Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals, LLC, 40874 [2021-16137]

Download as PDF 40874 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices The company plans to bulk manufacture the listed controlled substances for distribution to its customers. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–869] Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals, LLC Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–16137 Filed 7–28–21; 8:45 am] BILLING CODE P Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: DEPARTMENT OF JUSTICE AMPAC Fine Chemicals, LLC. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before September 27, 2021. Such persons may also file a written request for a hearing on the application on or before September 27, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on June 14, 2021, AMPAC Fine Chemicals, LLC., Highway 50 and Hazel Avenue, Rancho Cordova, California 95670, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUMMARY: Controlled substance Norlevorphanol ............... Methylphenidate ............. Levomethorphan ............. Levorphanol .................... Thebaine ......................... Remifentanil .................... Tapentadol ...................... Drug code Schedule 9634 1724 9210 9220 9333 9739 9780 I II II II II II II Drug Enforcement Administration [Docket No. DEA–870] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Nusachi Labs, LLC. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections to the issuance of the proposed registration on or before September 27, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW 8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper handling of comments, please reference Docket No—DEA–870 in all correspondence, including attachments. SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) SUMMARY: prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted. The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA-registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on June 23, 2021, Nusachi Labs, LLC., 2909 Armory Drive, Nashville, Tennessee 37204, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Controlled substance Drug code jbell on DSKJLSW7X2PROD with NOTICES Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–16141 Filed 7–28–21; 8:45 am] BILLING CODE P VerDate Sep<11>2014 19:19 Jul 28, 2021 Jkt 253001 PO 00000 Frm 00073 Fmt 4703 Sfmt 9990 E:\FR\FM\29JYN1.SGM 29JYN1 7360 7370 Schedule I I

Agencies

[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Page 40874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16137]



[[Page 40874]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-869]


Bulk Manufacturer of Controlled Substances Application: AMPAC 
Fine Chemicals, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: AMPAC Fine Chemicals, LLC. has applied to be registered as a 
bulk manufacturer of basic class(es) of controlled substance(s). Refer 
to Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before September 27, 
2021. Such persons may also file a written request for a hearing on the 
application on or before September 27, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on June 14, 2021, AMPAC Fine Chemicals, LLC., Highway 50 
and Hazel Avenue, Rancho Cordova, California 95670, applied to be 
registered as a bulk manufacturer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Norlevorphanol.........................    9634  I
Methylphenidate........................    1724  II
Levomethorphan.........................    9210  II
Levorphanol............................    9220  II
Thebaine...............................    9333  II
Remifentanil...........................    9739  II
Tapentadol.............................    9780  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for distribution to its customers.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-16137 Filed 7-28-21; 8:45 am]
BILLING CODE P
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