2018-07442. 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 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.

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.