Skip to Content

Notice

Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

ACTION:

Notice of application.

DATES:

Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before July 16, 2018.

ADDRESSES:

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

End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or Start Printed Page 22517revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.33(a), this is notice that on April 5, 2017, Patheon API Manufacturing, Inc., 309 Delaware Street, Building 1106, Greenville, South Carolina 29605 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substanceDrug codeSchedule
Thebaine9333II
Noroxymorphone9668II

The company plans to manufacture the above-listed controlled substances as Active Pharmaceutical Ingredient (API) for supply to its customers.

Start Signature

Dated: May 1, 2018.

Susan A. Gibson,

Deputy Assistant Administrator.

End Signature End Supplemental Information

[FR Doc. 2018-10303 Filed 5-14-18; 8:45 am]

BILLING CODE 4410-09-P