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Section
1300 > Section 1300.01
Section 1300.01 Definitions relating to controlled
substances.
(a) Any term not defined in this part shall have the
definition set forth in section 102 of the Act (21
U.S.C. 802), except that
certain terms used in part 1316 of this chapter are defined at the beginning of
each subpart of that part.
(b) As used in parts 1301 through
1308 and part 1312 of
this chapter, the following terms shall have the meanings specified:
(1) The term Act means the Controlled Substances Act, as
amended (84 Stat. 1242; 21
U.S.C. 801) and/or the Controlled Substances Import
and Export Act, as amended (84 Stat. 1285; 21
U.S.C. 951).
(2) The term Administration means the Drug Enforcement
Administration.
(3) The term Administrator means the Administrator of the
Drug Enforcement Administration. The Administrator has been delegated
authority under the Act by the Attorney General (28 CFR 0.100).
(4) The term anabolic steroid means any drug or hormonal substance,
chemically and pharmacologically related to testosterone (other than estrogens,
progestins, corticosteroids, and dehydroepiandrosterone), and includes:
(i) 3[beta],17-dihydroxy-5a-androstane
(ii) 3[alpha],17[beta]-dihydroxy-5a-androstane
(iii) 5[alpha]-androstan-3,17-dione
(iv) 1-androstenediol (3[beta],17[beta]-dihydroxy-5[alpha]-androst-1- ene)
(v) 1-androstenediol (3[alpha],17[beta]-dihydroxy-5[alpha]-androst-1- ene)
(vi) 4-androstenediol (3[beta],17[beta]-dihydroxy-androst-4-ene)
(vii) 5-androstenediol (3[beta],17[beta]-dihydroxy-androst-5-ene)
(viii) 1-androstenedione ([5[alpha]]-androst-1-en-3,17-dione)
(ix) 4-androstenedione (androst-4-en-3,17-dione)
(x) 5-androstenedione (androst-5-en-3,17-dione)
(xi) bolasterone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyandrost-
4-en-3-one)
(xii) boldenone (17[beta]-hydroxyandrost-1,4,-diene-3-one)
(xiii) calusterone (7[beta],17[alpha]-dimethyl-17[beta]-hydroxyandrost-
4-en-3-one)
(xiv) clostebol (4-chloro-17[beta]-hydroxyandrost-4-en-3-one)
(xv) dehydrochloromethyltestosterone (4-chloro-17[beta]-hydroxy-
17[alpha]-methyl-androst-1,4-dien-3-one)
(xvi) [Delta]1-dihydrotestosterone (a.k.a. '1-testosterone') (17[beta]-
hydroxy-5[alpha]-androst-1-en-3-one)
(xvii) 4-dihydrotestosterone (17[beta]-hydroxy-androstan-3-one)
(xviii) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-5[alpha]-
androstan-3-one)
(xix) ethylestrenol (17[alpha]-ethyl-17[beta]-hydroxyestr-4-ene)
(xx) fluoxymesterone (9-fluoro-17[alpha]-methyl-11[beta],17[beta]-
dihydroxyandrost-4-en-3-one)
(xxi) formebolone (2-formyl-17[alpha]-methyl-11[alpha],17[beta]-
dihydroxyandrost-1,4-dien-3-one)
(xxii) furazabol (17[alpha]-methyl-17[beta]-hydroxyandrostano[2,3-c]- furazan)
(xxiii)
13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one
(xxiv) 4-hydroxytestosterone (4,17[beta]-dihydroxy-androst-4-en-3-one)
(xxv) 4-hydroxy-19-nortestosterone (4,17[beta]-dihydroxy-estr-4-en-3- one)
(xxvi) mestanolone (17[alpha]-methyl-17[beta]-hydroxy-5-androstan-3- one)
(xxvii) mesterolone (1[alpha]methyl-17[beta]-hydroxy-[5[alpha]]-
androstan-3-one)
(xxviii) methandienone (17[alpha]-methyl-17[beta]-hydroxyandrost-1,4-
dien-3-one)
(xxix) methandriol (17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-
5-ene)
(xxx) methenolone (1-methyl-17[beta]-hydroxy-5[alpha]-androst-1-en-3- one)
(xxxi) 17[alpha]-methyl-3[beta], 17[beta]-dihydroxy-5a-androstane
(xxxii) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy-5a-androstane
(xxxiii) 17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-4-ene
(xxxiv) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-methyl-4-
hydroxy-17[beta]-hydroxyestr-4-en-3-one)
(xxxv) methyldienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9(10)-
dien-3-one)
(xxxvi) methyltrienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9-
11-trien-3-one)
(xxxvii) methyltestosterone (17[alpha]-methyl-17[beta]-hydroxyandrost-
4-en-3-one)
(xxxviii) mibolerone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyestr-
4-en-3-one)
(xxxix) 17[alpha]-methyl-[Delta]1-dihydrotestosterone (17b[beta]-
hydroxy-17[alpha]-methyl-5[alpha]-androst-1-en-3-one) (a.k.a. '17-
[alpha]-methyl-1-testosterone')
(xl) nandrolone (17[beta]-hydroxyestr-4-en-3-one)
(xli) 19-nor-4-androstenediol (3[beta], 17[beta]-dihydroxyestr-4-ene)
(xlii) 19-nor-4-androstenediol (3[alpha], 17[beta]-dihydroxyestr-4-ene)
(xliii) 19-nor-5-androstenediol (3[beta], 17[beta]-dihydroxyestr-5-ene)
(xliv) 19-nor-5-androstenediol (3[alpha], 17[beta]-dihydroxyestr-5-ene)
(xlv) 19-nor-4-androstenedione (estr-4-en-3,17-dione)
(xlvi) 19-nor-5-androstenedione (estr-5-en-3,17-dione
(xlvii) norbolethone (13[beta], 17[alpha]-diethyl-17[beta]-hydroxygon-
4-en-3-one)
(xlviii) norclostebol (4-chloro-17[beta]-hydroxyestr-4-en-3-one)
(xlix) norethandrolone (17[alpha]-ethyl-17[beta]-hydroxyestr-4-en-3- one)
(l) normethandrolone (17[alpha]-methyl-17[beta]-hydroxyestr-4-en-3-one)
(li) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-2-oxa-[5[alpha]]-
androstan-3-one)
(lii) oxymesterone (17[alpha]-methyl-4,17[beta]-dihydroxyandrost-4-en- 3-one)
(liii) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-17[beta]- hydroxy-[5[alpha]]-androstan-3-one)
(liv)
stanozolol (17[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-
androst-2-eno[3,2-c]-pyrazole)
(lv) stenbolone (17[beta]-hydroxy-2-methyl-[5[alpha]]-androst-1-en-3- one)
(lvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid
lactone)
(lvii) testosterone (17[beta]-hydroxyandrost-4-en-3-one)
(lviii) tetrahydrogestrinone (13[beta], 17[alpha]-diethyl-17[beta]-
hydroxygon-4,9,11-trien-3-one)
(lix) trenbolone (17[beta]-hydroxyestr-4,9,11-trien-3-one)
(lx) Any salt, ester, or ether of a drug or substance described in this
paragraph. Except such term does not include an anabolic steroid that is
expressly intended for administration through implants to cattle or other
nonhuman species and that has been approved by the Secretary of Health and Human
Services for such administration. If any person prescribes, dispenses, or
distributes such steroid for human use, the person shall be considered to have
prescribed, dispensed, or distributed an anabolic steroid within the meaning of
this paragraph.
(5) The term basic class means, as to controlled substances
listed in Schedules I and II:
(i) Each of the opiates, including its isomers, esters,
ethers, salts, and salts of isomers, esters, and ethers whenever the
existence of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in Sec. 1308.11(b) of this chapter;
(ii) Each of the opium derivatives, including its salts,
isomers, and salts of isomers whenever the existence of such salts, isomers,
and salts of isomers is possible within the specific chemical designation,
listed in Sec. 1308.11(c) of this chapter;
(iii) Each of the hallucinogenic substances, including
its salts, isomers, and salts of isomers whenever the existence of such
salts, isomers, and salts of isomers is possible within the specific
chemical designation, listed in Sec. 1308.11(d) of this chapter;
(iv) Each of the following substances, whether produced
directly or indirectly by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis:
(A) Opium, including raw opium, opium extracts, opium
fluid extracts, powdered opium, granulated opium, deodorized opium and
tincture of opium;
(B) Apomorphine;
(C) Codeine;
(D) Etorphine hydrochloride;
(E) Ethylmorphine;
(F) Hydrocodone;
(G) Hydromorphone;
(H) Metopon;
(I) Morphine;
(J) Oxycodone;
(K) Oxymorphone;
(L) Thebaine;
(M) Mixed alkaloids of opium listed in Section
1308.12(b)(2) of this chapter;
(N) Cocaine; and
(O) Ecgonine;
(v) Each of the opiates, including its isomers, esters,
ethers, salts, and salts of isomers, esters, and ethers whenever the
existence of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in Sec. 1308.12(c) of this chapter;
and
(vi) Methamphetamine, its salts, isomers, and salts of
its isomers;
(vii) Amphetamine, its salts, optical isomers, and salts
of its optical isomers;
(viii) Phenmetrazine and its salts;
(ix) Methylphenidate;
(x) Each of the substances having a depressant effect on
the central nervous system, including its salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and salts of isomers
is possible within the specific chemical designation, listed in Sec.
1308.12(e) of this chapter.
(6) The term commercial container means any bottle, jar,
tube, ampule, or other receptacle in which a substance is held for
distribution or dispensing to an ultimate user, and in addition, any box or
package in which the receptacle is held for distribution or dispensing to an
ultimate user. The term commercial container does not include any package
liner, package insert or other material kept with or within a commercial
container, nor any carton, crate, drum, or other package in which commercial
containers are stored or are used for shipment of controlled substances.
(7) The term compounder means any person engaging in
maintenance or detoxification treatment who also mixes, prepares, packages or
changes the dosage form of a narcotic drug listed in Schedules II, III, IV or
V for use in maintenance or detoxification treatment by another narcotic
treatment program.
(8) The term controlled substance has the meaning given in
section 802(6) of Title 21, United States Code
(U.S.C.).
(9) The term customs territory of the United States means
the several States, the District of Columbia, and Puerto Rico.
(10) The term detoxification treatment means the
dispensing, for a period of time as specified below, of a narcotic drug or
narcotic drugs in decreasing doses to an individual to alleviate adverse
physiological or psychological effects incident to withdrawal from the
continuous or sustained use of a narcotic drug and as a method of bringing the
individual to a narcotic drug-free state within such period of time. There are
two types of detoxification treatment: Short-term detoxification treatment and
long-term detoxification treatment.
(i) Short-term detoxification treatment is for a period
not in excess of 30 days.
(ii) Long-term detoxification treatment is for a period
more than 30 days but not in excess of 180 days.
(11) The term dispenser means an individual practitioner,
institutional practitioner, pharmacy or pharmacist who dispenses a controlled
substance.
(12) The term export means, with respect to any article,
any taking out or removal of such article from the jurisdiction of the United
States (whether or not such taking out or removal constitutes an exportation
within the meaning of the customs and related laws of the United States).
(13) The term exporter includes every person who exports,
or who acts as an export broker for exportation of, controlled substances
listed in any schedule.
(14) The term hearing means:
(i) In part 1301 of this chapter, any hearing held for
the granting, denial, revocation, or suspension of a registration pursuant
to sections 303, 304, and 1008 of the Act (21
U.S.C. 823, 824 and 958).
(ii) In part 1303 of this chapter, any hearing held
regarding the determination of aggregate production quota or the issuance,
adjustment, suspension, or denial of a procurement quota or an individual
manufacturing quota.
(iii) In part 1308 of this chapter, any hearing held for
the issuance, amendment, or repeal of any rule issuable pursuant to section
201 of the Act (21 U.S.C. 811).
(15) The term import means, with respect to any article,
any bringing in or introduction of such article into either the jurisdiction
of the United States or the customs territory of the United States, and from
the jurisdiction of the United States into the customs territory of the United
States (whether or 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)
(i)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.
(ii) As used in Sec. 1308.11(d) of this chapter, the term "positional
isomer'' means any substance possessing the same molecular formula and core
structure and having the same functional group(s) and/ or substituent(s) as
those found in the respective schedule I hallucinogen, attached at any
position(s) on the core structure, but in such manner that no new chemical
functionalities are created and no existing chemical functionalities are
destroyed relative to the respective schedule I hallucinogen. Rearrangements
of alkyl moieties within or between functional group(s) or substituent(s), or
divisions or combinations of alkyl moieties, that do not create new chemical
functionalities or destroy existing chemical functionalities, are allowed
i.e., result in compounds which are positional isomers. For purposes of this
definition, the "core structure'' is the parent molecule that is the common
basis for the class; for example, tryptamine, phenethylamine, or ergoline.
Examples of rearrangements resulting in creation and/or destruction of
chemical functionalities (and therefore resulting in compounds which are not
positional isomers) include, but are not limited to: ethoxy to alpha-hydroxyethyl,
hydroxy and methyl to methoxy, or the repositioning of a phenolic or alcoholic
hydroxy group to create a hydroxyamine. Examples of rearrangements resulting
in compounds which would be positional isomers include: tert- butyl to
sec-butyl, methoxy and ethyl to isopropoxy, N,N-diethyl to N- methyl-N-propyl,
or alpha-methylamino to N-methylamino.
(22) The term jurisdiction of the United States means the
customs territory of the United States, the Virgin Islands, the Canal Zone,
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
(23) The term label means any display of written, printed,
or graphic matter placed upon the commercial container of any controlled
substance by any manufacturer of such substance.
(24) The term labeling means all labels and other written,
printed, or graphic matter:
(i) Upon any controlled substance or any of its
commercial containers or wrappers, or
(ii) Accompanying such controlled substance.
(25) The term Long Term Care Facility (LTCF) means a
nursing home, retirement care, mental care or other facility or institution
which provides extended health care to resident patients.
(26) The term maintenance treatment means the dispensing
for a period in excess of twenty-one days, of a narcotic drug or narcotic
drugs in the treatment of an individual for dependence upon heroin or other
morphine-like drug.
(27) The term manufacture means the producing, preparation,
propagation, compounding, or processing of a drug or other substance or the
packaging or repackaging of such substance, or the labeling or relabeling of
the commercial container of such substance, but does not include the
activities of a practitioner who, as an incident to his/her administration or
dispensing such substance in the course of his/her professional practice,
prepares, compounds, packages or labels such substance. The term manufacturer
means a person who manufactures a drug or other substance, whether under a
registration as a manufacturer or under authority of registration as a
researcher or chemical analyst.
(28) The term mid-level practitioner means an individual
practitioner, other than a physician, dentist, veterinarian, or podiatrist,
who is licensed, registered, or otherwise permitted by the United States or
the jurisdiction in which he/she practices, to dispense a controlled substance
in the course of professional practice. Examples of mid-level practitioners
include, but are not limited to, health care providers such as nurse
practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists
and physician assistants who are authorized to dispense controlled substances
by the state in which they practice.
(29) The term name means the official name, common or usual
name, chemical name, or brand name of a substance.
(30) The term narcotic drug means any of the following
whether produced directly or indirectly by extraction from substances of
vegetable origin or independently by means of chemical synthesis or by a
combination of extraction and chemical synthesis:
(i) Opium, opiates, derivatives of opium and opiates,
including their isomers, esters, ethers, salts, and salts of isomers,
esters, and ethers whenever the existence of such isomers, esters, ethers
and salts is possible within the specific chemical designation. Such term
does not include the isoquinoline alkaloids of opium.
(ii) Poppy straw and concentrate of poppy straw.
(iii) Coca leaves, except coca leaves and extracts of
coca leaves from which cocaine, ecgonine and derivatives of ecgonine or
their salts have been removed.
(iv) Cocaine, its salts, optical and geometric isomers,
and salts of isomers.
(v) Ecgonine, its derivatives, their salts, isomers and
salts of isomers.
(vi) Any compound, mixture, or preparation which contains
any quantity of any of the substances referred to in paragraphs (b)(31)(i)
through (v) of this section.
(31) The term narcotic treatment program means a program
engaged in maintenance and/or detoxification treatment with narcotic drugs.
(32) The term net disposal means, for a stated period, the
quantity of a basic class of controlled substance distributed by the
registrant to another person, plus the quantity of that basic class used by
the registrant in the production of (or converted by the registrant into)
another basic class of controlled substance or a noncontrolled substance, plus
the quantity of that basic class otherwise disposed of by the registrant, less
the quantity of that basic class returned to the registrant by any purchaser,
and less the quantity of that basic class distributed by the registrant to
another registered manufacturer of that basic class for purposes other than
use in the production of, or conversion into, another basic class of
controlled substance or a noncontrolled substance or in the manufacture of
dosage forms of that basic class.
(33) The term pharmacist means any pharmacist licensed by a
State to dispense controlled substances, and shall include any other person
(e.g., pharmacist intern) authorized by a State to dispense controlled
substances under the supervision of a pharmacist licensed by such State.
(34) The term person includes any individual, corporation,
government or governmental subdivision or agency, business trust, partnership,
association, or other legal entity.
(35) The term prescription means an order for medication
which is dispensed to or for an ultimate user but does not include an order
for medication which is dispensed for immediate administration to the ultimate
user. (e.g., an order to dispense a drug to a bed patient for immediate
administration in a hospital is not a prescription.)
(36) The term proceeding means all actions taken for the
issuance, amendment, or repeal of any rule issued pursuant to section 201 of
the Act (21 U.S.C. 811), commencing with the publication by the Administrator
of the proposed rule, amended rule, or repeal in the Federal Register.
(37) The term purchaser means any registered person
entitled to obtain and execute order forms pursuant to 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.
(43) The term central fill pharmacy means a
pharmacy which is permitted by the state in which it is located to
prepare controlled substances orders for dispensing pursuant to a
valid prescription transmitted to it by a registered retail pharmacy
and to return the labeled and filled prescriptions to the retail
pharmacy for delivery to the ultimate user. Such central fill pharmacy
shall be deemed "authorized'' to fill prescriptions on behalf of a
retail pharmacy only if the retail pharmacy and central fill pharmacy
have a contractual relationship providing for such activities or share
a common owner.
(44) The term central fill pharmacy means a pharmacy which is permitted by the state in which it is located to prepare controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user. Such central fill pharmacy shall be deemed “authorized” to fill prescriptions on behalf of a retail pharmacy only if the retail pharmacy and central fill pharmacy have a contractual relationship providing for such activities or share a common owner.
(45) The term automated dispensing system means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information.
[62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 68 FR 37409, June 24, 2003; 68 FR 41228, July 11, 2003; 70 FR 25465, May 13,
2005 ; 70 FR 74656, December 16, 2005; 71 FR
60427, October 13, 2006; 72 FR 67852, Dec. 3, 2007]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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