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 7, 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 February 1, 2019, Synthcon, LLC, 770 Wooten Road, Unit 101, Colorado Springs, Colorado 80915 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Amphetamine | 1100 | II |
| Methamphetamine | 1105 | II |
| 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 |
| ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) | 7035 | I |
| JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) | 7118 | I |
| JWH-073 (1-Butyl-3-(1-naphthoyl)indole) | 7173 | I |
| JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) | 7200 | I |
| JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) | 7203 | 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 |
| 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 |
| 5-Methoxy-N,N-diisopropyltryptamine | 7439 | I |
| N-Ethyl-1-phenylcyclohexylamine | 7455 | I |
| 1-(1-Phenylcyclohexyl)pyrrolidine | 7458 | I |
| 1-Phenylcyclohexylamine | 7460 | II |
| 1-[1-(2-Thienyl)cyclohexyl]piperidine | 7470 | I |
| Phencyclidine | 7471 | II |
| 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 |
| 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 |
| Etorphine (except HCl) | 9056 | I |
| Diphenoxylate | 9170 | II |
| Ecgonine | 9180 | II |
| Heroin | 9200 | I |
| 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 |
| Normorphine | 9313 | I |
| Acetorphine | 9319 | 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 |
| Acetylmethadol | 9601 | I |
| Allylprodine | 9602 | 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 |
| Ketobemidone | 9628 | I |
| Levo-alphacetylmethadol | 9648 | II |
| 1-Methyl-4-phenyl-4-propionoxypiperidine | 9661 | I |
| 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine | 9663 | I |
| Alfentanil | 9737 | II |
| Remifentanil | 9739 | II |
| Sufentanil | 9740 | II |
| Carfentanil | 9743 | II |
| Tilidine | 9750 | I |
| Tapentadol | 9780 | II |
| Fentanyl | 9801 | II |
| 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 |
| N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide | 9843 | I |
| Cyclopropyl Fentanyl | 9845 | I |
| Fentanyl related-compounds as defined in 21 CFR 1308.11&h) | 9850 | I |
The company plans to manufacture the above-listed controlled substances as analytical reference standards for distribution to its customers. No other activities for these drug codes are authorized for this registration.
Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06846 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P