Notice2022-09779
Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc.
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
May 6, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Patheon Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer 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 88 (Friday, May 6, 2022)</title>
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[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Page 27185]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09779]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-991]
Bulk Manufacturer of Controlled Substances Application: Patheon
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Patheon Pharmaceuticals Inc. has applied to be registered as a
bulk manufacturer 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
July 5, 2022. Such persons may also file a written request for a
hearing on the application on or before July 5, 2022.
ADDRESSES: The Drug Enforcement Administration 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 web page 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.''
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 3, 2022, Patheon Pharmaceuticals Inc., 2110
East Galbraith Road, Cincinnati, Ohio 45237-1625, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
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Drug
Controlled substance code Schedule
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Gamma Hydroxybutyric Acid............... 2010 I
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The company plans to manufacture the above-listed controlled
substance as Active Pharmaceutical Ingredient (API) that will be
further synthesized into Food and Drug Administration-approved dosage
forms. No other activities for this drug code are authorized for this
registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-09779 Filed 5-5-22; 8:45 am]
BILLING CODE P
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