Bulk Manufacturer of Controlled Substances Registration

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Federal RegisterMar 6, 2019
84 Fed. Reg. 8114 (Mar. 6, 2019)

ACTION:

Notice of registration.

SUMMARY:

Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of schedule I or schedule II controlled substances.

SUPPLEMENTARY INFORMATION:

The companies listed below applied to be registered as bulk manufacturers of schedule I or schedule II controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices.

Company FR docket Published
Patheon API Manufacturing, Inc. 83 FR 58596 November 20, 2018.
Insys Manufacturing, LLC 83 FR 60899 November 27, 2018.
Cayman Chemical Company 83 FR 60900 November 27, 2018.
Noramco Inc. 83 FR 60898 November 27, 2018.

The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of the listed 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: February 18, 2019.

John J. Martin,

Assistant Administrator.

[FR Doc. 2019-04033 Filed 3-5-19; 8:45 am]

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