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Notice

Importer of Controlled Substances, Notice of Registration, Myoderm

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Information about this document as published in the Federal Register.

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By Notice dated June 28, 2012, and published in the Federal Register on July 5, 2012, 77 FR 39741, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401, 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
Lisdexamfetamine (1205)II
Methylphenidate (1724)II
Pentobarbital (2270)II
Nabilone (7379)II
Codeine (9050)II
Oxycodone (9143)II
Hydromorphone (9150)II
Hydrocodone (9193)II
Levomethorphan (9210)II
Meperidine (9230)II
Methadone (9250)II
Methadone intermediate (9254)II
Morphine (9300)II
Oxymorphone (9652)II
Fentanyl (9801)II

The company plans to import the listed controlled substances in finished dosage form for clinical trials, and research.

The import of the above listed basic classes of controlled substances is 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.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Myoderm, 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, at this time. DEA has investigated Myoderm, 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: January 15, 2013.

Joseph T. Rannazzisi,

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

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[FR Doc. 2013-01540 Filed 1-24-13; 8:45 am]

BILLING CODE 4410-09-P