Notice of Registration - 2011
[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Page 3160]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-942]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances Notice of Registration
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 Sec. 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 Sec. 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: 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]
BILLING CODE 4410-09-P
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