-CITE-
21 USC Sec. 812 01/22/02
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL SUBCHAPTER I - CONTROL
AND ENFORCEMENT Part B - Authority To Control; Standards and Schedules
-HEAD-
Sec. 812. Schedules of controlled
substances
-STATUTE-
(a) Establishment
There are established five schedules of controlled substances, to be
known as schedules I, II, III, IV, and V. Such schedules shall initially
consist of the substances listed in this section. The schedules established
by this section shall be updated and republished on a semiannual basis
during the two-year period beginning one year after October 27, 1970,
and shall be updated and republished on an annual basis thereafter.
(b) Placement
on schedules; findings required Except where control is required by
United States obligations under an international treaty, convention,
or protocol, in effect on October 27, 1970, and except in the case of
an immediate precursor, a drug or other substance may not be placed
in any schedule unless the findings required for such schedule are made
with respect to such drug or other substance. The findings required
for each of the schedules are as follows:
(1) Schedule I. -
(A) The drug or other
substance has a high potential for abuse.
(B) The drug or other
substance has no currently accepted medical use in treatment in
the United States.
(C) There is a lack of
accepted safety for use of the drug or other substance under medical
supervision.
(2) Schedule II. -
(A) The drug or other
substance has a high potential for abuse.
(B) The drug or other
substance has a currently accepted medical use in treatment in the
United States or a currently accepted medical use with severe restrictions.
(C) Abuse of the drug
or other substances may lead to severe psychological or physical
dependence.
(3) Schedule III. -
(A) The drug or other
substance has a potential for abuse less than the drugs or other
substances in schedules I and II.
(B) The drug or other
substance has a currently accepted medical use in treatment in the
United States.
(C) Abuse of the drug
or other substance may lead to moderate or low physical dependence
or high psychologicaldependence.
(4) Schedule IV. -
(A) The drug or other
substance has a low potential for abuse relative to the drugs or
other substances in schedule III.
(B) The drug or other
substance has a currently accepted medical use in treatment in the
United States.
(C) Abuse of the drug
or other substance may lead to limited physical dependence or psychological
dependence relative to the drugs or other substances in schedule
III.
(5) Schedule V. -
(A) The drug or other
substance has a low potential for abuse relative to the drugs or
other substances in schedule IV.
(B) The drug or other
substance has a currently accepted medical use in treatment in the
United States.
(C) Abuse of the drug
or other substance may lead to limited physical dependence or psychological
dependence relative to the drugs or other substances in schedule
IV.
(c) Initial
schedules of controlled substances Schedules I, II, III, IV, and V shall,
unless and until amended (FOOTNOTE 1) pursuant to section 811
of this title, consist of the following drugs or other substances, by
whatever official name, common or usual name, chemical name, or brand
name designated: (FOOTNOTE 1) Revised schedules are published in the
Code of Federal Regulations, Part 1308 of Title 21, Food and Drugs.
SCHEDULE
I
(a) Unless specifically excepted
or unless listed in another schedule, any of the following opiates,
including their isomers, esters, ethers, salts, and salts of isomers,
esters, and ethers, whenever the existence of such isomers, esters,
ethers, and salts is possible within the specific chemical designation:
(1) Acetylmethadol.
(2) Allylprodine.
(3) Alphacetylmathadol.
(FOOTNOTE 2)
(FOOTNOTE 2) So in original.
Probably should be ''Alphacetylmethadol.''
(4) Alphameprodine.
(5) Alphamethadol.
(6) Benzethidine.
(7) Betacetylmethadol.
(8) Betameprodine.
(9) Betamethadol.
(10) Betaprodine.
(11) Clonitazene.
(12) Dextromoramide.
(13) Dextrorphan.
(14) Diampromide.
(15) Diethylthiambutene.
(16) Dimenoxadol.
(17) Dimepheptanol.
(18) Dimethylthiambutene.
(19) Dioxaphetyl butyrate.
(20) Dipipanone.
(21) Ethylmethylthiambutene.
(22) Etonitazene.
(23) Etoxeridine.
(24) Furethidine.
(25) Hydroxypethidine.
(26) Ketobemidone.
(27) Levomoramide.
(28) Levophenacylmorphan.
(29) Morpheridine.
(30) Noracymethadol.
(31) Norlevorphanol.
(32) Normethadone.
(33) Norpipanone.
(34) Phenadoxone.
(35) Phenampromide.
(36) Phenomorphan.
(37) Phenoperidine.
(38) Piritramide.
(39) Propheptazine.
(40) Properidine.
(41) Racemoramide.
(42) Trimeperidine.
(b) Unless specifically excepted
or unless listed in another schedule,
any of the following opium derivatives, heir 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.
(2) Acetyldihydrocodeine.
(3) Benzylmorphine.
(4) Codeine methylbromide.
(5) Codeine-N-Oxide.
(6) Cyprenorphine.
(7) Desomorphine.
(8) Dihydromorphine.
(9) Etorphine.
(10) Heroin.
(11) Hydromorphinol.
(12) Methyldesorphine.
(13) Methylhydromorphine.
(14) Morphine methylbromide.
(15) Morphine methylsulfonate.
(16) Morphine-N-Oxide.
(17) Myrophine.
(18) Nicocodeine.
(19) Nicomorphine.
(20) Normorphine.
(21) Pholcodine.
(22) Thebacon.
(c) 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 their salts, isomers, and salts
of isomers whenever the existence of such salts, isomers, and salts
of isomers is possible within the specific chemical designation:
(1) 3,4-methylenedioxy amphetamine.
(2) 5-methoxy-3,4-methylenedioxy
amphetamine.
(3) 3,4,5-trimethoxy amphetamine.
(4) Bufotenine.
(5) Diethyltryptamine.
(6) Dimethyltryptamine.
(7) 4-methyl-2,5-diamethoxyamphetamine.
(8) Ibogaine.
(9) Lysergic acid diethylamide.
(10) Marihuana.
(11) Mescaline.
(12) Peyote.
(13) N-ethyl-3-piperidyl
benzilate.
(14) N-methyl-3-piperidyl
benzilate.
(15) Psilocybin.
(16) Psilocyn.
(17) Tetrahydrocannabinols.
SCHEDULE
II
(a) 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.
(2) Any salt, compound,
derivative, or preparation thereof which is chemically equivalent
or identical with any of the substances referred to in clause (1),
except that these substances shall not include the isoquinoline alkaloids
of opium.
(3) Opium poppy and poppy
straw.
(4) coca (FOOTNOTE 3) leaves,
except coca leaves and extracts of coca leaves from which cocaine,
ecgonine, and derivatives of ecgonine or their salts have been removed;
cocaine, its salts, optical and geometric isomers, and salts of isomers;
ecgonine, its derivatives, their salts, isomers, and salts of isomers;
or any compound, mixture, or preparation which contains any quantity
of any of the substances referred to in this paragraph.
(FOOTNOTE 3) So in original.
Probably should be capitalized.
(b) Unless specifically excepted
or unless listed in another schedule, any of the following opiates,
including their isomers, esters, ethers, salts, and salts of isomers,
esters and ethers, whenever the existence of such isomers, esters, ethers,
and salts is possible within the specific chemical designation:
(1) Alphaprodine.
(2) Anileridine.
(3) Bezitramide.
(4) Dihydrocodeine.
(5) Diphenoxylate.
(6) Fentanyl.
(7) Isomethadone.
(8) Levomethorphan.
(9) Levorphanol.
(10) Metazocine.
(11) Methadone.
(12) Methadone-Intermediate,
4-cyano-2-dimethylamino-4,4-diphenyl butane.
(13) Moramide-Intermediate,
2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid.
(14) Pethidine.
(15) Pethidine-Intermediate-A,
4-cyano-1-methyl-4-phenylpiperidine.
(16) Pethidine-Intermediate-B,
ethyl-4-phenylpiperidine-4-carboxylate.
(17) Pethidine-Intermediate-C,
1-methyl-4-phenylpiperidine-4-carboxylic acid.
(18) Phenazocine.
(19) Piminodine.
(20) Racemethorphan.
(21) Racemorphan.
(c) Unless specifically excepted
or unless listed in another schedule, any injectable liquid which contains
any quantity of methamphetamine, including its salts, isomers, and salts
of isomers.
SCHEDULE
III
(a) 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 optical isomers.
(2) Phenmetrazine and its
salts.
(3) Any substance (except
an injectable liquid) which contains any quantity of methamphetamine,
including its salts, isomers, and salts of isomers.
(4) Methylphenidate.
(b) 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 substance which
contains any quantity of a derivative of barbituric acid, or any salt
of a derivative of barbituric acid.
(2) Chorhexadol.
(3) Glutethimide.
(4) Lysergic acid.
(5) Lysergic acid amide.
(6) Methyprylon.
(7) Phencyclidine.
(8) Sulfondiethylmethane.
(9) Sulfonethylmethane.
(10) Sulfonmethane.
(c) Nalorphine.
(d) Unless specifically excepted
or unless listed in another schedule, any material, compound, mixture,
or preparation containing limited quantities of any of the following
narcotic drugs, or any salts thereof:
(1) Not more than 1.8 grams
of codeine per 100 milliliters or not 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 more than 90 milligrams per
dosage unit, with one or more active, non-narcotic ingredients in
recognized therapeutic amounts.
(3) Not more than 300 milligrams
of dihydrocodeinone 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 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 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 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 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 or per 100 grams with one or more
active, nonnarcotic ingredients in recognized therapeutic amounts.
(e) Anabolic steroids.
SCHEDULE
IV
(1) Barbital.
(2) Chloral betaine.
(3) Chloral hydrate.
(4) Ethchlorvynol.
(5) Ethinamate.
(6) Methohexital.
(7) Meprobamate.
(8) Methylphenobarbital.
(9) Paraldehyde.
(10) Petrichloral.
(11) Phenobarbital.
SCHEDULE
V
Any compound, mixture, or
preparation containing any of the following limited quantities of narcotic
drugs, which shall include one or more nonnarcotic active medicinal
ingredients in sufficient proportion to confer upon the compound, mixture,
or preparation valuable medicinal qualities other than those possessed
by the narcotic drug alone:
(1) Not more than 200 milligrams
of codeine per 100 milliliters or per 100 grams.
(2) Not more than 100 milligrams
of dihydrocodeine per 100 milliliters or per 100 grams.
(3) Not more than 100 milligrams
of ethylmorphine per 100 milliliters or per 100 grams.
(4) Not more than 2.5 milligrams
of diphenoxylate and not less than 25 micrograms of atropine sulfate
per dosage unit.
(5) Not more than 100 milligrams
of opium per 100 milliliters or per 100 grams.
-SOURCE-
(Pub. L. 91-513, title II,
Sec. 202, Oct. 27, 1970, 84 Stat. 1247; Pub. L. 95-633, title I, Sec.
103, Nov. 10, 1978, 92 Stat. 3772; Pub. L. 98-473, title II, Sec. 507(c),
509(b), Oct. 12, 1984, 98 Stat. 2071, 2072; Pub. L. 99-570, title I,
Sec. 1867, Oct. 27, 1986, 100 Stat. 3207-55; Pub. L. 99-646, Sec. 84,
Nov. 10, 1986, 100 Stat. 3619; Pub. L. 101-647, title XIX, Sec. 1902(a),
Nov. 29, 1990, 104 Stat. 4851.)
-MISC1-
AMENDMENTS
1990 - Subsec.
(c). Pub. L. 101-647 added item (e) at end of schedule III.
1986 - Subsec.
(c). Pub. L. 99-646 amended schedule II(a)(4) generally. Prior to amendment,
schedule II(a)(4) read as follows: ''Coca leaves (except coca leaves
and extracts of coca leaves from which cocaine, ecgonine, and derivatives
of ecgonine or their salts have been removed); cocaine, its salts, optical
and geometric isomers, and salts of isomers; and ecgonine, its derivatives,
their salts, isomers, and salts of isomers.''
Pub. L. 99-570
amended schedule II(a)(4) generally. Prior to amendment, schedule II(a)(4)
read as follows: ''Coca leaves and any salt, compound, derivative, or
preparation of coca leaves (including cocaine and ecgonine 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, which extractions do not contain cocaine or ecgonine.''
1984 - Subsec. (c). Pub. L. 98-473, Sec. 507(c), in schedule II(a)(4)
added applicability to cocaine and ecgonine and their salts, isomers,
etc.
Subsec. (d).
Pub. L. 98-473, Sec. 509(b), struck out subsec. (d) which related to
authority of Attorney General to except stimulants or depressants containing
active medicinal ingredients. 1978 - Subsec. (d)(3). Pub. L. 95-633
added cl. (3).
EFFECTIVE
DATE OF 1990 AMENDMENT
Amendment by
Pub. L. 101-647 effective 90 days after Nov. 29, 1990, see section 1902(d)
of Pub. L. 101-647, set out as a note under section 802
of this title.
EFFECTIVE
DATE OF 1978 AMENDMENT
Amendment by
Pub. L. 95-633 effective on date the Convention on Psychotropic Substances
enters into force in the United States (July 15, 1980), see section
112 of Pub. L. 95-633, set out as an Effective Date note under section
801a of this title.
CONGRESSIONAL
FINDING; EMERGENCY SCHEDULING OF GHB IN CONTROLLED SUBSTANCES ACT
Pub. L. 106-172,
Sec. 2, 3(a), Feb. 18, 2000, 114 Stat. 7, 8, provided that:
''SEC. 2. FINDINGS.
''Congress finds as follows:
''(1) Gamma hydroxybutyric
acid (also called G, Liquid X, Liquid Ecstasy, Grievous Bodily
Harm, Georgia Home Boy, Scoop) has become a significant and growing
problem in law enforcement. At least 20 States have scheduled
such drug in their drug laws and law enforcement officials have
been experiencing an increased presence of the drug in driving
under the influence, sexual assault, and overdose cases especially
at night clubs and parties.
''(2) A behavioral depressant
and a hypnotic, gamma hydroxybutyric acid ('GHB') is being used
in conjunction with alcohol and other drugs with detrimental effects
in an increasing number of cases. It is difficult to isolate the
impact of such drug's ingestion since it is so typically taken
with an ever-changing array of other drugs and especially alcohol
which potentiates its impact.
''(3) GHB takes the
same path as alcohol, processes via alcohol dehydrogenase, and
its symptoms at high levels of intake and as impact builds are
comparable to alcohol ingestion/intoxication. Thus, aggression
and violence can be expected in some individuals who use such
drug.
''(4) If taken for human
consumption, common industrial chemicals such as gamma butyrolactone
and 1.4-butanediol are swiftly converted by the body into GHB.
Illicit use of these and other GHB analogues and precursor chemicals
is a significant and growing law enforcement problem.
''(5) A human pharmaceutical
formulation of gamma hydroxybutyric acid is being developed as
a treatment for cataplexy, a serious and debilitating disease.
Cataplexy, which causes sudden and total loss of muscle control,
affects about 65 percent of the estimated 180,000 Americans with
narcolepsy, a sleep disorder. People with cataplexy often are
unable to work, drive a car, hold their children or live a normal
life.
'(6) Abuse of illicit
GHB is an imminent hazard to public safety that requires immediate
regulatory action under the Controlled Substances Act (21 U.S.C.
801 et seq.).
''SEC. 3. EMERGENCY SCHEDULING
OF GAMMA HYDROXYBUTYRIC ACID AND LISTING OF GAMMA BUTYROLACTONE AS LIST
I CHEMICAL.
''(a) Emergency Scheduling
of GHB. -
''(1) In general. - The
Congress finds that the abuse of illicit gamma hydroxybutyric acid
is an imminent hazard to the public safety. Accordingly, the Attorney
General, notwithstanding sections 201(a), 201(b), 201(c), and 202
of the Controlled Substances Act (21 U.S.C. 811(a)-(c),
812), shall issue, not later than 60 days after
the date of the enactment of this Act (Feb. 18, 2000), a final order
that sch edules such drug (together with its salts, isomers, and salts
of isomers) in the same schedule under section 202(c) of the Controlled
Substances Act as would apply to a scheduling of a substance by the
Attorney General under section 201(h)(1) of such Act (relating to
imminent hazards to the public safety), except as follows:
''(A) For purposes of
any requirements that relate to the physical security of registered
manufacturers and registered distributors, the final order shall
treat such drug, when the drug is manufactured, distributed, or
possessed in accordance with an exemption under section 505(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) (whether
the exemption involved is authorized before, on, or after the date
of the enactment of this Act (Feb. 18, 2000)), as being in the same
schedule as that recommended by the Secretary of Health and Human
Services for the drug when the drug is the subject of an authorized
investigational new drug application (relating to such section 505(i)).
The recommendation referred to in the preceding sentence is contained
in the first paragraph of the letter transmitted on May 19, 1999,
by such Secretary (acting through the Assistant Secretary for Health)
to the Attorney General (acting through the Deputy Administrator
of the Drug Enforcement Administration), which letter was in response
to the letter transmitted by the Attorney General (acting through
such Deputy Administrator) on September 16, 1997. In publishing
the final order in the Federal Register, the Attorney General shall
publish a copy of the letter that was transmitted by the Secretary
of Health and Human Services.
''(B) In the case of gamma
hydroxybutyric acid that is contained in a drug product for which
an application is approved under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) (whether the application
involved is approved before, on, or after the date of the enactment
of this Act (Feb. 18, 2000)), the final order shall schedule such
drug in the same schedule as that recommended by the Secretary of
Health and Human Services for authorized formulations of the drug.
The recommendation referred to in the preceding sentence is contained
in the last sentence of the fourth paragraph of the letter referred
to in subparagraph (A) with respect to May 19, 1999.
''(2) Failure to issue
order. - If the final order is not issued within the period specified
in paragraph (1), gamma hydroxybutyric acid (together with its salts,
isomers, and salts of isomers) is deemed to be scheduled under section
202(c) of the Controlled Substances Act (21 U.S.C. 812(c))
in accordance with the policies described in paragraph (1), as if
the Attorney General had issued a final order in accordance with
such paragraph.''
PLACEMENT
OF PIPRADROL AND SPA IN SCHEDULE IV TO CARRY OUT OBLIGATION UNDER CONVENTION
ON PSYCHOTROPIC SUBSTANCES
Section 102(c) of Pub. L.
95-633 provided that: ''For the purpose of carrying out the minimum
United States obligations under paragraph 7 of article 2 of the Convention
on Psychotropic Substances, signed at Vienna, Austria, on February 21,
1971, with respect to pipradrol and SPA (also known as (-)-1-dimethylamino-1,2-diphenylethane),
the Attorney General shall by order, made without regard to sections
201 and 202 of the Controlled Substances Act (this section and section
811 of this title), place such drugs in schedule
IV of such Act (see subsec. (c) of this section).''
Provision of section 102(c)
of Pub. L. 95-633, set out above, effective on the date the Convention
on Psychotropic Substances enters into force in the United States (July
15, 1980), see section 112 of Pub. L. 95-633, set out as an Effective
Date note under section 801a of this title.
-SECREF-
SECTION
REFERRED TO IN OTHER SECTIONS
This section is referred to
in sections 384, 811, 1115, 1523, 1703 of this
title; title 10 section 912a; title 19 section 2484; title 20 sections
1415, 7161; title 29 sections 705, 2006; title 41 section 706; title
42 sections 12111, 12210.
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