[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Notices]
[Page 27472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10727]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Myoderm

ACTION: Notice of registration.

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

SUPPLEMENTARY INFORMATION: By notice dated January 4, 2016, and 
published in the Federal Register on January 11, 2016, 81 FR 1207, 
Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401 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 Myoderm 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
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Oxymorphone (9652).........................  II
Fentanyl (9801)............................  II
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    The company plans to import the listed controlled substances in 
finished dosage form for clinical trials, research, and analytical 
purposes.
    The import of the above listed basic classes of controlled 
substances will be granted only for analytical testing, research, and 
clinical trials. This authorization does not extend to the import of a 
finished FDA approved or non-approved dosage form for commercial sale.

    Dated: April 29, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-10727 Filed 5-5-16; 8:45 am]
 BILLING CODE 4410-09-P