2014-24018. Manufacturer of Controlled Substances Registration: Austin Pharma, LLC

ACTION:

Notice of registration.

SUMMARY:

Austin Pharma, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Austin Pharma, LLC registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION:

By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32322, Austin Pharma, LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665-2402, applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Austin Pharma, 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 basic classes of controlled substances:

Controlled substance	Schedule
Marihuana (7360)	I
Tetrahydrocannabinols (7370)	I

The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for distribution and new product development to its customers. The company plans to bulk manufacture a synthetic tetrahydrocannabinol.

In reference to drug code 7360, the company plans to manufacture a synthetic cannabinol in bulk for sale to its customers. The controlled substance will be further synthesized to bulk manufacture a synthetic tetrahydrocannabinol (7370). No other activity for this drug code is authorized for this registration.

Dated: October 2, 2014.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.