Bulk Manufacturer of Controlled Substances Application: Organix Chemistry Solutions, LLC, 93345-93346 [2024-27674]

Download as PDF 93345 Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices Controlled substance Drug code Secobarbital ............................................................................................................................................................... Glutethimide ............................................................................................................................................................... 1-Phenylcyclohexylamine .......................................................................................................................................... Phencyclidine ............................................................................................................................................................. ANPP (4-Anilino-N-phenethyl-4-piperidine) ............................................................................................................... Norfentanyl (N-phenyl-N-(piperidin-4-yl) propionamide) ........................................................................................... Phenylacetone ........................................................................................................................................................... 1-Piperidinocyclohexanecarbonitrile .......................................................................................................................... Cocaine ...................................................................................................................................................................... Codeine ..................................................................................................................................................................... Etorphine HCl ............................................................................................................................................................ Dihydrocodeine .......................................................................................................................................................... Oxycodone ................................................................................................................................................................. Hydromorphone ......................................................................................................................................................... Ecgonine .................................................................................................................................................................... Ethylmorphine ............................................................................................................................................................ Hydrocodone ............................................................................................................................................................. Levomethorphan ........................................................................................................................................................ Levorphanol ............................................................................................................................................................... Isomethadone ............................................................................................................................................................ Meperidine ................................................................................................................................................................. Meperidine intermediate-B ........................................................................................................................................ Oliceridine (N-[(3-methoxythiophen-2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-oxaspiro[4.5] decan-9-yl] ethyl {time})amine fumarate). Methadone ................................................................................................................................................................. Dextropropoxyphene, bulk (non-dosage forms) ........................................................................................................ Morphine .................................................................................................................................................................... Thebaine .................................................................................................................................................................... Oxymorphone ............................................................................................................................................................ Noroxymorphone ....................................................................................................................................................... Thiafentanil ................................................................................................................................................................ Alfentanil .................................................................................................................................................................... Remifentanil ............................................................................................................................................................... Sufentanil ................................................................................................................................................................... Carfentanil ................................................................................................................................................................. Tapentadol ................................................................................................................................................................. Fentanyl ..................................................................................................................................................................... The company plans to bulk manufacture the listed controlled substances for forensic purposes, to research analytical reference standards and as Active Pharmaceutical Ingredients for Phase 1 trials. In reference to drug 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2024–27670 Filed 11–25–24; 8:45 am] lotter on DSK11XQN23PROD with NOTICES1 BILLING CODE P VerDate Sep<11>2014 18:03 Nov 25, 2024 Jkt 265001 Drug Enforcement Administration [Docket No. DEA–1455] Bulk Manufacturer of Controlled Substances Application: Organix Chemistry Solutions, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Organix Chemistry Solutions, 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 27, 2025. Such persons may also file a written request for a hearing on the application on or before January 27, 2025. SUMMARY: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 2315 2550 7460 7471 8333 8366 8501 8603 9041 9050 9059 9120 9143 9150 9180 9190 9193 9210 9220 9226 9230 9233 9245 II II II II II II II II II II II II II II II II II II II II II II II 9250 9273 9300 9333 9652 9668 9729 9737 9739 9740 9743 9780 9801 II II II II II II II II II II II II II 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 16, 2024, Organix Chemistry Solutions, LLC, 32 Cabot Road, Woburn, Massachusetts, 01801–1004 applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): ADDRESSES: DEPARTMENT OF JUSTICE Schedule E:\FR\FM\26NON1.SGM 26NON1 93346 Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices Controlled substance Drug code Gamma Hydroxybutyric Acid ..................................................................................................................................... Lysergic acid diethylamide ........................................................................................................................................ Marihuana .................................................................................................................................................................. Tetrahydrocannabinols .............................................................................................................................................. 3,4-Methylenedioxyamphetamine .............................................................................................................................. 3,4-Methylenedioxymethamphetamine ...................................................................................................................... 5-Methoxy-N–N-dimethyltryptamine .......................................................................................................................... Alpha-Methyltryptamine ............................................................................................................................................. Bufotenine .................................................................................................................................................................. Diethyltryptamine ....................................................................................................................................................... Dimethyltryptamine .................................................................................................................................................... Psilocybin ................................................................................................................................................................... Psilocyn ..................................................................................................................................................................... 2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C–D) ............................................................................................ 2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) ........................................................................................................... Heroin ........................................................................................................................................................................ Morphine .................................................................................................................................................................... The company plans to synthesize the listed controlled substances for distribution to its customers. In reference to drug 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2024–27674 Filed 11–25–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1446] Importer of Controlled Substances Application: National Center for Natural Products Research Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: National Center for Natural Products Research 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. SUMMARY: 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, 2024. Such persons may also file a written request for a hearing on the application on or before December 26, 2024. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically lotter on DSK11XQN23PROD with NOTICES1 DATES: VerDate Sep<11>2014 18:03 Nov 25, 2024 Jkt 265001 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 September 16, 2024, National Center for Natural Products Research, 806 Hathorn Road, 135 Coy Waller Lab, University, Mississippi 38677 applied to be registered as an importer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Marihuana ...................... Tetrahydrocannabinols .. I 7360 7370 Schedule I I I The company plans to acquire new genetic materials with improved cannabinoids for research and PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 2010 7315 7360 7370 7400 7405 7431 7432 7433 7434 7435 7437 7438 7508 7517 9200 9300 Schedule I I I I I I I I I I I I I I I I II manufacturing purposes. 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 nonapproved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2024–27694 Filed 11–25–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1458] 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. 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 27, 2025. Such persons may also file a written request for a hearing on the application on or before January 27, 2025. ADDRESSES: The Drug Enforcement Administration requires that all SUMMARY: E:\FR\FM\26NON1.SGM 26NON1

Agencies

[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93345-93346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27674]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1455]


Bulk Manufacturer of Controlled Substances Application: Organix 
Chemistry Solutions, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Organix Chemistry Solutions, 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 27, 2025. Such persons may also file a written request for a 
hearing on the application on or before January 27, 2025.

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 16, 2024, Organix Chemistry Solutions, LLC, 
32 Cabot Road, Woburn, Massachusetts, 01801-1004 applied to be 
registered as a bulk manufacturer of the following basic class(es) of 
controlled substance(s):

[[Page 93346]]



------------------------------------------------------------------------
       Controlled substance             Drug code           Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.........               2010  I
Lysergic acid diethylamide........               7315  I
Marihuana.........................               7360  I
Tetrahydrocannabinols.............               7370  I
3,4-Methylenedioxyamphetamine.....               7400  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
2-(2,5-Dimethoxy-4-methylphenyl)                 7508  I
 ethanamine (2C-D).
2-(2,5-Dimethoxyphenyl) ethanamine               7517  I
 (2C-H).
Heroin............................               9200  I
Morphine..........................               9300  II
------------------------------------------------------------------------

    The company plans to synthesize the listed controlled substances 
for distribution to its customers. In reference to drug 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.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-27674 Filed 11-25-24; 8:45 am]
BILLING CODE 4410-09-P
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