Notice2023-05944
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
March 23, 2023
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 Supplementary Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 88 Issue 56 (Thursday, March 23, 2023)</title>
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[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Page 17622]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05944]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1166]
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 Supplementary 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
May 22, 2023. Such persons may also file a written request for a
hearing on the application on or before May 22, 2023.
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 1, 2023, Patheon Pharmaceuticals Inc., 2110
East Galbraith Road, Cincinnati, Ohio 45237, 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 Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-05944 Filed 3-22-23; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on March 23, 2023.
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