[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