77 FR 168 pg. 52368 - Manufacturer of Controlled Substances; Notice of Registration; Austin Pharma, LLC.
Type: NOTICEVolume: 77Number: 168Page: 52368
FR document: [FR Doc. 2012-21283 Filed 8-28-12; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration; Austin Pharma, LLC.
By Notice dated May 9, 2012, and published in the Federal Register on May 21, 2012, 77 FR 30027, 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.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Austin Pharma LLC., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Austin Pharma LLC., to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823, 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.
Dated: August 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2012-21283 Filed 8-28-12; 8:45 am]
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