FR Doc E9-25888[Federal Register: October 28, 2009 (Volume
74, Number 207)] [Notices] [Page 55585] From the Federal
Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-102]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
By Notice dated June 3, 2009, and published in the Federal
Register on June 9, 2009 (74 FR 27349), Mylan Pharmaceuticals
Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505,
made application by letter to the Drug Enforcement
Administration (DEA) to be registered as an importer of the
basic classes of controlled substances listed in schedule II:
|
Drug
|
Schedule
|
|
Methylphenidate (1724)
|
II
|
|
Fentanyl (9801)
|
II
|
The company plans to import the listed controlled substances
for analytical research and clinical trials.
Two objections and one request for a hearing were received.
The request for a hearing has been withdrawn. DEA has examined
the other objections to the registration and has determined that
the objections and comments received are not valid for this
specific situation. The company will import finished dosage
forms for clinical trials and analytical comparison only. They
will not purchase raw material for the manufacture of finished
goods and/or commercial distribution. No other use of the
imported material in question will be allowed.
DEA has considered the factors in 21
U.S.C. 823(a) and Sec.
952(a) and determined that the registration of Mylan
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, at this
time. DEA has investigated Mylan 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.
Dated: October 16, 2009.
Joseph T. Rannazzisi, Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration.
[FR Doc. E9-25888 Filed 10-27-09; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
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