Notice of Registration - 2012
[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Page 47114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19202]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration;
Catalent Pharma Solutions, Inc.
By Notice dated April 17, 2012, and published in the Federal
Register on April 26, 2012, 77 FR 24984, Catalent Pharma Solutions,
Inc., 10381 Decatur Road, Philadelphia, Pennsylvania 19114, made
application to the Drug Enforcement Administration (DEA) to be
registered as an importer of Noroxymorphone (9668), a basic class of
controlled substance listed in schedule II.
The company plans to import the listed controlled substance in
finished dosage form for clinical trials.
The import of the above listed basic class of controlled substance
would 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. DEA has considered
the factors in 21 U.S.C. 823(a) and 952(a) and determined that the
registration of Catalent Pharma Solutions, 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 Catalent Pharma Solutions, 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: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-19202 Filed 8-6-12; 8:45 am]
BILLING CODE 4410-09-P
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