By Notice dated May 28, 2010, and published in the Federal Register on June 8, 2010 (75 FR 32505), Meda Pharmaceuticals, Inc. 705 Eldorado Street, Decatur, Illinois 62523, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of Nabilone (7379), a basic class of controlled substance listed in schedule II.
The company plans to import the listed controlled substance as a finished drug product in dosage form only for distribution to its customers. The company does not import the listed controlled substance in bulk active pharmaceutical ingredient (API) form.
There are no domestic sources of Nabilone in finished drug product form available in the United States. The U.S. Food and Drug Administration has approved this product for medical use 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 Meda Pharmaceuticals 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 Meda Pharmaceuticals 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.Start Signature
Dated: December 20, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2011-942 Filed 1-18-11; 8:45 am]
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