By Notice dated December 23, 2013, and published in the Federal Register on January 10, 2014, 79 FR 1887, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances:
|Methadone intermediate (9254)||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 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.
No comments or objections have been received. The 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 class of controlled substance is consistent with the public interest and in accordance with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The 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.
Dated: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2014-09551 Filed 4-25-14; 8:45 am]
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