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Notice

Importer of Controlled Substances, Notice of Registration, Watson Pharma, Inc.

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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By Notice dated November 5, 2012, and published in the Federal Register on November 13, 2012, 77 FR 67675, Watson Pharma, Inc., 2455 Wardlow Road, Corona, California 92880-2882, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances:

DrugSchedule
Amphetamine (1100)II
Methylphenidate (1724)II
Oxycodone (9143)II
Hydromorphone (9150)II

The company plans to import the listed controlled substances for analytical testing and clinical trials.

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

One comment objecting to the granting of registration as an importer of the basic class of controlled substance listed to this applicant and a request for a hearing were received on December 31, 2012. The objection and request for a hearing were withdrawn.

DEA has considered the factors in 21 U.S.C. 823(a) and § 952(a) and determined that the registration of Watson Pharma, 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. DEA has investigated Watson Pharma, Inc., to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems; verification of the company's compliance with state and local laws; and a review of 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 basic classes of controlled substances listed.

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Dated: March 12, 2013.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

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[FR Doc. 2013-06328 Filed 3-19-13; 8:45 am]

BILLING CODE 4410-09-P