Manufacturers Notice of Application - 2021
[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17171]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-865]
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: PA Options for Wellness, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
SUMMARY: 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 October 12, 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-865 in all correspondence, including attachments.
SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) 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 May 26, 2021, PA Options for Wellness, Inc., 4711 Queen Avenue, Suite 201, Harrisburg, Pennsylvania 17109-3125, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:
|Controlled Substance||Drug Code||Schedule|
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17171 Filed 8-11-21; 8:45 am]
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NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).