2017-28180. Bulk Manufacturer of Controlled Substances Application: Organix, Inc.

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 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:

Controlled substance	Drug code	Schedule
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

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.

DC:____

DCX:____

Return to ODW—Mike Lewis

DCX:____

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