Bulk Manufacturer of Controlled Substances Registration

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Federal RegisterAug 10, 2016
81 Fed. Reg. 52908 (Aug. 10, 2016)

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 various classes of controlled substances.

SUPPLEMENTARY INFORMATION:

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

81 FR 921781 FR 1557181 FR 22122
Company FR Docket Published
Noramco, Inc. 81 FR 7587 February 12, 2016.
Cayman Chemical Company February 24, 2016.
Janssen Pharmaceutical, Inc. 81 FR 9219 February 24, 2016.
Insys Therapeutics, Inc. 81 FR 9220 February 24, 2016.
Siemens Healthcare Diagnostics, Inc. 81 FR 15565 March 23, 2016.
Siegfried USA, LLC 81 FR 15567 March 23, 2016.
Patheon Pharmaceuticals, Inc. March 23, 2016.
Navinta, LLC 81 FR 20418 April 7, 2016.
Patheon API Manufacturing, Inc. April 14, 2016.

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 of the 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 persons.

Dated: August 2, 2016.

Louis J. Milione,

Deputy Assistant Administrator.

[FR Doc. 2016-18921 Filed 8-9-16; 8:45 am]

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