
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC812]

 
                        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
 
Sec. 812. Schedules of controlled substances


(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 psychological dependence.

    (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 \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:
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    \1\ Revised schedules are published in the Code of Federal 
Regulations, Part 1308 of Title 21, Food and Drugs.
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                               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.\2\
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    \2\ So in original. Probably should be ``Alphacetylmethadol.''
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        (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, their salts, isomers, 
and salt 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 \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.
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    \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) Glutehimide.
        (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.

(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, Secs. 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.)


                               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, Secs. 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 schedules 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.

                  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 
section 1415; title 29 sections 705, 2006; title 41 section 706; title 
42 sections 12111, 12210.
