2018-21351. Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City  

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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 December 3, 2018.

    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 June 8, 2018, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer of the basic classes of controlled substances:

    Controlled substanceDrug codeSchedule
    Gamma Hydroxybutyric Acid2010I
    Amphetamine1100II
    Lisdexamfetamine1205II
    Methylphenidate1724II
    4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
    Phenylacetone8501II
    Cocaine9041II
    Codeine9050II
    Oxycodone9143II
    Hydromorphone9150II
    Hydrocodone9193II
    Morphine9300II
    Oripavine9330II
    Thebaine9333II
    Opium extracts9610II
    Opium fluid extract9620II
    Opium tincture9630II
    Opium, powdered9639II
    Oxymorphone9652II
    Noroxymorphone9668II
    Fentanyl9801II

    The company plans to manufacture the listed controlled substances in bulk for conversion to other controlled substances and sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies.

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    Dated: September 20, 2018.

    John J. Martin,

    Assistant Administrator.

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    [FR Doc. 2018-21351 Filed 10-1-18; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Published:
10/02/2018
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2018-21351
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 December 3, 2018.
Pages:
49579-49579 (1 pages)
Docket Numbers:
Docket No. DEA-392
PDF File:
2018-21351.Pdf