2019-02883. Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.  

  • Start Preamble

    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 April 22, 2019.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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 October 30, 2018, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substanceDrug codeSchedule
    Marihuana7360I
    Tetrahydrocannabinols7370I
    Codeine-N-oxide9053I
    Dihydromorphine9145I
    Hydromorphinol9301I
    Morphine-N-oxide9307I
    Amphetamine1100II
    Methylphenidate1724II
    Nabilone7379II
    Phenylacetone8501II
    Codeine9050II
    Dihydrocodeine9120II
    Oxycodone9143II
    Hydromorphone9150II
    Hydrocodone9193II
    Morphine9300II
    Oripavine9330II
    Thebaine9333II
    Opium extracts9610II
    Opium fluid extract9620II
    Opium tincture9630II
    Opium, powdered9639II
    Opium, granulated9640II
    Oxymorphone9652II
    Noroxymorphone9668II
    Tapentadol9780II

    The company plans to manufacture bulk active pharmaceutical ingredients (APIs) and reference standards for distribution to their customers.

    In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.

    Start Signature

    Dated: February 11, 2019.

    John J. Martin,

    Assistant Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2019-02883 Filed 2-20-19; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Published:
02/21/2019
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2019-02883
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 April 22, 2019.
Pages:
5499-5499 (1 pages)
Docket Numbers:
Docket No. DEA-392
PDF File:
2019-02883.Pdf