Manufacturer of Controlled Substances; Notice of Application; Austin Pharma, LLC.

Download PDF
Federal RegisterMay 21, 2012
77 Fed. Reg. 30027 (May. 21, 2012)

Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on April 11, 2012, Austin Pharma, LLC., 811 Paloma Drive, Suite C, Round Rock, Texas 78665-2402, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Drug Schedule
Marihuana (7360) I
Tetrahydrocannabinols (7370) I

The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers.

In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture a synthetic THC (7370). No other activity for this drug code is authorized for this registration.

Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).

Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than July 20, 2012.

Dated: May 9, 2012.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

[FR Doc. 2012-12280 Filed 5-18-12; 8:45 am]

BILLING CODE 4410-09-P