Bulk Manufacturer of Controlled Substances Application: Isosciences, LLC, 82400-82401 [2023-25947]

Download as PDF 82400 Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 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 23, 2024. Such persons may also file a written request for a hearing on the application on or before January 23, 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 DATES: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1292] Bulk Manufacturer of Controlled Substances Application: Isosciences, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Isosciences, 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. SUMMARY: 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. In accordance with 21 CFR 1301.33(a), this is notice that on October 25, 2023, Isosciences, LLC, 340 Mathers Road, Ambler, Pennsylvania 19002–3420, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code ddrumheller on DSK120RN23PROD with NOTICES1 Controlled substance Cathinone ..................................................................................................................................................................................... Methcathinone .............................................................................................................................................................................. Lysergic acid diethylamide ........................................................................................................................................................... Marihuana ..................................................................................................................................................................................... Tetrahydrocannabinols ................................................................................................................................................................. 3,4-Methylenedioxyamphetamine ................................................................................................................................................. 3,4-Methylenedioxy-N-ethylamphetamine .................................................................................................................................... 3,4-Methylenedioxymethamphetamine ......................................................................................................................................... 5-Methoxy-N-N-dimethyltryptamine .............................................................................................................................................. Alpha-methyltryptamine ................................................................................................................................................................ Bufotenine .................................................................................................................................................................................... Diethyltryptamine .......................................................................................................................................................................... Dimethyltryptamine ....................................................................................................................................................................... Psilocybin ..................................................................................................................................................................................... Psilocyn ........................................................................................................................................................................................ 5-Methoxy-N,N-diisopropyltryptamine .......................................................................................................................................... Dihydromorphine .......................................................................................................................................................................... Heroin ........................................................................................................................................................................................... Nicocodeine .................................................................................................................................................................................. Nicomorphine ............................................................................................................................................................................... Normorphine ................................................................................................................................................................................. Thebacon ...................................................................................................................................................................................... Normethadone .............................................................................................................................................................................. Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) .............................................................................................. Para-Fluorofentanyl ...................................................................................................................................................................... 3-Methylfentanyl ........................................................................................................................................................................... Alpha-methylfentanyl .................................................................................................................................................................... Acetyl-alpha-methylfentanyl ......................................................................................................................................................... N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide .................................................................................................... Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ............................................................................................ Butyryl Fentanyl ............................................................................................................................................................................ 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) ...................................................... 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide ...................................................................................................... Beta-hydroxyfentanyl .................................................................................................................................................................... Beta-hydroxy-3-methylfentanyl ..................................................................................................................................................... Alpha-methylthiofentanyl .............................................................................................................................................................. 3-Methylthiofentanyl ..................................................................................................................................................................... Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) .......................................................................... Thiofentanyl .................................................................................................................................................................................. Beta-hydroxythiofentanyl .............................................................................................................................................................. N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide ....................................................................................... Amphetamine ............................................................................................................................................................................... Methamphetamine ........................................................................................................................................................................ Codeine ........................................................................................................................................................................................ Dihydrocodeine ............................................................................................................................................................................. Oxycodone ................................................................................................................................................................................... Hydromorphone ............................................................................................................................................................................ Hydrocodone ................................................................................................................................................................................ Isomethadone ............................................................................................................................................................................... Methadone .................................................................................................................................................................................... Methadone intermediate ............................................................................................................................................................... VerDate Sep<11>2014 21:46 Nov 22, 2023 Jkt 262001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\24NON1.SGM 24NON1 1235 1237 7315 7360 7370 7400 7404 7405 7431 7432 7433 7434 7435 7437 7438 7439 9145 9200 9309 9312 9313 9315 9635 9811 9812 9813 9814 9815 9816 9821 9822 9824 9825 9830 9831 9832 9833 9834 9835 9836 9843 1100 1105 9050 9120 9143 9150 9193 9226 9250 9254 Schedule I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I II II II II II II II II II II 82401 Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices Drug code Controlled substance Morphine ....................................................................................................................................................................................... Thebaine ....................................................................................................................................................................................... Levo-alphacetylmethadol .............................................................................................................................................................. Oxymorphone ............................................................................................................................................................................... Thiafentanil ................................................................................................................................................................................... Alfentanil ....................................................................................................................................................................................... Sufentanil ...................................................................................................................................................................................... Carfentanil .................................................................................................................................................................................... Fentanyl ........................................................................................................................................................................................ The company plans to manufacture bulk controlled substances for use in analytical testing. In reference to drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–25947 Filed 11–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1294] Importer of Controlled Substances Application: VHG Labs DBA LGC Standards Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: VHG Labs DBA LGC Standards 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 December 26, 2023. Such persons may also file a written request for a hearing on the application on or before December 26, 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 SUMMARY: In accordance with 21 CFR 1301.34(a), this is notice that on November 6, 2023, VHG Labs DBA LGC Standards, 3 Perimeter Road, Manchester, New Hampshire 03103–3341, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with NOTICES1 Drug code Amineptine (7-[(10,11-dihydro-5Hdibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid) ........................................................ Mesocarb (N-phenyl-N′-(3-(1-phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium-5-yl)carbamimidate) .............................................. 3-Fluoro-N-methylcathinone (3-FMC) ..................................................................................................................................... 4-Fluoro-N-methylcathinone (4-FMC) 1238 I N ..................................................................................................................... Pentedrone (a-methylaminovalerophenone) .......................................................................................................................... 4-Methyl-N-ethylcathinone (4-MEC) ....................................................................................................................................... Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2-amine) 1478 I N .............................................................................. N,N-Dimethylamphetamine .................................................................................................................................................... Fenethylline ............................................................................................................................................................................ 4-Methylaminorex (cis isomer) ............................................................................................................................................... 4,4′-Dimethylaminorex (4,4′-DMAR; 4,5-dihydro-4-1595 I N methyl-5-(4-methylphenyl)-2-oxazolamine; 4-methyl-5-(4methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine). Mecloqualone ......................................................................................................................................................................... ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .................... 5-Fluoro-UR-144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ........................ AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ............................. JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) .............................................................................................................................. FUB-AMB, MMB-FUBINACA, AMB-FUBINACA (2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3-methylbutanoate) .... AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ................................................. THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) ........................................................................ 5F-AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluropentyl)-1H-indazole-3-carboximide) ................................ AB-CHMINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) ....................... 5F-ADB, 5F-MDMB-PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ............... 5F-MDMB-PICA (methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ....................................... MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) .. 5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ........................................... 21:46 Nov 22, 2023 Jkt 262001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 II II II II II II II II II 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. Controlled substance VerDate Sep<11>2014 9300 9333 9648 9652 9729 9737 9740 9743 9801 Schedule E:\FR\FM\24NON1.SGM 24NON1 Schedule 1219 1227 1233 1238 1246 1249 1478 1480 1503 1590 1595 I I I I I I I I I I I 2572 7010 7011 7012 7019 7021 7023 7024 7025 7031 7034 7041 7042 7049 I I I I I I I I I I I I I I

Agencies

[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Pages 82400-82401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25947]



[[Page 82400]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1292]


Bulk Manufacturer of Controlled Substances Application: 
Isosciences, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Isosciences, 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 
January 23, 2024. Such persons may also file a written request for a 
hearing on the application on or before January 23, 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on October 25, 2023, Isosciences, LLC, 340 Mathers Road, 
Ambler, Pennsylvania 19002-3420, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Cathinone..............................     1235  I
Methcathinone..........................     1237  I
Lysergic acid diethylamide.............     7315  I
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
3,4-Methylenedioxyamphetamine..........     7400  I
3,4-Methylenedioxy-N-ethylamphetamine..     7404  I
3,4-Methylenedioxymethamphetamine......     7405  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
Dihydromorphine........................     9145  I
Heroin.................................     9200  I
Nicocodeine............................     9309  I
Nicomorphine...........................     9312  I
Normorphine............................     9313  I
Thebacon...............................     9315  I
Normethadone...........................     9635  I
Acryl fentanyl (N-(1-phenethylpiperidin-    9811  I
 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
4-Fluoroisobutyryl fentanyl (N-(4-          9824  I
 fluorophenyl)-N-(1-phenethylpiperidin-
 4-yl)isobutyramide).
2-methoxy-N-(1-phenethylpiperidin-4-yl)-    9825  I
 N-phenylacetamide.
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
N-(1-phenethylpiperidin-4-yl)-N-            9843  I
 phenyltetrahydrofuran-2-carboxamide.
Amphetamine............................     1100  II
Methamphetamine........................     1105  II
Codeine................................     9050  II
Dihydrocodeine.........................     9120  II
Oxycodone..............................     9143  II
Hydromorphone..........................     9150  II
Hydrocodone............................     9193  II
Isomethadone...........................     9226  II
Methadone..............................     9250  II
Methadone intermediate.................     9254  II

[[Page 82401]]

 
Morphine...............................     9300  II
Thebaine...............................     9333  II
Levo-alphacetylmethadol................     9648  II
Oxymorphone............................     9652  II
Thiafentanil...........................     9729  II
Alfentanil.............................     9737  II
Sufentanil.............................     9740  II
Carfentanil............................     9743  II
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to manufacture bulk controlled substances for use 
in analytical testing. In reference to drug codes 7360 (Marihuana) and 
7370 (Tetrahydrocannabinols), the company plans to bulk manufacture 
these drugs as synthetics. No other activities for these drug codes are 
authorized for this registration.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-25947 Filed 11-22-23; 8:45 am]
BILLING CODE P
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