[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Page 42545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17523]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Mallinckrodt, 
LLC

ACTION: Notice of registration.

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SUMMARY: Mallinckrodt, LLC applied to be registered as a manufacturer 
of certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Mallinckrodt, LLC registration as a 
manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated January 21, 2015, and 
published in the Federal Register on January 28, 2015, 80 FR 4592, 
Mallinckrodt LLC, 3600 North Second Street, St. Louis, Missouri 63147 
applied to be registered as a manufacturer of certain basic classes of 
controlled substances. No comments or objections were submitted to this 
notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Mallinckrodt, LLC to manufacture 
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. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the following basic classes of controlled substances:

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            Controlled substance                       Schedule
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Gamma Hydroxybutyric Acid (2010)...........  I
Lisdexamfetamine (1205)....................  II
Oripavine (9330)...........................  II
Tapentadol (9780)..........................  II
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    The company plans to manufacturer bulk active pharmaceutical 
ingredients (API) for distribution and product development to its 
customers.

    Dated: July 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-17523 Filed 7-16-15; 8:45 am]
 BILLING CODE 4410-09-P