29 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 202
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, when- ever the existence of such isomers, esters, ethers, and salts is pos- sible within the specific chemical designation:
(1) Acetylmethadol.
(2) Allylprodine.
(3) Alphacetylmathadol. 24
(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) Proheptazine.
(40) Properidine.
(41) Racemoramide.
(42) Trimeperidine.
(2) Allylprodine.
(3) Alphacetylmathadol. 24
(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) Proheptazine.
(40) Properidine.
(41) Racemoramide.
(42) Trimeperidine.
24 So in law. Probably should be ‘‘Alphacetylmethadol.’’
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Sec. 202 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 30
(b) Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, their salts, iso- mers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chem- ical 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.
(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-dimethoxy amphetamine.
(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.
(18) 4-methylmethcathinone (Mephedrone).
(19) 3,4-methylenedioxypyrovalerone (MDPV).
(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E). (21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D).
(2) 5-methoxy-3,4-methylenedioxy amphetamine.
(3) 3,4,5-trimethoxy amphetamine.
(4) Bufotenine.
(5) Diethyltryptamine.
(6) Dimethyltryptamine.
(7) 4-methyl-2,5-dimethoxy amphetamine.
(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.
(18) 4-methylmethcathinone (Mephedrone).
(19) 3,4-methylenedioxypyrovalerone (MDPV).
(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E). (21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D).
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(d)(1) Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of cannabimimetic agents, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the spe- cific chemical designation.
(2) In paragraph (1):
(A) The term ‘‘cannabimimetic agents’’ means any sub-
(A) The term ‘‘cannabimimetic agents’’ means any sub-
stance that is a cannabinoid receptor type 1 (CB1 receptor) agonist as demonstrated by binding studies and functional as- says within any of the following structural classes:
(i) 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-position of the phenolic ring by alkyl or alkenyl, whether or not substituted on the cyclohexyl ring to any extent.
(ii) 3-(1-naphthoyl)indole or 3-(1- naphthylmethane)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not sub- stituted on the naphthoyl or naphthyl ring to any extent.
(iii) 3-(1-naphthoyl)pyrrole by substitution at the nitro- gen atom of the pyrrole ring, whether or not further sub- stituted in the pyrrole ring to any extent, whether or not substituted on the naphthoyl ring to any extent.
(iv) 1-(1-naphthylmethylene)indene by substitution of the 3-position of the indene ring, whether or not further substituted in the indene ring to any extent, whether or not substituted on the naphthyl ring to any extent.
(v) 3-phenylacetylindole or 3-benzoylindole by substi- tution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent, whether or not substituted on the phenyl ring to any ex- tent.
(B) Such term includes—
(B) Such term includes—
(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3- hydroxycyclohexyl]ΓΈ¿-phenol (CP–47,497);
(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3- hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP– 47,497 C8-homolog);
(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678);
(iv) 1-butyl-3-(1-naphthoyl)indole (JWH–073); (v) 1-hexyl-3-(1-naphthoyl)indole (JWH–019);
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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 202
(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C). (23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I).
(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–
(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–
T–2).
(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine
(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine
(2C–T–4).
(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H).
(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N). (28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–
(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H).
(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N). (28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–
P).
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Sec. 202
TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 32
(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200);
(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH– 250);
(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH– 081);
(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH– 122);
(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398); (xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201); (xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole
(AM694);
(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19
(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19
and RCS–4);
(xiv) 1-cyclohexylethyl-3-(2-
(xiv) 1-cyclohexylethyl-3-(2-
methoxyphenylacetyl)indole (SR–18 and RCS–8); and
(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH–
(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH–
203).
SCHEDULE II
(a) Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced di- rectly or indirectly by extraction from substances of vegetable ori- gin, or independently by means of chemical synthesis, or by a com- bination 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 sub- stances referred to in clause (1), except that these substances shall not include the isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4) coca25 leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgo- nine or their salts have been removed; cocaine, its salts, optical and geometric isomers, and salts of isomers; ecgonine, its de- rivatives, their salts, isomers, and salts of isomers; or any com- pound, 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
(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, when- ever the existence of such isomers, esters, ethers, and salts is pos- sible within the specific chemical designation:
(1) Alphaprodine. (2) Anileridine.
(3) Bezitramide.
(4) Dihydrocodeine. (5) Diphenoxylate. (6) Fentanyl.
(3) Bezitramide.
(4) Dihydrocodeine. (5) Diphenoxylate. (6) Fentanyl.
(7) Isomethadone. (8) Levomethorphan.
25 So in law. Probably should be ‘‘Coca’’.
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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 202
(9) Levorphanol.
(10) Metazocine.
(11) Methadone.
(12) Methadone-Intermediate, 4-cyano-2-dimethylamino-
(10) Metazocine.
(11) Methadone.
(12) Methadone-Intermediate, 4-cyano-2-dimethylamino-
4,4-diphenyl butane.
(13) Moramide-Intermediate, 2-methyl-3 morpholino-1,1-
(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.
(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 iso- mers.
SCHEDULE III
(a)26 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 stimu- lant 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 con- tains any quantity of methamphetamine, including its salts, isomers, and salts of isomers.
(4) Methylphenidate.
(b) Unless specifically excepted or unless listed in another
(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 depres- sant effect on the central nervous system:
(1) Any substance which contains any quantity of a deriva- tive of barbituric acid, or any salt of a derivative of barbituric acid.
(2) Chorexadol.
(3) Glutethimide.
(4) Lysergic acid.
(5) Lysergic acid amide. (6) Methyprylon.
(7) Phencyclidine.
(8) Sulfondiethylmethane. (9) Sulfonethylmethane. (10) Sulfonmethane.
(3) Glutethimide.
(4) Lysergic acid.
(5) Lysergic acid amide. (6) Methyprylon.
(7) Phencyclidine.
(8) Sulfondiethylmethane. (9) Sulfonethylmethane. (10) Sulfonmethane.
26 The substances referred to in schedule III(a) have been administratively moved to schedule II.
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Sec. 202 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 34
(c) Nalorphine.
(d) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation con- taining 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, nonnarcotic 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 milli- liters 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 mil- liliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(e) Anabolic steroids.
(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.
(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
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35 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 204
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 nar- cotic drug alone:
(1) Not more than 200 milligrams of codeine per 100 milli- liters 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 milli- liters or per 100 grams.
TREATMENT OF CONTROLLED SUBSTANCE ANALOGUES
SEC. 203. ΓΈ21 U.S.C. 813¿ A controlled substance analogue shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I.
REMOVAL OF EXEMPTION OF CERTAIN DRUGS
SEC. 204. ΓΈ21 U.S.C. 814¿ (a) REMOVAL OF EXEMPTION.—The Attorney General shall by regulation remove from exemption under section 102(39)(A)(iv) a drug or group of drugs that the Attorney General finds is being diverted to obtain a listed chemical for use in the illicit production of a controlled substance.
(b) FACTORS TO BE CONSIDERED.—In removing a drug or group of drugs from exemption under subsection (a), the Attorney General shall consider, with respect to a drug or group of drugs that is pro- posed to be removed from exemption—
(1) the scope, duration, and significance of the diversion;
(2) whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit produc- tion of a controlled substance; and
(3) whether the listed chemical can be readily recovered from the drug or group of drugs.
(c) SPECIFICITY OF DESIGNATION.—The Attorney General shall
(c) SPECIFICITY OF DESIGNATION.—The Attorney General shall
limit the designation of a drug or a group of drugs removed from exemption under subsection (a) to the most particularly identifiable type of drug or group of drugs for which evidence of diversion exists unless there is evidence, based on the pattern of diversion and other relevant factors, that the diversion will not be limited to that particular drug or group of drugs.
(d) REINSTATEMENT OF EXEMPTION WITH RESPECT TO PAR- TICULAR DRUG PRODUCTS.—
(1) REINSTATEMENT.—On application by a manufacturer of a particular drug product that has been removed from exemp- tion under subsection (a), the Attorney General shall by regu- lation reinstate the exemption with respect to that particular drug product if the Attorney General determines that the par- ticular drug product is manufactured and distributed in a man- ner that prevents diversion.
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Sec. 301 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 36
(2) FACTORS TO BE CONSIDERED.—In deciding whether to reinstate the exemption with respect to a particular drug prod- uct under paragraph (1), the Attorney General shall consider—
(A) the package sizes and manner of packaging of the drug product;
(B) the manner of distribution and advertising of the drug product;
(C) evidence of diversion of the drug product;
(D) any actions taken by the manufacturer to prevent diversion of the drug product; and
(E) such other factors as are relevant to and consistent with the public health and safety, including the factors de- scribed in subsection (b) as applied to the drug product.
(3) STATUS PENDING APPLICATION FOR REINSTATEMENT.—A
(3) STATUS PENDING APPLICATION FOR REINSTATEMENT.—A
transaction involving a particular drug product that is the sub- ject of a bona fide pending application for reinstatement of ex- emption filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to subsection (a) shall not be considered to be a regulated transaction if the transaction occurs during the pendency of the application and, if the Attorney General denies the applica- tion, during the period of 60 days following the date on which the Attorney General denies the application, unless—
(A) the Attorney General has evidence that, applying the factors described in subsection (b) to the drug product, the drug product is being diverted; and
(B) the Attorney General so notifies the applicant.
(4) AMENDMENT AND MODIFICATION.—A regulation rein- stating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a find-
(4) AMENDMENT AND MODIFICATION.—A regulation rein- stating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a find-
ing that—
(A) applying the factors described in subsection (b) to
(A) applying the factors described in subsection (b) to
the drug product, the drug product is being diverted; or
(B) there is a significant change in the data that led
(B) there is a significant change in the data that led
to the issuance of the regulation.
PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES; PIPERIDINE REPORTING 27
RULES AND REGULATIONS
SEC. 301. ΓΈ21 U.S.C. 821¿ The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees
27 Prior to the enactment of Public Law 100–690, section 310 of this title concerned reporting requirements regarding the distribution, sale, or import of piperidine. Section 6052 of such Pub- lic Law (102 Stat. 4312) amended section 310 in its entirety, with the result that the section now concerns reporting requirements related to listed chemicals, tableting machines, and encap- sulating machines. Section 6054 of such Public Law (102 Stat. 4316) made amendments to the definitions in section 102 of this title, including establishing definitions for the terms ‘‘listed chemical’’ and ‘‘listed precursor chemical’’. Piperidine and its salts were included as listed pre- cursor chemicals.
Section 2(a) of Public Law 103–200 (107 Stat. 2333) made amendments to the definitions in section 102 of this title, including replacing the term ‘‘listed precursor chemical’’ with the term ‘‘list I chemical’’. Piperidine and its salts are currently included as list I chemicals. See section 102(34)(J).
Section 2(a) of such Public Law also replaced the term ‘‘listed essential chemical’’ with the term ‘‘list II chemical’’.
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37 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 302
relating to the registration and control of the manufacture, dis- tribution, and dispensing of controlled substances and to listed chemicals.
PERSONS REQUIRED TO REGISTER
SEC. 302. ΓΈ21 U.S.C. 822¿ (a)(1) Every person who manufac- tures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a reg- istration issued by the Attorney General in accordance with the rules and regulations promulgated by him.
(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, de- termine the period of such registrations. In no event; however, shall such registrations be issued for less than one year nor for more than three years.
(b) Persons registered by the Attorney General under this title to manufacture, distribute, or dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their reg- istration and in conformity with the other provisions of this title.
(c) The following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this title:
(1) An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance or list I chemical if such agent or employee is acting in the usual course of his business or employment.
(2) A common or contract carrier or warehouseman, or an employee thereof, whose possession of the controlled substance or list I chemical is in the usual course of his business or em- ployment.
(3) An ultimate user who possesses such substance for a purpose specified in section 102(25). 28
(d) The Attorney General may, by regulation, waive the re-
(d) The Attorney General may, by regulation, waive the re-
quirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safe- ty.
(e)(1) A separate registration shall be required at each prin- cipal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals.
(2) Notwithstanding paragraph (1), a registrant who is a vet- erinarian shall not be required to have a separate registration in order to transport and dispense controlled substances in the usual course of veterinary practice at a site other than the registrant’s
28 So in law. Probably should be ‘‘102(27)’’. Former paragraph (25) of section 102 was redesig- nated as paragraph (26) by section 507(a) of Public Law 98–473 (98 Stat. 2071), and section 1003(b)(2) of Public Law 99–570 (100 Stat. 3207–6) redesignated paragraph (26) as paragraph (27).
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Sec. 303 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 38
registered principal place of business or professional practice, so long as the site of transporting and dispensing is located in a State where the veterinarian is licensed to practice veterinary medicine and is not a principal place of business or professional practice.
(f) The Attorney General is authorized to inspect the establish- ment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.
(g)(1) An ultimate user who has lawfully obtained a controlled substance in accordance with this title may, without being reg- istered, deliver the controlled substance to another person for the purpose of disposal of the controlled substance if—
(A) the person receiving the controlled substance is author- ized under this title to engage in such activity; and
(B) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of con- trolled substances.
(2) In developing regulations under this subsection, the Attor-
(2) In developing regulations under this subsection, the Attor-
ney General shall take into consideration the public health and safety, as well as the ease and cost of program implementation and participation by various communities. Such regulations may not re- quire any entity to establish or operate a delivery or disposal pro- gram.
(3) The Attorney General may, by regulation, authorize long- term care facilities, as defined by the Attorney General by regula- tion, to dispose of controlled substances on behalf of ultimate users who reside, or have resided, at such long-term care facilities in a manner that the Attorney General determines will provide effective controls against diversion and be consistent with the public health and safety.
(4) If a person dies while lawfully in possession of a controlled substance for personal use, any person lawfully entitled to dispose of the decedent’s property may deliver the controlled substance to another person for the purpose of disposal under the same condi- tions as provided in paragraph (1) for an ultimate user.
REGISTRATION REQUIREMENTS
SEC. 303. ΓΈ21 U.S.C. 823¿ (a) The Attorney General shall reg- ister an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under inter- national treaties, conventions, or protocols in effect on the effective date of this part. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than le- gitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such con- trolled substances to a number of establishments which can produce an adequate and uninterrupted supply of these sub- stances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;
(2) compliance with applicable State and local law;
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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 303
(3) promotion of technical advances in the art of manufac- turing these substances and the development of new sub- stances;
(4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dis- pensing of such substances;
(5) past experience in the manufacture of controlled sub- stances, and the existence in the establishment of effective con- trol against diversion; and
(6) such other factors as may be relevant to and consistent with the public health and safety.
(b) The Attorney General shall register an applicant to dis-
(b) The Attorney General shall register an applicant to dis-
January 16, 2018
tribute a controlled substance in schedule I or II unless he deter- mines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dis- pensing of such substances;
(4) past experience in the distribution of controlled sub- stances; and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(c) Registration granted under subsections (a) and (b) of this
(c) Registration granted under subsections (a) and (b) of this
section shall not entitle a registrant to (1) manufacture or dis- tribute controlled substances in schedule I or II other than those specified in the registration, or (2) manufacture any quantity of those controlled substances in excess of the quota assigned pursu- ant to section 306.
(d) The Attorney General shall register an applicant to manu- facture controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the fol- lowing factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific, or industrial channels;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufac- turing these substances and the development of new sub- stances;
(4) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dis- pensing of such substances;
(5) past experience in the manufacture, distribution, and dispensing of controlled substances, and the existence in the establishment of effective controls against diversion; and
(6) such other factors as may be relevant to and consistent with the public health and safety.
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