[Federal Register Volume 88, Number 231 (Monday, December 4, 2023)]
[Notices]
[Pages 84167-84171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26555]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1305]
Importer of Controlled Substances Application: Restek Corporation
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Restek Corporation has applied to be registered as an importer
of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
January 3, 2024. Such persons may also file a written request for a
hearing on the application on or before January 3, 2024.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on November 6, 2023, Restek Corporation, 110 Benner
Circle, Bellefonte, Pennsylvania 16823-8433, applied to be registered
as an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amineptine................................... 1219 I
Mesocarb..................................... 1227 I
3-Fluoro-N-methylcathinone (3-FMC)........... 1233 I
Cathinone.................................... 1235 I
Methcathinone................................ 1237 I
4-Fluoro-N-methylcathinone (4-FMC)........... 1238 I
Para-Methoxymethamphetamine (PMMA), 1-(4-1245 1245 I
I N methoxyphenyl)-N-methylpropan-2-amine.
Pentedrone ([alpha]-methylaminovalerophenone) 1246 I
Mephedrone (4-Methyl-N-methylcathinone)...... 1248 I
4-Methyl-N-ethylcathinone (4-MEC)............ 1249 I
Naphyrone.................................... 1258 I
N-Ethylamphetamine........................... 1475 I
Methiopropamine (N-methyl-1-(thiophen-2- 1478 I
yl)propan-2-1478 I N amine).
N,N-Dimethylamphetamine...................... 1480 I
Fenethylline................................. 1503 I
Aminorex..................................... 1585 I
4-Methylaminorex (cis isomer)................ 1590 I
4,4'-Dimethylaminorex........................ 1595 I
Gamma Hydroxybutyric Acid.................... 2010 I
Methaqualone................................. 2565 I
Mecloqualone................................. 2572 I
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) 6250 I
indole).
SR-18 (1-Cyclohexylethyl-3-(2- 7008 I
methoxyphenylacetyl) 7008 I N SR-18 and RCS-
8 indole) SR-19 (1-P.
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1- 7010 I
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide).
5-Fluoro-UR-144 and XLR11 ([1-(5-Fluoro- 7011 I
pentyl)1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone).
AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2- 7012 I
yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide).
1-(4-Fluorobenzyl)-1H-indol-3-yl)(2,2,3,3- 7014 I
7014 I N FUB-144
tetramethylcyclopropyl)methanone.
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)...... 7019 I
MDMB-FUBINACA (Methyl 2-(1-(4-fluorobenzyl)- 7020 I
1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate).
FUB-AMB, MMB-FUBINACA, AMB-FUBINACA (2-(1-(4- 7021 I
fluorobenzyl)-1Hindazole-3-carboxamido)-3-
methylbutanoate).
AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2- 7023 I
yl)-1-pentyl-1H-indazole-)3-carboxamide.
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3- 7024 I
yl](naphthalen-1-yl)methanone).
5F-AB-PINACA (N-(1-amino-3methyl-1-oxobutan-2- 7025 I
yl)-1-(5-fluoropentyl)-1H-indazole-3-
carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl-1-oxobutan-2- 7031 I
yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide).
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1- 7032 I
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide).
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H- 7033 I
indazole-3-carboxamido)-3-methylbutanoate).
5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5- 7034 I
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3-dimethyl-1- 7035 I
oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide).
Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 7036 I
carboxamido) 3,3-dimethylbutanoate).
5F-MDMB-PICA................................. 7041
MDMB-CHMICA, MMB-CHMINACA.................... 7042 I
Methyl 2-7043 I N (1-(4-fluorobutyl)-1H- 7043 I
indazole-3-carboxamido)-
3,3dimethylbutanoate).
MMB-CHMICA................................... 7044 I
FUB-AKB48; FUB-APINACA; AKB48 N-(4- 7047 I
FLUOROBENZYL).
[[Page 84168]]
APINACA and AKB48............................ 7048 I
5F-APINACA, 5F-AKB48......................... 7049 I
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) 7081 I
indole).
1-(5-Fluoropentyl)-1H-indazole-3-carboxamide. 7083 I
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2- 7085 I
phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-
3-carboxamide).
4-CN-CUMYL-BUTINACA.......................... 7089 I
SR-19 (1-Pentyl-3-[(4-methoxy)-benzoyl] 7104 I
indole.
JWH-018 (also known as AM678) (1-Pentyl-3-(1- 7118 I
naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) 7122 I
indole).
UR-144....................................... 7144 I
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).
NM2201, CBL2201 (Naphthalen-1-yl 1-(5- 7221 I
fluoropentyl)-1H-indole-3-carboxylate).
PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3- 7222 I
carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5-fluoropentyl)-1H- 7225 I
indole-3-carboxylate).
4-methyl-alpha-ethylaminopentiophenone (4- 7245 I
MEAP).
N-ethylhexedrone............................. 7246 I
Alpha-ethyltryptamine........................ 7249 I
Ibogaine..................................... 7260 I
2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan- 7286 I
1-one 7286 I N MXE, methoxetamine
(methoxetamine).
CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)- 7297 I
3-hydroxycyclohexyl-phenol).
CP-47,497 C8 Homologue (5-(1,1-Dimethyloctyl)- 7298 I
2-[(1R,3S)3-hydroxycyclohexyl-phenol).
Lysergic acid diethylamide................... 7315 I
2,5-Dimethoxy-4-(n)-propylthiophenethylamine. 7348 I
Marihuana extract............................ 7350 I
Marihuana.................................... 7360 I
Tetrahydrocannabinols........................ 7370 I
Parahexyl.................................... 7374 I
Mescaline.................................... 7381 I
2C-T-2, (2-(4-Ethylthio-2,5-dimethoxyphenyl) 7385 I
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-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
Peyote....................................... 7415 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
4-chloro-alpha-pyrrolidinovalerophenone (4- 7443 I
chloro-a-PVP).
4[acute]-methyl-alpha-pyrrolidinohexiophenone 7446 I
(MPHP).
N-Ethyl-1-phenylcyclohexylamine.............. 7455 I
1-(1-Phenylcyclohexyl)pyrrolidine............ 7458 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
4-MePPP (4-Methyl- 7498 I
alphapyrrolidinopropiophenone).
2C-D (2-(2,5-Dimethoxy-4-methylphenyl) 7508 I
ethanamine).
2C-E (2-(2,5-Dimethoxy-4-ethylphenyl) 7509 I
ethanamine).
2C-H (2-(2,5-Dimethoxyphenyl) ethanamine).... 7517 I
2C-I (2-(4-iodo-2,5-dimethoxyphenyl) 7518 I
ethanamine).
2C-C (2-(4-Chloro-2,5-dimethoxyphenyl) 7519 I
ethanamine).
2C-N (2-(2,5-Dimethoxy-4-nitro-phenyl) 7521 I
ethanamine).
2C-P (2-(2,5-Dimethoxy-4-(n)-propylphenyl) 7524 I
ethanamine).
2C-T-4 (2-(4-Isopropylthio)-2,5- 7532 I
dimethoxyphenyl) ethanamine).
MDPV (3,4-Methylenedioxypyrovalerone)........ 7535 I
[[Page 84169]]
2-(4-bromo-2,5-dimethoxyphenyl)-N-(2- 7536 I
methoxybenzyl) ethanamine).
2-(4-chloro-2,5-dimethoxyphenyl)-N-(2- 7537 I
methoxybenzyl) ethanamine).
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2- 7538 I
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-Pyrrolidinohexanophenone............... 7544 I
[alpha]-PVP (alpha-pyrrolidinopentiophenone). 7545 I
[alpha]-PBP (alpha-pyrrolidinobutiophenone).. 7546 I
Ethylone..................................... 7547 I
PV8, alpha-Pyrrolidinoheptaphenone........... 7548 I
AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) 7694 I
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
Brorphine.................................... 9098 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
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]benzamide)).
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
Betameprodine................................ 9608 I
Betamethadol................................. 9609 I
Betaprodine.................................. 9611 I
Clonitazene.................................. 9612 I
Dextromoramide............................... 9613 I
Isotonitazene (N,N-diethyl-2-(2-(4 9614 I
isopropoxybenzyl)-5-nitro nitro-1H-
benzimidazol-1-yl)ethan-1-amine).
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
[[Page 84170]]
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-propionoxypiperidine..... 9661 I
1-(2-Phenylethyl)-4-phenyl-4- 9663 I
acetoxypiperidine.
Tilidine..................................... 9750 I
Butonitazene................................. 9751 I
Flunitazene.................................. 9756 I
METONITAZENE................................. 9757 I
N-PYRROLIDINO ETONITAZENE; ETONITAZEPYNE..... 9758 I
PROTONITAZENE................................ 9759 I
METODESNITAZENE.............................. 9764 I
ETODESNITAZENE; ETAZENE...................... 9765 I
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)- 9811 I
N-phenylacrylamide).
Para-Fluorofentanyl.......................... 9812 I
3-Methylfentanyl............................. 9813 I
Alpha-Methylfentanyl......................... 9814 I
Acetyl-alpha-methylfentanyl.................. 9815 I
N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4- 9816 I
yl)propionamide.
Para-Methylfentanyl.......................... 9817 I
4'-Methyl Acetyl fentanyl.................... 9819 I
Ortho-Methyl methoxyacetyl fentanyl.......... 9820 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4- 9821 I
yl)-N-phenylacetamide).
Butyryl Fentanyl............................. 9822 I
Para-fluorobutyryl fentanyl.................. 9823 I
4-Fluoroisobutyryl fentanyl.................. 9824 I
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N- 9825 I
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............................. 9834 I
Thiofentanyl................................. 9835 I
Beta-hydroxythiofentanyl..................... 9836 I
Para-methoxybutyryl fentanyl................. 9837 I
Ocfentanil................................... 9838 I
Thiofuranyl fentanyl......................... 9839 I
Valeryl fentanyl............................. 9840 I
Phenyl fentanyl.............................. 9841 I
Beta'-Phenyl fentanyl........................ 9842 I
N-(1-phenethylpiperidin-4-yl)-N- 9843 I
phenyltetrahydrofuran-2-carboxamide).
Crotonyl fentanyl............................ 9844 I
Cyclopropyl Fentanyl......................... 9845 I
ortho-Fluorobutyryl fentanyl (N-(2- 9846 I
fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)butyramide; also known as 2-fluorobutyryl
fentanyl).
Cyclopentyl fentanyl......................... 9847 I
Ortho-Methyl acetylfentanyl.................. 9848 I
Fentanyl related-compounds as defined in 21 9850 I
CFR 1308.11(h).
Fentanyl Carbamate........................... 9851 I
ORTHO-FLUOROACRYL FENTANYL................... 9852 I
ORTHO-FLUOROISOBUTYRYL FENTANYL.............. 9853 I
Para-Fluoro furanyl fentanyl................. 9854 I
2'-Fluoro ortho-fluorofentanyl............... 9855 I
Beta-Methyl fentanyl......................... 9856 I
Zipeprol..................................... 9873 I
Amphetam..................................... 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
[[Page 84171]]
Dronabinol in an oral solution in a drug 7365 II
product approved for marketing by the U.S.
Food and Drug Administration (FDA).
Nabilone..................................... 7379 II
1-Phenylcyclohexylamine...................... 7460 II
Phencyclidine................................ 7471 II
ANPP (4-Anilino-N-phenethyl-4-piperidine).... 8333 II
Norfentanyl.................................. 8366 II
Phenylacetone................................ 8501 II
1-Piperidinocyclohexanecarbonitrile.......... 8603 II
Alphaprodine................................. 9010 II
Anileridine.................................. 9020 II
Coca Leaves.................................. 9040 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
Oliceridine.................................. 9245 II
Methadone.................................... 9250 II
Methadone intermediate....................... 9254 II
Metopon...................................... 9260 II
Dextropropoxyphene, bulk (non-dosage forms).. 9273 II
Morphine..................................... 9300 II
Oripavine.................................... 9330 II
Thebaine..................................... 9333 II
Dihydroetorphine............................. 9334 II
Opium, raw................................... 9600 II
Opium extracts............................... 9610 II
Opium fluid extract.......................... 9620 II
Opium tincture............................... 9630 II
Opium, powdered.............................. 9639 II
Opium, granulated............................ 9640 II
Levo-alphacetylmethadol...................... 9648 II
Opium poppy.................................. 9650 II
Oxymorphone.................................. 9652 II
Noroxymorphone............................... 9668 II
Poppy Straw Concentrate...................... 9670 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 the listed controlled substances for
the use in the manufacture of exempted certified reference materials.
No other activities for these drug codes are authorized for this
registration.
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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-26555 Filed 12-1-23; 8:45 am]
BILLING CODE P