[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.
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
[FR Doc. 2017-28180 Filed 1-3-18; 8:45 am]
BILLING CODE 4410-09-P