[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Page 16440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06966]



[[Page 16440]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Apertus 
Pharmaceuticals

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before May 26, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearings should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on March 
20, 2014, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, 
Missouri 63011, applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

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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: March 20, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-06966 Filed 3-26-15; 8:45 am]
 BILLING CODE 4410-09-P