80 FR 37302 - Manufacturer of Controlled Substances Registration: Insys Therapeutics, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 125 (June 30, 2015)

Insys Therapeutics, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Insys Therapeutics, Inc. registration as a manufacturer of those controlled substances.

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Page 37302]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16030]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Insys 
Therapeutics, Inc.

ACTION: Notice of registration.

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SUMMARY: Insys Therapeutics, Inc. applied to be registered as a 
manufacturer of certain basic classes of controlled substances. The 
Drug Enforcement Administration (DEA) grants Insys Therapeutics, Inc. 
registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated February 5, 2015, and 
published in the Federal Register on February 11, 2015, 80 FR 7635, 
Insys Therapeutics, Inc., 2700 Oakmont, Round Rock, Texas 78665 applied 
to be registered as a manufacturer of certain basic classes of 
controlled substances. No comments or objections were submitted to this 
notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Insys Therapeutics, Inc. 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 listed:

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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 manufacture bulk synthetic active 
pharmaceutical ingredients (APIs) for product development and 
distribution to its customers. No other activity for this drug code is 
authorized for this registration.

    Dated: June 24, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16030 Filed 6-29-15; 8:45 am]
 BILLING CODE 4410-09-P