21 C.F.R. § 1308.12

Current through February 29, 2024
Section 1308.12 - Schedule II
(a) Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the Controlled Substances Code Number set forth opposite it.
(b)Substances, vegetable origin or chemical synthesis. 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 excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, naloxegol, naloxone, 6[BETA]-naltrexol, naltrexone, and samidorphan, and their respective salts, but including the following:

(i) Codeine9050
(ii) Dihydroetorphine9334
(iii) Ethylmorphine9190
(iv) Etorphine hydrochloride9059
(v) Granulated opium9640
(vi) Hydrocodone9193
(vii) Hydromorphone9150
(viii) Metopon9260
(ix) Morphine9300
(x) Noroxymorphone9668
(xi) Opium extracts9610
(xii) Opium fluid9620
(xiii) Oripavine9330
(xiv) Oxycodone9143
(xv) Oxymorphone9652
(xvi) Powdered opium9639
(xvii) Raw opium9600
(xviii) Thebaine9333
(xix) Tincture of opium9630

(2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in paragraph (b) (1) of this section, except that these substances shall not include the isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4) Coca leaves (9040) and any salt, compound, derivative or preparation of coca leaves (including cocaine (9041) and ecgonine (9180) 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:
(i) Decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine;
(ii) [123I]ioflupane; or
(iii) [18F]FP-CIT.
(5) Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid or powder form which contains the phenanthrene alkaloids of the opium poppy), 9670.
(c)Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its 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, dextrorphan and levopropoxyphene excepted:

(1) Alfentanil9737
(2) Alphaprodine9010
(3) Anileridine9020
(4) Bezitramide9800
(5) Bulk dextropropoxyphene (non-dosage forms)9273
(6) Carfentanil9743
(7) Dihydrocodeine9120
(8) Diphenoxylate9170
(9) Fentanyl9801
(10) Isomethadone9226
(11) Levo-alphacetylmethadol9648
[Some other names: levo-alpha-acetylmethadol, levomethadyl acetate, LAAM]
(12) Levomethorphan9210
(13) Levorphanol9220
(14) Metazocine9240
(15) Methadone9250
(16) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane9254
(17) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid9802
(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine)9245
(19) Pethidine (meperidine)9230
(20) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine9232
(21) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate9233
(22) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid9234
(23) Phenazocine9715
(24) Piminodine9730
(25) Racemethorphan9732
(26) Racemorphan9733
(27) Remifentanil9739
(28) Sufentanil9740
(29) Tapentadol9780
(30) Thiafentanil9729

(d)Stimulants. 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 isomers1100
(2) Methamphetamine, its salts, isomers, and salts of its isomers1105
(3) Phenmetrazine and its salts1631
(4) Methylphenidate1724
(5) Lisdexamfetamine, its salts, isomers, and salts of its isomers1205.

(e)Depressants. 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, including its 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) Amobarbital2125
(2) Glutethimide2550
(3) Pentobarbital2270
(4) Phencyclidine7471
(5) Secobarbital2315

(f)Hallucinogenic substances.

(1) Nabilone7379
[Another name for nabilone: (±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one]
(2) Dronabinol [(-)-delta-9-trans tetrahydrocannabinol] in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration(7365)

(g)Immediate precursors. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances:
(1) Immediate precursor to amphetamine and methamphetamine:

(i) Phenylacetone8501
Some trade or other names: phenyl-2-propanone; P2P; benzyl methyl ketone; methyl benzyl ketone;

(2) Immediate precursors to phencyclidine (PCP):

(i) 1-phenylcyclohexylamine7460
(ii) 1-piperidinocyclohexanecarbonitrile (PCC)8603

(3) Immediate precursor to fentanyl:

(i) 4-anilino-N-phenethylpiperidine (ANPP)8333
(ii) N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl)8366

21 C.F.R. §1308.12

39 FR 22142, June 20, 1974
81 FR 58839, 8/26/2016; 82 FR 14820, 3/23/2017; 82 FR 45438, 9/29/2017; 84 FR 2449, 2/7/2019; 84 FR 41914, 8/16/2019; 85 FR 4217, 1/24/2020; 85 FR 21325, 5/18/2020; 85 FR 68753, 10/30/2020; 86 FR 20286, 4/19/2021; 86 FR 30774, 7/12/2021; 87 FR 70717, 12/21/2022

For FEDERAL REGISTER citations affecting § 1308.12 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.