AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Lipomed has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
DATES:
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 24, 2021. Such persons may also file a written request for a hearing on the application on or before May 24, 2021.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.34(a), this is notice that on February 26, 2021, 150 Cambridgepark Drive, Suite 705, Cambridge, Massachusetts 02140, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
| 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 |
| 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-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 |
| MDMB-FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) | 7020 | I |
| FUB-AMB, MMB-FUBINACA, AMB-FUBINACA (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 |
| 5F-AB-PINACA (N-(1-amino-3methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) | 7025 | 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-indazole-3-carboxamido)-3-methylbutanoate) | 7033 | I |
| 5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) | 7034 | I |
| ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) | 7035 | I |
| Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido) 3,3-dimethylbutanoate) | 7036 | I |
| MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) | 7042 | I |
| MMB-CHMICA , AMB-CHMICA (methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate) | 7044 | I |
| N-(Adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboximide) | 7047 | I |
| APINACA and AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide) | 7048 | I |
| 5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) | 7049 | I |
| JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) | 7081 | I |
| 1-(5-Fluoropentyl)-1H-indazole-3-carboxamide | 7083 | I |
| 5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide) | 7085 | I |
| 4-CN-CUMYL-BUTINACA, 4-cyano-CUMYL-BUTINACA, 4-CN-CUMYL BINACA, CUMYL-4CN-BINACA, SGT-78 (1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide) | 7089 | 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 |
| NM2201, CBL2201 (Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate) | 7221 | 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 |
| 4-methyl-alpha-ethylaminopentiophenone (4-MEAP) | 7245 | I |
| N-ethylhexedrone | 7246 | 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 extract | 7350 | I |
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
| Parahexyl | 7374 | I |
| Mescaline | 7381 | I |
| 2C-T-2, (2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine) | 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 |
| 4-chloro-alpha-pyrrolidinovalerophenone (4-chloro-a-PVP) | 7443 | 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-MePPP (4-Methyl-alphapyrrolidinopropiophenone) | 7498 | I |
| 2C-D (2-(2,5-Dimethoxy-4-methylphenyl) ethanamine) | 7508 | I |
| 2C-E (2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine) | 7509 | I |
| 2C-H (2-(2,5-Dimethoxyphenyl) ethanamine) | 7517 | I |
| 2C-I (2-(4-iodo-2,5-dimethoxyphenyl) ethanamine) | 7518 | I |
| 2C-C (2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine) | 7519 | I |
| 2C-N (2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine) | 7521 | I |
| 2C-P (2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine) | 7524 | I |
| 2C-T-4 (2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine) | 7532 | I |
| MDPV (3,4-Methylenedioxypyrovalerone) | 7535 | I |
| 25B-NBOMe (2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) | 7536 | I |
| 25C-NBOMe (2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) | 7537 | I |
| 25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) | 7538 | I |
| Methylone (3,4-Methylenedioxy-N-methylcathinone) | 7540 | I |
| Butylone | 7541 | I |
| Pentylone | 7542 | I |
| N-Ethylpentylone, ephylone (1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-pentan-1-one) | 7543 | I |
| α-PHP, alpha-Pyrrolidinohexanophenone | 7544 | I |
| α-PVP (alpha-pyrrolidinopentiophenone) | 7545 | I |
| α-PBP (alpha-pyrrolidinobutiophenone) | 7546 | I |
| PV8, alpha-Pyrrolidinoheptaphenone | 7548 | I |
| AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) | 7694 | I |
| Norfentanyl | 8366 | I |
| Acetyldihydrocodeine | 9051 | I |
| Benzylmorphine | 9052 | I |
| Codeine-N-oxide | 9053 | I |
| Cyprenorphine | 9054 | I |
| Desomorphine | 9055 | I |
| Etorphine (except HCl) | 9056 | I |
| Codeine methylbromide | 9070 | I |
| Dihydromorphine | 9145 | I |
| Difenoxin | 9168 | I |
| Heroin | 9200 | I |
| Hydromorphinol | 9301 | I |
| Methyldesorphine | 9302 | I |
| Methyldihydromorphine | 9304 | I |
| Morphine methylbromide | 9305 | I |
| Morphine methylsulfonate | 9306 | I |
| Morphine-N-oxide | 9307 | I |
| Myrophine | 9308 | I |
| Nicocodeine | 9309 | I |
| Nicomorphine | 9312 | I |
| Normorphine | 9313 | I |
| Pholcodine | 9314 | I |
| Thebacon | 9315 | I |
| Acetorphine | 9319 | I |
| Drotebanol | 9335 | 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 |
| MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine)) | 9560 | 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 |
| Betameprodine | 9608 | I |
| Betamethadol | 9609 | I |
| Betaprodine | 9611 | I |
| Clonitazene | 9612 | I |
| Dextromoramide | 9613 | I |
| Diampromide | 9615 | I |
| Diethylthiambutene | 9616 | I |
| Dimenoxadol | 9617 | I |
| Dimepheptanol | 9618 | I |
| Dimethylthiambutene | 9619 | I |
| Dioxaphetyl butyrate | 9621 | I |
| Dipipanone | 9622 | I |
| Ethylmethylthiambutene | 9623 | I |
| Etonitazene | 9624 | I |
| Etoxeridine | 9625 | I |
| Furethidine | 9626 | I |
| Hydroxypethidine | 9627 | I |
| Ketobemidone | 9628 | I |
| Levomoramide | 9629 | I |
| Levophenacylmorphan | 9631 | I |
| Morpheridine | 9632 | I |
| Noracymethadol | 9633 | I |
| Norlevorphanol | 9634 | I |
| Normethadone | 9635 | I |
| Norpipanone | 9636 | I |
| Phenadoxone | 9637 | I |
| Phenampromide | 9638 | I |
| Phenoperidine | 9641 | I |
| Piritramide | 9642 | I |
| Proheptazine | 9643 | I |
| Properidine | 9644 | I |
| Racemoramide | 9645 | I |
| Trimeperidine | 9646 | I |
| Phenomorphan | 9647 | I |
| Propiram | 9649 | I |
| 1-Methyl-4-phenyl-4-propionoxypiperidine | 9661 | I |
| 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine | 9663 | 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-(1-phenethylpiperidin-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 |
| Glutethimide | 2550 | II |
| Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration (FDA) | 7365 | II |
| Nabilone | 7379 | II |
| 1-Phenylcyclohexylamine | 7460 | II |
| Phencyclidine | 7471 | II |
| ANPP (4-Anilino-N-phenethyl-4-piperidine) | 8333 | II |
| Phenylacetone | 8501 | II |
| 1-Piperidinocyclohexanecarbonitrile | 8603 | II |
| Alphaprodine | 9010 | II |
| Anileridine | 9020 | II |
| Cocaine | 9041 | II |
| Codeine | 9050 | II |
| Etorphine HCl | 9059 | II |
| Dihydrocodeine | 9120 | II |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Diphenoxylate | 9170 | II |
| Ecgonine | 9180 | II |
| Ethylmorphine | 9190 | II |
| Hydrocodone | 9193 | II |
| Levomethorphan | 9210 | II |
| Levorphanol | 9220 | II |
| Isomethadone | 9226 | II |
| Meperidine | 9230 | II |
| Meperidine-intermediate-A | 9232 | II |
| Meperidine intermediate-B | 9233 | II |
| Meperidine intermediate-C | 9234 | II |
| Metazocine | 9240 | II |
| Methadone | 9250 | II |
| Methadone intermediate | 9254 | II |
| Metopon | 9260 | II |
| Dextropropoxyphene, bulk (non-dosage forms) | 9273 | II |
| Morphine | 9300 | II |
| Oripavine | 9330 | II |
| Thebaine | 9333 | II |
| Dihydroetorphine | 9334 | II |
| Levo-alphacetylmethadol | 9648 | II |
| Oxymorphone | 9652 | II |
| Noroxymorphone | 9668 | II |
| Phenazocine | 9715 | II |
| Thiafentanil | 9729 | II |
| Piminodine | 9730 | II |
| Racemethorphan | 9732 | II |
| Racemorphan | 9733 | II |
| Alfentanil | 9737 | II |
| Remifentanil | 9739 | II |
| Sufentanil | 9740 | II |
| Carfentanil | 9743 | II |
| Tapentadol | 9780 | II |
| Bezitramide | 9800 | II |
| Fentanyl | 9801 | II |
| Moramide-intermediate | 9802 | II |
The company plans to import analytical reference standards for distribution to its customers for research and analytics purposes. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized in 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-08535 Filed 4-22-21; 8:45 am]
BILLING CODE 4410-09-P