[Federal Register Volume 86, Number 44 (Tuesday, March 9, 2021)]
[Notices]
[Page 13586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04809]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-802]


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 file written comments on or objections to 
the issuance of the proposed registration on or before May 10, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before May 10, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on February 2, 2021, Patheon Pharmaceuticals Inc, 2110 
East Galbraith Road, Cincinnati, Ohio 45237-1625, applied to be 
registered as a bulk manufacturer of the following basic class of 
controlled substance:

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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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-04809 Filed 3-8-21; 8:45 am]
BILLING CODE 4410-09-P