[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Page 17622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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.

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