83 FR 78 pgs. 17678-17681 - Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Type: NOTICEVolume: 83Number: 78Pages: 17678 - 17681
Pages: 17678, 17679, 17681Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2018-08348 Filed 4-20-18; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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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 June 22, 2018.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 March 8, 2018, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
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| Controlled substance | Drug code | Schedule |
|---|---|---|
| 3-Fluoro-N-methylcathinone (3-FMC) | 1233 | I |
| Cathinone | 1235 | I |
| Methcathinone | 1237 | I |
| 4-Fluoro-N-methylcathinone (4-FMC) | 1238 | I |
| Pentedrone (a-methylaminovalerophenone) | 1246 | I |
| Mephedrone (4-Methyl-N-methylcathinone) | 1248 | I |
| 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-methoxyphenylacetyl) indole) | 6250 | I |
| SR-18 (Also known as RCS-8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) | 7008 | I |
| ADB-FUBINACA (n-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) | 7010 | I |
| 5-Flouro-UR-144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone | 7011 | I |
| AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) | 7012 | I |
| JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) | 7019 | I |
| MDMB-FUBINACA (Methyl 2-(1-4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) | 7020 | I |
| 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3- methylbutanoate | 7021 | I |
| AB-PINACA (N-(1-amino-3-methyl- 1-oxobutan-2-yl)-1-pentyl-1H-indazole- 3-carboxamide) | 7023 | I |
| THJ-2201 [1-(5-fluoropentyl)-1H-indazol-3- yl](naphthalen-1-yl)methanone | 7024 | I |
| AB-CHMINACA (N-(1-amino-3-methyl-1- oxobutan-2-yl)-1-(cyclohexylmethyl)- 1H-indazole-3-carboxamide | 7031 | I |
| MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) | 7032 | I |
| 5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazola-3-carboxamido)-3-methylbutanoate) | 7033 | I |
| 5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5fluoropentyl)-1H-indazole-3-carboxamido)-3,3dimethylbutanoate) | 7034 | I |
| ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) | 7035 | I |
| MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-(cyclohenxylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanote)- | 7042 | I |
| APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide | 7048 | I |
| 5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1-(5fluoropentyl)-1H-indazole-3-carboxamide) | 7049 | I |
| JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) | 7081 | I |
| SR-19 (Also known as RCS-4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole | 7104 | I |
| JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) | 7118 | I |
| JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) | 7122 | I |
| UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone | 7144 | I |
| JWH-073 (1-Butyl-3-(1-naphthoyl)indole) | 7173 | I |
| JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) | 7200 | I |
| AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) | 7201 | I |
| JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) | 7203 | I |
| PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate) | 7222 | I |
| 5F-PB-22 (Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate) | 7225 | I |
| Alpha-ethyltryptamine | 7249 | I |
| Ibogaine | 7260 | I |
| CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) | 7297 | I |
| CP-47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol) | 7298 | I |
| Lysergic acid diethylamide | 7315 | I |
| 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) | 7348 | I |
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
| Mescaline | 7381 | I |
| 2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C-T-2 ) | 7385 | I |
| 3,4,5-Trimethoxyamphetamine | 7390 | I |
| 4-Bromo-2,5-dimethoxyamphetamine | 7391 | I |
| 4-Bromo-2,5-dimethoxyphenethylamine | 7392 | I |
| 4-Methyl-2,5-dimethoxyamphetamine | 7395 | I |
| 2,5-Dimethoxyamphetamine | 7396 | I |
| JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole) | 7398 | I |
| 2,5-Dimethoxy-4-ethylamphetamine | 7399 | I |
| 3,4-Methylenedioxyamphetamine | 7400 | I |
| 5-Methoxy-3,4-methylenedioxyamphetamine | 7401 | I |
| N-Hydroxy-3,4-methylenedioxyamphetamine | 7402 | I |
| 3,4-Methylenedioxy-N-ethylamphetamine | 7404 | I |
| 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 |
| Psilocybin | 7437 | I |
| Psilocyn | 7438 | I |
| 5-Methoxy-N,N-diisopropyltryptamine | 7439 | I |
| N-Ethyl-1-phenylcyclohexylamine | 7455 | I |
| 1-(1-Phenylcyclohexyl)pyrrolidine | 7458 | I |
| 1-[1-(2-Thienyl)cyclohexyl]piperidine | 7470 | I |
| 1-[1-(2-Thienyl)cyclohexyl]pyrrolidine | 7473 | I |
| N-Benzylpiperazine | 7493 | I |
| 2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C-D) | 7508 | I |
| 2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C-E ) | 7509 | I |
| 2-(2,5-Dimethoxyphenyl) ethanamine (2C-H) | 7517 | I |
| 2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) | 7518 | I |
| 2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C) | 7519 | I |
| 2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine (2C-N) | 7521 | I |
| 2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine (2C-P) | 7524 | I |
| 2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C-T-4 ) | 7532 | I |
| MDPV (3,4-Methylenedioxypyrovalerone) | 7535 | I |
| 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B-NBOMe) | 7536 | I |
| 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25C-NBOMe) | 7537 | I |
| 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe) | 7538 | I |
| Methylone (3,4-Methylenedioxy-N-methylcathinone) | 7540 | I |
| Butylone | 7541 | I |
| Pentylone | 7542 | I |
| alpha-pyrrolidinopentiophenone (a-PVP) | 7545 | I |
| alpha-pyrrolidinobutiophenone (a-PBP) | 7546 | I |
| AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) | 7694 | I |
| 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-(dimethylamino)cyclohexyl]-N-methylbenzamide) | 9547 | I |
| MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine)) | 9560 | I |
| Tilidine | 9750 | I |
| Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) | 9811 | I |
| Para-Fluorofentanyl | 9812 | I |
| 3-Methylfentanyl | 9813 | I |
| Alpha-methylfentanyl | 9814 | I |
| Acetyl-alpha-methylfentanyl | 9815 | I |
| N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide | 9816 | I |
| Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) | 9821 | I |
| Butyryl Fentanyl | 9822 | I |
| Para-fluorobutyryl fentanyl | 9823 | I |
| 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1phenethylpiperidin-4-yl)isobutyramide) | 9824 | I |
| 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide | 9825 | I |
| 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-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) | 9834 | I |
| 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-phenyltetrahydrofuran-2-carboxamide | 9843 | I |
| Cyclopropyl Fentanyl | 9845 | I |
| Cyclopentyl fentanyl | 9847 | I |
| Fentanyl related-compounds as defined in 21 CFR 1308.11(h) | 9850 | I |
| Amphetamine | 1100 | II |
| Methamphetamine | 1105 | II |
| Lisdexamfetamine | 1205 | II |
| Phenmetrazine | 1631 | II |
| Methylphenidate | 1724 | II |
| Amobarbital | 2125 | II |
| Pentobarbital | 2270 | II |
| Secobarbital | 2315 | II |
| Phencyclidine | 7471 | II |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) | 8333 | II |
| Phenylacetone | 8501 | II |
| 1-Piperidinocyclohexanecarbonitrile | 8603 | II |
| 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-dosage forms) | 9273 | II |
| 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 |
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The company plans to manufacture bulk controlled substances for use in product development of analytical reference standards for distribution to its customers.
The company will manufacture marihuana (7360) and tetrahydrocannabinols (7370) for use by their researchers under the above-listed controlled substances as Active Pharmaceutical Ingredient (API) for clinical trials.
In reference to drug code (7370) the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activities for this drug code are authorized for this registration.
Dated: April 13, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-08348 Filed 4-20-18; 8:45 am]
BILLING CODE 4410-09-P