[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Pages 21891-21895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08341]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-615]
Importer of Controlled Substances Application: Lipomed
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before May 20, 2020.
Such persons may also file a written request for a
[[Page 21892]]
hearing on the application on or before May 20, 2020.
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 a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on March 13, 2020, Lipomed, 150 Cambridge Park Drive,
Suite 705, Cambridge, Massachusetts 02140-2300 applied to be registered
as an importer of the following basic class(es) of controlled
substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
3-Fluoro-N-methylcathinone (3-FMC). 1233 I
Cathinone.......................... 1235 I
Methcathinone...................... 1237 I
4-Fluoro-N-methylcathinone (4-FMC). 1238 I
Pentedrone ([alpha]- 1246 I
methylaminovalerophenone).
Mephedrone (4-Methyl-N- 1248 I
methylcathinone).
4-Methyl-N-ethylcathinone (4-MEC).. 1249 I
Naphyrone.......................... 1258 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).
ADB-FUBINACA (N-(1-amino-3,3- 7010 I
dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-
carboxamide).
5-Fluoro-UR-144 and XLR11 ([1-(5- 7011 I
Fluoro-pentyl)1H-indol-3-
yl](2,2,3,3-
tetramethylcyclopropyl)methanone).
AB-FUBINACA (N-(1-amino-3-methyl-1- 7012 I
oxobutan-2-yl)-1-(4-fluorobenzyl)-
1H-indazole-3-carboxamide).
JWH-019 (1-Hexyl-3-(1- 7019 I
naphthoyl)indole).
MDMB-FUBINACA (Methyl 2-(1-(4- 7020 I
fluorobenzyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate).
FUB-;AMB, MMB-FUBINACA, AMB- 7021 I
FUBINACA (2-(1-(4-fluorobenzyl)-
1Hindazole-3-carboxamido)-3-
methylbutanoate).
AB-PINACA (N-(1-amino-3-methyl-1- 7023 I
oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide).
THJ-2201 ([1-(5-fluoropentyl)-1H- 7024 I
indazol-3-yl](naphthalen-1-
yl)methanone).
5F-AB-PINACA (N-(1-amino-3methyl-1- 7025 I
oxobutan-2-yl)-1-(5-fluoropentyl)-
1H-indazole-3-carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl-1- 7031 I
oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide).
MAB-CHMINACA (N-(1-amino- 7032 I
3,3dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide).
5F-AMB (Methyl 2-(1-(5- 7033 I
fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate).
5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1- 7034 I
(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3-dimethyl- 7035 I
1-oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide).
MDMB-CHMICA, MMB-CHMINACA (Methyl 2- 7042 I
(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-
dimethylbutanoate).
MMB-CHMICA, AMB-CHMICA (methyl 2-(1- 7044 I
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate).
APINACA and AKB48 (N-(1-Adamantyl)- 7048 I
1-pentyl-1H-indazole-3-
carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan- 7049 I
1-yl)-1-(5-fluoropentyl)-1H-
indazole-3-carboxamide).
JWH-081 (1-Pentyl-3-(1-(4- 7081 I
methoxynaphthoyl) indole).
5F-CUMYL-P7AICA (1-(5-fluoropentyl)- 7085 I
N-(2-phenylpropan-2-yl)-1H-
pyrrolo[2,3-b]pyridine-3-
carboxamide).
4-CN-CUMYL-BUTINACA, 4-cyano-CUMYL- 7089 I
BUTINACA, 4-CN-CUMYL BINACA, CUMYL-
4CN-BINACA, SGT-78 (1-(4-
cyanobutyl)-N-(2-phenylpropan-2-
yl)-1H-indazole-3-carboximide).
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).
UR-144 (1-Pentyl-1H-indol-3- 7144 I
yl)(2,2,3,3-
tetramethylcyclopropyl)methanone).
JWH-073 (1-Butyl-3-(1- 7173 I
naphthoyl)indole).
JWH-200 (1-[2-(4-Morpholinyl)ethyl]- 7200 I
3-(1-naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1- 7201 I
naphthoyl) indole).
JWH-203 (1-Pentyl-3-(2- 7203 I
chlorophenylacetyl) indole).
NM2201, CBL2201 (Naphthalen-1-yl 1- 7221 I
(5-fluoropentyl)-1H-indole-3-
carboxylate).
PB-22 (Quinolin-8-yl 1-pentyl-1H- 7222 I
indole-3-carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5- 7225 I
fluoropentyl)-1H-indole-3-
carboxylate).
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 extract.................. 7350 I
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
[[Page 21893]]
Parahexyl.......................... 7374 I
Mescaline.......................... 7381 I
2C-T-2, (2-(4-Ethylthio-2,5- 7385 I
dimethoxyphenyl) ethanamine).
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- 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-Methylenedioxymethamphetamine.. 7405 I
4-Methoxyamphetamine............... 7411 I
5-Methoxy-N-N-dimethyltryptamine... 7431 I
Alpha-methyltryptamine............. 7432 I
Bufotenine......................... 7433 I
Diethyltryptamine.................. 7434 I
Dimethyltryptamine................. 7435 I
Psilocybin......................... 7437 I
Psilocyn........................... 7438 I
5-Methoxy-N,N-diisopropyltryptamine 7439 I
N-Ethyl-1-phenylcyclohexylamine.... 7455 I
1-(1-Phenylcyclohexyl)pyrrolidine.. 7458 I
1-[1-(2- 7470 I
Thienyl)cyclohexyl]piperidine.
1-[1-(2- 7473 I
Thienyl)cyclohexyl]pyrrolidine.
N-Ethyl-3-piperidyl benzilate...... 7482 I
N-Methyl-3-piperidyl benzilate..... 7484 I
N-Benzylpiperazine................. 7493 I
4-MePPP (4-Methyl- 7498 I
alphapyrrolidinopropiophenone).
2C-D (2-(2,5-Dimethoxy-4- 7508 I
methylphenyl) ethanamine).
2C-E (2-(2,5-Dimethoxy-4- 7509 I
ethylphenyl) ethanamine).
2C-H (2-(2,5-Dimethoxyphenyl) 7517 I
ethanamine).
2C-I (2-(4-iodo-2,5- 7518 I
dimethoxyphenyl) ethanamine).
2C-C (2-(4-Chloro-2,5- 7519 I
dimethoxyphenyl) ethanamine).
2C-N (2-(2,5-Dimethoxy-4-nitro- 7521 I
phenyl) ethanamine).
2C-P (2-(2,5-Dimethoxy-4-(n)- 7524 I
propylphenyl) ethanamine).
2C-T-4 (2-(4-Isopropylthio)-2,5- 7532 I
dimethoxyphenyl) ethanamine).
MDPV (3,4- 7535 I
Methylenedioxypyrovalerone).
25B-NBOMe (2-(4-bromo-2,5- 7536 I
dimethoxyphenyl)-N-(2-
methoxybenzyl) ethanamine).
25C-NBOMe (2-(4-chloro-2,5- 7537 I
dimethoxyphenyl)-N-(2-
methoxybenzyl) ethanamine).
25I-NBOMe (2-(4-iodo-2,5- 7538 I
dimethoxyphenyl)-N-(2-
methoxybenzyl) ethanamine).
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Butylone........................... 7541 I
Pentylone.......................... 7542 I
N-Ethylpentylone, ephylone (1-(1,3- 7543 I
benzodioxol-5-yl)-2-(ethylamino)-
pentan-1-one).
[alpha]-PVP (alpha- 7545 I
pyrrolidinopentiophenone).
[alpha]-PBP (alpha- 7546 I
pyrrolidinobutiophenone).
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
[[Page 21894]]
Drotebanol......................... 9335 I
U-47700 (3,4-dichloro-N-[2- 9547 I
(dimethylamino)cyclohexyl]-N-
methylbenzamide).
AH-7921 (3,4-dichloro-N-[(1- 9551 I
dimethylamino)cyclohexylmethyl]ben
zamide)).
MT-45 (1-cyclohexyl-4-(1,2- 9560 I
diphenylethyl)piperazine)).
Acetylmethadol..................... 9601 I
Allylprodine....................... 9602 I
Alphacetylmethadol except levo- 9603 I
alphacetylmethadol.
Alphameprodine..................... 9604 I
Alphamethadol...................... 9605 I
Benzethidine....................... 9606 I
Betacetylmethadol.................. 9607 I
Betameprodine...................... 9608 I
Betamethadol....................... 9609 I
Betaprodine........................ 9611 I
Clonitazene........................ 9612 I
Dextromoramide..................... 9613 I
Diampromide........................ 9615 I
Diethylthiambutene................. 9616 I
Dimenoxadol........................ 9617 I
Dimepheptanol...................... 9618 I
Dimethylthiambutene................ 9619 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
1-Methyl-4-phenyl-4- 9661 I
propionoxypiperidine.
1-(2-Phenylethyl)-4-phenyl-4- 9663 I
acetoxypiperidine.
Tilidine........................... 9750 I
Acryl fentanyl (N-(1- 9811 I
phenethylpiperidin-4-yl)-N-
phenylacrylamide).
Para-Fluorofentanyl................ 9812 I
3-Methylfentanyl................... 9813 I
Alpha-Methylfentanyl............... 9814 I
Acetyl-alpha-methylfentanyl........ 9815 I
N-(2-fluorophenyl)-N-(1- 9816 I
phenethylpiperidin-4-
yl)propionamide.
Acetyl Fentanyl (N-(1- 9821 I
phenethylpiperidin-4-yl)-N-
phenylacetamide).
Butyryl Fentanyl................... 9822 I
Para-fluorobutyryl fentanyl........ 9823 I
4-Fluoroisobutyryl fentanyl (N-(4- 9824 I
fluorophenyl)-N-(1-
phenethylpiperidin-4-
yl)isobutyramide).
2-methoxy-N-(1-phenethylpiperidin-4- 9825 I
yl)-N-phenylacetamide.
Para-chloroisobutyryl fentanyl..... 9826 I
Isobutyryl fentanyl................ 9827 I
Beta-hydroxyfentanyl............... 9830 I
Beta-hydroxy-3-methylfentanyl...... 9831 I
Alpha-methylthiofentanyl........... 9832 I
3-Methylthiofentanyl............... 9833 I
Furanyl fentanyl (N-(1- 9834 I
phenethylpiperidin-4-yl)-N-
phenylfuran-2-carboxamide).
Thiofentanyl....................... 9835 I
Beta-hydroxythiofentanyl........... 9836 I
Para-methoxybutyryl fentanyl....... 9837 I
Ocfentanil......................... 9838 I
Valeryl fentanyl................... 9840 I
N-(1-phenethylpiperidin-4-yl)-N- 9843 I
phenyltetrahydrofuran-2-
carboxamide).
Cyclopropyl Fentanyl............... 9845 I
[[Page 21895]]
Cyclopentyl fentanyl............... 9847 I
Fentanyl related-compounds as 9850 I
defined in 21 CFR 1308.11(h).
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
Dronabinol in an oral solution in a 7365 II
drug product approved for
marketing by the U.S. Food and
Drug Administration.
Nabilone........................... 7379 II
1-Phenylcyclohexylamine............ 7460 II
Phencyclidine...................... 7471 II
ANPP (4-Anilino-N-phenethyl-4- 8333 II
piperidine).
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-A.......... 9232 II
Meperidine intermediate-B.......... 9233 II
Meperidine intermediate-C.......... 9234 II
Metazocine......................... 9240 II
Methadone.......................... 9250 II
Methadone intermediate............. 9254 II
Metopon............................ 9260 II
Dextropropoxyphene, bulk (non- 9273 II
dosage forms).
Morphine........................... 9300 II
Oripavine.......................... 9330 II
Thebaine........................... 9333 II
Dihydroetorphine................... 9334 II
Levo-alphacetylmethadol............ 9648 II
Oxymorphone........................ 9652 II
Noroxymorphone..................... 9668 II
Phenazocine........................ 9715 II
Thiafentanil....................... 9729 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
Moramide-intermediate.............. 9802 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 in 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.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-08341 Filed 4-17-20; 8:45 am]
BILLING CODE 4410-09-P