2015-19162. Importer of Controlled Substances Registration: Actavis Laboratories FL, Inc.

ACTION:

Notice of registration.

SUMMARY:

Actavis Laboratories FL, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Actavis Laboratories FL, Inc., registration as an importer of those controlled substances.

SUPPLEMENTARY INFORMATION:

By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22554, Actavis Laboratories FL, Inc., 4955 Orange Drive, Davie, Florida 33314 applied to be registered as an importer of a certain basic classes of controlled substances. 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 Actavis Laboratories FL, Inc. to import 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the following basic classes of controlled substances:

Controlled substance	Schedule
Amphetamine (1100)	II
Methylphenidate (1724)	II
Oxycodone (9143)	II
Hydromorphone (9150)	II
Hydrocodone (9193)	II
Fentanyl (9801)	II

The company plans to import the above-listed controlled substances for clinical trials, research and analytical purposes.

The import of the above-listed basic classes of controlled substances would be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished Food and Drug Administration approved or non-approved dosage form for commercial distribution in the United States.

Dated: July 29, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.