Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
| Court | Drug Enforcement Administration |
| Citation | 88 FR 53917 |
| Published date | 09 August 2023 |
| Record Number | 2023-17036 |
| Section | Notices |
Federal Register, Volume 88 Issue 152 (Wednesday, August 9, 2023)
[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Notices]
[Pages 53917-53922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17036]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1238]
Bulk Manufacturer of Controlled Substances Application: Chemtos,
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Chemtos, LLC has applied to be registered as a bulk
manufacturer 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
October 10, 2023. Such persons may also file a written request for a
hearing on the application on or before October 10, 2023.
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on July 6, 2023, Chemtos, LLC., 16713 Picadilly Court,
Round Rock, Texas 78664-8544, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
[[Page 53918]]
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Controlled substance Drug code Schedule
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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
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
Methiopropamine.................... 1478 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).
FUB-144 (1-(4-fluorobenzyl)-1H- 7014 I
indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone).
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-3-methyl-1- 7025 I
oxobutan-2-yl)-1-(5-fluropentyl)-
1H-indazole-3-carboximide).
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).
5F-EDMB-PINACA (ethyl 2-(1-(5- 7036 I
fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate).
5F-MDMB-PICA (methyl 2-(1-(5- 7041 I
fluoropentyl)-1H-indole-3-
carboxamido)-3,3-
dimethylbutanoate).
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).
FUB-AKB48, FUB-APINACA, AKB48 N-(4- 7047 I
FLUOROBENZYL) (N-(adamantan-1-yl)-
1-(4-fluorobenzyl)-1H-indazole-3-
carboximide).
APINACA and AKB48 N-(1-Adamantyl)-1- 7048 I
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-PINACA, 5GT-25 (1-(5- 7083 I
fluoropentyl)-N-(2-phenylpropan-2-
yl)-1H-indazole-3-carboxamide).
5F-CUMYL-P7AICA (1-(5-fluoropentyl)- 7085 I
N-(2-phenylpropan-2-yl)-1H-
pyrrolo[2,3-b]pyridine-3-
carboxamide).
4-CN-CUML-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-carboxamide).
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).
4-MEAP (4-Methyl-alpha- 7245 I
ethylaminopentiophenone).
N-Ethylhexedrone................... 7246 I
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
Parahexyl.......................... 7374 I
[[Page 53919]]
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- 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
4'-Chloro-alpha- 7443 I
pyrrolidinovalerophenone.
MPHP, 4'-Methyl-alpha- 7446 I
pyrrolidinohexiophenone.
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-Methyl- 7498 I
alphapyrrolidinopropiophenone (4-
MePPP).
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) ethanamine 7517 I
(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).
2-(4-bromo-2,5-dimethoxyphenyl)-N- 7536 I
(2-methoxybenzyl) ethanamine (25B-
NBOMe).
2-(4-chloro-2,5-dimethoxyphenyl)-N- 7537 I
(2-methoxybenzyl) ethanamine (25C-
NBOMe).
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2- 7538 I
methoxybenzyl) ethanamine (25I-
NBOMe).
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Butylone........................... 7541 I
Pentylone.......................... 7542 I
N-Ethypentylone, ephylone (1-(1,3- 7543 I
benzodioxol-5-yl)-2-(ethylamino)-
pentan-1-one).
[alpha]-PHP, alpha- 7544 I
Pyrrolidinohexanophenone.
alpha-pyrrolidinopentiophenone 7545 I
([alpha]-PVP).
alpha-pyrrolidinobutiophenone 7546 I
([alpha]-PBP).
Ethylone........................... 7547 I
Eutylone........................... 7549 I
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
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
[[Page 53920]]
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]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
Isotonitazene...................... 9614 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.
Para-Methylfentanyl................ 9817 I
4'-Methyl Acetyl Fentanyl.......... 9819 I
Ortho-Methyl Methoxyacetyl Fentanyl 9820 I
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
[[Page 53921]]
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
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....... 9846 I
Cyclopentyl Fentanyl............... 9847 I
Ortho-Methyl Acetylfentanyl........ 9848 I
Fentanyl related-compounds as 9850 I
defined in 21 CFR 1308.11(h).
Fentanyl Carbamate................. 9851 I
Ortho-Fluoracryl 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
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 8333 II
(ANPP).
Norfentanyl........................ 8366 II
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
Oliceridine........................ 9245 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
[[Page 53922]]
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
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The company plans to bulk manufacture the listed controlled
substances for distribution to its customers. In reference to dug codes
7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans
to bulk manufacture these drugs as synthetic. No other activities for
these drug codes are authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-17036 Filed 8-8-23; 8:45 am]
BILLING CODE P
