Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: PA Options for Wellness, Inc.

CourtDrug Enforcement Administration,Justice Department
Citation86 FR 44405
Publication Date12 Aug 2021
Record Number2021-17171
Federal Register, Volume 86 Issue 153 (Thursday, August 12, 2021)
[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.
                -----------------------------------------------------------------------
                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:
                ------------------------------------------------------------------------
                 Drug
                 Controlled substance code Schedule
                ------------------------------------------------------------------------
                Marihuana Extract....................... 7350 I
                Marihuana............................... 7360 I
                Tetrahydrocannabinols................... 7370 I
                ------------------------------------------------------------------------
                Brian S. Besser,
                Acting Assistant Administrator.
                [FR Doc. 2021-17171 Filed 8-11-21; 8:45 am]
                BILLING CODE P
                

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