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Notice

Importer of Controlled Substances Application: Lipomed, Inc.

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Start Preamble

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 1301.34(a) on or before August 5, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before August 5, 2015.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

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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 1301.34(a), this is notice that on March 31, 2014, Lipomed, Inc., One Broadway, Cambridge, Massachusetts 02142 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substanceSchedule
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
AM-2201 (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
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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-methylenedioxyamphetaimine (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-lodo-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-Fluropentyl)-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 HCI) (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-alphacetyl-methadol (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
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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 HCI (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
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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.

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Dated: June 25, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.

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[FR Doc. 2015-16448 Filed 7-2-15; 8:45 am]

BILLING CODE 4410-09-P