Justia Regulation Tracker

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[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Notices]               
[Page 55585-55586]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-104]                         

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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 Technologies Inc., 110 Lake 
Street, Saint Albans, Vermont 05478, made application 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request for a hearing has been withdrawn.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,

[[Page 55586]]

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 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: October 20, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-25908 Filed 10-27-09; 8:45 am]

BILLING CODE 4410-09-P