80 FR 45550 - Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 146 (July 30, 2015)

Apertus Pharmaceuticals applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Apertus Pharmaceuticals registration as a manufacturer of those controlled substances.

[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Page 45550]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18695]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Apertus 
Pharmaceuticals

ACTION: Notice of registration.

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

SUPPLEMENTARY INFORMATION: By notice dated March 20, 2015, and 
published in the Federal Register on March 27, 2015, 80 FR 16440, 
Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, Missouri 63011 
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 Apertus Pharmaceuticals 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 basic classes of controlled substances listed:

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            Controlled substance                       Schedule
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Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
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    The company plans to divide the synthesized cannabidiol, with a 
portion going for sale as an API in nabiximol. The raw material will be 
used to synthesize dronabinol. Therefore, they anticipate consuming and 
purchasing small quantities of CS for generating data to support the 
Drug Master File with the FDA including validation batches, standards 
and stability studies.
    No other activity for this drug code is authorized for this 
registration.

    Dated: July 23, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-18695 Filed 7-29-15; 8:45 am]
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