2015-09350. Manufacturer of Controlled Substances Registration: Cedarburg Pharmaceuticals, Inc.

ACTION:

Notice of registration.

SUMMARY:

Cedarburg Pharmaceuticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Cedarburg Pharmaceuticals, Inc. registration as a manufacturer of the controlled substances.

SUPPLEMENTARY INFORMATION:

By notice dated June 10, 2014, and published in the Federal Register on June 17, 2014, 79 FR 34553, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cedarburg Pharmaceuticals, Inc. to manufacture the 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 above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed:

Controlled substance	Schedule
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333)	II
Remifentanil (9739)	II
Fentanyl (9801)	II

The company plans to manufacture the listed controlled substances in bulk for distribution to its customers.

Regarding the drug code (8333), the company plans to manufacture this listed controlled substance for commercial sale.

Dated: April 14, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.