2019 - Patheon API Manufacturing, Inc. | Chattem Chemicals

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Bulk Manufacturer of Controlled Substances Registration

[DRG No. 20-019]

ACTION: Notice of registration.

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

SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as a bulk manufacturer of various classes of scheduled I and II controlled substances. Information on a previously published notices is listed below. No comments or objections were submitted for these notices.

Company FR Docket Published
Patheon API Manufacturing, Inc. 84 FR 64563 November 22, 2019
Chattem Chemicals 84 FR 64564 November 22, 2019

The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants 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 each company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each 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 companies.

Dated: 2/10/2020

William T. McDermott,
Assistant Administrator.

 

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