Justia Regulation Tracker

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[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]                         

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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request for a hearing has been withdrawn.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