Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2020

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


Drug Enforcement Administration

[Docket No. DEA-585]

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

ACTION: Notice of application.

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:

Controlled Substance Drug Code Schedule
Gamma Hydroxybutyric Acid 2010 I

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]


NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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