Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Federal Register, Volume 83 Issue 228 (Tuesday, November 27, 2018)
Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)
Notices
Pages 60900-60903
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-25865
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Docket No. DEA-392
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 28, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on July 25, 2018, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108 applied to be registered as a bulk manufacturer for the basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
3-Fluoro-N-methylcathinone (3- 1233 I
FMC).
Cathinone........................ 1235 I
Methcathinone.................... 1237 I
4-Fluoro-N-methylcathinone (4- 1238 I
FMC).
Page 60901
Pentedrone (alpha- 1246 I
methylaminovalerophenone).
Mephedrone (4-Methyl-N- 1248 I
methylcathinone).
4-Methyl-N-ethylcathinone (4-MEC) 1249 I
Naphyrone........................ 1258 I
N-Ethylamphetamine............... 1475 I
N,N-Dimethylamphetamine.......... 1480 I
Fenethylline..................... 1503 I
Aminorex......................... 1585 I
4-Methylaminorex (cis isomer).... 1590 I
Gamma Hydroxybutyric Acid........ 2010 I
Methaqualone..................... 2565 I
Mecloqualone..................... 2572 I
JWH-250 (1-Pentyl-3-(2- 6250 I
methoxyphenylacetyl) indole).
SR-18 (Also known as RCS-8) (1- 7008 I
Cyclohexylethyl-3-(2-
methoxyphenylacetyl) indole).
ADB-FUBINACA (N-(1-amino-3,3- 7010 I
dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-
carboxamide).
5-Fluoro-UR-144 and XLR11 1-(5- 7011 I
Fluoro-pentyl)1H-indol-3-
yl(2,2,3,3-
tetramethylcyclopropyl)methanone.
AB-FUBINACA (N-(1-amino-3-methyl- 7012 I
1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-
carboxamide).
JWH-019 (1-Hexyl-3-(1- 7019 I
naphthoyl)indole).
MDMB-FUBINACA (Methyl 2-(1-(4- 7020 I
fluorobenzyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate).
2-(1-(4-fluorobenzyl)-1Hinsazole- 7021 I
3-carboxamido)-3-methylbutanoate.
AB-PINACA (N-(1-amino-3-methyl-1- 7023 I
oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide).
THJ-2201 1-(5-fluoropentyl)-1H- 7024 I
indazol-3-yl(naphthalen-1-
yl)methanone.
5F-AB-PINACA (N-(1-amino-3-methyl- 7025 I
1-oxobutan-2yl)-1-(5-
fluoropentyl)-1 H-indazole-3-
carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl- 7031 I
1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide.
MAB-CHMINACA (N-(1-amino- 7032 I
3,3dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide).
5F-AMB (Methyl 2-(1-(5- 7033 I
fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate).
5F-ADB; 5F-MDMB-PINACA (Methyl 2- 7034 I
(1-(5-fluoropentyl)-1H-indazole-
3-carboxamido)-3,3-
dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3- 7035 I
dimethyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-
carboxamide).
MDMB-CHMICA, MMB-CHMINACA (Methyl 7042 I
2-(1-(cyclohexylmethyl)-1H-
indole-3-carboxamido)-3,3-
dimethylbutanoate).
MMB-CHMICA, AMB-CHMICA (methyl 2- 7044 I
(1(cyclohexylmethyl)-1 H-indole-
3-carboxamido)-3methylbutanoate).
APINACA and AKB48 N-(1-Adamantyl)- 7048 I
1-pentyl-1H-indazole-3-
carboxamide.
5F-APINACA, 5F-AKB48 (N- 7049 I
(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-
carboxamide).
JWH-081 (1-Pentyl-3-(1-(4- 7081 I
methoxynaphthoyl) indole).
5F-CUMYL-P7AICA (1-(5- 7085 I
fluoropentyl)-N-(2phenylpropan-2-
yl)-1 H-pyrrolo2,3-bpyridine-
3carboxamide).
4-CN-CUMYL-BUTINACA (1-(4- 7089 I
cyanobutyl)-N-(2phenylpropan-2-
yl)-1 H-indazole-3-carboxamide).
SR-19 (Also known as RCS-4) (1- 7104 I
Pentyl-3-(4-methoxy)-benzoyl
indole.
JWH-018 (also known as AM678) (1- 7118 I
Pentyl-3-(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1- 7122 I
naphthoyl) indole).
UR-144 (1-Pentyl-1H-indol-3- 7144 I
yl)(2,2,3,3-
tetramethylcyclopropyl)methanone.
JWH-073 (1-Butyl-3-(1- 7173 I
naphthoyl)indole).
JWH-200 (1-2-(4- 7200 I
Morpholinyl)ethyl-3-(1-
naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1- 7201 I
naphthoyl) indole).
JWH-203 (1-Pentyl-3-(2- 7203 I
chlorophenylacetyl) indole).
NM2201; CBL2201 (Naphthalen-1-yl 7221 I
1-(5-fluoropentyl)1 H-indole-3-
carboxylate).
PB-22 (Quinolin-8-yl 1-pentyl-1H- 7222 I
indole-3-carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5- 7225 I
fluoropentyl)-1H-indole-3-
carboxylate).
Alpha-ethyltryptamine............ 7249 I
Ibogaine......................... 7260 I
CP-47,497 (5-(1,1-Dimethylheptyl)- 7297 I
2-(1R,3S)-3-hydroxycyclohexyl-
phenol).
CP-47,497 C8 Homologue (5-(1,1- 7298 I
Dimethyloctyl)-2-(1R,3S)3-
hydroxycyclohexyl-phenol).
Lysergic acid diethylamide....... 7315 I
2,5-Dimethoxy-4-(n)- 7348 I
propylthiophenethylamine (2C-T-
7).
Marihuana........................ 7360 I
Tetrahydrocannabinols............ 7370 I
Mescaline........................ 7381 I
2-(4-Ethylthio-2,5- 7385 I
dimethoxyphenyl) ethanamine (2C-
T-2 ).
3,4,5-Trimethoxyamphetamine...... 7390 I
4-Bromo-2,5-dimethoxyamphetamine. 7391 I
4-Bromo-2,5- 7392 I
dimethoxyphenethylamine.
4-Methyl-2,5-dimethoxyamphetamine 7395 I
2,5-Dimethoxyamphetamine......... 7396 I
JWH-398 (1-Pentyl-3-(4-chloro-1- 7398 I
naphthoyl) indole).
2,5-Dimethoxy-4-ethylamphetamine. 7399 I
3,4-Methylenedioxyamphetamine.... 7400 I
5-Methoxy-3,4- 7401 I
methylenedioxyamphetamine.
N-Hydroxy-3,4- 7402 I
methylenedioxyamphetamine.
3,4-Methylenedioxy-N- 7404 I
ethylamphetamine.
3,4-Methylenedioxymethamphetamine 7405 I
4-Methoxyamphetamine............. 7411 I
5-Methoxy-N-N-dimethyltryptamine. 7431 I
Alpha-methyltryptamine........... 7432 I
Diethyltryptamine................ 7434 I
Dimethyltryptamine............... 7435 I
Page 60902
Psilocybin....................... 7437 I
Psilocyn......................... 7438 I
5-Methoxy-N,N- 7439 I
diisopropyltryptamine.
N-Ethyl-1-phenylcyclohexylamine.. 7455 I
1-(1-Phenylcyclohexyl)pyrrolidine 7458 I
1-1-(2- 7470 I
Thienyl)cyclohexylpiperidine.
1-1-(2- 7473 I
Thienyl)cyclohexylpyrrolidine.
N-Benzylpiperazine............... 7493 I
2-(2,5-Dimethoxy-4-methylphenyl) 7508 I
ethanamine (2C-D).
2-(2,5-Dimethoxy-4-ethylphenyl) 7509 I
ethanamine (2C-E ).
2-(2,5-Dimethoxyphenyl) 7517 I
ethanamine (2C-H).
2-(4-iodo-2,5-dimethoxyphenyl) 7518 I
ethanamine (2C-I).
2-(4-Chloro-2,5-dimethoxyphenyl) 7519 I
ethanamine (2C-C).
2-(2,5-Dimethoxy-4-nitro-phenyl) 7521 I
ethanamine (2C-N).
2-(2,5-Dimethoxy-4-(n)- 7524 I
propylphenyl) ethanamine (2C-P).
2-(4-Isopropylthio)-2,5- 7532 I
dimethoxyphenyl) ethanamine (2C-
T-4 ).
MDPV (3,4- 7535 I
Methylenedioxypyrovalerone).
2-(4-bromo-2,5-dimethoxyphenyl)-N- 7536 I
(2-methoxybenzyl) ethanamine
(25B-NBOMe).
2-(4-chloro-2,5-dimethoxyphenyl)- 7537 I
N-(2-methoxybenzyl) ethanamine
(25C-NBOMe).
2-(4-iodo-2,5-dimethoxyphenyl)-N- 7538 I
(2-methoxybenzyl) ethanamine
(25I-NBOMe).
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Butylone......................... 7541 I
Pentylone........................ 7542 I
alpha-pyrrolidinopentiophenone 7545 I
(alpha-PVP).
alpha-pyrrolidinobutiophenone 7546 I
(alpha-PBP).
AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I
iodobenzoyl) indole).
Acetyldihydrocodeine............. 9051 I
Benzylmorphine................... 9052 I
Codeine-N-oxide.................. 9053 I
Desomorphine..................... 9055 I
Etorphine (except HCl)........... 9056 I
Codeine methylbromide............ 9070 I
Dihydromorphine.................. 9145 I
Heroin........................... 9200 I
Morphine-N-oxide................. 9307 I
Normorphine...................... 9313 I
U-47700 (3,4-dichloro-N-2- 9547 I
(dimethylamino)cyclohexyl-N-
methylbenzamide).
MT-45 (1-cyclohexyl-4-(1,2- 9560 I
diphenylethyl)piperazine)).
Tilidine......................... 9750 I
Acryl fentanyl (N-(1- 9811 I
phenethylpiperidin-4-yl)-N-
phenylacrylamide).
Para-Fluorofentanyl.............. 9812 I
3-Methylfentanyl................. 9813 I
Alpha-methylfentanyl............. 9814 I
Acetyl-alpha-methylfentanyl...... 9815 I
N-(2-fluorophenyl)-N-(1- 9816 I
phenethylpiperidin-4-
yl)propionamide.
Acetyl Fentanyl (N-(1- 9821 I
phenethylpiperidin-4-yl)-N-
phenylacetamide).
Butyryl Fentanyl................. 9822 I
Para-fluorobutyryl fentanyl...... 9823 I
4-Fluoroisobutyryl fentanyl (N-(4- 9824 I
fluorophenyl)-N-(1-
phenethylpiperidin-4-
yl)isobutyramide).
2-methoxy-N-(1-phenethylpiperidin- 9825 I
4-yl)-N-phenylacetamide.
Para-chloroisobutyryl fentanyl... 9826 I
Isobutyryl fentanyl.............. 9827 I
Beta-hydroxyfentanyl............. 9830 I
Beta-hydroxy-3-methylfentanyl.... 9831 I
Alpha-methylthiofentanyl......... 9832 I
3-Methylthiofentanyl............. 9833 I
Furanyl fentanyl (N-(1- 9834 I
phenethylpiperidin-4-yl)-N-
phenylfuran-2-carboxamide).
Thiofentanyl..................... 9835 I
Beta-hydroxythiofentanyl......... 9836 I
Para-methoxybutyryl fentanyl..... 9837 I
Ocfentanil....................... 9838 I
Valeryl fentanyl................. 9840 I
N-(1-phenethylpiperidin-4-yl)-N- 9843 I
phenyltetrahydrofuran-2-
carboxamide.
Cyclopropyl Fentanyl............. 9845 I
Cyclopentyl fentanyl............. 9847 I
Fentanyl related-compounds as 9850 I
defined in 21 CFR 1308.11&h).
Amphetamine...................... 1100 II
Methamphetamine.................. 1105 II
Lisdexamfetamine................. 1205 II
Phenmetrazine.................... 1631 II
Methylphenidate.................. 1724 II
Amobarbital...................... 2125 II
Pentobarbital.................... 2270 II
Secobarbital..................... 2315 II
Page 60903
Phencyclidine.................... 7471 II
4-Anilino-N-phenethyl-4- 8333 II
piperidine (ANPP).
Phenylacetone.................... 8501 II
1- 8603 II
Piperidinocyclohexanecarbonitril
e.
Cocaine.......................... 9041 II
Codeine.......................... 9050 II
Etorphine HCl.................... 9059 II
Dihydrocodeine................... 9120 II
Oxycodone........................ 9143 II
Hydromorphone.................... 9150 II
Ecgonine......................... 9180 II
Ethylmorphine.................... 9190 II
Hydrocodone...................... 9193 II
Levomethorphan................... 9210 II
Levorphanol...................... 9220 II
Isomethadone..................... 9226 II
Meperidine....................... 9230 II
Meperidine intermediate-B........ 9233 II
Methadone........................ 9250 II
Dextropropoxyphene, bulk (non- 9273 II
dosage forms).
Morphine......................... 9300 II
Thebaine......................... 9333 II
Oxymorphone...................... 9652 II
Thiafentanil..................... 9729 II
Alfentanil....................... 9737 II
Remifentanil..................... 9739 II
Sufentanil....................... 9740 II
Carfentanil...................... 9743 II
Tapentadol....................... 9780 II
Fentanyl......................... 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled substances to produce forensic and research analytical reference standards for distribution to its customers.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
FR Doc. 2018-25865 Filed 11-26-18; 8:45 am
BILLING CODE 4410-09-P