Importer of Controlled Substances Application: Peace of Mind Pharmaceuticals LLC

CourtDrug Enforcement Administration,Justice Department
Citation87 FR 13313
Record Number2022-04926
SectionNotices
Published date09 March 2022
Federal Register, Volume 87 Issue 46 (Wednesday, March 9, 2022)
[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
                [Notices]
                [Pages 13313-13314]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2022-04926]
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                DEPARTMENT OF JUSTICE
                Drug Enforcement Administration
                [Docket No. DEA-980]
                Importer of Controlled Substances Application: Peace of Mind
                Pharmaceuticals LLC
                AGENCY: Drug Enforcement Administration, Justice.
                ACTION: Notice of application.
                -----------------------------------------------------------------------
                SUMMARY: Peace of Mind Pharmaceuticals LLC has applied to be registered
                as an importer 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 submit electronic comments on or
                objections to the issuance of the proposed registration on or before
                April 8, 2022. Such persons may also file a written request for a
                hearing on the application on or before April 8, 2022.
                ADDRESSES: DEA requires that all comments be submitted electronically
                through the Federal eRulemaking Portal, which provides the ability to
                type short comments directly into the comment field on the webpage or
                attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for
                submitting comments. Upon submission of your comment, you will receive
                a Comment Tracking Number. Please be aware that submitted comments are
                not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number,
                your comment has been successfully submitted and there is no need to
                resubmit the same comment. All requests for a hearing must be sent to:
                (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701
                Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
                Enforcement Administration, Attn: DEA Federal Register Representative/
                DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests
                for a hearing should also be sent to: Drug Enforcement Administration,
                Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia
                22152.
                SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
                is notice that on March 15, 2021, Peace of Mind Pharmaceuticals LLC,
                3003 East 3rd Avenue, Suite B-109A, Denver, Colorado 80206-5110,
                applied to be registered as an importer of the
                [[Page 13314]]
                following basic class(es) of controlled substance(s):
                ------------------------------------------------------------------------
                 Drug
                 Controlled substance code Schedule
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                Pentobarbital.......................... 2270 II
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                 The company plans to import the listed controlled substance as bulk
                active pharmaceutical ingredient (API) for distribution to compounding
                pharmacies. It is intended for pharmacies who seek to compound the
                material into dosage units that will be distributed to terminally ill
                patients for ``medical aid in dying'' (MAID) in U.S. states where MAID
                is authorized. No other activity for this drug code is authorized for
                this registration.
                 Approval of permit applications can occur only when a registrant's
                business activity is consistent with what is authorized under 21 U.S.C.
                952(a)(2). Authorization will not extend to the import of Food and Drug
                Administration-approved or non-approved finished dosage forms for
                commercial sale.
                Matthew J. Strait,
                Deputy Assistant Administrator.
                [FR Doc. 2022-04926 Filed 3-8-22; 8:45 am]
                BILLING CODE 4410-09-P
                

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