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

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    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.

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    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 substanceDrug codeSchedule
    Gamma Hydroxybutyric Acid2010I
    Lysergic acid diethylamide7315I
    Marihuana7360I
    Tetrahydrocannabinols7370I
    Dimethyltryptamine7435I
    Psilocybin7437I
    Psilocyn7438I
    Heroin9200I
    Morphine9300II

    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.

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    Dated: December 20, 2017.

    Demetra Ashley,

    Acting Assistant Administrator.

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    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

    End Supplemental Information

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

    BILLING CODE 4410-09-P

Document Information

Published:
01/04/2018
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2017-28180
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.
Pages:
539-539 (1 pages)
Docket Numbers:
Docket No. DEA-392
PDF File:
2017-28180.Pdf