[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Page 44405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17171]



[[Page 44405]]

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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.

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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:

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                                           Drug
          Controlled substance             code          Schedule
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Marihuana Extract.......................    7350  I
Marihuana...............................    7360  I
Tetrahydrocannabinols...................    7370  I
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Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17171 Filed 8-11-21; 8:45 am]
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