Notice of Registration - 2011
[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Page 38209]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16286]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
By Notice dated April 11, 2011, and published in the Federal
Register on April 19, 2011, 76 FR 21915, Meda Pharmaceuticals, Inc.,
705 Eldorado Street, Decatur, Illinois 62523, made application by
renewal 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 Sec. 952(a), and determined that
the registration of Meda Pharmaceuticals Inc. to import the basic class
of controlled substance 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 class of controlled substance listed.
Dated: June 22, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2011-16286 Filed 6-28-11; 8:45 am]
BILLING CODE 4410-09-P
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