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CITE

    21 USC Sec. 812                                             01/05/2009

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 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:
                                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)
        (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 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 (!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.
      (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, 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.

FOOTNOTE

    (!1) Revised schedules are published in the Code of Federal
         Regulations, Part 1308 of Title 21, Food and Drugs.
    (!2) So in original. Probably should be "Alphacetylmethadol."
    (!3) So in original. Probably should be capitalized.
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