2014-21063. Importer of Controlled Substances Registration: Akorn, Inc.

ACTION:

Notice of registration.

SUMMARY:

Akorn, Inc., applied to be registered as an importer of a certain basic class of controlled substance. The DEA grants Akorn, Inc., registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION:

By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32317, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522, applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were reviewed for this notice.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Akorn, Inc., to import 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II.

The company plans to import Remifentanil in bulk for use in dosage form manufacturing.

Dated: August 27, 2014.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.