Notice of Registration - 2013
[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Page 17231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06328]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances, Notice of Registration, Watson
Pharma, Inc.
By Notice dated November 5, 2012, and published in the Federal
Register on November 13, 2012, 77 FR 67675, Watson Pharma, Inc., 2455
Wardlow Road, Corona, California 92880-2882, made application to the
Drug Enforcement Administration (DEA) to be registered as an importer
of the following basic classes of controlled substances:
| Drug |
Schedule |
| Amphetamine (1100) |
II |
| Methylphenidate (1724) |
II |
| Oxycodone (9143) |
II |
| Hydromorphone (9150) |
II |
The company plans to import the listed controlled substances for
analytical testing and clinical trials.
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.
One comment objecting to the granting of registration as an
importer of the basic class of controlled substance listed to this
applicant and a request for a hearing were received on December 31,
2012. The objection and request for a hearing were withdrawn.
DEA has considered the factors in 21 U.S.C. 823(a) and Sec. 952(a)
and determined that the registration of Watson Pharma, 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 Watson Pharma, 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.
Dated: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-06328 Filed 3-19-13; 8:45 am]
BILLING CODE 4410-09-P
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