Federal Register - July 29, 2021
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Source: Federal Register
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. DEA869
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals, LLC
Brian S. Besser, Acting Assistant Administrator.
FR Doc. 202116137 Filed 72821; 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 classes of controlled substances. Refer to Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic classes, 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 1301.33a, 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 classes of controlled substances:
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. DEA870
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 classes 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 classes, 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 NoDEA870 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 1301.33a, 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 classes, 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. 823a. 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
1301.33a, 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 classes of controlled substances:
Controlled substance
Drug code
jbell on DSKJLSW7X2PROD with NOTICES
Marihuana
Tetrahydrocannabinols
Brian S. Besser, Acting Assistant Administrator.
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