2015-30559. 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 Drug Enforcement Administration (DEA) grants Akorn, Inc. registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION:

By notice dated September 1, 2015, and published in the Federal Register on September 9, 2015, 80 FR 54327 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 submitted for this notice.

The 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 dosage form for distribution.

Dated: November 23, 2015.

Louis J. Milione,

Deputy Assistant Administrator.