[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.

-----------------------------------------------------------------------

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]]



------------------------------------------------------------------------
        Controlled substance            Drug 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
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
------------------------------------------------------------------------

    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