Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Importers Notice of Application - 2018

[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15627-15630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07442]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Importer of Controlled Substances Application: Lipomed

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 May 11, 2018. Such persons may also file a written request for a

[[Page 15628]]

hearing on the application on or before May 11, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 1301.34(a), this is notice that on January 22, 2016, Lipomed, 150 Cambridge Park Drive, Suite 705, Cambridge, MA 02140 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled Substance Drug Code Schedule
Cathinone 1235 I
Methcathinone 1237 I
Mephedrone (4-Methyl-N-methylcathinone) 1248 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
JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) 7019 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
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
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
Parahexyl 7374 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
Psilocybin 7437 I
Psilocyn 7438 I
5-Methoxy-N,N-diisopropyltryptamine 7439 I
N-Ethyl-1-phenylcyclohexylamine 7455 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
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
Methylone (3,4-Methylenedioxy-N-methylcathinone) 7540 I
AM–694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) 7694 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
Acetylmethadol 9601 I
Allylprodine 9602 I
Alphacetylmethadol except levo-alphacetylmethadol 9603 I
Alphamethadol 9605 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
Tilidine 9750 I
Para-Fluorofentanyl 9812 I
3-Methylfentanyl 9813 I
Acetyl-alpha-methylfentanyl 9815 I
Beta-hydroxy-3-methylfentanyl 9831 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
Nabilone 7379 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
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-B 9233 II
Metazocine 9240 II
Methadone 9250 II
Methadone intermediate 9254 II
Metopon 9260 II
Dextropropoxyphene, bulk (non-dosage forms) 9273 II
Morphine 9300 II
Thebaine 9333 II
Dihydroetorphine 9334 II
Levo-alphacetylmethadol 9648 II
Oxymorphone 9652 II
Noroxymorphone 9668 II
Phenazocine 9715 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

[[Page 15630]]

The company plans to import analytical reference standards for distribution to its customers for research and analytical 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 under 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.

Dated: April 4, 2018.

Susan A. Gibson,
Deputy Assistant Administrator.

[FR Doc. 2018-07442 Filed 4-10-18; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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