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§ 1308.12 21 CFR Ch. II (4–1–12 Edition)

§ 1308.12 Schedule II. stances, except that the substances (a) Schedule II shall consist of the shall not include decocainized coca and other substances, by what- leaves or extraction of coca leaves, ever official name, common or usual which extractions do not contain co- name, chemical name, or brand name caine or ecgonine. (5) Concentrate of (the designated, listed in this section. Each crude extract of poppy straw in either or substance has been assigned liquid, solid or powder form which con- the Controlled Substances Code Num- tains the phenanthrene alkaloids of the ber set forth opposite it. poppy), 9670. (b) Substances, vegetable origin or (c) . Unless specifically ex- chemical synthesis. Unless specifically cepted or unless in another schedule excepted or unless listed in another any of the following opiates, including schedule, any of the following sub- its isomers, esters, ethers, salts and stances whether produced directly or salts of isomers, esters and ethers indirectly by extraction from sub- whenever the existence of such iso- stances of vegetable origin, or inde- mers, esters, ethers, and salts is pos- pendently by means of chemical syn- sible within the specific chemical des- thesis, or by a combination of extrac- ignation, and tion and chemical synthesis: levopropoxyphene excepted: (1) Opium and , and any salt, (1) ...... 9737 compound, derivative, or preparation (2) Alphaprodine ...... 9010 of opium or opiate excluding (3) ...... 9020 apomorphine, -derived (4) ...... 9800 (5) Bulk (non-dosage forms) ...... 9273 , dextrorphan, , (6) ...... 9743 , , and , (7) ...... 9120 and their respective salts, but includ- (8) ...... 9170 (9) ...... 9801 ing the following: (10) ...... 9226 (i) ...... 9050 (11) Levo- ...... 9648 (ii) ...... 9334 [Some other names: levo-alpha-, (iii) ...... 9190 levomethadyl acetate, LAAM] (iv) hydrochloride ...... 9059 (12) ...... 9210 (v) Granulated opium ...... 9640 (13) ...... 9220 (vi) ...... 9193 (14) ...... 9240 (vii) ...... 9150 (15) ...... 9250 (viii) ...... 9260 (16) Methadone-Intermediate, 4-cyano-2- (ix) ...... 9300 dimethylamino-4,4-diphenyl butane ...... 9254 (x) Opium extracts ...... 9610 (17) Moramide-Intermediate, 2-methyl-3-morpholino-1, (xi) Opium fluid ...... 9620 1-diphenylpropane-carboxylic acid ...... 9802 (xii) ...... 9330 (18) (meperidine) ...... 9230 (xiii) ...... 9143 (19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4- (xiv) ...... 9652 phenylpiperidine ...... 9232 (xv) Powdered opium ...... 9639 (20) Pethidine-Intermediate-B, ethyl-4- (xvi) Raw opium ...... 9600 phenylpiperidine-4-carboxylate ...... 9233 (xvii) Thebaine ...... 9333 (21) Pethidine-Intermediate-C, 1-methyl-4- (xviii) Tincture of opium ...... 9630 phenylpiperidine-4-carboxylic acid ...... 9234 (22) ...... 9715 (2) Any salt, compound, derivative, or (23) ...... 9730 preparation thereof which is chemi- (24) Racemethorphan ...... 9732 (25) ...... 9733 cally equivalent or identical with any (26) ...... 9739 of the substances referred to in para- (27) ...... 9740 graph (b) (1) of this section, except that (28) ...... 9780 these substances shall not include the (d) Stimulants. Unless specifically ex- isoquinoline alkaloids of opium. cepted or unless listed in another (3) Opium poppy and poppy straw. schedule, any material, compound, (4) Coca leaves (9040) and any salt, mixture, or preparation which contains compound, derivative or preparation of any quantity of the following sub- coca leaves (including (9041) stances having a stimulant effect on and ecgonine (9180) and their salts, iso- the central nervous system: mers, derivatives and salts of isomers (1) Amphetamine, its salts, optical isomers, and salts and derivatives), and any salt, com- of its optical isomers ...... 1100 pound, derivative, or preparation (2) Methamphetamine, its salts, isomers, and salts of its isomers ...... 1105 thereof which is chemically equivalent (3) Phenmetrazine and its salts ...... 1631 or identical with any of these sub- (4) Methylphenidate ...... 1724

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(5) Lisdexamfetamine, its salts, isomers, and salts of the DEA Controlled Substances Code its isomers ...... 1205 Number set forth opposite it. (e) Depressants. Unless specifically (b) Stimulants. Unless specifically ex- excepted or unless listed in another cepted or unless listed in another schedule, any material, compound, schedule, any material, compound, mixture, or preparation which contains mixture, or preparation which contains any quantity of the following sub- any quantity of the following sub- stances having a depressant effect on stances having a stimulant effect on the central nervous system, including the central nervous system, including its salts, isomers, and salts of isomers its salts, isomers (whether optical, po- whenever the existence of such salts, sitional, or geometric), and salts of isomers, and salts of isomers is possible such isomers whenever the existence of within the specific chemical designa- such salts, isomers, and salts of iso- tion: mers is possible within the specific (1) ...... 2125 chemical designation: (2) ...... 2550 (1) Those compounds, mixtures, or preparations in (3) ...... 2270 dosage unit form containing any stimulant sub- (4) ...... 7471 stances listed in schedule II which compounds, mix- (5) ...... 2315 tures, or preparations were listed on August 25, 1971, as excepted compounds under § 1308.32, and (f) Hallucinogenic substances. any other drug of the quantitative composition (1) ...... 7379 shown in that list for those drugs or which is the [Another name for nabilone: (±)-trans-3-(1,1- same except that it contains a lesser quantity of dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hy- controlled substances ...... 1405 droxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one] (2) Benzphetamine ...... 1228 (3) Chlorphentermine ...... 1645 (g) Immediate precursors. Unless spe- (4) Clortermine ...... 1647 cifically excepted or unless listed in (5) Phendimetrazine ...... 1615 another schedule, any material, com- (c) Depressants. Unless specifically pound, mixture, or preparation which excepted or unless listed in another contains any quantity of the following schedule, any material, compound, substances: mixture, or preparation which contains (1) Immediate precursor to amphet- any quantity of the following sub- amine and methamphetamine: stances having a depressant effect on (i) Phenylacetone ...... 8501 the central nervous system: Some trade or other names: phenyl-2-propanone; (1) Any compound, mixture or preparation containing: P2P; benzyl methyl ketone; methyl benzyl ke- (i) Amobarbital ...... 2126 tone; (ii) Secobarbital ...... 2316 (2) Immediate precursors to (iii) Pentobarbital ...... 2271 or any salt thereof and one or more other active phencyclidine (PCP): medicinal ingredients which are not listed in any (i) 1-phenylcyclohexylamine ...... 7460 schedule. (ii) 1-piperidinocyclohexanecarbonitrile (PCC) ...... 8603 (2) Any suppository dosage form containing: (i) Amobarbital ...... 2126 (3) Immediate precursor to fentanyl: (ii) Secobarbital ...... 2316 (i) 4-anilino-N-phenethyl-4-pi- (iii) Pentobarbital ...... 2271 or any salt of any of these drugs and approved by peridine (ANPP) ...... 8333 the Food and Drug Administration for marketing only as a suppository. (ii) [Reserved] (3) Any substance which contains any quantity of a [39 FR 22142, June 20, 1974] derivative of barbituric acid or any salt thereof ...... 2100 (4) Chlorhexadol ...... 2510 EDITORIAL NOTE: For FEDERAL REGISTER ci- (5) Embutramide ...... 2020 tations affecting § 1308.12, see the List of CFR (6) Any drug product containing gamma hydroxybutyric Sections Affected, which appears in the acid, including its salts, isomers, and salts of iso- mers, for which an application is approved under Finding Aids section of the printed volume section 505 of the Federal Food, Drug, and Cos- and at www.fdsys.gov. metic Act ...... 2012 (7) , its salts, isomers, and salts of isomers .. 7285 § 1308.13 Schedule III. [Some other names for ketamine: (±)-2-(2- chlorophenyl)-2-(methylamino)-cyclohexanone] (a) Schedule III shall consist of the (8) Lysergic acid ...... 7300 drugs and other substances, by what- (9) Lysergic acid amide ...... 7310 ever official name, common or usual (10) ...... 2575 (11) Sulfondiethylmethane ...... 2600 name, chemical name, or brand name (12) Sulfonethylmethane ...... 2605 designated, listed in this section. Each (13) ...... 2610 drug or substance has been assigned (14) and zolazepam or any salt thereof ...... 7295 109

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