2020-03617. 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.