[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58601-58604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25227]
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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 December 20, 2018.
Such persons may also file a written request for a hearing on the
application on or before December 20, 2018.
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
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests 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/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152. Comments and requests for hearings on
applications to import narcotic raw material are not appropriate. 72 FR
3417, (January 25, 2007).
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.
[[Page 58602]]
In accordance with 21 CFR 1301.34(a), this is notice that on June
18, 2018, Lipomed, 150 Cambridge Park Dr., Suite 705, Cambridge,
Massachusetts 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-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- 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-naphthoyl)indole)... 7019 I
JWH-081 (1-Pentyl-3-(1-(4- 7081 I
methoxynaphthoyl) indole)................
SR-19 (Also known as RCS-4) (1-Pentyl-3- 7104 I
[(4-methoxy)-benzoyl] indole.............
JWH-018 (also known as AM678) (1-Pentyl-3- 7118 I
(1-naphthoyl)indole).....................
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) 7122 I
indole)..................................
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)... 7173 I
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1- 7200 I
naphthoyl)indole)........................
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) 7201 I
indole)..................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) 7203 I
indole)..................................
Alpha-ethyltryptamine..................... 7249 I
Ibogaine.................................. 7260 I
CP-47,497 (5-(1,1-Dimethylheptyl)-2- 7297 I
[(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-dimethoxyphenyl) 7385 I
ethanamine (2C-T-2 ).....................
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) 7398 I
indole)..................................
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) 7508 I
ethanamine (2C-D)........................
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine 7509 I
(2C-E )..................................
2-(2,5-Dimethoxyphenyl) ethanamine (2C-H). 7517 I
2-(4-iodo-2,5-dimethoxyphenyl) ethanamine 7518 I
(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)-propylphenyl) 7524 I
ethanamine (2C-P)........................
2-(4-Isopropylthio)-2,5-dimethoxyphenyl) 7532 I
ethanamine (2C-T-4 ).....................
MDPV (3,4-Methylenedioxypyrovalerone)..... 7535 I
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).........................
AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I
iodobenzoyl) indole).....................
Acetyldihydrocodeine...................... 9051 I
[[Page 58603]]
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
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
[[Page 58604]]
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 9273 II
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: November 2, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25227 Filed 11-19-18; 8:45 am]
BILLING CODE 4410-09-P