Notice2022-04926
Importer of Controlled Substances Application: Peace of Mind Pharmaceuticals LLC
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 9, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 46 (Wednesday, March 9, 2022)</title>
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[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Pages 13313-13314]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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):
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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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</html>Indexed from Federal Register on March 9, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.