2018-19444. Bulk Manufacturer of Controlled Substances Registration

ACTION:

Notice of registration.

SUMMARY:

Registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances.

SUPPLEMENTARY INFORMATION:

The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted for this notice.

Company	FR docket	Published
Patheon API Manufacturing, Inc	83 FR 22516	May 15, 2018.

The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company.

Dated: August 23, 2018.

John J. Martin,

Assistant Administrator.