2019-06852. Importer of Controlled Substances Application: SpecGx LLC  

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    ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written Start Printed Page 13955comments on or objections to the issuance of the proposed registration on or before May 8, 2019. Such persons may also file a written request for a hearing on the application on or before May 8, 2019.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw materials are not appropriate. 72 FR 3417 (January 25, 2007).

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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 1301.34(a), this is notice that on February 1, 2019, SpecGx LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as an importer of the following basic classes of controlled substances:

    Controlled substanceDrug codeSchedule
    Marihuana7360I
    Phenylacetone8501II
    Coca Leaves9040II
    Opium, raw9600II
    Poppy Straw Concentrate9670II

    The company plans to import the listed controlled substances to bulk manufacture into Active Pharmaceutical Ingredients (API) for distribution to its customers. In reference to drug code 7360 (marihuana), the company plans to import synthetic cannabidiol. No other activity for this drug code is authorized for this registration. Placement of these codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952 (a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.

    Start Signature

    Dated: March 21, 2019.

    John J. Martin,

    Assistant Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2019-06852 Filed 4-5-19; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Published:
04/08/2019
Department:
Justice Department
Agency:
Drug Enforcement Administration
EntryType:
Notice
Action:
Notice of application.
Document Number:
2019-06852
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 May 8, 2019. Such persons may also file a written request for a hearing on the application on or before May 8, 2019.
Pages:
13954-13955 (2 pages)
Docket Numbers:
Docket No. DEA-392
SectionNoes:
PDF File:
2019-06852.pdf