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 in accordance with 21 CFR 1301.33(a) on or before May 29, 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy 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 January 29, 2018, Synthcon, LLC, 770 Wooten Road, Unit 101, Colorado Springs, CO 80915 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
| 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 (α-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 |
| 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 |
| 5-Fluoro-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 |
| 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 |
| ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) | 7035 | I |
| APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide | 7048 | 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 |
| JWH018 (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 |
| 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 |
| 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 |
| Bufotenine | 7433 | I |
| Diethyltryptamine | 7434 | I |
| Dimethyltryptamine | 7435 | I |
| Psilocybin | 7437 | I |
| Psilocyn | 7438 | 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-Ethyl-3-piperidyl benzilate | 7482 | I |
| N-Methyl-3-piperidyl benzilate | 7484 | I |
| N-Benzylpiperazine | 7493 | I |
| 4-Methyl-alphapyrrolidinopropiophenone (4-MePPP) | 7498 | 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 (α-PVP) | 7545 | I |
| alpha-pyrrolidinobutiophenone (α-PBP) | 7546 | I |
| AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) | 7694 | I |
| Heroin | 9200 | I |
| Normorphine | 9313 | I |
| U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide) | 9547 | I |
| AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)) | 9551 | I |
| Alphacetylmethadol except levo-alphacetylmethadol | 9603 | I |
| Alphameprodine | 9604 | I |
| Alphamethadol | 9605 | I |
| Benzethidine | 9606 | I |
| Betacetylmethadol | 9607 | I |
| Clonitazene | 9612 | I |
| Diampromide | 9615 | I |
| Diethylthiambutene | 9616 | I |
| Dimethylthiambutene | 9619 | I |
| 1-Methyl-4-phenyl-4-propionoxypiperidine | 9661 | I |
| 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine | 9663 | I |
| Tilidine | 9750 | I |
| Para-Fluorofentanyl | 9812 | I |
| 3-Methylfentanyl | 9813 | I |
| Alpha-methylfentanyl | 9814 | I |
| Acetyl-alpha-methylfentanyl | 9815 | I |
| Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) | 9821 | 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 |
| Tetrahydrofuranyl fentanyl | 9843 | I |
| Cyclopropyl Fentanyl | 9845 | I |
| Fentanyl-related Substance | 9850 | I |
| Amphetamine | 1100 | II |
| Methamphetamine | 1105 | II |
| 1-Phenylcyclohexylamine | 7460 | II |
| Phencyclidine | 7471 | II |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) | 8333 | II |
| Phenylacetone | 8501 | II |
| 1-Piperidinocyclohexanecarbonitrile | 8603 | II |
| Alphaprodine | 9010 | II |
| Anileridine | 9020 | II |
| Cocaine | 9041 | II |
| Diphenoxylate | 9170 | II |
| Ecgonine | 9180 | II |
| Levorphanol | 9220 | II |
| Meperidine | 9230 | II |
| Meperidine intermediate-A | 9232 | II |
| Meperidine intermediate-B | 9233 | II |
| Meperidine intermediate-C | 9234 | II |
| Dextropropoxyphene, bulk (non-dosage forms) | 9273 | II |
| Morphine | 9300 | II |
| Levo-alphacetylmethadol | 9648 | II |
| Alfentanil | 9737 | II |
| Remifentanil | 9739 | II |
| Sufentanil | 9740 | II |
| Carfentanil | 9743 | II |
| Tapentadol | 9780 | II |
| Fentanyl | 9801 | II |
The company plans to manufacture the above-listed controlled substances as analytical reference standards for distribution to its customers. In reference to drug code 7370 tetrahydrocannabinols the company plans to bulk manufacture as synthetic substances. No other activity for this drug code is authorized for this registration.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06090 Filed 3-26-18; 8:45 am]
BILLING CODE 4410-09-P