2015-01306. Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals

ACTION:

Notice of registration.

SUMMARY:

Apertus Pharmaceuticals applied to be registered as a manufacturer of a certain basic class of controlled substance. The DEA grants Apertus Pharmaceuticals registration as a manufacturer of the controlled substance.

SUPPLEMENTARY INFORMATION:

By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32321, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, Missouri 63011, applied to be registered as a manufacturer of a certain basic class of controlled substance. 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 Apertus Pharmaceuticals to manufacture the basic class of controlled substance 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 Remifentanil (9739), a basic class of controlled substance listed in schedule II.

The company plans to manufacture small quantities of the listed controlled substance to make reference standards for distribution to their customers.

On March 27, 2014, Apertus Pharmaceuticals withdrew its request for the addition of Alfentanil (9737), Sufentanil (9740), and Fentanyl (9801) to this registration.

Dated: January 9, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.