[Federal Register Volume 81, Number 67 (Thursday, April 7, 2016)]
[Notices]
[Page 20419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07946]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Mylan 
Pharmaceuticals, Inc.

ACTION: Notice of registration.

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SUMMARY: Mylan Pharmaceuticals, Inc. applied to be registered as an 
importer of certain basic classes of controlled substances. The Drug 
Enforcement Administration (DEA) grants Mylan Pharmaceuticals, Inc. 
registration as an importer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated December 4, 2015, and 
published in the Federal Register on December 10, 2015, 80 FR 76709, 
Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West 
Virginia 26505 applied to be registered as an importer of certain basic 
classes of controlled substances. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(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. The DEA investigated the company's maintenance of effective 
controls against diversion by inspecting and testing the company's 
physical security systems, verifying the company's compliance with 
state and local laws, and reviewing 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 following basic classes of 
controlled substances:

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            Controlled substance                       Schedule
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Amphetamine (1100).........................   II
Lisdexamfetamine (1205)....................   II
Methylphenidate (1724).....................   II
Pentobarbital (2270).......................   II
Oxycodone (9143)...........................   II
Hydromorphone (9150).......................   II
Hydrocodone (9193).........................   II
Levorphanol (9220).........................   II
Morphine (9300)............................   II
Oxymorphone (9652).........................   II
Remifentanil (9739)........................   II
Fentanyl (9801)............................   II
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    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically-manufactured FDF to foreign 
markets.

    Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-07946 Filed 4-6-16; 8:45 am]
 BILLING CODE 4410-09-P