[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Page 10471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03617]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-585]


Bulk Manufacturer of Controlled Substances Application: Patheon 
Pharmaceuticals, Inc.

ACTION: Notice of application.

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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 April 24, 2020.

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 December 23, 2019, Patheon Pharmaceuticals, Inc., 
2100 E Galbraith Road, Cincinnati, Ohio 45237-1625 applied to be 
registered as a bulk manufacturer of the following basic class(es) 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 Gamma Hydroxbutyric Acid will be produced during the process of 
converting gamma-butyrolactone into a new product for development. The 
company plans to manufacture the above-listed controlled substance as 
Active Pharmaceutical Ingredient (API) that will be further synthesized 
into dosage forms of a new product. No other activities for this drug 
code are authorized for this registration.

    Dated: January 31, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-03617 Filed 2-21-20; 8:45 am]
BILLING CODE 4410-09-P