Importer of Controlled Substances Application: Lipomed
Federal Register, Volume 83 Issue 70 (Wednesday, April 11, 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
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Docket No. DEA-392
Importer of Controlled Substances Application: Lipomed
ACTION: Notice of application.
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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
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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:
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Controlled substance Drug code Schedule
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Cathinone....................... 1235 I.
Methcathinone................... 1237 I.
Mephedrone (4-Methyl-N- 1248 I.
methylcathinone).
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- 6250 I.
methoxyphenylacetyl) indole).
SR-18 (Also known as RCS-8) (1- 7008 I.
Cyclohexylethyl-3-(2-
methoxyphenylacetyl) indole).
JWH-019 (1-Hexyl-3-(1- 7019 I.
naphthoyl)indole).
JWH-081 (1-Pentyl-3-(1-(4- 7081 I.
methoxynaphthoyl) indole).
SR-19 (Also known as RCS-4) (1- 7104 I.
Pentyl-3-(4-methoxy)-benzoyl
indole.
JWH-018 (also known as AM678) (1- 7118 I.
Pentyl-3-(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1- 7122 I.
naphthoyl) indole).
JWH-073 (1-Butyl-3-(1- 7173 I.
naphthoyl)indole).
JWH-200 (1-2-(4- 7200 I.
Morpholinyl)ethyl-3-(1-
naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1- 7201 I.
naphthoyl) indole).
JWH-203 (1-Pentyl-3-(2- 7203 I.
chlorophenylacetyl) indole).
Alpha-ethyltryptamine........... 7249 I.
Ibogaine........................ 7260 I.
CP-47,497 (5-(1,1- 7297 I.
Dimethylheptyl)-2-(1R,3S)-3-
hydroxycyclohexyl-phenol).
CP-47,497 C8 Homologue (5-(1,1- 7298 I.
Dimethyloctyl)-2-(1R,3S)3-
hydroxycyclohexyl-phenol).
Lysergic acid diethylamide...... 7315 I.
2,5-Dimethoxy-4-(n)- 7348 I.
propylthiophenethylamine (2C-T-
7).
Marihuana....................... 7360 I.
Tetrahydrocannabinols........... 7370 I.
Parahexyl....................... 7374 I.
Mescaline....................... 7381 I.
2-(4-Ethylthio-2,5- 7385 I.
dimethoxyphenyl) ethanamine (2C-
T-2 ).
3,4,5-Trimethoxyamphetamine..... 7390 I.
4-Bromo-2,5-dimethoxyamphetamine 7391 I.
4-Bromo-2,5- 7392 I.
dimethoxyphenethylamine.
4-Methyl-2,5- 7395 I.
dimethoxyamphetamine.
2,5-Dimethoxyamphetamine........ 7396 I.
JWH-398 (1-Pentyl-3-(4-chloro-1- 7398 I.
naphthoyl) indole).
2,5-Dimethoxy-4-ethylamphetamine 7399 I.
3,4-Methylenedioxyamphetamine... 7400 I.
5-Methoxy-3,4- 7401 I.
methylenedioxyamphetamine.
N-Hydroxy-3,4- 7402 I.
methylenedioxyamphetamine.
3,4-Methylenedioxy-N- 7404 I.
ethylamphetamine.
3,4- 7405 I.
Methylenedioxymethamphetamine.
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- 7439 I.
diisopropyltryptamine.
N-Ethyl-1-phenylcyclohexylamine. 7455 I.
1-1-(2- 7470 I.
Thienyl)cyclohexylpiperidine.
1-1-(2- 7473 I.
Thienyl)cyclohexylpyrrolidine.
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N-Ethyl-3-piperidyl benzilate... 7482 I.
N-Methyl-3-piperidyl benzilate.. 7484 I.
N-Benzylpiperazine.............. 7493 I.
2-(2,5-Dimethoxy-4-methylphenyl) 7508 I.
ethanamine (2C-D).
2-(2,5-Dimethoxy-4-ethylphenyl) 7509 I.
ethanamine (2C-E ).
2-(2,5-Dimethoxyphenyl) 7517 I.
ethanamine (2C-H).
2-(4-iodo-2,5-dimethoxyphenyl) 7518 I.
ethanamine (2C-I).
2-(4-Chloro-2,5-dimethoxyphenyl) 7519 I.
ethanamine (2C-C).
2-(2,5-Dimethoxy-4-nitro-phenyl) 7521 I.
ethanamine (2C-N).
2-(2,5-Dimethoxy-4-(n)- 7524 I.
propylphenyl) ethanamine (2C-P).
2-(4-Isopropylthio)-2,5- 7532 I.
dimethoxyphenyl) ethanamine (2C-
T-4).
MDPV (3,4- 7535 I.
Methylenedioxypyrovalerone).
Methylone (3,4-Methylenedioxy-N- 7540 I.
methylcathinone).
AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I.
iodobenzoyl) indole).
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- 9603 I.
alphacetylmethadol.
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.
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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- 8333 II.
piperidine (ANPP).
Phenylacetone................... 8501 II.
1- 8603 II.
Piperidinocyclohexanecarbonitri
le.
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- 9273 II.
dosage forms).
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.
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
