narcotic drugs), shall sign for the narcotics
and place his specific title (if any) on any invoice. Copies of these
signed invoices shall be kept by the distributor.
(i) Narcotics dispensed or administered at a narcotic treatment
program will be dispensed or administered directly to the patient by
either (1) the licensed practitioner, (2) a registered nurse under the
direction of the licensed practitioner, (3) a licensed practical nurse
under the direction of the licensed practitioner, or (4) a pharmacist
under the direction of the licensed practitioner.
(j) Persons enrolled in a narcotic treatment program will be
required to wait in an area physically separated from the narcotic
storage and dispensing area. This requirement will be enforced by the
program physician and employees.
(k) All narcotic treatment programs must comply with standards
established by the Secretary of Health and Human Services (after
consultation with the Administration) respecting the quantities of
narcotic drugs which may be provided to persons enrolled in a narcotic
treatment program for unsupervised use.
(l) DEA may exercise discretion regarding the degree of security
required in narcotic treatment programs based on such factors as the
location of a program, the number of patients enrolled in a program and
the number of physicians, staff members and security guards. Similarly,
such factors will be taken into consideration when evaluating existing
security or requiring
[[Page 40]]
new security at a narcotic treatment program.
[36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, 1971, as amended at 36
FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, l973]
Editorial Note: For Federal Register citations affecting
Sec. 1301.74, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
Sec. 1301.75 Physical security controls for practitioners.
(a) Controlled substances listed in Schedule I shall be stored in a
securely locked, substantially constructed cabinet.
(b) Controlled substances listed in Schedules II, III, IV, and V
shall be stored in a securely locked, substantially constructed cabinet.
However, pharmacies and institutional practitioners may disperse such
substances throughout the stock of noncontrolled substances in such a
manner as to obstruct the theft or diversion of the controlled
substances.
(c) This section shall also apply to nonpractitioners authorized to
conduct research or chemical analysis under another registration.
(d) Carfentanil etorphine hydrochloride and diprenorphine shall be
stored in a safe or steel cabinet equivalent to a U.S. Government Class
V security container.
[39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54
FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997]
Sec. 1301.76 Other security controls for practitioners.
(a) The registrant shall not employ, as an agent or employee who has
access to controlled substances, any person who has been convicted of a
felony offense relating to controlled substances or who, at any time,
had an application for registration with the DEA denied, had a DEA
registration revoked or has surrendered a DEA registration for cause.
For purposes of this subsection, the term ``for cause'' means a
surrender in lieu of, or as a consequence of, any federal or state
administrative, civil or criminal action resulting from an investigation
of the individual's handling of controlled substances.
(b) The registrant shall notify the Field Division Office of the
Administration in his area of the theft or significant loss of any
controlled substances upon discovery of such loss or theft. The
registrant shall also complete DEA (or BND) Form 106 regarding such loss
or theft.
(c) Whenever the registrant distributes a controlled substance
(without being registered as a distributor, as permitted in
Sec. 1301.13(e)(1) and/or Secs. 1307.11-1307.12) he/she shall comply
with the requirements imposed on nonpractitioners in Sec. 1301.74 (a),
(b), and (e).
[36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971;
37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, l973;
47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957,
Mar. 24, 1997]
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]
[[Page 41]]
Employee Screening--Non- Practitioners
Sec. 1301.90 Employee screening procedures.
It is the position of DEA that the obtaining of certain information
by non-practitioners is vital to fairly assess the likelihood of an
employee committing a drug security breach. The need to know this
information is a matter of business necessity, essential to overall
controlled substances security. In this regard, it is believed that
conviction of crimes and unauthorized use of controlled substances are
activities that are proper subjects for inquiry. It is, therefore,
assumed that the following questions will become a part of an employer's
comprehensive employee screening program:
Question. Within the past five years, have you been convicted of a
felony, or within the past two years, of any misdemeanor or are you
presently formally charged with committing a criminal offense? (Do not
include any traffic violations, juvenile offenses or military
convictions, except by general court-martial.) If the answer is yes,
furnish details of conviction, offense, location, date and sentence.
Question. In the past three years, have you ever knowingly used any
narcotics, amphetamines or barbiturates, other than those prescribed to
you by a physician? If the answer is yes, furnish details.
Advice. An authorization, in writing, that allows inquiries to be
made of courts and law enforcement agencies for possible pending charges
or convictions must be executed by a person who is allowed to work in an
area where access to controlled substances clearly exists. A person must
be advised that any false information or omission of information will
jeopardize his or her position with respect to employment. The
application for employment should inform a person that information
furnished or recovered as a result of any inquiry will not necessarily
preclude employment, but will be considered as part of an overall
evaluation of the person's qualifications. The maintaining of fair
employment practices, the protection of the person's right of privacy,
and the assurance that the results of such inquiries will be treated by
the employer in confidence will be explained to the employee.
[40 FR 17143, Apr. 17, 1975]
Sec. 1301.91 Employee responsibility to report drug diversion.
Reports of drug diversion by fellow employees is not only a
necessary part of an overall employee security program but also serves
the public interest at large. It is, therefore, the position of DEA that
an employee who has knowledge of drug diversion from his employer by a
fellow employee has an obligation to report such information to a
responsible security official of the employer. The employer shall treat
such information as confidential and 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
[[Page 42]]
authorization from the employee may be required by certain law
enforcement agencies.
DEA inquiries. Inquiries supplying identifying information should
also be furnished to DEA Field Division Offices along with written
consent from the concerned individual for a check of DEA files for
records of convictions. The Regional check will result in a national
check being made by the Field Division Office.
[40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22, 1982]
PART 1302--LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES--Table of Contents
Sec.
1302.01 Scope of part 1302.
1302.02 Definitions.
1302.03 Symbol required; exceptions.
1302.04 Location and size of symbol on label and labeling.
1302.05 Effective dates of labeling requirements.
1302.06 Sealing of controlled substances.
1302.07 Labeling and packaging requirements for imported and exported
substances.
Authority: 21 U.S.C. 821, 825, 871(b), 958(e).
Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
Sec. 1302.01 Scope of part 1302.
Requirements governing the labeling and packaging of controlled
substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C.
825 and 958(d)) are set forth generally by those sections and
specifically by the sections of this part.
[36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973]
Sec. 1302.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13958, Mar. 24, 1997]
Sec. 1302.03 Symbol required; exceptions.
(a) Each commercial container of a controlled substance (except for
a controlled substance excepted by the Administrator pursuant to
Sec. 1308.31 of this chapter) shall have printed on the label the symbol
designating the schedule in which such controlled substance is listed.
Each such commercial container, if it otherwise has no label, must bear
a label complying with the requirement of this part.
(b) Each manufacturer shall print upon the labeling of each
controlled substance distributed by him the symbol designating the
schedule in which such controlled substance is listed.
(c) The following symbols shall designate the schedule corresponding
thereto:
Schedule
Schedule I................................ CI or C-I.
Schedule II............................... CII or C-II.
Schedule III.............................. CIII or C-III.
Schedule IV............................... CIV or C-IV.
Schedule V................................ CV or C-V.
The word ``schedule'' need not be used. No distinction need be made
between narcotic and nonnarcotic substances.
(d) The symbol is not required on a carton or wrapper in which a
commercial container is held if the symbol is easily legible through
such carton or wrapper.
(e) The symbol is not required on a commercial container too small
or otherwise unable to accommodate a label, if the symbol is printed on
the box or package from which the commercial container is removed upon
dispensing to an ultimate user.
(f) The symbol is not required on a commercial container containing,
or on the labeling of, a controlled substance being utilized in clinical
research involving blind and double blind studies.
[36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1302.04 Location and size of symbol on label and labeling.
The symbol shall be prominently located on the label or the labeling
of the commercial container and/or the panel of the commercial container
normally displayed to dispensers of any controlled substance. The symbol
on labels shall be clear and large enough to afford easy identification
of the schedule of the controlled substance upon inspection without
removal from the dispenser's shelf. The symbol on all other labeling
shall be clear and large enough to afford prompt identification
[[Page 43]]
of the controlled substance upon inspection of the labeling.
[62 FR 13958, Mar. 24, 1997]
Sec. 1302.05 Effective dates of labeling requirements.
All labels on commercial containers of, and all labeling of, a
controlled substance which either is transferred to another schedule or
is added to any schedule shall comply with the requirements of
Sec. 1302.03, on or before the effective date established in the final
order for the transfer or addition.
[62 FR 13958, Mar. 24, 1997]
Sec. 1302.06 Sealing of controlled substances.
On each bottle, multiple dose vial, or other commercial container of
any controlled substance, there shall be securely affixed to the
stopper, cap, lid, covering, or wrapper or such container a seal to
disclose upon inspection any tampering or opening of the container.
[62 FR 13958, Mar. 24, 1997]
Sec. 1302.07 Labeling and packaging requirements for imported and exported substances.
(a) The symbol requirements of Secs. 1302.03-1302.05 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 Secs. 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]
[[Page 44]]
Aggregate Production and Procurement Quotas
Sec. 1303.11 Aggregate production quotas.
(a) The Administrator shall determine the total quantity of each
basic class of controlled substance listed in Schedule I or II necessary
to be manufactured during the following calendar year to provide for the
estimated medical, scientific, research and industrial needs of the
United States, for lawful export requirements, and for the establishment
and maintenance of reserve stocks.
(b) In making his determinations, the Administrator shall consider
the following factors:
(1) Total net disposal of the class by all manufacturers during the
current and 2 preceding years;
(2) Trends in the national rate of net disposal of the class;
(3) Total actual (or estimated) inventories of the class and of all
substances manufactured from the class, and trends in inventory
accumulation;
(4) Projected demand for such class as indicated by procurement
quotas requested pursuant to Sec. 1303.12; and
(5) Other factors affecting medical, scientific, research, and
industrial needs in the United States and lawful export requirements, as
the Administrator finds relevant, including changes in the currently
accepted medical use in treatment with the class or the substances which
are manufactured from it, the economic and physical availability of raw
materials for use in manufacturing and for inventory purposes, yield and
stability problems, potential disruptions to production (including
possible labor strikes), and recent unforeseen emergencies such as
floods and fires.
(c) The Administrator shall, on or before May 1 of each year,
publish in the Federal Register, general notice of an aggregate
production quota for any basic class determined by him under this
section. A copy of said notice shall be mailed simultaneously to each
person registered as a bulk manufacturer of the basic class. The
Administrator shall permit any interested person to file written
comments on or objections to the proposal and shall designate in the
notice the time during which such 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
[[Page 45]]
desired to be procured or used. The applicant shall state whether he
intends to manufacture the basic class himself or purchase it from
another manufacturer. The applicant shall state separately each purpose
for which the basic class is desired, the quantity desired for that
purpose during the next calendar year, and the quantities used and
estimated to be used, if any, for that purpose during the current and
preceding 2 calendar years. If the purpose is to manufacture the basic
class into dosage form, the applicant shall state the official name,
common or usual name, chemical name, or brand name of that form. If the
purpose is to manufacture another substance, the applicant shall state
the official name, common or usual name, chemical name, or brand name of
the substance, and, if a controlled substance listed in any schedule,
the schedule number and Administration Controlled Substances Code
Number, as set forth in part 1308 of this chapter, of the substance. If
the purpose is to manufacture another basic class of controlled
substance listed in Schedule I or II, the applicant shall also state the
quantity of the other basic class which the applicant has applied to
manufacture pursuant to Sec. 1303.22 and the quantity of the first basic
class necessary to manufacture a specified unit of the second basic
class. DEA Form 250 shall be filed on or before April 1 of the year
preceding the calendar year for which the procurement quota is being
applied. Copies of DEA Form 250 may be obtained from, and shall be filed
with, the 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
[[Page 46]]
persons required to apply for a procurement quota under paragraph (b) of
this section unless the order is accompanied by a certification as
required under this section. The certification required by this section
shall contain the following: The date of the certification; the name and
address of the bulk manufacturer to whom the certification is directed;
a reference to the number of the DEA Form 222 to which the certification
applies; the name of the person giving the order to which the
certification applies; the name of the basic class specified in the DEA
Form 222 to which the certification applies; the appropriate schedule
within which is listed the basic class specified in the DEA Form 222 to
which the certification applies; a statement that the quantity
(expressed in grams) of the basic class specified in the DEA Form 222 to
which the certification applies does not exceed the unused and available
procurement quota of such basic class, issued to the person giving the
order, for the current calendar year; and the signature of the
individual who signed the DEA Form 222 to which the certification
applies.
[36 FR 7786, Apr. 24, 1971, 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
[[Page 47]]
a public hearing on one or more issues raised by the comments and
objections filed with him. In the event the Administrator decides to
hold such a hearing, he shall publish notice of the hearing in the
Federal Register, which notice shall summarize the issues to be heard
and shall set the time for the hearing, which shall not be less than 10
days after the date of publication of the notice. After consideration of
any comments or objections, or after a hearing if one is ordered by the
Administrator, the Administrator shall issue and publish in the Federal
Register his final order determining the aggregate production for the
basic class of controlled substance. The order shall include the
findings of fact and conclusions of law upon which the order is based.
The order shall specify the date on which it shall take effect. A copy
of said order shall be mailed simultaneously to each person registered
as a bulk manufacturer of the basic class.
[37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]
Individual Manufacturing Quotas
Sec. 1303.21 Individual manufacturing quotas.
(a) The Administrator shall, on or before July 1 of each year, fix
for and issue to each person who is registered to manufacture a basic
class of controlled substance listed in Schedule I or II, and who
applies for a manufacturing quota, an individual manufacturing quota
authorizing that person to manufacture during the next calendar year a
quantity of that basic class. Any manufacturing quota fixed and issued
by the Administrator shall be subject to his authority to reduce or
limit it at a later date pursuant to Sec. 1303.26 and to his authority
to revoke or suspend it at any time pursuant to Secs. 1301.36 of this
chapter.
(b) No individual manufacturing quota shall be required for
registrants listed in Sec. 1303.12(e).
[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
as amended at 62 FR 13958, Mar. 24, 1997]
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
[[Page 48]]
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 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
[[Page 49]]
quota is, or is likely to be, suspended pursuant to this paragraph to
continue manufacturing and to accumulate an inventory in excess of 65
percent of his estimated net disposal, upon such conditions and within
such limitations as the Administrator may find necessary or desirable.
(c) If, during a calendar year, a registrant has manufactured the
entire quantity of a basic class allocated to him under an individual
manufacturing quota, and his inventory of that class is less than 40
percent of his estimated net disposal of that class for that year, the
Administrator may, upon application pursuant to Sec. 1303.25, increase
the quota of such registrant sufficiently to allow restoration of the
inventory to 50 percent of the estimated net disposal for that year.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.25 Increase in individual manufacturing quotas.
(a) Any registrant who holds an individual manufacturing quota for a
basic class of controlled substance listed in Schedule I or II may file
with the Administrator an application on Administration Form 189 for an
increase in such quota in order for him to meet his estimated net
disposal, inventory and other requirements during the remainder of such
calendar year.
(b) The Administrator, in passing upon a registrant's application
for an increase in his individual manufacturing quota, shall take into
consideration any occurrences since the filing of such registrant's
initial quota application that may require an increased manufacturing
rate by such registrant during the balance of the calendar year. In
passing upon such application the Administrator may also take into
consideration the amount, if any, by which his determination of the
total quantity for the basic class of controlled substance to be
manufactured under Sec. 1303.11 exceeds the aggregate of all the
individual manufacturing quotas for the basic class of controlled
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
[[Page 50]]
Code Number, as set forth in part 1308 of this chapter, of the substance
and the amount which he has chosen not to manufacture. The Administrator
may, in his discretion, allocate such amount among the other
manufacturers in proportion to their respective quotas.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841,
May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Mar. 24, 1997]
Hearings
Sec. 1303.31 Hearings generally.
(a) In any case where the Administrator shall hold a hearing
regarding the determination of an aggregate production quota pursuant to
Sec. 1303.11(c), or regarding the adjustment of an aggregate production
quota pursuant to Sec. 1303.13(c), the procedures for such hearing shall
be governed generally by the rule making procedures set forth in the
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
section 306 of the Act (21 U.S.C. 826), by Secs. 1303.32-1303.37, and by
the procedures for administrative hearings under the Act set forth in
Secs. 1316.41-1316.67 of this chapter.
(b) In any case where the Administrator shall hold a hearing
regarding the issuance, adjustment, suspension, or denial of a
procurement quota pursuant to Sec. 1303.12, or the issuance, adjustment,
suspension, or denial of an individual manufacturing quota pursuant to
Secs. 1303.21-1303.27, the procedures for such hearing shall be governed
generally by the adjudication procedures set forth in the Administrative
Procedures Act (5 U.S.C. 551-559) and specifically by section 306 of the
Act (21 U.S.C. 826), by Secs. 1303.32-1303.37, and by the procedures for
administrative hearings under the Act set forth in Secs. 1316.41-1316.67
of this chapter.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1303.32 Purpose of hearing.
(a) The Administrator may, in his sole discretion, hold a hearing
for the purpose of receiving factual evidence regarding any one or more
issues (to be 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
[[Page 51]]
in Sec. 1303.11(c), file with the Administrator a written request for a
hearing in the form prescribed in Sec. 1316.47 of this chapter,
including in the request a statement of the grounds for a hearing.
(b) Any interested person who desires to participate in a hearing on
the determination or adjustment of an aggregate production quota, which
hearing is ordered by the Administrator pursuant to Sec. 1303.11(c) or
Sec. 1303.13(c) may do so by filing with the Administrator, within 30
days of the date of publication of notice of the hearing in the Federal
Register, a written notice of his intention to participate in such
hearing in the form prescribed in Sec. 1316.48 of this chapter.
(c) Any person entitled to a hearing or to participate in a hearing
pursuant to paragraph (b) of this section, may, within the period
permitted for filing a request for a hearing of notice of appearance,
file with the Administrator a waiver of an opportunity for a hearing or
to participate in a hearing, together with a written statement regarding
his position on the matters of fact and law involved in such hearing.
Such statement, if admissible, shall be made a part of the record and
shall be considered in light of the lack of opportunity for cross-
examination in determining the weight to be attached to matters of fact
asserted therein.
(d) If any person entitled to a hearing or to participate in a
hearing pursuant to paragraph (b) of this section, fails to file a
request for a hearing or notice of appearance, or if he so files and
fails to appear at the hearing, he shall be deemed to have waived his
opportunity for the hearing or to participate in the hearing, unless he
shows good cause for such failure.
(e) If all persons entitled to a hearing or to participate in a
hearing waive or are deemed to waive their opportunity for the hearing
or to participate in the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his final order pursuant to
Sec. 1303.37 without a hearing.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971;
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]
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
[[Page 52]]
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.
Inventory Requirements
1304.11 Inventory requirements.
Continuing Records
1304.21 General requirements for continuing records.
1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers, and exporters.
1304.23 Records for chemical analysts.
1304.24 Records for maintenance treatment programs and detoxification
treatment programs.
1304.25 Records for treatment programs which compound narcotics for
treatment programs and other locations.
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 Secs. 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
[[Page 53]]
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.
(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]
[[Page 54]]
Sec. 1304.04 Maintenance of records and inventories.
(a) Every inventory and other records required to be kept under this
part shall be kept by the registrant and be available, for at least 2
years from the date of such inventory or records, for inspection and
copying by authorized employees of the Administration, except that
financial and shipping records (such as invoices and packing slips but
not executed order forms subject to Sec. 1305.13 of this chapter) may be
kept at a central location, rather than at the registered location, if
the registrant has notified the Administration of his intention to keep
central records. Written notification must be submitted by registered or
certified mail, return receipt requested, in triplicate, to the Special
Agent in Charge of the Administration in the area in which the
registrant is located. Unless the registrant is informed by the Special
Agent in Charge that permission to keep central records is denied, the
registrant may maintain central records commencing 14 days after receipt
of his notification by the Special Agent in Charge.
All notifications must include:
(1) The nature of the records to be kept centrally.
(2) The exact location where the records will be kept.
(3) The name, address, DEA registration number and type of DEA
registration of the registrant whose records are being maintained
centrally.
(4) Whether central records will be maintained in a manual, or
computer readable form.
(b) All registrants that are authorized to maintain a central
recordkeeping system shall be subject to the following conditions:
(1) The records to be maintained at the central record location
shall not include executed order forms, prescriptions and/or inventories
which shall be maintained at each registered location.
(2) If the records are kept on microfilm, computer media or in any
form requiring special equipment to render the records easily readable,
the registrant shall provide access to such equipment with the records.
If any code system is used (other than pricing information), a key to
the code shall be provided to make the records understandable.
(3) The registrant agrees to deliver all or any part of such records
to the registered location within two business days upon receipt of a
written request from the Administration for such records, and if the
Administration chooses to do so in lieu of requiring delivery of such
records to the registered location, to allow authorized employees of the
Administration to inspect such records at the central location upon
request by such employees without a warrant of any kind.
(4) In the event that a registrant fails to comply with these
conditions, the Special Agent in Charge may cancel such central
recordkeeping authorization, and all other central recordkeeping
authorizations held by the registrant without a hearing or other
procedures. In the event of a cancellation of central recordkeeping
authorizations under this paragraph the registrant shall, within the
time specified by the Special Agent in Charge, comply with the
requirements of this section that all records be kept at the registered
location.
(c) Registrants need not notify the Special Agent in Charge or
obtain central recordkeeping approval in order to maintain records on an
in-house computer system.
(d) ARCOS participants who desire authorization to report from other
than their registered locations must obtain a separate central reporting
identifier. Request for central reporting identifiers will be submitted
to: ARCOS Unit, P.O. Box 28293, Central Station, Washington, DC 20005.
(e) All central recordkeeping permits previously issued by the
Administration expired September 30, 1980.
(f) Each registered manufacturer, distributor, importer, exporter,
narcotic treatment program and compounder for narcotic treatment program
shall maintain inventories and records of controlled substances as
follows:
(1) Inventories and records of controlled substances listed in
Schedules I and II shall be maintained separately from all of the
records of the registrant; and
(2) Inventories and records of controlled substances listed in
Schedules
[[Page 55]]
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 III, IV, and V shall be maintained either separately from all
other records of the pharmacy or in such form that the information
required is readily retrievable from ordinary business records of the
pharmacy, and prescriptions for such substances shall be maintained
either in a separate prescription file for controlled substances listed
in Schedules III, IV, and V only or in such form that they are readily
retrievable from the other prescription records of the pharmacy.
Prescriptions will be deemed readily retrievable if, at the time they
are initially filed, the face of the prescription is stamped in red ink
in the lower right corner with the letter ``C'' no less than 1 inch high
and filed either in the prescription file for controlled substances
listed in Schedules I and II or in the usual consecutively numbered
prescription file for non-controlled substances. However, if a pharmacy
employs an ADP system or other electronic recordkeeping system for
prescriptions which permits identification by prescription number and
retrieval of original documents by prescriber's name, patient's name,
drug dispensed, and date filled, then the requirement to mark the hard
copy prescription with a red ``C'' is waived.
(Authority: 21 U.S.C. 821 and 871(b); 28 CFR 0.100)
[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 39 FR 37985,
Oct. 25, 1974; 45 FR 44266, July 1, 1980; 47 FR 41735, Sept. 22, 1982;
51 FR 5320, Feb. 13, 1986; 62 FR 13959, Mar. 24, 1997]
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
[[Page 56]]
substances, in accordance with paragraph (e) of this section as
applicable. In the event a person commences business with no controlled
substances on hand, he/she shall record this fact as the initial
inventory.
(c) Biennial inventory date. After the initial inventory is taken,
the registrant shall take a new inventory of all stocks of controlled
substances on hand at least every two years. The biennial inventory may
be taken on any date which is within two years of the previous biennial
inventory date.
(d) Inventory date for newly controlled substances. On the effective
date of a rule by the Administrator pursuant to Secs. 1308.45, 1308.46,
or 1308.47 of this chapter adding a substance to any schedule of
controlled substances, which substance was, immediately prior to that
date, not listed on any such schedule, every registrant required to keep
records who possesses that substance shall take an inventory of all
stocks of the substance on hand. Thereafter, such substance shall be
included in each inventory made by the registrant 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 Secs. 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.
[[Page 57]]
(2) Inventories of distributors. Each person registered or
authorized to distribute controlled substances shall include in the
inventory the same information required of manufacturers pursuant to
paragraphs (e)(1) (iii) and (iv) of this section.
(3) Inventories of dispensers and researchers. Each person
registered or authorized to dispense or conduct research with controlled
substances shall include in the inventory the same information required
of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this
section. In determining the number of units of each finished form of a
controlled substance in a commercial container which has been opened,
the dispenser 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]
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 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]
[[Page 58]]
Sec. 1304.22 Records for manufacturers, distributors, dispensers, researchers, importers and exporters.
Each person registered or authorized (by Sec. 1301.13(e) or
Secs. 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
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
[[Page 59]]
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. 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.
(d) Records for importers and exporters. Each person registered or
authorized to import or export controlled substances shall maintain
records with the same information required of manufacturers pursuant to
paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In addition,
the quantity disposed of in any other manner by the registrant (except
quantities used in manufacturing by an importer under a registration as
a manufacturer), which quantities are to be recorded pursuant to
paragraphs (a)(1) (iv) and (v) of this section; and the quantity (or
number of units or volume in finished form) exported, including the
date, quantity (or number of units or volume), and the export permit or
declaration number for each exportation, but excluding all quantities
(and number of units and volumes) manufactured by an exporter under a
registration as a manufacturer, which quantities (and numbers of units
and volumes) are to be recorded pursuant to paragraphs (a)(1)(xiii) or
(a)(2)(xiii) of this section.
[62 FR 13960, Mar. 24, 1997]
Sec. 1304.23 Records for chemical analysts.
(a) Each person registered or authorized (by Sec. 1301.22(b) of this
chapter) to
[[Page 60]]
conduct chemical analysis with controlled substances shall maintain
records with the following information (to the extent known and
reasonably ascertainable by him) for each controlled substance:
(1) The name of the substance;
(2) The form or forms in which the substance is received, imported,
or manufactured by the registrant (e.g., powder, granulation, tablet,
capsule, or solution) and the concentration of the substance in such
form (e.g., C.P., U.S.P., N.F., 10-milligram tablet or 10-milligram
concentration per milliliter);
(3) The total number of the forms received, imported or manufactured
(e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder),
including the date and quantity of each receipt, importation, or
manufacture and the name, address, and registration number, if any, of
the person from whom the substance was received;
(4) The quantity distributed, exported, or destroyed in any manner
by the registrant (except quantities used in chemical analysis or other
laboratory work), including the date and manner of distribution,
exportation, or destruction, and the name, address, and registration
number, if any, of each person to whom the substance was distributed or
exported.
(b) Records of controlled substances used in chemical analysis or
other laboratory work are not required.
(c) Records relating to known or suspected controlled substances
received as evidentiary material for analysis are not required under
paragraph (a) of this section.
[36 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36
FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated at 62 FR 13961, Mar. 24, 1997]
Sec. 1304.24 Records for maintenance treatment programs and detoxification treatment programs.
(a) Each person registered or authorized (by Sec. 1301.22 of this
chapter) to maintain and/or detoxify controlled 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
[[Page 61]]
other person from whom the substance was received;
(4) The quantity imported directly by the registrant (under a
registration as an importer) for use in compounding by him, including
the date, quantity and import permit or declaration number of each
importation;
(5) The quantity used to compound the same substance in finished
form, including:
(i) The date and batch or other identifying number of each
compounding;
(ii) The quantity used in the compound;
(iii) The finished form (e.g., 10-milligram tablets or 10-milligram
concentration per fluid ounce or milliliter;
(iv) The number of units of finished form compounded;
(v) The quantity used in quality control;
(vi) The quantity lost during compounding and the causes therefore,
if known;
(vii) The total quantity of the substance contained in the finished
form;
(viii) The theoretical and actual yields; and
(ix) Such other information as is necessary to account for all
controlled substances used in the compounding process;
(6) The quantity used to manufacture other controlled and non-
controlled substances; including the name of each substance manufactured
and the information required in paragraph (a)(5) of this section;
(7) The quantity distributed in bulk form to other programs,
including the date and quantity of each distribution and the name,
address and registration number of each program to whom a distribution
was made;
(8) The quantity exported directly by the registrant (under a
registration as an exporter), including the date, quantity, and export
permit or declaration number of each exploration; and
(9) The quantity disposed of by destruction, including the reason,
date and manner of destruction. 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
[[Page 62]]
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]
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 63]]
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 64]]
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
or narcotic 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 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, 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 and 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). 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]
PART 1305--ORDER FORMS--Table of Contents
Sec.
1305.01 Scope of part 1305.
1305.02 Definitions.
1305.03 Distributions requiring order forms.
1305.04 Persons entitled to obtain and execute order forms.
1305.05 Procedure for obtaining order forms.
1305.06 Procedure for executing order forms.
1305.07 Power of attorney.
1305.08 Persons entitled to fill order forms.
1305.09 Procedure for filling order forms.
1305.10 Procedure for endorsing order forms.
[[Page 65]]
1305.11 Unaccepted and defective order forms.
1305.12 Lost and stolen order forms.
1305.13 Preservation of order forms.
1305.14 Return of unused order forms.
1305.15 Cancellation and voiding of order forms.
1305.16 Special procedure for filling certain order forms.
Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
Source: 36 FR 7796, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
Sec. 1305.01 Scope of part 1305.
Procedures governing the issuance, use, and preservation of order
forms pursuant to section 1308 of the Act (21 U.S.C. 828) are set forth
generally by that section and specifically by the sections of this part.
Sec. 1305.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13963, Mar. 24, 1997]
Sec. 1305.03 Distributions requiring order forms.
An order form (DEA Form 222) is required for each distribution of a
Schedule I or II controlled substance except to persons exempted from
registration under part 1301 of this chapter; which are exported from
the United States in conformity with the Act; or for delivery to a
registered analytical laboratory, or its agent approved by DEA.
[62 FR 13963, Mar. 24, 1997]
Sec. 1305.04 Persons entitled to obtain and execute order forms.
(a) Order forms may be obtained only by persons who are registered
under section 303 of the Act (21 U.S.C. 823) to handle controlled
substances listed in Schedules I and II, and by persons who are
registered under section 1008 of the Act (21 U.S.C. 958) to export such
substances. Persons not registered to handle controlled substances
listed in Schedule I or II and persons registered only to import
controlled substances listed in any schedule are not entitled to obtain
order forms.
(b) An order form may be executed only on behalf of the registrant
named thereon and only if his/her registration as to the substances
being purchased has not expired or been revoked or suspended.
[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
as amended at 62 FR 13964, Mar. 24, 1997]
Sec. 1305.05 Procedure for obtaining order forms.
(a) Order Forms are issued in mailing envelopes containing either
seven or fourteen forms, each form containing an original duplicate and
triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit,
which is based on the business activity of the registrant, will be
imposed on the number of order forms which will be furnished on any
requisition unless additional forms are specifically requested and a
reasonable need for such additional forms is shown.
(b) Any person applying for a registration which would entitle him/
her to obtain order forms may requisition such forms by so indicating on
the application form; order forms will be supplied upon the registration
of the applicant. Any person holding a registration entitling him/her to
obtain order forms may requisition such forms for the first time by
contacting any Division Office or the Registration Unit of the
Administration. Any person already holding order forms may requisition
additional forms on DEA Form 222a which is mailed to a registrant
approximately 30 days after each shipment of order forms to that
registrant or by contacting any Division Office or the Registration Unit
of the Administration. All requisition forms (DEA Form 222a) shall be
submitted to the Registration Unit, Drug Enforcement Administration,
Department of Justice, Post Office Box 28083, Central Station,
Washington, DC 20005.
(c) Each requisition shall show the name, address, and registration
number of the registrant and the number of books of order forms desired.
Each requisition shall be signed and dated by the same person who signed
the most recent application for registration or for reregistration, or
by any person authorized to obtain and execute order
[[Page 66]]
forms by a power of attorney pursuant to Sec. 1305.07.
(d) Order forms will be serially numbered and issued with the name,
address and registration number of the registrant, the authorized
activity and schedules of the registrant. This information cannot be
altered or changed by the registrant; any errors must be corrected by
the Registration Unit of the Administration by returning the forms with
notification of the error.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5319,
Feb. 13, 1986; 53 FR 4963, Feb. 19, 1988; 62 FR 13964, Mar. 24, 1997]
Sec. 1305.06 Procedure for executing order forms.
(a) Order forms shall be prepared and executed by the purchaser
simultaneously in triplicate by means of interleaved carbon sheets which
are part of the DEA Form 222. Order forms shall be prepared by use of a
typewriter, pen, or indelible pencil.
(b) Only one item shall be entered on each numbered line. An item
shall consist of one or more commercial or bulk containers of the same
finished or bulk form and quantity of the same substance. The number of
lines completed shall be noted on that form at the bottom of the form,
in the space provided. Order forms for carfentanil, etorphine
hydrochloride, and diprenorphine shall contain only these substances.
(c) The name and address of the supplier from whom the controlled
substances are being ordered shall be entered on the form. Only one
supplier may be listed on any form.
(d) Each order form shall be signed and dated by a person authorized
to sign an application for registration. The name of the purchaser, if
different from the individual signing the order form, shall also be
inserted in the signature space. Unexecuted order forms may be kept and
may be executed at a location other than the registered location printed
on the form, provided that all unexecuted forms are delivered promptly
to the registered location upon an inspection of such location by any
officer authorized to make inspections, or to enforce, any Federal,
State, or local law regarding controlled substances.
[62 FR 13963, Mar. 24, 1997]
Sec. 1305.07 Power of attorney.
Any purchaser may authorize one or more individuals, whether or not
located at the registered location of the purchaser, to obtain and
execute order forms on his/her behalf by executing a power of attorney
for each such individual. The power of attorney shall be signed by the
same person who signed the most recent application for registration or
reregistration and by the individual being authorized to obtain and
execute order forms. The power of attorney shall be filed with the
executed order forms of the purchaser, and shall be retained for the
same period as any order form bearing the signature of the attorney. The
power of attorney shall be available for inspection together with other
order form records. Any power of attorney may be revoked at any time by
executing a notice of revocation, signed by the person who signed (or
was authorized to sign) the power of attorney or by a successor, whoever
signed the most recent application for registration or reregistration,
and filing it with the power of attorney being revoked. The form for the
power of attorney and notice of revocation shall be similar to the
following:
Power of Attorney for DEA Order Forms
---------- (Name of registrant)
---------- (Address of registrant)
---------- (DEA registration number)
I, ---------- (name of person granting power), the undersigned, who
is authorized to sign the current application for registration of the
above-named registrant under the Controlled Substances Act or Controlled
Substances Import and Export Act, have made, constituted, and appointed,
and by these presents, do make, constitute, and appoint ---------- (name
of attorney-in-fact), my true and lawful attorney for me in my name,
place, and stead, to execute applications for books of official order
forms and to sign such order forms in requisition for Schedule I and II
controlled substances, in accordance with section 308 of the Controlled
Substances Act (21 U.S.C. 828) and part 1305 of Title 21 of the Code of
Federal Regulations. I hereby ratify and confirm all that said attorney
shall lawfully do or cause to be done by virtue hereof.
________________________________________________________________________
[[Page 67]]
(Signature of person granting power)
I, ---------- (name of attorney-in-fact), hereby affirm that I am
the person named herein as attorney-in-fact and that the signature
affixed hereto is my signature.
________________________________________________________________________
(Signature of attorney-in-fact)
Witnesses:
1. ----------.
2. ----------.
Signed and dated on the ------ day of ----------, (year), at ------
----.
Notice of Revocation
The foregoing power of attorney is hereby revoked by the
undersigned, who is authorized to sign the current application for
registration of the above-named registrant under the Controlled
Substances Act of the Controlled Substances Import and Export Act.
Written notice of this revocation has been given to the attorney-in-fact
---------- this same day.
________________________________________________________________________
(Signature of person revoking power)
Witnesses:
1. ----------.
2. ----------.
Signed and dated on the ------ day of ----------, (year), at ------
----.
[62 FR 13963, Mar. 24, 1997]
Sec. 1305.08 Persons entitled to fill order forms.
An order form may be filled only by a person registered as a
manufacturer or distributor of controlled substances listed in Schedule
I or II under section 303 of the Act (21 U.S.C. 823) or as an importer
of such substances under section 1008 of the Act (21 U.S.C. 958), except
for the following:
(a) A person registered to dispense such substances under section
303 of the Act, or to export such substances under section 1008 of the
Act, if he/she is discontinuing business or if his/her registration is
expiring without reregistration, may dispose of any controlled
substances listed in Schedule I or II in his/her possession pursuant to
order forms in accordance with Sec. 1307.14 of this chapter;
(b) A person who has obtained any controlled substance in Schedule I
or II by order form may return such substance, or portion thereof, to
the person from whom he obtained the substance or the manufacturer of
the substance pursuant to the order form of the latter person;
(c) A person registered to dispense such substances may distribute
such substances to another dispenser pursuant to, and only in the
circumstances described in, Sec. 1307.11 of this chapter; and
(d) A person registered or authorized to conduct chemical analysis
or research with controlled substances may distribute a controlled
substance listed in Schedule I or II to another person registered or
authorized to conduct chemical analysis, instructional activities, or
research with such substances pursuant to the order form of the latter
person, if such distribution is for the purpose of furthering such
chemical analysis, instructional activities, or research.
(e) A person registered as a compounder of narcotic substances for
use at off-site locations in conjunction with a narcotic treatment
program at the compounding location, who is authorized to handle
Schedule II narcotics, is authorized to fill order forms for
distribution of narcotic drugs to off-site narcotic treatment programs
only.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36
FR 18732, Sept. 21, 1971; 37 FR 15921, Aug. 8, 1972. Redesignated at 38
FR 26609, Sept. 24, 1973]
Editorial Note: For Federal Register citations affecting
Sec. 1305.08, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
Sec. 1305.09 Procedure for filling order forms.
(a) The purchaser shall submit Copy 1 and Copy 2 of the order form
to the supplier, and retain Copy 3 in his own files.
(b) The supplier shall fill the order, if possible and if he/she
desires to do so, and record on Copies 1 and 2 the number of commercial
or bulk containers furnished on each item and the date on which such
containers are shipped to the purchaser. If an order cannot be filled in
its entirety, it may be filled in part and the balance supplied by
additional shipments within 60 days following the date of the order
form. No order form shall be valid more than 60
[[Page 68]]
days after its execution by the purchaser, except as specified in
paragraph (f) of this section.
(c) The controlled substances shall only be shipped to the purchaser
and at the location printed by the Administration on the order form,
except as specified in paragraph (f) of this section.
(d) The supplier shall retain Copy 1 of the order form for his/her
own files and forward Copy 2 to the Special Agent in Charge of the Drug
Enforcement Administration in the area in which the supplier is located.
Copy 2 shall be forwarded at the close of the month during which the
order is filled; if an order is filled by partial shipments, Copy 2
shall be forwarded at the close of the month during which the final
shipment is made or during which the 60-day validity period expires.
(e) The purchaser shall record on Copy 3 of the order form the
number of commercial or bulk containers furnished on each item and the
dates on which such containers are received by the purchaser.
(f) Order forms submitted by registered procurement officers of the
Defense Personnel Support Center of Defense Supply Agency for delivery
to armed services establishments within the United States may be shipped
to locations other than the location printed on the order form, and in
partial shipments at different times not to exceed six months from the
date of the order, as designated by the procurement officer when
submitting the order.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735,
Sept. 22, 1982; 62 FR 13964, Mar. 24, 1997]
Sec. 1305.10 Procedure for endorsing order forms.
(a) An order form made out to any supplier who cannot fill all or a
part of the order within the time limitation set forth in Sec. 1305.09
may be endorsed to another supplier for filling. The endorsement shall
be made only by the supplier to whom the order form was first made,
shall state (in the spaces provided on the reverse sides of Copies 1 and
2 of the order form) the name and address of the second supplier, and
shall be signed by a person authorized to obtain and execute order forms
on behalf of the first supplier. The first supplier may not fill any
part of an order on an endorsed form. The second supplier shall fill the
order, if possible and if he/she desires to do so, in accordance with
Sec. 1305.09 (b), (c), and (d), including shipping all substances
directly to the purchaser.
(b) Distributions made on endorsed order forms shall be reported by
the second supplier in the same manner as all other distributions except
that where the name of the supplier is requested on the reporting form,
the second supplier shall record the name, address and registration
number of the first supplier.
[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
as amended at 62 FR 13964, Mar. 24, 1997]
Sec. 1305.11 Unaccepted and defective order forms.
(a) No order form shall be filled if it:
(1) Is not complete, legible, or properly prepared, executed, or
endorsed; or
(2) Shows any alteration, erasure, or change of any description.
(b) If an order form cannot be filled for any reason under this
section, the supplier shall return Copies 1 and 2 to the purchaser with
a statement as to the reason (e.g., illegible or altered). A supplier
may for any reason refuse to accept any order and if a supplier refuses
to accept the order, a statement that the order is not accepted shall be
sufficient for purposes of this paragraph.
(c) When received by the purchaser, Copies 1 and 2 of the order form
and the statement shall be attached to Copy 3 and retained in the files
of the purchaser in accordance with Sec. 1305.13. A defective order form
may not be corrected; it must be replaced by a new order form in order
for the order to be filled.
Sec. 1305.12 Lost and stolen order forms.
(a) If a purchaser ascertains that an unfilled order form has been
lost, he shall execute another in triplicate and a statement containing
the serial number and date of the lost form, and stating that the goods
covered by the first order form were not received through
[[Page 69]]
loss of that order form. Copy 3 of the second form and a copy of the
statement shall be retained with Copy 3 of the order form first
executed. A copy of the statement shall be attached to Copies 1 and 2 of
the second order form sent to the supplier. If the first order form is
subsequently received by the supplier to whom it was directed, the
supplier shall mark upon the face thereof ``Not accepted'' and return
Copies 1 and 2 to the purchaser, who shall attach it to Copy 3 and the
statement.
(b) Whenever any used or unused order forms are stolen or lost
(otherwise than in the course of transmission) by any purchaser or
supplier, he/she shall immediately upon discovery of such theft or loss,
report the same to the Special Agent in Charge of the Drug Enforcement
Administration in the Divisional Office responsible for the area in
which the registrant is located, stating the serial number of each form
stolen or lost. If the theft or loss includes any original order forms
received from purchasers and the supplier is unable to state the serial
numbers of such order forms, he/she shall report the date or approximate
date of receipt thereof and the names and addresses of the purchasers.
If an entire book of order forms is lost or stolen, and the purchaser is
unable to state the serial numbers of the order forms contained therein,
he/she shall report, in lieu of the numbers of the forms contained in
such book, the date or approximate date of issuance thereof. If any
unused order form reported stolen or lost is subsequently recovered or
found, the Special Agent in Charge of the Drug Enforcement
Administration in the Divisional Office responsible for the area in
which the registrant is located shall immediately be notified.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5319,
Feb. 13, 1986; 62 FR 13964, Mar. 24, 1997]
Sec. 1305.13 Preservation of order forms.
(a) The purchaser shall retain Copy 3 of each order form which has
been filled. He/She shall also retain in his files all copies of each
unaccepted or defective order form and each statement attached thereto.
(b) The supplier shall retain Copy 1 of each order form which he/she
has filled.
(c) Order forms must be maintained separately from all other records
of the registrant. Order forms are required to be kept available for
inspection for a period of 2 years. If a purchaser has several
registered locations, he/she must retain Copy 3 of the executed order
forms and any attached statements or other related documents (not
including unexecuted order forms which may be kept elsewhere pursuant to
Sec. 1305.06(d)) at the registered location printed on the order form.
(d) The supplier of carfentanil etorphine hydrochloride and
diprenorphine shall maintain order forms for these substances separately
from all other order forms and records required to be maintained by the
registrant.
[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 39 FR 17839, May 21, 1974; 54 FR 33674, Aug. 16, 1989; 62
FR 13964, Mar. 24, 1997]
Sec. 1305.14 Return of unused order forms.
If the registration of any purchaser terminates (because the
purchaser dies, ceases legal existence, discontinues business or
professional practice, or changes his name or address as shown on his
registration) or is suspended or revoked pursuant to Sec. 1301.36 of
this chapter as to all controlled substances listed in Schedules I and
II for which he/she is registered, he/she shall return all unused order
forms for such substance to the nearest office of the Administration.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13964,
Mar. 24, 1997]
Sec. 1305.15 Cancellation and voiding of order forms.
(a) A purchaser may cancel part or all of an order on an order form
by notifying the supplier in writing of such cancellation. The supplier
shall indicate the cancellation on Copies 1 and 2 of the order form by
drawing a line through the canceled items and printing ``canceled'' in
the space provided for number of items shipped.
[[Page 70]]
(b) A supplier may void part or all of an order on an order form by
notifying the purchaser in writing of such voiding. The supplier shall
indicate the voiding in the manner prescribed for cancellation in
paragraph (a) of this section.
(c) No cancellation or voiding permitted by this section shall
affect in any way contract rights of either the purchaser or the
supplier.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973]
Sec. 1305.16 Special procedure for filling certain order forms.
(a) The purchaser of carfentanil etorphine hydrochloride or
diprenorphine shall submit copy 1 and 2 of the order form to the
supplier and retain copy 3 in his own files.
(b) The supplier, if he/she determines that the purchaser is a
veterinarian engaged in zoo and exotic animal practice, wildlife
management programs and/or research and authorized by the Administrator
to handle these substances shall fill the order in accordance with the
procedures set forth in Sec. 1305.09 except that:
(1) Order forms for carfentanil etorphine hydrochloride and
diprenorphine shall only contain these substances in reasonable
quantities and
(2) The substances shall only be shipped to the purchaser at the
location printed by the Administration upon the order form under secure
conditions using substantial packaging material with no markings on the
outside which would indicate the content.
[39 FR 17839, May 21, 1974, as amended at 54 FR 33674, Aug. 16, 1989; 62
FR 13964, Mar. 24, 1997]
PART 1306--PRESCRIPTIONS--Table of Contents
General Information
Sec.
1306.01 Scope of part 1306.
1306.02 Definitions.
1306.03 Persons entitled to issue prescriptions.
1306.04 Purpose of issue of prescription.
1306.05 Manner of issuance of prescriptions.
1306.06 Persons entitled to fill prescriptions.
1306.07 Administering or dispensing of narcotic drugs.
Controlled Substances Listed in Schedule II
1306.11 Requirement of prescription.
1306.12 Refilling prescriptions.
1306.13 Partial filling of prescriptions.
1306.14 Labeling of substances and filling of prescriptions.
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.
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
Secs. 1301.22(c) and 1301.23 of this chapter.
[[Page 71]]
(b) A prescription issued by an individual practitioner may be
communicated to a pharmacist by an employee or agent of the individual
practitioner.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966,
Mar. 24, 1997]
Sec. 1306.04 Purpose of issue of prescription.
(a) A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice. The
responsibility for the proper prescribing and dispensing of controlled
substances is upon the prescribing practitioner, but a corresponding
responsibility rests with the pharmacist who fills the prescription. An
order purporting to be a prescription issued not in the usual course of
professional treatment or in legitimate and authorized research is not a
prescription within the meaning and intent of section 309 of the Act (21
U.S.C. 829) and the person knowingly filling such a purported
prescription, as well as the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to
controlled substances.
(b) A prescription may not be issued in order for an individual
practitioner to obtain controlled substances for supplying the
individual practitioner for the purpose of general dispensing to
patients.
(c) A prescription may not be issued for the dispensing of narcotic
drugs listed in any schedule for ``detoxification treatment'' or
``maintenance treatment'' as defined in Section 102 of the Act (21
U.S.C. 802).
[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 39 FR 37986, Oct. 25, 1974]
Sec. 1306.05 Manner of issuance of prescriptions.
(a) All prescriptions for controlled substances shall be dated as
of, and signed on, the day when issued and shall bear the full name and
address of the patient, the drug name, strength, dosage form, quantity
prescribed, directions for use and the name, address and registration
number of the practitioner. 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 who fills a prescription not prepared in the form
prescribed by these regulations.
(b) An individual practitioner exempted from registration under
Sec. 1301.22(c) of this chapter shall include on all prescriptions
issued by him or her the registration number of the hospital or other
institution and the special internal code number assigned to him or her
by the hospital or other institution as provided in Sec. 1301.22(c) of
this chapter, in lieu of the registration number of the practitioner
required by this section. Each written prescription shall have the name
of the physician stamped, typed, or handprinted on it, as well as the
signature of the physician.
(c) An official exempted from registration under Sec. 1301.22(c)
shall include on all prescriptions issued by him his branch of service
or agency (e.g., ``U.S. Army'' or ``Public Health Service'') and his
service identification number, in lieu of the registration number of the
practitioner required by this section. The service identification number
for a Public Health Service employee is his Social Security
identification number. Each prescription shall have the name of the
officer stamped, typed, or handprinted on it, as well as the signature
of the officer.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 56 FR 25026,
June 3, 1991; 60 FR 36641, July 18, 1995; 62 FR 13966, Mar. 24, 1997]
[[Page 72]]
Sec. 1306.06 Persons entitled to fill prescriptions.
A prescription for controlled substances 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 or
registered institutional practitioner.
Sec. 1306.07 Administering or dispensing of narcotic drugs.
(a) The administering or dispensing directly (but not prescribing)
of narcotic drugs listed in any schedule to a narcotic drug dependent
person for ``detoxification treatment'' or ``maintenance treatment'' as
defined in section 102 of the Act (21 U.S.C. 802) shall be deemed to be
within the meaning of the term ``in the course of his professional
practice or research'' in section 308(e) and section 102(20) of the Act
(21 U.S.C. 828 (e)): Provided, That the practitioner is separately
registered with the Attorney General as required by section 303(g) of
the Act (21 U.S.C. 823(g)) and then thereafter complies with the
regulatory standards imposed relative to treatment qualification,
security, records and unsupervised use of drugs pursuant to such Act.
(b) Nothing in this section shall prohibit a physician who is not
specifically registered to conduct a narcotic treatment program from
administering (but not prescribing) narcotic drugs to a person for the
purpose of relieving acute withdrawal symptoms when necessary while
arrangements are being made for referral for treatment. Not more than
one day's medication may be administered to the person or for the
person's use at one time. Such emergency treatment may be carried out
for not more than three days and may not be renewed or extended.
(c) This section is not intended to impose any limitations on a
physician or authorized hospital staff to administer or dispense
narcotic drugs in a hospital to maintain or detoxify a person as an
incidental adjunct to medical or surgical treatment of conditions other
than addiction, or to administer or dispense narcotic drugs to persons
with intractable pain in which no relief or cure is possible or none has
been found after reasonable efforts.
[39 FR 37986, Oct. 25, 1974]
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);
[[Page 73]]
(2) The prescription shall be immediately reduced to writing by the
pharmacist and shall contain all information required in Sec. 1306.05,
except for the signature of the prescribing individual practitioner;
(3) If the prescribing individual practitioner is not known to the
pharmacist, he must make a reasonable effort to determine that the oral
authorization came from a registered individual practitioner, which may
include a callback to the prescribing individual practitioner using his
phone number as listed in the telephone directory and/or other good
faith efforts to insure his identity; and
(4) Within 7 days after authorizing an emergency oral prescription,
the prescribing individual practitioner shall cause a written
prescription for the emergency quantity prescribed to be delivered to
the dispensing pharmacist. In addition to conforming to the requirements
of Sec. 1306.05, the prescription shall have written on its face
``Authorization for Emergency Dispensing,'' and the date of the oral
order. The written prescription may be delivered to the pharmacist in
person or by mail, but if delivered by mail it must be postmarked within
the 7 day period. Upon receipt, the dispensing pharmacist shall attach
this prescription to the oral emergency prescription which had earlier
been reduced to writing. The pharmacist shall notify the nearest office
of the Administration if the prescribing individual practitioner fails
to deliver a written prescription to him; failure of the pharmacist to
do so shall void the authority conferred by this paragraph to dispense
without a written prescription of a prescribing individual practitioner.
(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]
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
[[Page 74]]
further quantity may be supplied beyond 72 hours without a new
prescription.
(b) A prescription for a Schedule II controlled substance written
for a patient in a Long Term Care Facility (LTCF) or for a patient with
a medical diagnosis documenting a terminal illness may be filled in
partial quantities to include individual dosage units. If there is any
question whether a patient may be classified as having a terminal
illness, the pharmacist must contact the practitioner prior to partially
filling the prescription. Both the pharmacist and the prescribing
practitioner have a corresponding responsibility to assure that the
controlled substance is for a terminally ill patient. The pharmacist
must record on the prescription whether the patient is ``terminally
ill'' or an ``LTCF patient.'' A prescription that is partially filled
and does not contain the notation ``terminally ill'' or ``LTCF patient''
shall be deemed to have been filled in violation of the Act. For each
partial filling, the dispensing pharmacist shall record on the back of
the prescription (or on another appropriate record, uniformly
maintained, and readily retrievable) the date of the partial filling,
quantity dispensed, remaining quantity authorized to be dispensed, and
the identification of the dispensing pharmacist. The total quantity of
Schedule II controlled substances dispensed in all partial fillings must
not exceed the total quantity prescribed. Schedule II prescriptions for
patients in a LTCF or patients with a medical diagnosis documenting a
terminal illness shall be valid for a period not to exceed 60 days from
the issue date unless sooner terminated by the discontinuance of
medication.
(c) Information pertaining to current Schedule II prescriptions for
patients in a LTCF or for patients with a medical diagnosis documenting
a terminal illness may be maintained in a computerized system if this
system has the capability to permit:
(1) Output (display or printout) of the original prescription
number, date of 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) 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
[[Page 75]]
forth the directions for use and cautionary statements, if any,
contained in the prescription or required by law.
(c) 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]
Controlled Substances Listed in Schedules III, IV, and V
Sec. 1306.21 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed
in Schedule III, IV, or V which is a prescription drug as determined
under the Federal Food, Drug, and Cosmetic Act, only pursuant to either
a written prescription signed by a practitioner or a facsimile of a
written, signed prescription transmitted by the practitioner or the
practitioner's agent to the pharmacy or pursuant to an oral prescription
made by an individual practitioner and promptly reduced to writing by
the pharmacist containing all information required in Sec. 1306.05,
except for the signature of the practitioner.
(b) An individual practitioner may administer or dispense directly a
controlled substance listed in Schedule III, IV, or V in the course of
his/her professional practice without a prescription, subject to
Sec. 1306.07.
(c) An institutional practitioner may administer or dispense
directly (but not prescribe) a controlled substance listed in Schedule
III, IV, or V only pursuant to a written prescription signed by an
individual practitioner, or pursuant to a facsimile of a written
prescription or order for medication transmitted by the practitioner or
the practitioner's agent to the institutional practitioner-pharmacist,
or pursuant to an oral prescription made by an individual practitioner
and promptly reduced to writing by the pharmacist (containing all
information required in Section 1306.05 except for the signature of the
individual practitioner), or pursuant to an order for medication made by
an individual practitioner which is dispensed for immediate
administration to the ultimate user, subject to Sec. 1306.07.
[62 FR 13965, Mar. 24, 1997]
Sec. 1306.22 Refilling of prescriptions.
(a) No prescription for a controlled substance listed in Schedule
III or IV shall be filled or refilled more than six months after the
date on which such prescription was issued and no such prescription
authorized to be refilled may be refilled more than five times. Each
refilling of a prescription shall be entered on the back of the
prescription or on another appropriate document. If entered on another
document, such as a medication record, the document must be uniformly
maintained and readily retrievable. The following information must be
retrievable by the prescription number consisting of the name and dosage
form of the controlled substance, the date filled or refilled, the
quantity dispensed, initials of the dispensing pharmacist for each
refill, and the total number of refills for that prescription. If the
pharmacist merely initials and dates the back of the prescription it
shall be deemed that the full face amount of the prescription has been
dispensed. The prescribing practitioner may authorize additional refills
of Schedule III or IV controlled substances on the original prescription
through an oral refill authorization transmitted to the pharmacist
provided the following conditions are met:
(1) The total quantity authorized, including the amount of the
original prescription, does not exceed five refills nor extend beyond
six months from the 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.
[[Page 76]]
(4) The prescribing practitioner must execute a new and separate
prescription for any additional quantities beyond the five refill, six-
month limitation.
(b) As an alternative to the procedures provided by subsection (a),
an automated data processing system may be used for the storage and
retrieval of refill information for prescription orders for controlled
substances in Schedule III and IV, subject to the following conditions:
(1) Any such proposed computerized system must provide on-line
retrieval (via CRT display or hard-copy printout) of original
prescription order information for those prescription orders which are
currently authorized for refilling. This shall include, but is not
limited to, data such as the original prescription number, date of
issuance of the original prescription order by the practitioner, full
name and address of the patient, name, address, and DEA registration
number of the practitioner, and the name, strength, dosage form,
quantity of the controlled substance prescribed (and quantity dispensed
if different from the quantity prescribed), and the total number of
refills authorized by the prescribing practitioner.
(2) Any such proposed computerized system must also provide on-line
retrieval (via CRT display or hard-copy printout) of the current refill
history for Schedule III or IV controlled substance prescription orders
(those authorized for refill during the past six months.) This refill
history shall include, but is not limited to, the name of the controlled
substance, the date of refill, the quantity dispensed, the
identification code, or name or initials of the dispensing pharmacist
for each refill and the total number of refills dispensed to date for
that prescription order.
(3) Documentation of the fact that the refill information entered
into the computer each time a pharmacist refills an original
prescription order for a Schedule III or IV controlled substance is
correct must be provided by the individual pharmacist who makes use of
such a system. If such a system provides a hard-copy printout of each
day's controlled substance prescription order refill data, that printout
shall be verified, dated, and signed by the individual pharmacist who
refilled such a prescription order. The individual pharmacist must
verify that the data indicated is correct and then sign this document in
the same manner as he would sign a check or legal document (e.g., J. H.
Smith, or John H. Smith). This document shall be maintained in a
separate file at that pharmacy for a period of two years from the
dispensing date. This printout of the day's controlled substance
prescription order refill data must be provided to each pharmacy using
such a computerized system within 72 hours of the date on which the
refill was dispensed. It must be verified and signed by each pharmacist
who is involved with such dispensing. In lieu of such a printout, the
pharmacy shall maintain a bound log book, or separate file, in which
each individual pharmacist involved in such dispensing shall sign a
statement (in the manner previously described) each day, attesting to
the fact that the refill information entered into the computer that day
has been reviewed by him and is correct as shown. Such a book or file
must be maintained at the pharmacy employing such a system for a period
of two years after the date of dispensing the appropriately authorized
refill.
(4) Any such computerized system shall have the capability of
producing a printout of any refill data which the user pharmacy is
responsible for maintaining under the Act and its implementing
regulations. For example, this would include a refill-by-refill audit
trail for any specified strength and dosage form of any controlled
substance (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
[[Page 77]]
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) 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.
(c) 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]
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:
[[Page 78]]
(1) The transfer is communicated directly between two licensed
pharmacists and the transferring pharmacist records the following
information:
(i) Write the word ``VOID'' on the face of the invalidated
prescription.
(ii) Record on the reverse of the invalidated prescription the name,
address and DEA registration number of the pharmacy to which it was
transferred and the name of the pharmacist receiving the prescription
information.
(iii) Record the date of the transfer and the name of the pharmacist
transferring the information.
(b) The pharmacist receiving the transferred prescription
information shall reduce to writing the following:
(1) Write the word ``transfer'' on the face of the transferred
prescription.
(2) Provide all information required to be on a prescription
pursuant to 21 CFR 1306.05 and include:
(i) Date of issuance of original prescription;
(ii) Original number of refills authorized on original prescription;
(iii) Date of original dispensing;
(iv) Number of valid refills remaining and date(s) and locations of
previous refill(s);
(v) Pharmacy's name, address, DEA registration number and
prescription number from which the prescription information was
transferred;
(vi) Name of pharmacist who transferred the prescription.
(vii) Pharmacy's name, address, DEA registration number and
prescription number from which the prescription was originally filled;
(3) The original and transferred prescription(s) must be maintained
for a period of two years from the date of last refill.
(c) Pharmacies electronically accessing the same prescription record
must satisfy all information requirements of a manual mode for
prescription transferral.
(d) The procedure allowing the transfer of prescription information
for refill purposes is permissible only if allowable under existing
state or other applicable law.
[46 FR 48919, Oct. 5, 1981. Redesignated and amended at 62 FR 13966,
Mar. 24, 1997]
Sec. 1306.26 Dispensing without prescription.
A controlled substance listed in Schedules II, III, IV, or V which
is not a prescription drug as determined under the Federal Food, Drug,
and Cosmetic Act, may be dispensed by a pharmacist without a
prescription to a purchaser at retail, provided that:
(a) Such dispensing is made only by a pharmacist (as defined in part
1300 of this chapter), and not by a nonpharmacist employee even if under
the supervision of a pharmacist (although after the pharmacist has
fulfilled his professional and legal responsibilities set forth in this
section, the actual cash, credit transaction, or delivery, may be
completed by a nonpharmacist);
(b) Not more than 240 cc. (8 ounces) of any such controlled
substance containing opium, nor more than 120 cc. (4 ounces) of any
other such controlled substance nor more than 48 dosage units of any
such controlled substance containing opium, nor more than 24 dosage
units of any other such controlled substance may be dispensed at retail
to the same purchaser in any given 48-hour period;
(c) The purchaser is at least 18 years of age;
(d) The pharmacist requires every purchaser of a controlled
substance under this section not known to him to 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
[[Page 79]]
(f) A prescription is not required for distribution or dispensing of
the substance pursuant to any other Federal, State or local law.
[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]
PART 1307--MISCELLANEOUS--Table of Contents
General Information
Sec.
1307.01 Definitions.
1307.02 Application of State law and other Federal law.
1307.03 Exceptions to regulations.
Special Exceptions for Manufacture and Distribution of Controlled
Substances
1307.11 Distribution by dispenser to another practitioner.
1307.12 Distribution to supplier.
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.
(a) A practitioner who is registered to dispense a controlled
substance may distribute (without being registered to distribute) a
quantity of such substance to another practitioner for the purpose of
general dispensing by the practitioner to his or its patients: Provided,
That:
(1) The practitioner to whom the controlled substance is to be
distributed is registered under the Act to dispense that controlled
substance;
(2) The distribution is recorded by the distributing practitioner in
accordance with Sec. 1304.22(c) of this chapter and by the receiving
practitioner in accordance with Sec. 1304.22(c) of this chapter;
(3) If the substance is listed in Schedule I or II, an order form is
used as required in part 1305 of this chapter;
(4) 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
[[Page 80]]
number of dosage units of all controlled substances distributed and
dispensed by the practitioner during the same calendar year.
(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 this section and Sec. 1301.25 of this
chapter will exceed 5 percent of the 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.
[36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 50 FR 31590, Aug. 5, 1985; 62 FR 13967, Mar. 24,
1997]
Sec. 1307.12 Distribution to supplier.
(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 obtained it or to
the manufacturer of the substance, 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]
Sec. 1307.13 Incidental manufacture of controlled substances.
Any registered manufacturer who, incidentally but necessarily,
manufactures a controlled substance as a result of the manufacture of a
controlled substance or basic class of controlled substance for which he
is registered and has been issued an individual manufacturing quota
pursuant to part 1303 of this chapter (if such substance or class is
listed in Schedule I or II) shall be exempt from the requirement of
registration pursuant to part 1301 of this chapter and, if
such incidentally manufactured substance is listed in Schedule I or II,
shall be exempt from the requirement of an individual manufacturing
quota pursuant to part 1303 of this chapter, if such substances are
disposed of in accordance with Sec. 1307.21.
[36 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated at 62 FR 13967, Mar. 24, 1997]
Disposal of Controlled Substances
Sec. 1307.21 Procedure for disposing of controlled substances.
(a) Any person in possession of any controlled substance and
desiring or required to dispose of such substance may request assistance
from the Special Agent in Charge of the Administration in the area in
which the person is located for authority and instructions to dispose of
such substance. The request should be made as follows:
(1) If the person is a registrant, he/she shall list the controlled
substance or substances which he/she desires to dispose of on DEA Form
41, and submit three copies of that form to the Special Agent in Charge
in his/her area; or
(2) If the person is not a registrant, he/she shall submit to the
Special Agent in Charge a letter stating:
(i) The name and address of the person;
(ii) The name and quantity of each controlled substance to be
disposed of;
(iii) How the applicant obtained the substance, if known; and
[[Page 81]]
(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 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.
[[Page 82]]
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
Secs. 1301.35 of this chapter and on certain order forms issued by the
Administration pursuant to Sec. 1305.05(d) of this chapter. Applicants
for procurement and/or individual manufacturing quotas must include the
appropriate code number on the application as required in
Secs. 1303.12(b) and 1303.22(a) of this chapter. Applicants for import
and export permits must include the appropriate code number on the
application as required in Secs. 1312.12(a) and 1312.22(a) of this
chapter. Authorized registrants who desire to import or export a
controlled substance for which an import or export permit is not
required must include the appropriate Administration Controlled
Substances Code Number beneath or beside the name of each controlled
substance listed on the DEA Form 236 (Controlled Substance Import/Export
Declaration) which is executed for such importation or exportation as
required in Secs. 1312.18(c) and 1312.27(b) of this chapter.
(b) Except as stated in paragraph (a) of this section, no applicant
or registrant is required to use the Administration Controlled
Substances Code Number for any purpose.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973
and amended at 51 FR 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997]
Schedules
Sec. 1308.11 Schedule I.
(a) Schedule I shall consist of the drugs and other substances, by
whatever official name, common or usual name, chemical name, or brand
name designated, listed in this section. Each drug or substance has been
assigned the DEA Controlled Substances Code Number set forth opposite
it.
(b) Opiates. Unless specifically excepted or unless listed in
another schedule, any of the following opiates, including their isomers,
esters, ethers,
[[Page 83]]
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 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
[[Page 84]]
Some trade or other names: DOET .....
(6) 4-methoxyamphetamine......................................... 7411
Some trade or other names: 4-methoxy-[alpha]- .....
methylphenethylamine; paramethoxyamphetamine, PMA
(7) 5-methoxy-3,4-mdthylenedioxy-amphetamine..................... 7401
(8) 4-methyl-2,5-dimethoxy-amphetamine........................... 7395
Some trade and other names: 4-methyl-2,5-dimethoxy-[alpha]- .....
methylphenethylamine; ``DOM''; and ``STP''
(9) 3,4-methylenedioxy amphetamine............................... 7400
(10) 3,4-methylenedioxymethamphetamine (MDMA).................... 7405
(11) 3,4-methylenedioxy-N-ethylamphetamine (also known as N-ethyl- 7404
alpha-methyl-3,4(methylenedioxy)phenethylamine, N-ethyl MDA,
MDE, MDEA.......................................................
(12) N-hydroxy-3,4-methylenedioxyamphetamine (also known as N- 7402
hydroxy-alpha-methyl-3,4(methylenedioxy)phenethylamine, and N-
hydroxy MDA.....................................................
(13) 3,4,5-trimethoxy amphetamine................................ 7390
(14) 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
(15) Diethyltryptamine........................................... 7434
Some trade and other names: N,N-Diethyltryptamine; DET .....
(16) Dimethyltryptamine.......................................... 7435
Some trade or other names: DMT
(17) 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 [lsqb]1',
2':1,2[rsqb] azepino [lsqb]5,4-b[rsqb] indole; Tabernanthe
iboga
(18) Lysergic acid diethylamide.................................. 7315
(19) Marihuana................................................... 7360
(20) Mescaline................................................... 7381
(21) 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.
(22) 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)) .....
(23) N-ethyl-3-piperidyl benzilate............................... 7482
(24) N-methyl-3-piperidyl benzilate.............................. 7484
(25) Psilocybin.................................................. 7437
(26) Psilocyn.................................................... 7438
(27) Tetrahydrocannabinols....................................... 7370
Synthetic equivalents of the substances contained in the plant, .....
or in the resinous extractives of Cannabis, sp. and/or
synthetic substances, derivatives, and their isomers with
similar chemical structure and pharmacological activity such
as the following:
[Delta]1 cis or trans tetrahydrocannabinol, and their optical .....
isomers
[Delta]6 cis or trans tetrahydrocannabinol, and their optical .....
isomers
[Delta]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.)
(28) Ethylamine analog of phencyclidine.......................... 7455
Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1- .....
phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)ethylamine,
cyclohexamine, PCE
(29) Pyrrolidine analog of phencyclidine......................... 7458
Some trade or other names: 1-(1-phenylcyclohexyl)-pyrrolidine, .....
PCPy, PHP
(30) Thiophene analog of phencyclidine........................... 7470
Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]- .....
piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP
(31) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine...................... 7473
Some other names: TCPy .....
(e) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a depressant
effect on the central nervous system, including its salts, isomers, and
salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation:
(1) gamma-hydroxybutyric acid (some other names include GHB; 2010
gamma-hydroxybutyrate; 4-hydroxybutyrate; 4-hydroxybutanoic
acid; sodium oxybate; sodium oxybutyrate).......................
(2) Mecloqualone................................................. 2572
(3) Methaqualone................................................. 2565
(f) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a stimulant
effect on the central nervous system, including its salts, isomers, and
salts of isomers:
(1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2- 1585
oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine)...............
(2) Cathinone.................................................... 1235
Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha- .....
aminopropiophenone, 2-aminopropiophenone, and norephedrone
(3) Fenethylline................................................. 1503
(4) 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....................
(5) ([plusmn])cis-4-methylaminorex (([plusmn])cis-4,5-dihydro-4- 1590
methyl-5-phenyl-2-oxazolamine)..................................
(6) N-ethylamphetamine........................................... 1475
(7) 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:
[[Page 85]]
(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 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
[[Page 86]]
(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: ([plusmn])-trans-3-(1,1-
dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-
dimethyl-9H-dibenzo[b,d]pyran-9-one]
(g) Immediate precursors. Unless specifically excepted or unless
listed in another schedule, any material, compound, mixture, or
preparation which contains any quantity of the following substances:
(1) Immediate precursor to amphetamine and methamphetamine:
(i) Phenylacetone................................................ 8501
Some trade or other names: phenyl-2-propanone; P2P; benzyl .....
methyl ketone; methyl benzyl ketone;
(2) Immediate precursors to phencyclidine (PCP):
(i) 1-phenylcyclohexylamine...................................... 7460
(ii) 1-piperidinocyclohexanecarbonitrile (PCC)................... 8603
[39 FR 22142, June 20, 1974]
Editorial Note: For Federal Register citations affecting
Sec. 1308.12, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
Sec. 1308.13 Schedule III.
(a) Schedule III shall consist of the drugs and other substances, by
whatever official name, common or usual name, chemical name, or brand
name designated, listed in this section. Each drug or substance has been
assigned the DEA Controlled Substances Code Number set forth opposite
it.
(b) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a stimulant
effect on the central nervous sxstem, including its salts, isomers
(whether optical, position, or geometric), and salts of such isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation:
(1) Those compounds, mixtures, or preparations in dosage unit 1405
form containing any stimulant substances listed in schedule II
which compounds, mixtures, or preparations were listed on August
25, 1971, as excepted compounds under Sec. 1308.32, and any
other drug of the quantitative composition shown in that list
for those drugs or which is the same except that it contains a
lesser quantity of controlled substances........................
(2) Benzphetamine................................................ 1228
(3) Chlorphentermine............................................. 1645
(4) Clortermine.................................................. 1647
(5) Phendimetrazine.............................................. 1615
(c) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a depressant
effect on the central nervous system:
(1) Any compound, mixture or preparation containing:
(i) Amobarbital.............................................. 2126
(ii) Secobarbital............................................ 2316
(iii) Pentobarbital.......................................... 2271
or any salt thereof and one or more other active medicinal
ingredients which are not listed in any schedule.
(2) Any suppository dosage form containing:
(i) Amobarbital.............................................. 2126
(ii) Secobarbital............................................ 2316
(iii) Pentobarbital.......................................... 2271
or any salt of any of these drugs and approved by the Food and
Drug Administration for marketing only as a suppository.
(3) Any substance which contains any quantity of a derivative of 2100
barbituric acid or any salt thereof.............................
(4) Chlorhexadol................................................. 2510
(5) Any drug product containing gamma hydroxybutyric acid, 2012
including its salts, isomers, and salts of isomers, for which an
application is approved under section 505 of the Federal Food,
Drug, and Cosmetic Act..........................................
(6) Ketamine, its salts, isomers, and salts of isomers........... 7285
[[Page 87]]
[Some other names for ketamine: ([plusmn])-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, 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 1.8 grams of codeine per 100 milliliters or not 9803
more than 90 milligrams per dosage unit, with an equal or
greater quantity of an isoquinoline alkaloid of opium...........
(2) Not more than 1.8 grams of codeine per 100 milliliters or not 9804
more than 90 milligrams per dosage unit, with one or more
active, nonnarcotic ingredients in recognized therapeutic
amounts.........................................................
(3) 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..................................
(4) 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...............................
(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters 9807
or not more than 90 milligrams per dosage unit, with one or more
active nonnarcotic ingredients in recognized therapeutic amounts
(6) 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.............................................
(7) Not more than 500 milligrams of opium per 100 milliliters or 9809
per 100 grams or not more than 25 milligrams per dosage unit,
with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.............................................
(8) Not more than 50 milligrams of morphine per 100 milliliters 9810
or per 100 grams, with one or more active, nonnarcotic
ingredients in recognized therapeutic amounts...................
(f) Anabolic steroids. Unless specifically excepted or unless listed
in another schedule, any material, compound, mixture, or preparation
containing any quantity of the following substances, including its
salts, isomers, and salts of isomers whenever the existence of such
salts of isomers is possible within the specific chemical designation:
(1) Anabolic Steroids...............................................4000
(g) Hallucinogenic substances.
(1) Dronabinol (synthetic) in sesame oil and encapsulated in a soft
gelatin capsule in a U.S. Food and Drug Administration approved product-
-7369.
[Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro-
6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-
(trans)-tetrahydrocannabinol]
(2) [Reserved]
[39 FR 22142, June 20, 1974, as amended at 41 FR 43401, Oct. 1, 1976; 43
FR 3359, Jan. 25, 1978; 44 FR 40888, July 13, l979; 46 FR 52334, Oct.
27, 1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan. 21, 1987; 52 FR
5952, Feb. 27, 1987; 56 FR 5754, Feb. 13, 1991; 56 FR 11932, Mar. 21,
1991; 62 FR 13968, Mar. 24, 1997; 64 FR 35930, July 2, 1999; 64 FR
37675, July 13, 1999; 65 FR 13238, Mar. 13, 2000; 65 FR 17440, Apr. 3,
2000]
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
[[Page 88]]
(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
(d) Fenfluramine. Any material, compound, mixture, or preparation
which contains any quantity of the following substances, including its
salts, isomers (whether optical, position, or geometric), and salts of
such isomers, whenever the existence of such salts, isomers, and salts
of isomers is possible:
(1) Fenfluramine................................................. 1670
(e) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a stimulant
effect on the central nervous system, including its salts, isomers and
salts of isomers:
(1) Cathine ((+)-norpseudoephedrine)............................. 1230
(2) Diethylpropion............................................... 1610
(3) Fencamfamin.................................................. 1760
(4) Fenproporex.................................................. 1575
(5) Mazindol..................................................... 1605
(6) Mefenorex.................................................... 1580
(7)Modafinil..................................................... 1680
(8) Pemoline (including organometallic complexes and chelates 1530
thereof)........................................................
(9) Phentermine.................................................. 1640
(10) Pipradrol................................................... 1750
(11) Sibutramine................................................. 1675
(12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane)............... 1635
(f) Other substances. Unless specifically excepted or unless listed
in another schedule, any material, compound, mixture or preparation
which contains any quantity of the following substances, including its
salts:
(1) Pentazocine.................................................. 9709
(2) Butorphanol (including its optical isomers).................. 9720
[39 FR 22143, June 20, 1974]
Editorial Note: For Federal Register citations affecting
Sec. 1308.14, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
Sec. 1308.15 Schedule V.
(a) Schedule V shall consist of the drugs and other substances, by
whatever official name, common or usual name, chemical name, or brand
name designated, listed in this section.
(b) Narcotic drugs. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
containing any of the following narcotic drugs and their salts, as set
forth below:
(1) Buprenorphine................................................ 9064
(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
[[Page 89]]
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]
[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]
Excluded Nonnarcotic Substances
Sec. 1308.21 Application for exclusion of a nonnarcotic substance.
(a) Any person seeking to have any nonnarcotic substance which may,
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be
lawfully sold over the counter without a prescription, excluded from any
schedule, pursuant to section 201(g) (1) of the Act (21 U.S.C. 811 (g)
(1)), may apply to the Administrator, Drug Enforcement Administration,
Department of Justice, Washington, DC 20537.
(b) An application for an exclusion under this section shall contain
the following information:
(1) The name and address of the applicant;
(2) The name of the substance for which exclusion is sought; and
(3) The complete quantitative composition of the substance.
(c) Within a reasonable period of time after the receipt of an
application for an exclusion under this section, the Administrator shall
notify the applicant of his acceptance or nonacceptance of his
application, and if not accepted, the reason therefore. The
Administrator need not accept an application for filing if any of the
requirements prescribed in paragraph (b) of this section is lacking or
is not set forth as to be readily understood. If the applicant desires,
he may amend the application to meet the requirements of paragraph (b)
of this section. If the application is accepted for filing, the
Administrator shall issue and publish in the Federal Register his order
on the application, which shall include a reference to the legal
authority under which the order is issued and the findings of fact and
conclusions of law upon which the order is based. This order shall
specify the date on which it shall take effect. The Administrator shall
permit any interested person to file written comments on or objections
to the order within 60 days of the date of publication of his order in
the Federal Register. If any such comments or objections raise
significant issues regarding any finding of fact or conclusion of law
upon which the order is based, the Administrator shall immediately
suspend the effectiveness of the order until he may reconsider the
application in light of the comments and objections filed. Thereafter,
the Administrator shall reinstate, revoke, or amend his original order
as he determines appropriate.
(d) The Administrator may at any time revoke any exclusion granted
pursuant to section 201(g) of the Act (21 U.S.C. 811(g)) by following
the procedures set forth in paragraph (c) of this section for handling
an application for an exclusion which has been accepted for filing.
Sec. 1308.22 Excluded substances.
The following nonnarcotic substances which may, under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the
counter without a prescription, are excluded from all schedules pursuant
to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):
[[Page 90]]
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, l973,
and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46
FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan.
19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997]
Exempt Chemical Preparations
Sec. 1308.23 Exemption of certain chemical preparations; application.
(a) The Administrator may, by regulation, exempt from the
application of all or any part of the Act any chemical preparation or
mixture containing one or more controlled substances listed in any
schedule, which preparation or mixture is intended for laboratory,
industrial, educational, or special research purposes and not for
general administration to a human being or other animal, if the
preparation or mixture either:
(1) Contains no narcotic controlled substance and is packaged in
such a form or concentration that the packaged quantity does not present
any significant potential for abuse (the type of packaging and the
history of abuse of the same or similar preparations may be considered
in determining the potential for abuse of the preparation or mixture);
or
(2) Contains either a narcotic or nonnarcotic controlled substance
and one or more adulterating or denaturing agents in such a manner,
combination, quantity, proportion, or concentration, that the
preparation or mixture does not present any potential for abuse. If the
preparation or mixture contains a narcotic controlled substance, the
preparation or mixture must be formulated in such a manner that it
incorporates methods of denaturing or other means so that the
preparation or mixture is not liable to be abused or have ill effects,
if abused, and so that the narcotic substance cannot in practice be
removed.
(b) Any person seeking to have any preparation or mixture containing
a controlled substance and one or more noncontrolled substances exempted
from the application of all or any part of the Act, pursuant to
paragraph (a) of this section, may apply to the Administrator, Drug
Enforcement Administration, Department of Justice, Washington, DC 20537.
(c) An application for an exemption under this section shall contain
the following information:
(1) The name, address, and registration number, if any, of the
applicant;
(2) The name, address, and registration number, if any, of the
manufacturer or importer of the preparation or mixture, if not the
applicant;
(3) The exact trade name or other designation of the preparation or
mixture;
(4) The complete qualitative and quantitative composition of the
preparation or mixture (including all active and inactive ingredients
and all controlled and noncontrolled substances);
(5) The form of the immediate container in which the preparation or
mixture will be distributed with sufficient descriptive detail to
identify the preparation or mixture (e.g., bottle, packet,
[[Page 91]]
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.
(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 Secs. 1301.71--1301.73 and 1301.74 (a),
(b), (d), (e) and (f) of this chapter to the extent as hereinafter may
be provided.
(b) Registration and security: Any person who manufactures an exempt
chemical preparation or mixture must be registered under the Act and
comply with all relevant security requirements regarding controlled
substances being used in the manufacturing process until the preparation
or mixture is in the form described in paragraph (i) of this section.
Any other person who
[[Page 92]]
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 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.
[[Page 93]]
(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) EmitR 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 th e printed volume and on GPO Access.
Excluded Veterinary Anabolic Steroid Implant Products
Sec. 1308.25 Exclusion of a veterinary anabolic steroid implant product; application.
(a) Any person seeking to have any anabolic steroid product, which
is expressly intended for administration through implants to cattle or
other nonhuman species and which has been approved by the Secretary of
Health and Human Services for such administration, identified as being
excluded from any schedule, pursuant to section 102(41)(B)(i) of the Act
(21 U.S.C. 802(41)(B)(i)), may apply to the Administrator, Drug
Enforcement Administration, Department of Justice, Washington, DC 20537.
(b) An application for any exclusion under this section shall be
submitted in triplicate and contain the following information:
(1) The name and address of the applicant;
(2) The name of the product;
(3) The chemical structural formula or description for any anabolic
steroid contained in the product;
(4) A complete description of dosage and quantitative composition of
the dosage form;.
(5) The conditions of use including whether or not Federal law
restricts this product to use by or on the order of a licensed
veterinarian;
(6) A description of the delivery system in which the dosage form
will be distributed with sufficient detail to identify the product (e.g.
20 cartridge brown plastic belt);
(7) The label and labeling of the immediate container and the
commercial containers, if any, of the product;.
(8) The name and address of the manufacturer of the dosage form if
different from that of the applicant; and
(9) Evidence that the product has been approved by the Secretary of
Health and Human Services for administration through implant to cattle
or other nonhuman species.
(c) Within a reasonable period of time after the receipt of an
application for an exclusion under this section, the Administrator shall
notify the applicant of his acceptance or nonacceptance of the
application, and if not accepted, the reason therefore. The
Administrator need not accept an application for filing if any of the
requirements prescribed in paragraph (b) of this section is lacking or
is not set forth as to be readily understood. The applicant may amend
the application to meet the requirements of paragraph (b) of this
section. If the application is accepted for filing, the Administrator
shall issue and have published in the Federal Register his order on the
application, which shall include a reference to the legal authority
under which the order is issued and the findings of fact and conclusions
of law upon which the order is based. This order shall specify the date
on which it will take effect. The Administrator shall permit any
interested person to file written comments on or objections to the order
within 60 days of the date of publication in the Federal Register. If
any such comments or objections raise significant issues regarding any
finding of fact or conclusion of law upon which the order is based, the
Administrator shall immediately suspend the effectiveness of the order
until he may reconsider the application in light of the comments and
objections filed. Thereafter, the Administrator shall reinstate, revoke,
or amend his original order as he determines appropriate.
(d) The Administrator may at any time revoke or modify any
designation of excluded status granted pursuant to this section by
following the procedures set forth in paragraph (c) of this
[[Page 94]]
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.
(5) Deterrent effects of the noncontrolled ingredients.
(6) Complete copies of all literature in support of claims.
(7) Reported instances of abuse.
(8) Reported and anticipated adverse effects.
(9) Number of dosage units produced for the past 2 years.
(c) Within a reasonable period of time after the receipt of an
application for an exemption under this section, the Administrator shall
notify the applicant of his acceptance or non-acceptance of the
application, and if not accepted, the reason therefor. The Administrator
need not accept an application for filing if any of the requirements
prescribed in paragraph (b) of this section is lacking or is not set
forth so as to be readily understood. If the applicant desires, he may
amend the application to meet the requirements of paragraph (b) of this
section. If accepted for filing, the Administrator shall publish in the
Federal Register general notice of this proposed rulemaking in granting
or denying the application. Such notice shall include a reference to the
legal authority under which the rule is proposed, a statement of the
proposed rule granting or denying an exemption, and, in the discretion
of the Administrator, a summary of the subjects and issues involved. The
Administrator shall permit any interested person to file written
comments on or objections to the proposal and shall designate in the
notice of proposed rule making the time during which such filings may be
made. After consideration of the application and any comments on or
objections to his proposed rulemaking, the Administrator shall issue and
publish in the Federal Register his final order on the application,
which shall set forth the findings of fact and conclusions of law upon
which the order is based. This
[[Page 95]]
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
Secs. 1301.13, 1301.22, and Secs. 1301.71 through 1301.76 of this
chapter for administrative purposes only. An exception to the above is
that those products containing butalbital shall not be exempt from the
requirement of 21 U.S.C. 952-954 concerning importation, exportation,
transshipment and in-transit shipment of controlled substances. Any
deviation from the quantitative composition of any of the listed drugs
shall require a petition of exemption in order for the product to be
exempted. A listing of the Exempted Prescription Products may be
obtained by submitting a written request to the Drug and Chemical
Evaluation Section, Drug Enforcement Administration, Washington, DC
20537.
[62 FR 13967, Mar. 24, 1997]
Exempt Anabolic Steroid Products
Sec. 1308.33 Exemption of certain anabolic steroid products; application.
(a) The Administrator, upon the recommendation of the Secretary of
Health and Human Services, may, by regulation, exempt from the
application of all or any part of the Act any compound, mixture, or
preparation containing an anabolic steroid as defined in part 1300 of
this chapter if, because of its concentration, preparation, mixture or
delivery system, it has no significant potential for abuse (Pub. L. 101-
647 section 1903(a)).
(b) Any person seeking to have any compound, mixture, or preparation
containing an anabolic steroid as defined in part 1300 of this chapter
exempted from the application of all or any part of the Act, pursuant to
paragraph (a) of this section, may apply to the Administrator, Drug
Enforcement Administration, Department of Justice, Washington, DC 20537.
(c) An application for an exemption under this section shall be
submitted in triplicate and contain the following information:
(1) The name and address of the applicant;
(2) The name of the product;
(3) The chemical structural formula or description for any anabolic
steroid contained in the product;
(4) The complete description of dosage and quantitative composition
of the dosage form;
(5) A description of the delivery system, if applicable;
(6) The indications and conditions for use in which species,
including whether or not this product is a prescription drug;
(7) Information to facilitate identification of the dosage form,
such as shape, color, coating, and scoring;
(8) The label and labeling of the immediate container and the
commercial containers, if any, of the product;
(9) The units in which the dosage form is ordinarily available; and
(10) The facts which the applicant believes justify:
[[Page 96]]
(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]
Sec. 1308.34 Exempt anabolic steroid products.
The list of compounds, mixtures, or preparations that contain an
anabolic steroid that have been exempted by the Administrator from
application of sections 302 through 309 and 1002 through 1004 of the Act
(21 U.S.C. 822-829 and 952-954) and Secs. 1301.13, 1301.22, and 1301.71
through 1301.76 of this chapter for administrative purposes only may be
obtained by submitting a written request to the Drug and Chemical
Evaluation Section, Drug Enforcement Administration, 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.
[[Page 97]]
(b) As used in this section, the following terms shall have the
meanings specified:
(1) The term processed plant material means cannabis plant material
that has been subject to industrial processes, or mixed with other
ingredients, such that it cannot readily be converted into any form that
can be used for human consumption.
(2) The term animal feed mixture means sterilized cannabis seeds
mixed with other ingredients (not derived from the cannabis plant) in a
formulation that is designed, marketed, and distributed for animal
consumption (and not for human consumption).
(3) The term used for human consumption means either:
(i) Ingested orally or
(ii) Applied by any means such that THC enters the human body.
(4) The term intended for use for human consumption means any of the
following:
(i) Designed by the manufacturer for human consumption;
(ii) Marketed for human consumption; or
(iii) Distributed, exported, or imported, with the intent that it be
used for human consumption.
(c) In any proceeding arising under the Act or this chapter, the
burden of going forward with the evidence that a material, compound,
mixture, or preparation containing THC is exempt from control pursuant
to this section shall be upon the person claiming such exemption, as set
forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to
meet this burden with respect to a product or plant material that has
not been expressly exempted from control by the Administrator pursuant
to Sec. 1308.23, the person claiming the exemption must present rigorous
scientific evidence, including well-documented scientific studies by
experts trained and qualified to evaluate the effects of drugs on
humans.
[66 FR 51544, Oct. 9, 2001]
Hearings
Sec. 1308.41 Hearings generally.
In any case where the Administrator shall hold a hearing on the
issuance, amendment, or repeal of rules pursuant to section 201 of the
Act, the procedures for such hearing and accompanying proceedings shall
be governed generally by the rulemaking procedures set forth in the
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
section 201 of the Act (21 U.S.C. 811), by Secs. 1308.42-1308.51, and by
Secs. 1316.41-1316.67 of this chapter.
Sec. 1308.42 Purpose of hearing.
If requested by any interested person after proceedings are
initiated pursuant to Sec. 1308.43, the Administrator shall hold a
hearing for the purpose of receiving factual evidence and expert opinion
regarding the issues involved in the issuance, amendment or repeal of a
rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)).
Extensive argument should not be offered into evidence but rather
presented in opening or closing statements of counsel or in memoranda or
proposed findings of fact and conclusions of law. Additional information
relating to hearings to include waivers or modification of rules,
request for hearing, burden of proof, time and place, and final order
are set forth in part 1316 of this chapter.
[62 FR 13968, Mar. 24, 1997]
Sec. 1308.43 Initiation of proceedings for rulemaking.
(a) Any interested person may submit a petition to initiate
proceedings for the issuance, amendment, or repeal of any rule or
regulation issuable pursuant to the provisions of section 201 of the
Act.
(b) Petitions shall be submitted in quintuplicate to the
Administrator 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
[[Page 98]]
amendment or repeal of an existing rule, the existing rule, together
with a reference to the section in the Code of Federal Regulations where
it appears, should be included.)
(B) A statement of the grounds which the petitioner relies for the
issuance (amendment or repeal) of the rule. (Such grounds shall include
a reasonably concise statement of the facts relied upon by the
petitioner, including a summary of any relevant medical or scientific
evidence known to the petitioner.)
All notices to be sent regarding this petition should be addressed
to:
________________________________________________________________________
(Name)
________________________________________________________________________
(Street Address)
________________________________________________________________________
(City and State)
Respectfully yours,
________________________________________________________________________
(Signature of petitioner)
(c) Within a reasonable period of time after the receipt of a
petition, the Administrator shall notify the petitioner of his
acceptance or nonacceptance of the petition, and if not accepted, the
reason therefor. The Administrator need not accept a petition for filing
if any of the requirements prescribed in paragraph (b) of this section
is lacking or is not set forth so as to be readily understood. If the
petitioner desires, he may amend the petition to meet the requirements
of paragraph (b) of this section. If accepted for filing, a petition may
be denied by the Administrator within a reasonable period of time
thereafter if he finds the grounds upon which the petitioner relies are
not sufficient to justify the initiation of proceedings.
(d) The Administrator shall, before initiating proceedings for the
issuance, amendment, or repeal of any rule either to control a drug or
other substance, or to transfer a drug or other substance from one
schedule to another, or to remove a drug or other substance entirely
from the schedules, and after gathering the necessary data, request from
the Secretary a scientific and medical evaluation and the Secretary's
recommendations as to whether such drug or other substance should be so
controlled, transferred, or removed as a controlled substance. The
recommendations of the Secretary to the Administrator shall be binding
on the Administrator as to such scientific and medical matters, and if
the Secretary recommends that a drug or other substance not be
controlled, the Administrator shall not control that drug or other
substance.
(e) If the Administrator determines that the scientific and medical
evaluation and recommendations of the Secretary and all other relevant
data constitute substantial evidence of potential for abuse such as to
warrant control or additional control over the drug or other substance,
or substantial evidence that the drug or other substances should be
subjected to lesser control or removed entirely from the schedules, he
shall initiate proceedings for control, transfer, or removal as the case
may be.
(f) If and when the Administrator determines to initiate
proceedings, he shall publish in the Federal Register general notice of
any proposed rule making to issue, amend, or repeal any rule pursuant to
section 201 of the Act. Such published notice shall include a statement
of the time, place, and nature of any hearings on the proposal in the
event a hearing is requested pursuant to Sec. 1308.44. Such hearings may
not be commenced until after the expiration of at least 30 days from the
date the general notice is published in the Federal Register. Such
published notice shall also include a reference to the legal authority
under which the rule is proposed, a statement of the proposed rule, and,
in the discretion of the Administrator, a summary of the subjects and
issues involved.
(g) The Administrator may permit any interested persons to file
written comments on or objections to the proposal and shall designate in
the notice of proposed rule making the time during which such filings
may be made.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973,
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]
[[Page 99]]
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]
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]
[[Page 100]]
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.
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 Exemption of agents and employees.
1309.25 Exemption of certain controlled substance registrants.
1309.26 Exemption of law enforcement officials.
1309.27 Exemption of certain manufacturers.
1309.28 Exemption of distributors of regulated prescription drug
products.
1309.29 Waiver of registration requirement for certain activities.
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.
[[Page 101]]
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
a annual registration.
(b) For each reregistration to manufacture for distribution,
distribute, import, or export, the registrant shall pay a fee of $477
for an annual registration.
(c) For each initial registration to conduct business as a retail
distributor the applicant shall pay an application processing fee of $7
and an investigation fee of $248, for an annual registration.
(d) For each reregistration to conduct business as a retail
distributor the registrant shall pay a fee of $116.
Sec. 1309.12 Time and method of payment; refund.
(a) For each application for registration or reregistration to
manufacture for distribution, distribute, import, or export, the
applicant shall pay the fee when the application for registration or
reregistration is submitted for filing.
(b) For retail the distributor initial applications, the applicant
shall pay the application processing fee when the application for
registration is submitted for filing. The investigation fee shall be
paid within 30 days after DEA notifies the applicant that the
preregistration investigation has been scheduled.
(c) For retail distributor reregistration applications, the
registrant shall pay the fee when the application for reregistration is
submitted for filing.
(d) Payments should be made in the form of a personal, certified, or
cashier's check or money order made payable to ``Drug Enforcement
Administration.'' Payments made in the form of stamps, foreign currency,
or third
[[Page 102]]
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. 1310.01(b)(28)(i)(D) 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 Secs. 1309.24 through 1309.28 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. 1310.01(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 Secs. 1309.24 through
1309.28 of this part.
[61 FR 32926, June 26, 1996, as amended at 62 FR 13968, Mar. 24, 1997]
Effective Date Note: At 67 FR 14860, Mar. 28, 2002, Sec. 1309.21 was
revised effective Apr. 29, 2002. For the convenience of the user, the
revised text follows:
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 Secs. 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 Secs. 1309.24 through
1309.26 of this part.
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 Secs. 1309.24
through 1309.28 of this part, 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]
Effective Date Note: At 67 FR 14860, Mar. 28, 2002, Sec. 1309.22 was
amended by revising paragraph (b), effective Apr. 29, 2002. For the
convenience of the user, the revised text follows:
Sec. 1309.22 Separate registration for independent activities.
* * * * *
(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 Secs. 1309.24
through 1309.26, except that a
[[Page 103]]
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.
Sec. 1309.23 Separate registration for separate locations.
(a) A separate registration is required for each principal place of
business at one general physical location where List I chemicals are
distributed, imported, or exported by a person.
(b) The following locations shall be deemed to be places not subject
to the registration requirement:
(1) A warehouse where List I chemicals are stored by or on behalf of
a registered person, unless such chemicals are distributed directly from
such warehouse to locations other than the registered location from
which the chemicals were originally delivered; and
(2) An office used by agents of a registrant where sales of List I
chemicals are solicited, made, or supervised but which neither contains
such chemicals (other than chemicals for display purposes) nor serves as
a distribution point for filling sales orders.
Sec. 1309.24 Exemption of agents and employees.
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.
Effective Date Note: At 67 FR 14860, Mar. 28, 2002, Sec. 1309.24 was
revised, effective Apr. 29, 2002. For the convenience of the user, the
revised text follows:
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.
The threshold for a distribution of a product in a single transaction to
an individual for legitimate medical use is 24 grams of pseudoephedrine,
phenylpropanolamine, or ephedrine base.
(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 isotainers (with capacities greater than or equal to 2500
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),
[[Page 104]]
(e), (f) or (g) of this section pursuant to the procedures set forth in
Secs. 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
Secs. 1309.71-1309.73 of this part and the recordkeeping and reporting
requirements set forth under parts 1310 and 1313 of this chapter.
Sec. 1309.25 Exemption of certain controlled substance registrants.
(a) The requirement of registration is waived for any person who
distributes a product containing a List I chemical that is regulated
pursuant to Sec. 1310.01(b)(28)(i)(D), if that person is registered with
the Administration to manufacture, distribute or dispense a controlled
substance.
(b) 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. 1310.01(b)(28)(i)(D), if that person is
registered with the Administration to engage in the same activity with a
controlled substance.
(c) The Administrator may, upon finding that continuation of the
waiver would not be in the public interest, suspend or revoke a person's
waiver pursuant to the procedures set forth in Secs. 1309.43 through
1309.46 and 1309.51 through 1309.57. In considering the revocation or
suspension of a person's waiver, 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.
(d) Any person exempted from the registration requirement under this
section shall comply with the security requirements set forth in
Sections 1309.71-1309.73 and the recordkeeping and reporting
requirements set forth under Parts 1310 and 1313 of this chapter.
[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
Effective Date Note: At 67 FR 14860, Mar. 28, 2002, Sec. 1309.25 was
revised, effective Apr. 29, 2002. For the convenience of the user, the
revised text follows:
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.
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
[[Page 105]]
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.
Sec. 1309.27 Exemption of certain manufacturers.
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.
Effective Date Note: At 67 FR 14861, Mar. 28, 2002, Sec. 1309.27 was
removed, effective Apr. 29, 2002.
Sec. 1309.28 Exemption of distributors of regulated prescription drug products.
(a) 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. 1310.01(f)(1)(iv) of this chapter.
(b) If any person exempted by this section also engages in the
distribution, importation or exportation of a List I chemical, other
than as described in paragraph (a) of this section, the person shall
obtain a registration for such activities, as required by Sec. 1309.21
of this part.
(c) The Administrator may, upon finding that continuation of the
waiver granted in paragraph (a) of this section would not be in the
public interest, suspend or revoke a person's waiver pursuant to the
procedures set forth in Secs. 1309.43 through 1309.46 and 1309.51
through 1309.57 of this part.
[61 FR 32926, June 26, 1996]
Effective Date Note: At 67 FR 14861, Mar. 28, 2002, Sec. 1309.28 was
removed, effective Apr. 29, 2002.
1309.29 Waiver of registration requirement for certain activities.
(a) The requirement of registration is waived for any retail
distributor whose activities with respect to List I chemicals are
restricted to the distribution of below-threshold quantities of a drug
product that contains a List I chemical that is regulated pursuant to
Sec. 1300.02(b)(28)(i)(D) of this chapter to an individual for
legitimate medical use.
(b) 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.
(c) 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 isotainers (with capacities greater than or equal to 2500
gallons in a single container).
(d) If any person exempted under paragraph (b) or (c) 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.
(e) 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) or (c) of this section pursuant to the
procedures set forth in Secs. 1309.43 through 1309.46 and 1309.51
through 1309.57 of this part.
(f) Any person exempted from the registration requirement under this
section shall comply with the security requirements set forth in
Secs. 1309.71-1309.73 of this part and the recordkeeping and reporting
requirements set forth under parts 1310 and 1313 of this chapter.
[66 FR 52674, Oct. 17, 2001]
Effective Date Note: At 67 FR 14861, Mar. 28, 2002, Sec. 1309.29 was
removed, effective Apr. 29, 2002.
[[Page 106]]
Application for Registration
Sec. 1309.31 Time for application for registration; expiration date.
(a) Any person who is required to be registered and who is not so
registered may apply for registration at any time. No person required to
be registered shall engage in any activity for which registration is
required until the application for registration is approved and a
Certificate of Registration is issued by the Administrator to such
person.
(b) Any person who is registered may apply to be reregistered not
more than 60 days before the expiration date of his registration.
(c) At the time a person is first registered, that person shall be
assigned to one of twelve groups, which shall correspond to the months
of the year. The expiration date of the registrations of all registrants
within any group will be the last day of the month designated for that
group. In assigning any of the above persons to a group, the
Administration may select a group the expiration date of which is less
than one year from the date such business activity was registered. If
the person is assigned to a group which has an expiration date less than
eleven months from the date of which the person is registered, the
registration shall not expire until one year from that expiration date;
in all other cases, the registration shall expire on the expiration date
following the date on which the person is registered.
Sec. 1309.32 Application forms; contents; signature.
(a) Any person who is required to be registered pursuant to
Sec. 1309.21 and is not so registered, shall apply on DEA Form 510.
(b) Any person who is registered pursuant to Section 1309.21, shall
apply for reregistration on DEA Form 510a.
(c) DEA Form 510 may be obtained at any divisional office of the
Administration or by writing to the Registration Unit, Drug Enforcement
Administration, Department of Justice, Post Office Box 28083, Central
Station, Washington, DC 20005. DEA Form 510a will be mailed to each List
I chemical registrant approximately 60 days before the expiration date
of his or her registration; if any registered person does not receive
such forms within 45 days before the expiration date of the
registration, notice must be promptly given of such fact and DEA Form
510a must be requested by writing to the Registration Unit of the
Administration at the foregoing address.
(d) Each application for registration shall include the
Administration Chemical Code Number, as set forth in Sec. 1310.02 of
this chapter, for each List I chemical to be distributed, imported, or
exported.
(e) Registration shall not entitle a person to engage in any
activity with any List I chemical not specified in his or her
application.
(f) Each application shall include all information called for in the
form, unless the item is not applicable, in which case this fact shall
be indicated.
(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
[[Page 107]]
application must be complete and must not refer to any accompanying
application for required information.
Sec. 1309.34 Acceptance for filing; defective applications.
(a) Applications submitted for filing are dated upon receipt. If
found to be complete, the application will be accepted for filing.
Applications failing to comply with the requirements of this part will
not generally be accepted for filing. In the case of minor defects as to
completeness, the Administrator may accept the application for filing
with a request to the applicant for additional information. A defective
application will be returned to the applicant within 10 days of receipt
with a statement of the reason for not accepting the application for
filing. A defective application may be corrected and resubmitted for
filing at any time.
(b) Accepting an application for filing does not preclude any
subsequent request for additional information pursuant to Sec. 1309.35
and has no bearing on whether the application will be granted.
Sec. 1309.35 Additional information.
The Administrator may require an applicant to submit such documents
or written statements of fact relevant to the application as he deems
necessary to determine whether the application should be granted. The
failure of the applicant to provide such documents or statements within
a reasonable time after being requested to do so shall be deemed to be a
waiver by the applicant of an opportunity to present such documents or
facts for consideration by the Administrator in granting or denying the
application.
Sec. 1309.36 Amendments to and withdrawals of applications.
(a) An application may be amended or withdrawn without permission of
the Administration at any time before the date on which the applicant
receives an order to show cause pursuant to Sec. 1309.46. An application
may be amended or withdrawn with permission of the Administrator at any
time where good cause is shown by the applicant or where the amendment
or withdrawal is in the public interest.
(b) After an application has been accepted for filing, the request
by the applicant that it be returned or the failure of the applicant to
respond to official correspondence regarding the application, including
a request that the applicant submit the required fee, when sent by
registered or certified mail, return receipt requested, shall be deemed
to be a withdrawal of the application.
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
[[Page 108]]
any official, agent or employee of the Administration or of any Federal,
State, or local agency engaged in enforcement of laws relating to List I
chemicals or controlled substances.
Sec. 1309.43 Suspension or revocation of registration.
(a) The Administrator may suspend any registration pursuant to
section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he
determines.
(b) The Administrator may revoke any registration pursuant to
section 304(a) of the Act (21 U.S.C. 824(a)).
(c) Before revoking or suspending any registration, the
Administrator shall issue an order to show cause pursuant to Section
1309.46 and, if requested by the registrant, shall hold a hearing
pursuant to Section 1309.51. Notwithstanding the requirements of this
Section, however, the Administrator may suspend any registration pending
a final order pursuant to Sec. 1309.44.
(d) Upon service of the order of the Administrator suspending or
revoking registration, the registrant shall immediately deliver his or
her Certificate of Registration to the nearest office of the
Administration. Also, upon service of the order of the Administrator
revoking or suspending registration, the registrant shall, as instructed
by the Administrator:
(1) Deliver all List I chemicals in his or her possession that were
obtained under the authority of a registration or an exemption from
registration granted by the Administrator by regulation, to the nearest
office of the Administration or to authorized agents of the
Administration; or
(2) Place all such List I chemicals in his or her possession under
seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).
(e) In the event that revocation or suspension is limited to a
particular chemical or chemicals, the registrant shall be given a new
Certificate of Registration for all substances not affected by such
revocation or suspension; no fee shall be required for the new
Certificate of Registration. The registrant shall deliver the old
Certificate of Registration to the nearest office of the Administration.
Also, upon service of the order of the Administrator revoking or
suspending registration with respect to a particular chemical or
chemicals, the registrant shall, as instructed by the Administrator:
(1) Deliver to the nearest office of the Administration or to
authorized agents of the Administration all of the particular chemical
or chemicals in his or her possession that were obtained under the
authority of a registration or an exemption from registration granted by
the Administrator by regulation, 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)).
[[Page 109]]
(c) Any suspension shall continue in effect until the conclusion of
all proceedings upon the revocation or suspension, including any
judicial review thereof, unless sooner withdrawn by the Administrator or
dissolved by a court of competent jurisdiction. Any registrant whose
registration is suspended under this section may request a hearing on
the revocation or suspension of his registration at a time earlier than
specified in the order to show cause pursuant to Section 1309.46, which
request shall be granted by the Administrator, who shall fix a date for
such hearing as early as reasonably possible.
[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]
Sec. 1309.45 Extension of registration pending final order.
In the event that an applicant for reregistration (who is doing
business under a registration previously granted and not revoked or
suspended) has applied for reregistration at least 45 days before the
date on which the existing registration is due to expire, and the
Administrator has issued no order on the application on the date on
which the existing registration is due to expire, the existing
registration of the applicant shall automatically be extended and
continue in effect until the date on which the Administrator so issues
his order. The Administrator may extend any other existing registration
under the circumstances contemplated in this section even though the
registrant failed to apply for reregistration at least 45 days before
expiration of the existing registration, with or without request by the
registrant, if the Administrator finds that such extension is not
inconsistent with the public health and safety.
Sec. 1309.46 Order to show cause.
(a) If, upon examination of the application for registration from
any applicant and other information gathered by the Administration
regarding the applicant, the Administrator is unable to make the
determinations required by the applicable provisions of section 303 of
the Act (21 U.S.C. 823) to register the applicant, the Administrator
shall serve upon the applicant an order to show cause why the
application for registration should not be denied.
(b) If, upon information gathered by the Administration regarding
any registrant, the Administrator determines that the registration of
such registrant is subject to suspension or revocation pursuant to
section 304 of the Act (21 U.S.C. 824), the Administrator shall serve
upon the registrant an order to show cause why the registration should
not be revoked or suspended.
(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 Secs. 1309.52
through 1309.57, and by the procedures for administrative hearings under
the Act set forth in Secs. 1316.41 through 1316.67 of this chapter.
(b) Any hearing under this part shall be independent of, and not in
lieu of, criminal prosecutions or other proceedings under the Act or any
other law of the United States.
[[Page 110]]
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 Secs. 1309.42 and
1309.43 and desiring a hearing shall, within 30 days after the date of
receipt of the order to show cause, file with the Administrator a
written request for a hearing in the form prescribed in Sec. 1316.47 of
this chapter.
(b) Any person entitled to a hearing pursuant to Secs. 1309.42 and
1309.43 may, within the period permitted for filing a request for a
hearing, file with the Administrator a waiver of an opportunity for a
hearing, together with a written statement regarding his position on the
matters of fact and law involved in such hearing. Such statement, if
admissible, shall be made a part of the record and shall be considered
in light of the lack of opportunity for cross-examination in determining
the weight to be attached to matters of fact asserted therein.
(c) If any person entitled to a hearing pursuant to Secs. 1309.42
and 1309.43 fails to file a request for a hearing, or if he so files and
fails to appear at the hearing, he shall be deemed to have waived his
opportunity for the hearing, unless he shows good cause for such
failure.
(d) If any person entitled to a hearing waives or is deemed to waive
his or her opportunity for the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his final order pursuant to
Sec. 1309.57 without a hearing.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]
Sec. 1309.54 Burden of proof.
(a) At any hearing for the denial of a registration, the
Administration shall have the burden of proving that the requirements
for such registration pursuant to section 303 of the Act (21 U.S.C. 823)
are not satisfied.
(b) At any hearing for the revocation or suspension of a
registration, the Administration shall have the burden of proving that
the requirements for such revocation or suspension pursuant to section
304(a) of the Act (21 U.S.C. 824(a)) are satisfied.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]
Sec. 1309.55 Time and place of hearing.
The hearing will commence at the place and time designated in the
order to show cause or notice of hearing published in the Federal
Register (unless expedited pursuant to Section 1309.44(c)) but
thereafter it may be moved to a different place and may be continued
from day to day or recessed to a later day without notice other than
announcement thereof by the presiding officer at the hearing.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]
Modification, Transfer and Termination of Registration
Sec. 1309.61 Modification in registration.
Any registrant may apply to modify his or her registration to
authorize the handling of additional List I chemicals or to change his
or her name or address, by submitting a letter of request to the 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.
[[Page 111]]
Sec. 1309.62 Termination of registration.
(a) The registration of any person shall terminate if and when such
person dies, ceases legal existence, or discontinues business or
professional practice. Any registrant who cases legal existence or
discontinues business or professional practice shall promptly notify the
Special Agent in Charge of the Administration in the area in which the
person is located of such fact and seek authority and instructions to
dispose of any List I chemicals obtained under the authority of that
registration.
(b) The Special Agent in Charge shall authorize and instruct the
person to dispose of the List I chemical in one of the following
manners:
(1) By transfer to person registered under the Act and authorized to
possess the substances;
(2) By delivery to an agent of the Administration or to the nearest
office of the Administration;
(3) By such other means as the Special Agent in Charge may determine
to assure that the substance does not become available to unauthorized
persons.
[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]
Sec. 1309.63 Transfer of registration.
No registration or any authority conferred thereby shall be assigned
or otherwise transferred except upon such conditions as the
Administrator may specifically designate and then only pursuant to his
written consent.
Security Requirements
Sec. 1309.71 General security requirements.
(a) All applicants and registrants shall provide effective controls
and procedures to guard against theft and diversion of List I chemicals.
Specific attention shall be paid to storage of and controlling access to
List I chemicals as follows:
(1) Chemicals shall be stored in containers sealed in such a manner
as to indicate any attempts at tampering with the container. Where
chemicals cannot be stored in sealed containers, access to the chemicals
should be controlled through physical means or through human or
electronic monitoring.
(2) In retail settings open to the public where drugs containing
List I chemicals that are regulated pursuant to
Sec. 1310.01(b)(28)(i)(D) 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]
Effective Date Note: At 67 FR 14861, Mar. 28, 2002, Sec. 1309.71 was
amended by revising paragraph (a)(2), effective Apr. 29, 2002. For the
convenience of the user, the revised text follows:
[[Page 112]]
Sec. 1309.71 General security requirements.
(a) * * *
(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.
* * * * *
Sec. 1309.72 Felony conviction; employer responsibilities.
(a) The registrant shall exercise caution in the consideration of
employment of persons who will have access to listed chemicals, who have
been convicted of a felony offense relating to controlled substances or
listed chemicals, or who have, at any time, had an application for
registration with the DEA denied, had a DEA registration revoked, or
surrendered a DEA registration for cause. (For purposes of this
subsection, the term ``for cause'' means a surrender in lieu of, or as a
consequence of, any Federal or State administrative, civil or criminal
action resulting from an investigation of the individual's handling of
controlled substances or listed chemicals.) The registrant should be
aware of the circumstances regarding the action against the potential
employee and the rehabilitative efforts following the action. The
registrant shall assess the risks involved in employing such persons,
including the potential for action against the registrant pursuant to
Sec. 1309.43, If such person is found to have diverted listed chemicals,
and, in the event of employment, shall institute procedures to limit the
potential for diversion of List I chemicals.
(b) It is the position of DEA that employees who possess, sell, use
or divert listed chemicals or controlled substances will subject
themselves not only to State or Federal prosecution for any illicit
activity, but shall also immediately become the subject of independent
action regarding their continued employment. The employer will assess
the seriousness of the employee's violation, the position of
responsibility held by the employee, past record of employment, etc., in
determining whether to suspend, transfer, terminate or take other action
against the employee.
Sec. 1309.73 Employee responsibility to report diversion.
Reports of listed chemical diversion by fellow employees is not only
a necessary part of an overall employee security program but also serves
the public interest at large. It is, therefore, the position of DEA that
an employee who has knowledge of diversion from his employer by a fellow
employee has an obligation to report such information to a responsible
security official of the employer. The employer shall treat such
information as confidential and shall take all reasonable steps to
protect the confidentiality of the information and the identity of the
employee furnishing information. A failure to report information of
chemical diversion will be considered in determining the feasibility of
continuing to allow an employee to work in an area with access to
chemicals. The employer shall inform all employees concerning this
policy.
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES--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.
1310.14 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.
Authority: 21 U.S.C. 802, 830, 871(b).
Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.
[[Page 113]]
Sec. 1310.01 Definitions.
Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13968, Mar. 24, 1997]
Sec. 1310.02 Substances covered.
The following chemicals have been specifically designated by the
Administrator of the Drug Enforcement Administration as the listed
chemicals subject to the provisions of this part and parts 1309 and 1313
of this chapter. Each chemical has been assigned the DEA Chemical Code
Number set forth opposite it.
(a) List I chemicals
(1) Anthranilic acid, its esters, and its salts.....................8530
(2) Benzyl cyanide..................................................8735
(3) Ephedrine, its salts, optical isomers, and salts of optical isomers
8113
(4) Ergonovine and its salts........................................8675
(5) Ergotamine and its salts........................................8676
(6) N-Acetylanthranilic acid, its esters, and its salts.............8522
(7) Norpseudoephedrine, its salts, optical isomers, and salts of optical
isomers.............................................................8317
(8) Phenylacetic acid, its esters, and its salts....................8791
(9) Phenylpropanolamine, its salts, optical isomers, and salts of
optical isomers.....................................................1225
(10) Piperidine and its salts.......................................2704
(11) Pseudoephedrine, its salts, optical isomers, and salts of optical
isomers.............................................................8112
(12) 3,4-Methylenedioxyphenyl-2-propanone...........................8502
(13) Methylamine and its salts......................................8520
(14) Ethylamine and its salts.......................................8678
(15) Propionic anhydride............................................8328
(16) Isosafrole.....................................................8704
(17) Safrole........................................................8323
(18) Piperonal......................................................8750
(19) N-Methylephedrine, its salts, optical isomers, and salts of optical
isomers (N-Methylephedrine).........................................8115
(20) N-Methylpseudoephedrine, its salts, optical isomers, and salts of
optical isomers.....................................................8119
(21) Hydriodic Acid.................................................6695
(22) Benzaldehyde...................................................8256
(23) Nitroethane....................................................6724
(24) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2 (3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid
lactone; gamma-hydroxybutyric acid lactone).........................2011
(25) Red phosphorus.................................................6795
(26) White phosphorus (Other names: Yellow Phosphorus)..............6796
(27) Hypophosphorous acid and its salts (Including ammonium
hypophosphite, calcium hypophosphite, iron hypophosphite, potassium
hypophosphite, manganese hypophosphite, magnesium hypophosphite and
sodium hypophosphite)...............................................6797
(b) List II chemicals:
(1) Acetic anhydride................................................8519
(2) Acetone.........................................................6532
(3) Benzyl chloride.................................................8570
(4) Ethyl ether.....................................................6584
(5) Potassium permanganate..........................................6579
(6) 2-Butanone (or Methyl Ethyl Ketone or MEK)......................6714
(7) Toluene.........................................................6594
(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
[[Page 114]]
therefor. The Administrator need not accept a petition if any of the
requirements prescribed in paragraph (e) of this section or requested
pursuant to paragraph (f) of this section are lacking or are not clearly
set forth as to be readily understood. If the petitioner desires, he may
amend and resubmit the petition to meet the requirements of paragraphs
(e) and (f) of this section.
(h) If a petition is granted or the Administrator, upon his own
motion, proposes to add or delete substances as listed chemicals as set
forth in paragraph (c) of this section, he shall issue and publish in
the Federal Register a proposal to add or delete a substance as a listed
chemical. The Administrator shall permit any interested person to file
written comments regarding the proposal within 30 days of the date of
publication of his order in the Federal Register. The Administrator will
consider any comments filed by interested persons and publish a final
rule in accordance with his decision in the matter.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991;
57 FR 43615, Sept. 22, 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460,
June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65
FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001]
Sec. 1310.03 Persons required to keep records and file reports.
(a) Each regulated person who engages in a regulated transaction
involving a listed chemical, a tableting machine, or an encapsulating
machine shall keep a record of the transaction as specified by
Sec. 1310.04 and file reports as specified by Sec. 1310.05. However, a
non-regulated person who acquires listed chemicals for internal
consumption or ``end use'' and becomes a regulated person by virtue of
infrequent or rare distribution of a listed chemical from inventory,
shall not be required to maintain receipt records of listed chemicals
under this section.
(b) Each regulated person who manufactures a List I or List II
chemical shall file reports regarding such manufacture as specified in
Section 1310.05.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 8277, Feb. 28, 1991; 61
FR 14023, Mar. 29, 1996]
Effective Date Note: At 67 FR 14861, Mar. 28, 2002, Sec. 1310.03 was
amended by adding paragraph (c), effective Apr. 29, 2002. For the
convenience of the user, the added text follows:
Sec. 1310.03 Persons required to keep records and file reports.
* * * * *
(c) Each regulated person who engages in a transaction with a
nonregulated person which involves ephedrine, pseudoephedrine, or
phenylpropanolamine (including drug products containing these
chemicals), and uses or attempts to use the Postal Service or any
private or commercial carrier shall file monthly reports of each such
transaction as specified in Sec. 1310.05 of this part.
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.
[[Page 115]]
(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:
------------------------------------------------------------------------
Chemical Threshold by base weight
------------------------------------------------------------------------
(i) Anthranilic acid and its salts... 30 kilograms.
(ii) Benzyl cyanide.................. 1 kilogram.
(iii) Ergonovine and its salts....... 10 grams.
(iv) Ergotamine and its salts........ 20 grams.
(v) N-Acetylanthranilic acid and its 40 kilograms
salts.
(vi) Norpseudoephedrine, its salts, 2.5 kilograms.
optical isomers, and salts of
optical isomers.
(vii) Phenylacetic acid and its salts 1 kilogram.
(viii) Phenylpropanolamine, its 2.5 kilograms.
salts, optical isomers, and salts of
optical isomers.
(ix) Piperidine and its salts........ 500 grams.
(x) Pseudoephedrine, its salts, 1 kilogram
optical isomers, and salts of
optical isomers.
(xi) 3, 4-Methylenedioxyphenyl-2- 4 kilograms.
propanone.
(xii) Methylamine and its salts...... 1 kilogram.
(xiii) Ethylamine and its salts...... 1 kilogram.
(xiv) Propionic anhydride............ 1 gram.
(xv) Isosafrole...................... 4 kilograms.
(xvi) Safrole........................ 4 kilograms.
(xvii) Piperonal..................... 4 kilograms.
(xviii) N-Methylephedrine, its salts, 1 kilogram.
optical isomers, and salts of
optical isomers.
(xix) N-Methylpseudoephedrine, its 1 kilogram.
salts, optical isomers, and salts of
optical isomers.
(xx) Hydriotic acid (57%)............ 1.7 kilograms (or 1 liter by
volume).
(xxi) Benzaldehyde................... 4 Kilograms.
(xxii) Nitroethane................... 2.5 Kilograms.
------------------------------------------------------------------------
(2) List II Chemicals:
(i) Imports and Exports
----------------------------------------------------------------------------------------------------------------
Chemical Threshold by volume Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride................... 250 gallons........................ 1,023 kilograms.
(B) Acetone............................ 500 gallons........................ 1,500 kilograms.
(C) Benzyl chloride.................... N/A................................ 4 kilograms.
(D) Ethyl ether........................ 500 gallons........................ 1,364 kilograms.
(E) Potassium permanganate............. N/A................................ 500 kilograms.
(F) 2-Butanone (MEK)................... 500 gallons........................ 1,455 kilograms.
(G) Toluene............................ 500 gallons........................ 1,591 kilograms.
----------------------------------------------------------------------------------------------------------------
(ii) Domestic Sales
----------------------------------------------------------------------------------------------------------------
Chemical Threshold by volume Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride................... 250 gallons........................ 1,023 kilograms.
(B) Acetone............................ 50 gallons......................... 150 kilograms.
(C) Benzyl chloride.................... N/A................................ 1 kilogram.
(D) Ethyl ether........................ 50 gallons......................... 135.8 kilograms.
(E) Potassium permanganate............. N/A................................ 55 kilograms.
(F) 2-Butanone (MEK)................... 50 gallons......................... 145 kilograms.
(G) Toluene............................ 50 gallons......................... 159 kilograms.
(H) Iodine............................. N/A................................ 0.4 kilograms.
(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
[[Page 116]]
(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. 1310.01(f). All such transactions, regardless of
size, are subject to recordkeeping and reporting requirements as set
forth in this part 1310 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
(2) [Reserved]
[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]
Effective Date Note: At 67 FR 14861, Mar. 28, 2002, Sec. 1310.04 was
amended by removing paragraph (g) and revising paragraph (f)(1),
effective Apr. 29, 2002. For the convenience of the user, the revised
text follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(f) * * *
(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) Ephedrine, its salts, optical isomers, No threshold. All
and salts of optical isomers. transactions regulated.
(D) Ergonovine and its salts.............. 10 grams.
(E) Ergotamine and its salts.............. 20 grams.
(F) N-Acetylanthranilic acid, its esters, 40 kilograms.
and its salts.
(G) Norpseudoephedrine, its salts, optical 2.5 kilograms.
isomers, and salts of optical isomers.
(H) Phenylacetic acid, its esters, and its 1 kilogram.
salts.
(I) Phenylpropanolamine, its salts, 2.5 kilograms.
optical isomers, and salts of optical
isomers.
(J) Piperidine and its salts.............. 500 grams.
(K) Pseudoephedrine, its salts, optical 1 kilogram.
isomers, and salts of optical isomers.
(L) 3,4-Methylenedioxyphenyl-2-propanone.. 4 kilograms.
(M) Methylamine and its salts............. 1 kilogram.
(N) Ethylamine and its salts.............. 1 kilogram.
(O) Propionic anhydride................... 1 gram.
(P) Isosafrole............................ 4 kilograms.
(Q) Safrole............................... 4 kilograms.
(R) Piperonal............................. 4 kilograms.
(S) N-Methylephedrine, its salts, optical 1 kilogram.
isomers, and salts of optical isomers (N-
Methylephedrine).
(T) N-Methylpseudoephedrine, its salts, 1 kilogram.
optical isomers, and salts of optical
isomers.
(U) Hydriodic Acid........................ 1.7 kilograms (or 1 liter by
volume).
(V) Benzaldehyde.......................... 4 kilograms.
(W) Nitroethane........................... 2.5 kilograms.
------------------------------------------------------------------------
(ii) Notwithstanding the thresholds established in paragraph
(f)(1)(i) 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 24 grams.
distributors.
[[Page 117]]
(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)(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 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)(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 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 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 24 grams.
to report under Sec. 1310.03(c) of
this part.
(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.
------------------------------------------------------------------------
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 28346, 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.
[[Page 118]]
(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 Secs. 1310.01(f)(1)(iv) or
1310.01(f)(1)(v) except as set forth in Sec. 1310.06(h)(5). Bulk
manufacturers that produce a listed chemical solely for internal
consumption shall not be required to report for that listed chemical.
For purposes of these reporting requirements, internal consumption shall
consist of any quantity of a listed chemical otherwise not available for
further resale or distribution. Internal consumption shall include (but
not be limited to) quantities used for quality control testing,
quantities consumed in-house or production losses. Internal consumption
does not include the quantities of a listed chemical consumed in the
production of exempted products. If an existing standard industry report
contains the information required in Sec. 1310.06(h) and such
information is separate or readily retrievable from the report, that
report may be submitted in satisfaction of this requirement. Each report
shall be submitted to the DEA under company letterhead and signed by an
appropriate, responsible official. For purposes of this paragraph only,
the term regulated bulk manufacturer of a listed chemical means a person
who manufactures a listed chemical by means of 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.
[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]
Effective Date Note: At 67 FR 14862, Mar. 28, 2002, Sec. 1310.05 was
amended by adding paragraph (e), effective Apr. 29, 2002. For the
convenience of the user, the added text follows:
Sec. 1310.05 Reports.
* * * * *
(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.
Sec. 1310.06 Content of records and reports.
(a) Each record required by Sec. 1310.03 shall include the
following:
(1) The name, address, and, if required, DEA registration number of
each party to the regulated transaction.
(2) The date of the regulated transaction.
(3) The name, quantity and form of packaging of the listed chemical
or a description of the tableting machine or encapsulating machine
(including make, model and serial number).
(4) The method of transfer (company truck, picked up by customer,
etc.).
(5) The type of identification used by the purchaser and any unique
number on that identification.
[[Page 119]]
(b) For purposes of this section, normal business records shall be
considered adequate if they contain the information listed in paragraph
(a) of this section and are readily retrievable from other business
records of the regulated person. For prescription drug products,
prescription and hospital records kept in the normal course of medical
treatment shall be considered adequate for satisfying the requirements
of paragraph (a) of this section with respect to dispensing to patients,
and records required to be maintained pursuant to the Federal Food and
Drug Administration regulations relating to the distribution of
prescription drugs, as set forth in 21 CFR part 205, shall be considered
adequate for satisfying the requirements of paragraph (a) of this
section with respect to distributions.
(c) Each report required by Section 1310.05(a) shall include the
information as specified by Section 1310.06(a) and, where obtainable,
the registration number of the other party, if such party is registered.
A report submitted pursuant to Sec. 1310.05(a)(1) or (a)(4) must also
include a description of the circumstances leading the regulated person
to make the report, such as the reason that the method of payment was
uncommon or the loss unusual. If the report is for a loss or
disappearance under Sec. 1310.05(a)(4), the circumstances of such loss
must be provided (in-transit, theft from premises, etc.)
(d) A suggested format for the reports is provided below:
Supplier:
Registration Number_____________________________________________________
Name____________________________________________________________________
Business Address________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Business Phone__________________________________________________________
Purchaser:
Registration Number_____________________________________________________
Name____________________________________________________________________
Business Address________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Business Phone__________________________________________________________
Identification__________________________________________________________
Shipping Address (if different than purchaser Address):
Street__________________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Date of Shipment________________________________________________________
Name of Listed Chemical(s)______________________________________________
Quantity and Form of Packaging__________________________________________
Description of Machine:
Make____________________________________________________________________
Model___________________________________________________________________
Serial ________________________________________________________
Method of Transfer______________________________________________________
If Loss or Disappearance:
Date of Loss____________________________________________________________
Type of Loss____________________________________________________________
Description of Circumstances____________________________________________
Public reporting burden for this collection of information is estimated
to average ten minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to the Drug Enforcement Administration, Records
Management Section, Washington, D.C. 20537; and to the Office of
Management and Budget, Paperwork Reduction Project No. 1117-0024,
Washington, D.C. 20503.
(e) Each report of an importation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c) shall include the
following information:
(1) The name, address, telephone number, telex number, and, where
available, the facsimile number of the regulated person; the name,
address, telephone number, telex number, and, where available, the
facsimile number of the import broker or forwarding agent, if any:
(2) The description of each machine (including make, model, and
serial number) and the number of machines being received;
(3) The proposed import date, and the first U.S. Customs Port of
Entry; and
(4) The name, address, telephone number, telex number, and, where
available, the facsimile number of the
[[Page 120]]
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 28346, 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.
[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]
Effective Date Note: At 67 FR 14862, Mar. 28, 2002, Sec. 1310.06 was
amended by adding paragraphs (i) and (j), effective Apr. 29, 2002. For
the convenience of the user, the added text follows:
Sec. 1310.06 Content of records and reports.
* * * * *
(i) Each monthly report required by Sec. 1310.05(e) of this part
shall provide the following information for each distribution:
(1) Supplier name and registration number.
(2) Purchaser's name and address.
(3) Name/address shipped to (if different from purchaser's name/
address).
(4) Name of the chemical and total amount shipped (i.e.
Pseudoephedrine, 250 grams).
(5) Date of shipment.
(6) Product name (if drug product).
(7) Dosage form (if drug product) (i.e., pill, tablet, liquid).
(8) Dosage strength (if drug product) (i.e., 30mg, 60mg, per dose
etc.).
(9) Number of dosage units (if drug product) (100 doses per
package).
(10) Package type (if drug product) (bottle, blister pack, etc.).
(11) Number of packages (if drug product) (10 bottles).
(12) Lot number (if drug product).
[[Page 121]]
(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.
Sec. 1310.07 Proof of identity.
(a) Each regulated person who engages in a regulated transaction
must identify the other party to the transaction. For domestic
transaction, this shall be accomplished by having the other party
present documents which would verify the identity, or registration
status if a registrant, of the other party to the regulated person at
the time the order is placed. For export transactions, this shall be
accomplished by good faith inquiry through reasonably available research
documents or publicly available information which would indicate the
existence of the foreign customer. No proof of identity is required for
foreign suppliers.
(b) The regulated person must verify the existence and apparent
validity of a business entity ordering a listed chemical, tableting
machine or encapsulating machine. For domestic transactions, this may be
accomplished by such methods as checking the telephone directory, the
local credit bureau, the local Chamber of Commerce or the local Better
Business Bureau, or, if the business entity is a registrant, by
verification of the registration. For export transactions, a good faith
inquiry to verify the existence and apparent validity of a foreign
business entity may be accomplished by such methods as verifying the
business telephone listing through international telephone information,
the firm's listing in international or foreign national chemical
directories or other commerce directories or trade publications,
confirmation through foreign subsidiaries of the U.S. regulated person,
verification through the country of destination's embassy Commercial
Attache, or official documents provided by the purchaser which confirm
the existence and apparent validity of the business entity.
(c) When transacting business with a new representative of a firm,
the regulated person must verify the claimed agency status of the
representative.
(d) For sales to individuals or cash purchasers, the type of
documents and other evidence of proof must consist of at least a
signature of the purchaser, a driver's license and one other form of
identification. Any exports to individuals or exports paid in cash are
suspect and should be handled as such. For such exports, the regulated
person shall diligently obtain from the purchaser or independently seek
to confirm clear documentation which proves the person is properly
identified such as through foreign identity documents, driver's license,
passport information and photograph, etc. Any regulated person who fails
to adequately prove the identity of the other party to the transaction
may be subject to the specific penalties provided for violations of law
related to regulated transactions in listed chemicals.
(e) For a new customer who is not an individual or cash customer,
the regulated person shall establish the identity of the authorized
purchasing agent or agents and have on file that person's signature,
electronic password, or other identification. Once the authorized
purchasing agent has been established, the agent list may be updated
annually rather than on each order. The regulated person must ensure
that shipments are not made unless the order is placed by an authorized
agent of record.
(f) With respect to electronic orders, the identity of the purchaser
shall consist of a computer password, identification number or some
other means of identification consistent with electronic orders and with
Sec. 1310.07(e).
[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32461, June 22, 1995]
Sec. 1310.08 Excluded transactions.
Pursuant to 21 U.S.C. 802(39)(A)(iii), regulation of the following
transactions has been determined to be unnecessary for the enforcement
of the Chemical Diversion and Trafficking Act and, therefore, they have
been excluded from the definitions of regulated transactions:
(a) Domestic and import transactions of hydrochloric and sulfuric
acids but
[[Page 122]]
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 return shipments of reusable containers from customer
to producer containing residual red phosphorus or white phosphorus in
isotainers and rail cars with capacities greater than or equal to 2500
gallons (in a single container).
[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]
Sec. 1310.09 Temporary exemption from registration.
(a) Each person required by section 302 of the act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export a combination
ephedrine product is temporarily exempted from the registration
requirement, provided that the person submits a proper application for
registration on or before July 12, 1997. The exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in parts 1309, 1310, and 1313 of this chapter remain in full
force and effect.
(b) Each person required by section 302 of the act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export a drug product
that contains pseudoephedrine or phenylpropanolamine that is regulated
pursuant to Sec. 1300.02(b)(28)(1)(D) of this chapter is temporarily
exempted from the registration requirement, provided that the person
submits a proper application for registration on or before December 3,
1997. The exemption will remain in effect for each person who has made
such application until the Administration has approved or denied that
application. This exemption applies only to registration; all other
chemical control requirements set forth in parts 1309, 1310, and 1313 of
this chapter remain in full force and effect.
(c) Each person required by section 302 of the act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export GBL is
temporarily exempted from the registration requirement, provided that
the DEA receives a proper 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
[[Page 123]]
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.
[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]
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 under paragraph (a) of
this section, 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
[[Page 124]]
upon which the order is based, the Administrator shall immediately
suspend the effectiveness of the order until he may reconsider the
application in light of the comments and objections filed. Thereafter,
the Administrator shall reinstate, revoke, or amend his original order
as he determines appropriate.
(f) Unless the Administrator has evidence that the drug product is
being diverted, as determined by applying the factors set forth in
paragraph (a) of this section, and the Administrator so notifies the
applicant, transactions involving a specific drug product will not be
considered regulated transactions during the following periods:
(1) While a bonafide application for reinstatement of exemption
under paragraph (d) of this section for the specific drug product is
pending resolution, provided that the application for reinstatement is
filed not later than 60 days after the publication of the final order
removing the exemption; and
(2) For a period of 60 days following the Administrator's denial of
an application for reinstatement.
(g) An order published by the Administrator in the Federal Register,
pursuant to paragraph (e) of this section, to reinstate an exemption may
be modified or revoked with respect to a particular drug product upon a
finding that:
(1) Applying the factors set forth in paragraph (a) of this section
to the particular drug product, the drug product is being diverted; or
(2) There is a significant change in the data that led to the
issuance of the final rule.
[60 FR 32461, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
Effective Date Note: At 67 FR 14862, Mar. 28, 2002, Sec. 1310.10 was
amended by revising the introductory text of paragraph (d), effective
Apr. 29, 2002. For the convenience of the user, the revised text
follows:
Sec. 1310.10 Removal of the exemption of drugs distributed under the
Food, Drug, and Cosmetic Act.
* * * * *
(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:
* * * * *
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. 1310.14 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
[[Page 125]]
ephedrine together with a therapeutically significant quantity of
another active medicinal ingredient.
(b) An application for an exemption under this section shall contain
the following information:
(1) The name and address of the applicant;
(2) The exact trade name of the drug product for which exemption is
sought;
(3) The complete quantitative and qualitative composition of the
drug product;
(4) A brief statement of the facts which the applicant believes
justify the granting of an exemption under this section; and
(5) Certification by the applicant that the product may be lawfully
marketed or distributed under the Food, Drug, and Cosmetic Act.
(6) The identification of any information on the application which
is considered by the applicant to be a trade secret or confidential and
entitled to protection under U.S. laws restricting the public disclosure
of such information by government employees.
(c) The Administrator may require the applicant to submit such
additional documents or written statements of fact relevant to the
application which he deems necessary for determining if the application
should be granted.
(d) Within a reasonable period of time after the receipt of a
completed application for an exemption under this section, the
Administrator shall notify the applicant of acceptance or non-acceptance
of the application. If the application is not accepted, an explanation
will be provided. The Administrator is not required to accept an
application if any of the information required in paragraph (b) of this
section or requested pursuant to paragraph (c) of this section is
lacking or not readily understood. The applicant may, however, amend the
application to meet the requirements of paragraphs (b) and (c) of this
section. If the application is accepted for filing, the Administrator
shall issue and publish in the Federal Register an order on the
application, which shall include a reference to the legal authority
under which the order is based. This order shall specify the date on
which it shall take effect. The Administrator shall permit any
interested person to file written comments on or objections to the
order. If any comments or objections raise significant issues regarding
any findings of fact or law upon which the order is based, the
Administrator shall immediately suspend the effectiveness of the order
until he may reconsider the application in light of the comments and
objections filed. Thereafter, the Administrator shall reinstate, revoke,
or amend the original order as deemed appropriate.
[60 FR 32462, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
Sec. 1310.15 Exempt drug products containing ephedrine and
therapeutically significant quantities of another active medicinal
ingredient.
(a) The drug products containing ephedrine and therapeutically
significant quantities of another active medicinal ingredient listed in
paragraph (e) of this section have been exempted by the Administrator
from application of sections 302, 303, 310, 1007, and 1008 of the Act
(21 U.S.C. 822-3, 830, and 957-8) to the extent described in paragraphs
(b), (c), and (d) of this section.
(b) No exemption granted pursuant to 1310.14 affects the criminal
liability for illegal possession or distribution of listed chemicals
contained in the exempt drug product.
(c) Changes in drug product compositions: Any change in the
quantitative or qualitative composition of an exempt drug product listed
in paragraph (d) requires a new application for exemption.
(d) In addition to the drug products listed in the compendium set
forth in Sec. 1310.01(b)(28)(i)(D)(1), the following 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]........................... ....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
[[Page 126]]
[60 FR 32463, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
PARTS 1311 [RESERVED]
PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES--Table of Contents
Sec.
1312.01 Scope of part 1312.
1312.02 Definitions.
Importation of Controlled Substances
1312.11 Requirement of authorization to import.
1312.12 Application for import permit.
1312.13 Issuance of import permit.
1312.14 Distribution of copies of import permit.
1312.15 Shipments in greater or less amount than authorized.
1312.16 Cancellation of permit; expiration date.
1312.17 Special report from importers.
1312.18 Contents of import declaration.
1312.19 Distribution of import declaration.
Exportation of Controlled Substances
1312.21 Requirement of authorization to export.
1312.22 Application for export permit.
1312.23 Issuance of export permit.
1312.24 Distribution of copies of export permit.
1312.25 Expiration date.
1312.26 Records required of exporter.
1312.27 Contents of special controlled substances invoice.
1312.28 Distribution of special controlled substances invoice.
1312.29 Domestic release prohibited.
1312.30 Schedule III, IV, and V non-narcotic controlled substances
requiring an import and export permit.
Transshipment and In-Transit Shipment of Controlled Substances
1312.31 Schedule I: Application for prior written approval.
1312.32 Schedules II, III, IV: Advance notice.
Hearings
1312.41 Hearings generally.
1312.42 Purpose of hearing.
1312.43 Waiver or modification of rules.
1312.44 Request for hearing or appearance; waiver.
1312.45 Burden of proof.
1312.46 Time and place of hearing.
1312.47 Final order.
Authority: 21 U.S.C. 952, 953, 954, 957, 958.
Source: 36 FR 7815, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
Sec. 1312.01 Scope of part 1312.
Procedures governing the importation, exportation, transshipment and
intransit shipment of controlled substances pursuant to section 1002,
1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are governed
generally by those sections and specifically by the sections of this
part.
Sec. 1312.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13969, Mar. 24, 1997]
Importation of Controlled Substances
Sec. 1312.11 Requirement of authorization to import.
(a) No person shall import or cause to be imported any controlled
substance listed in Schedule I or II or any narcotic controlled
substance listed in Schedule III, IV or V or any non-narcotic controlled
substance in Schedule III which the Administrator has specifically
designated by regulation in Sec. 1312.30 of this part or any non-
narcotic controlled substance in Schedule IV or V which is also listed
in Schedule I or II of the Convention on Psychotropic Substances unless
and until such person is properly registered under the Act (or exempt
from registration) and the Administrator has issued him a permit to do
so pursuant to Sec. 1312.13 of this part.
(b) No person shall import or cause to be imported any non-narcotic
controlled substance listed in Schedule III, IV or V, excluding those
described in paragraph (a) of this section, unless and until such person
is properly registered under the Act (or exempt from registration) and
has filed an import declaration to do so with the Administrator,
pursuant to Sec. 1312.18 of this part.
(c) When an import permit or declaration is required, a separate
permit or declaration must be obtained for
[[Page 127]]
each consignment of controlled substances to be imported.
[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17289,
May 7, 1987]
Sec. 1312.12 Application for import permit.
(a) An application for a permit to import controlled substances
shall be made on DEA Form 357. DEA Form 357 may be obtained from, and
shall be filed with, the Drug Enforcement Administration, Drug
Operations Section, Washington, DC 20537. Each application shall show
the date of execution; the registration number of the importer; a
detailed description of each controlled substance to be imported
including the drug name, dosage form, National Drug Code (NDC) number,
the Administration Controlled Substance Code Number as set forth in part
1308 of this chapter, the number and size of packages or containers, the
name and quantity of the controlled substance contained in any finished
dosage units, and the net quantity of any controlled substance
(expressed in anhydrous acid, base or alkaloid) given in kilograms or
parts thereof. The application shall also include the following:
(1) The name, address, and business of the consignor, if known at
the time application is submitted, but if unknown at that time, the fact
should be indicated and the name and address afterwards furnished to the
Administrator as soon as ascertained by the importer;
(2) The foreign port of exportation (i.e., the place where the
article will begin its journey of exportation to the United States);
(3) The port of entry into the United States;
(4) The latest date said shipment will leave said foreign port;
(5) The stock on hand of the controlled substance desired to be
imported;
(6) The name of the importing carrier or vessel (if known, or if
unknown it should be stated whether shipment will be made by express,
freight, or otherwise, imports of controlled substances in Schedules I
or II and narcotic drugs in Schedules III, IV, or V by mail being
prohibited);
(7) The total tentative allotment to the importer of such controlled
substance for the current calendar year;
(8) The total number of kilograms of said allotment for which
permits have previously been issued and the total quantity of controlled
substance actually imported during the current year to date.
(b) If desired, alternative foreign ports of exportation within the
same country may be indicated upon the application (e.g., (1) Calcutta,
(2) Bombay). If a formal permit is issued pursuant to such application,
it will bear the names of the two ports in the order given in the
application and will authorize shipment from either port. Alternate
ports in different countries will not be authorized in the same permit.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 43218,
Dec. 11, 1974; 45 FR 74715, Nov. 12, 1980; 51 FR 5319 and 5320, Feb. 13,
1986; 52 FR 17289, May 7, 1987; 62 FR 13969, Mar. 24, 1997]
Sec. 1312.13 Issuance of import permit.
(a) The Administrator may authorize importation of any controlled
substance listed in Schedule I or II or any narcotic drug listed in
Schedule III, IV, or V if he finds:
(1) That the substance is crude opium, poppy straw, concentrate of
poppy straw, or coca leaves, in such quantity as the Administrator finds
necessary to provide for medical, scientific, or other legitimate
purposes;
(2) That the substance is necessary to provide for medical and
scientific needs or other legitimate needs of the United States during
an emergency where domestic supplies of such substance or drug are found
to be inadequate, or in any case in which the Administrator finds that
competition among domestic manufacturers of the controlled substance is
inadequate and will not be rendered adequate by the registration of
additional manufacturers under section 303 of the Controlled Substances
Act (21 U.S.C. 823); or
(3) That the domestic supply of any controlled substance is
inadequate for scientific studies, and that the importation of that
substance for scientific
[[Page 128]]
purposes is only for delivery to officials of the United Nations, of the
United States, or of any State, or to any person registered or exempted
from registration under sections 1007 and 1008 of the Act (21 U.S.C. 957
and 958).
(4) That the importation of the controlled substance is for
ballistics or other analytical or scientific purposes, and that the
importation of that substance is only for delivery to officials of the
United Nations, of the United States, or of any State, or to any person
registered or exempted from registration under sections 1007 and 1008 of
the Act (21 U.S.C. 957 and 958).
(b) The Administrator may require that such non-narcotic controlled
substances in Schedule III as he shall designate by regulation in
Sec. 1312.30 of this part be imported only pursuant to the issuance of
an import permit. The Administrator may authorize the importation of
such substances if he finds that the substance is being imported for
medical, scientific or other legitimate uses.
(c) If a non-narcotic substance listed in Schedule IV or V is also
listed in Schedule I or II of the Convention on Psychotropic Substances,
1971, it shall be imported only pursuant to the issuance of an import
permit. The Administrator may authorize the importation of such
substances if it is found that the substance is being imported for
medical, scientific or other legitimate uses.
(d) The Administrator may require an applicant to submit such
documents or written statements of fact relevant to the application as
he deems necessary to determine whether the application should be
granted. The failure of the applicant to provide such documents or
statements within a reasonable time after being requested to do so shall
be deemed to be a waiver by the applicant of an opportunity to present
such documents or facts for consideration by the Administrator in
granting or denying the application.
(e) Each import permit shall be issued in sextuplet and serially
numbered, with all six copies bearing the same serial number and being
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc.,
respectively. All copies of import permits shall bear the signature of
the Director or his delegate, and facsimiles of signatures shall not be
used. No permit shall be altered or changed by any person after being
signed by the Administrator or his delegate and any change or alteration
upon the face of any permit after it shall have been signed by the
Administrator or his delegate shall render it void and of no effect.
Permits are not transferable. Each copy of the permit shall have printed
or stamped thereon the disposition to be made thereof. Each permit shall
be dated and shall certify that the importer named therein is thereby
permitted as a registrant under the Act, to import, through the port
named, one shipment of not to exceed the specified quantity of the named
controlled substances, shipment to be made before a specified date. Not
more than one shipment shall be made on a single import permit. The
permit shall state that the Administrator is satisfied that the
consignment proposed to be imported is required for legitimate purposes.
(f) Notwithstanding paragraphs (a)(1) and (a)(2) of this section,
the Administrator shall permit, pursuant to 21 U.S.C. 952(a)(1) or
(a)(2)(A), the importation of approved narcotic raw material (opium,
poppy straw and concentrate of poppy straw) having as its source:
(1) Turkey,
(2) India,
(3) Yugoslavia,
(4) France,
(5) Poland,
(6) Hungary, and
(7) Australia.
(g) At least eighty (80) percent of the narcotic raw material
imported into the United States shall have as its original source Turkey
and India. Except under conditions of insufficient supplies of narcotic
raw materials, not more than twenty (20) percent of the narcotic raw
material imported into the United States annually shall have as its
source Yugoslavia, France, Poland, Hungary and Australia.
[36 FR 23624, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 41776,
Aug. 18, 1981; 52 FR 17289, May 7, 1987]
[[Page 129]]
Sec. 1312.14 Distribution of copies of import permit.
Copies of the import permit shall be distributed and serve purposes
as follows:
(a) The original and quintuplet copies (Copy 1 and Copy 5) shall be
transmitted by the Administration to the importer, who shall retain the
quintuplet copy (Copy 5) on file as his record of authority for the
importation, and shall transmit the original copy (Copy 1) to the
foreign exporter. The foreign exporter will submit the original copy
(Copy 1) to the proper governmental authority in the exporting country,
if required, as a prerequisite to the issuance of an export
authorization. This copy of the permit will accompany the shipment. Upon
arrival of the imported merchandise, the District Director of the U.S.
Customs Service at the port of entry will, after appraising the
merchandise, forward the original copy (Copy 1) to the Drug Operations
Section with a report on the reverse side of such copy, showing the name
of the port of importation, date prepared, name and net quantity of each
substance, and report of analysis of the merchandise entered.
(b) The duplicate copy (Copy 2) shall be forwarded by the
Administration to the proper governmental authorities of the exporting
country.
(c) The quadruplet copy (Copy 4) shall be forwarded by the
Administration to the District Director of the U.S. Customs Service at
the U.S. port of entry, which shall be the customs port of destination
in the case of shipments transported under immediate transportation
entries, in order that the District Director may compare it with the
original copy (Copy 1) and the bill of lading upon arrival of the
merchandise. If a discrepancy is noted between corresponding items upon
different copies of a permit bearing the same serial number when
compared by the District Director, he shall refuse to permit entry of
the merchandise until the facts are communicated to the Administration
and further instructions are received.
(d) The triplicate copy (Copy 3) and sextuplet copy (Copy 6) shall
be retained by the Administration.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45
FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov.
30, 1988; 62 FR 13969, Mar. 24, 1997]
Sec. 1312.15 Shipments in greater or less amount than authorized.
(a) If the shipment made under an import permit is greater than the
maximum amount authorized to be imported under the permit, as determined
at the weighing by the District Director of the U.S. Customs Service,
such difference shall be seized subject to forfeiture, pending an
explanation; except that shipments of substances exceeding the maximum
authorized amount by less than 1 percent may be released to the importer
upon the filing by him of an amended import permit. If the substance is
included in Schedule I, it will be summarily forfeited to the
Government.
(b) If the shipment made under the permit is less than the maximum
amount authorized to be imported under the permit as determined at the
weighing by the District Director of the U.S. Customs Service, such
difference, when ascertained by the Administration, shall be recredited
to the tentative allotment against which the quantity covered by the
permit was charged, and the balance of any such tentative allotment with
any such recredits will remain available to the importer to whom made
(unless previously revoked in whole or in part), for importations
pursuant to any permit or permits as are requested and issued during the
remainder of the calendar year to which the allotment is applicable. No
permit shall be issued for importation of a quantity of controlled
substances as a charge against the tentative allotment for a given
calendar year, after the close of such calendar year, unless the
Director of the Administration decides to make an exception for good
cause shown.
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 46 FR 28841, May 29, 1981]
[[Page 130]]
Sec. 1312.16 Cancellation of permit; expiration date.
(a) A permit may be canceled after being issued, at the request of
the importer, provided no shipment has been made thereunder. In the
event that a permit is lost, the Administrator may, upon the production
by the importer of satisfactory proof, by affidavit or otherwise, issue
a duplicate permit. Nothing in this part shall affect the right, hereby
reserved by the Administrator, to cancel a permit at any time for proper
cause.
(b) An import permit shall not be valid after the date specified
therein, and in no event shall the date be subsequent to 6 months after
the date the permit is issued. Any unused import permit shall be
returned for cancellation by the registrant to the Drug Enforcement
Administration, Drug Operations Section, Washington, DC 20537.
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]
Sec. 1312.17 Special report from importers.
Whenever requested by the Administrator, importers shall render to
him not later than 30 days after receipt of the request therefor a
statement under oath of the stocks of controlled substances on hand as
of the date specified by the Administrator in his request, and, if
desired by the Administrator, an estimate of the probable requirements
for legitimate uses of the importer for any subsequent period that may
be designated by the Administrator. In lieu of any special statement
that may be considered necessary, the Administrator may accept the
figures given upon the reports subsequent by said importer under part
1304 of this chapter.
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
as amended at 62 FR 13969, Mar. 24, 1997]
Sec. 1312.18 Contents of import declaration.
(a) Any non-narcotic controlled substance listed in Schedule III,
IV, or V, not subject to the requirement of an import permit pursuant to
Sec. 1312.13 (b) or (c) of this chapter, may be imported if that
substance is needed for medical, scientific or other legitimate uses in
the United States, and will be imported pursuant to a controlled
substances import declaration.
(b) Any person registered or authorized to import and desiring to
import any non-narcotic controlled substance in Schedules III, IV, or V
which is not subject to the requirement of an import permit as described
in paragraph (a) of this section, must furnish a controlled substances
import declaration on DEA Form 236 to the Drug Enforcement
Administration, Drug Operations Section, Washington, DC 20537, not later
than 15 calendar days prior to the proposed date of importation and
distribute four copies of same as hereinafter directed in Sec. 1312.19.
(c) DEA Form 236 must be executed in quintuplicate and will include
the following information:
(1) The name, address, and registration number of the importer; and
the name and address and registration number of the import broker, if
any; and
(2) A complete description of the controlled substances to be
imported, including drug name, dosage form, National Drug Code (NDC)
number, the Administration Controlled Substances Code Number as set
forth in part 1308 of this chapter, the number and size of packages or
containers, the name and quantity of the controlled substance contained
in any finished dosage units, and the net quantity of any controlled
substance (expressed in anhydrous acid, base, or alkaloid) given in
kilograms or parts thereof; and
(3) The proposed import date, the foreign port of exportation to the
United States, the port of entry, and the name, address, and
registration number of the recipient in the United States; and
(4) The name and address of the consignor in the foreign country of
exportation, and any registration or license numbers if the consignor is
required to have such numbers either by the country of exportation or
under U.S. law.
(d) Notwithstanding the time limitations included in paragraph (a)
of this section, an applicant may obtain a special waiver of these time
limitations in
[[Page 131]]
emergency or unusual instances, provided that a specific confirmation is
received from the Administrator or his delegate advising the registrant
to proceed pursuant to the special waiver.
[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715,
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62
FR 13969, Mar. 24, 1997]
Sec. 1312.19 Distribution of import declaration.
The required five copies of the controlled substances import
declaration will be distributed as follows:
(a) Copy 1, Copy 2, and Copy 3 shall be transmitted to the foreign
shipper. The foreign shipper will submit Copy 1 to the proper
governmental authority in the foreign country, if required as a
prerequisite to export authorization. Copy 1 will then accompany the
shipment to its destination, and shall be retained on file by the
importer. Copy 2 shall be detached and retained by the appropriate
customs official of the foreign country. Copy 3 shall be removed by the
District Director of the U.S. Customs Service at the port of entry, who
shall sign and date the certification of customs on Copy 3, noting any
changes from the entries made by the importer, and shall then forward
that copy to the Drug Operations Section of the Administration.
(b) Copy 4 shall be forwarded, within the time limit required in
Sec. 1312.18, directly to the Drug Enforcement Administration, Drug
Operations Section, Washington, DC 20537.
(c) Copy 5 shall be retained by the importer on file as his record
of authority for the importation.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971; 37
FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and
further amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13,
1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]
Exportation of Controlled Substances
Sec. 1312.21 Requirement of authorization to export.
(a) No person shall in any manner export or cause to be exported
from the United States any controlled substance listed in Schedule I or
II, or any narcotic substance listed in Schedule III or IV, or any non-
narcotic substance in Schedule III which the Administrator has
specifically designated by regulation in Sec. 1312.30 of this part or
any non-narcotic substance in Schedule IV or V which is also listed in
Schedule I or II of the Convention on Psychotropic Substances unless and
until such person is properly registered under the Act (or exempted from
registration) and the Administrator has issued a permit pursuant to
Sec. 1312.23 of this part.
(b) No person shall in any manner export or cause to be exported
from the United States any non-narcotic controlled substance listed in
Schedule III, IV, or V, excluding those described in paragraph (a) of
this section, or any narcotic controlled substance listed in Schedule V,
unless and until such person is properly registered under the Act (or
exempted from registration) and has furnished a special controlled
substance export invoice as provided by section 1003 of the Act (21
U.S.C. 953(e)) to the Administrator pursuant to Sec. 1312.28 of this
part.
(c) A separate authorization repuest is obtained for each
consignment of such controlled substances to be exported.
[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290,
May 7, 1987]
Sec. 1312.22 Application for export permit.
(a) An application for a permit to export controlled substances
shall be made on DEA Form 161 which may be obtained from, and shall be
filed with, the Drug Enforcement Administration, Drug Operations
Section, Washington, DC 20537. Each application shall show the
exporter's name, address, and registration number; a detailed
description of each controlled substance desired to be exported
including the drug name, dosage form, National Drug Code (NDC) number,
the Administration Controlled Substance Code Number as set forth in part
1308 of this chapter, the number and size of packages or containers, the
name and quantity of the controlled substance contained in any finished
dosage units, and the
[[Page 132]]
quantity of any controlled substance (expressed in anhydrous acid, base,
or alkaloid) given in kilograms or parts thereof. The application shall
include the name, address, and business of the consignee, foreign port
of entry, the port of exportation, the approximate date of exportation,
the name of the exporting carrier or vessel (if known, or if unknown it
should be stated whether shipment will be made by express, freight, or
otherwise, exports of controlled substances by mail being prohibited),
the date and number, if any, of the supporting foreign import license or
permit accompanying the application, and the authority by whom such
foreign license or permit was issued. The application shall also contain
an affidavit that the packages are labeled in conformance with
obligations of the United States under international treaties,
conventions, or protocols in effect on May 1, 1971, and that, to the
best of affiant's knowledge and belief, the controlled substances
therein are to be applied exclusively to medical or scientific uses
within the country to which exported, will not be reexported therefrom
and that there is an actual need for the controlled substance for
medical or scientific uses within such country. In the case of
exportation of crude cocaine, the affidavit may state that to the best
of knowledge and belief, the controlled substances will be processed
within the country to which exported, either for medical or scientific
use within that country or for reexportation in accordance with the laws
of that country to another for medical or scientific use within that
country. The application shall be signed and dated by the exporter and
shall contain the address from which the substances will be shipped for
exportation.
(b) There shall also be submitted with the application any import
license or permit (and a translation thereof if in a foreign language)
or a certified copy of any such license or permit issued by competent
authorities in the country of destination, or other documentary evidence
deemed adequate by the Administrator, showing that the merchandise is
consigned to an authorized permittee, that it is to be applied
exclusively to medical or scientific use within the country of
destination, that it will not be reexported from such country, and that
there is an actual need for the controlled substance for medical or
scientific use within such country. (In the case of exportation of bulk
coca leaf alkaloid, the submitted evidence need only show the material
outlined in paragraph (a) of this section for such exportations.)
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, 1997]
Sec. 1312.23 Issuance of export permit.
(a) The Administrator may authorize exportation of any controlled
substance listed in Schedule I or II or any narcotic controlled
substance listed in Schedule III or IV if he finds that such exportation
is permitted by subsections 1003(a), (b), (c), or (d) of the Act (21
U.S.C. 953 (a), (b), (c), or (d).
(b) The Administrator may require that such non-narcotic controlled
substances in Schedule III as shall be designated by regulation in
Sec. 1312.30 of this part be exported only pursuant to the issuance of
an export permit. The Administrator may authorize the exportation of
such substances if he finds that such exportation is permitted by
section 1003(e) of the Act (21 U.S.C. 953(e)).
(c) If a non-narcotic substance listed in Schedule IV or V is also
listed in Schedule I or II of the Convention on Psychotropic Substances,
it shall be exported only pursuant to the issuance of an export permit.
The Administrator may authorize the exportation of such substances if he
finds that such exportation is permitted by section 1003(e) of the Act
(21 U.S.C. 953(e)).
(d) The Administrator may require an applicant to submit such
documents or written statements of fact relevant to the application as
he deems necessary to determine whether the application should be
granted. The failure of the applicant to provide such documents or
statements within a reasonable time after being requested to do so shall
be deemed to be a waiver by the applicant of an opportunity to present
such documents or facts for consideration by the Administrator in
granting or denying the application.
[[Page 133]]
(e) Each export permit shall be issued in septuplet and serially
numbered, with all seven copies bearing the same serial number and being
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc.,
respectively. Each export permit shall be predicated upon an import
certificate or other documentary evidence. Export permits are not
transferable.
(f) No export permit shall be issued for the exportation of any
narcotic drug to any country when the Administrator has information to
show that the estimates submitted with respect to that country for the
current period, under the Narcotic Limitation Convention of 1931, or the
Single Convention on Narcotic Drugs of 1961, have been, or, considering
the quantity proposed to be imported, will be exceeded. If it shall
appear through subsequent advice received from the International
Narcotic Control Board of the United Nations that the estimates of the
country of destination have been adjusted to permit further importation
of the narcotic drug, an export permit may then be issued if otherwise
permissible.
[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290,
May 7, 1987]
Sec. 1312.24 Distribution of copies of export permit.
Copies of the export permit shall be distributed and serve purposes
as follows:
(a) The original, duplicate, and triplicate copies (Copy 1, Copy 2,
and Copy 3) shall be transmitted by the Administration to the exporter
who will retain the triplicate copy (Copy 3) as his record of authority
for the exportation. The exporter shall present to the District Director
of the U.S. Customs Service at the port of export and at the time of
shipment, the original and duplicate copies (Copy 1 and Copy 2). After
endorsing the port of export on the reverse side of the original and
duplicate copies (Copy 1 and Copy 2) the District Director shall forward
the endorsed original copy (Copy 1) with the shipment, and return the
endorsed duplicate copy (Copy 2) to the Drug Enforcement Administration,
Drug Operations Section, Washington, DC 20537.
(b) The quadruplet copy (Copy 4) shall be forwarded by the
Administrator to the District Director of the U.S. Customs Service at
the port of export for comparison with the original copy (Copy 1) and
for retention for the customs record.
(c) The quintuplet copy (Copy 5) shall be forwarded by the
Administration to the officer in the country of destination who issued
the import certificate, or other documentary evidence upon which the
export permit is founded.
(d) The sextuplet and septuplet copies (Copy 6 and Copy 7) shall be
retained by the Administration.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715,
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62
FR 13969, Mar. 24, 1997]