Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2018

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Page 5810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02643]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Bulk Manufacturer of Controlled Substances Application: INSYS Manufacturing LLC

ACTION: Notice of application.


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 on or before April 10, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 November 13, 2017, INSYS Manufacturing LLC, 811 Paloma Drive, Suite C, Round Rock, TX 78665-2402 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled Substance Drug Code Schedule
Marihuana 7360 I
Tetrahydrocannabinols 7370 I

The company plans to manufacture the above listed controlled substances in bulk for distribution to its customers.

In reference to drug codes 7360 (marihuana), and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.

Dated: January 31, 2018.

Susan A. Gibson,
Deputy Assistant Administrator.

[FR Doc. 2018-02643 Filed 2-8-18; 8:45 am]

BILLING CODE 4410-09-P

 

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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