Bulk Manufacturer of Controlled Substances Application: Organix, Inc.

Federal Register, Volume 83 Issue 3 (Thursday, January 4, 2018)

Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)

Notices

Page 539

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2017-28180

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Docket No. DEA-392

Bulk Manufacturer of Controlled Substances Application: Organix, Inc.

ACTION: Notice of application.

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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 March 5, 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 Assistant Administrator of the DEA Diversion Control Division (``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 September 6, 2017, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

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Drug

Controlled substance code Schedule

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Gamma Hydroxybutyric Acid.............. 2010 I

Lysergic acid diethylamide............. 7315 I

Marihuana.............................. 7360 I

Tetrahydrocannabinols.................. 7370 I

Dimethyltryptamine..................... 7435 I

Psilocybin............................. 7437 I

Psilocyn............................... 7438 I

Heroin................................. 9200 I

Morphine............................... 9300 II

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The company plans to manufacture reference standards for distribution to its research and forensic customers. In reference to drug code 7360 (marihuana) and 7370 (THC) the company plans to manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.

Dated: December 20, 2017.

Demetra Ashley,

Acting Assistant Administrator.

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DCX:____---------------------------------------------------------------

Return to ODW--Mike Lewis

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DR:____----------------------------------------------------------------

DRX:____---------------------------------------------------------------

DRW:____---------------------------------------------------------------

DRW Policy Analyst:____------------------------------------------------

DRG:____---------------------------------------------------------------

DRG/A:____-------------------------------------------------------------

DRGR Unit Chief:____---------------------------------------------------

DRQ:____---------------------------------------------------------------

DRGR Staff Coordinator____---------------------------------------------

DRGR-L.Mckoy____10/25/2017

NOA--ORGANIX INC

Document#: DRGR-17-0306

DFN: 010.02.A1 General Correspondence

DFN: 301-04 Federal Register Files

FR Doc. 2017-28180 Filed 1-3-18; 8:45 am

BILLING CODE 4410-09-P