2017-04645. Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC  

  • 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 in accordance with 21 CFR 1301.33(a) on or before May 8, 2017.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    End Preamble Start Supplemental Information

    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 November 14, 2016, Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substanceDrug codeSchedule
    Gamma Hydroxybutyric Acid2010I
    Tetrahydrocannabinols7370I
    Codeine-N-oxide9053I
    Dihydromorphine9145I
    Difenoxin9168I
    Morphine-N-oxide9307I
    Normorphine9313I
    Norlevorphanol9634I
    Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)9821I
    Butyryl Fentanyl9822I
    Amphetamine1100II
    Methamphetamine1105II
    Lisdexamfetamine1205II
    Methylphenidate1724II
    Nabilone7379II
    4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
    Codeine9050II
    Dihydrocodeine9120II
    Oxycodone9143II
    Hydromorphone9150II
    Diphenoxylate9170II
    Ecgonine9180II
    Hydrocodone9193II
    Levorphanol9220II
    Meperidine9230II
    Methadone9250II
    Methadone intermediate9254II
    Dextropropoxyphene, bulk (non-dosage forms)9273II
    Morphine9300II
    Oripavine9330II
    Thebaine9333II
    Opium tincture9630II
    Opium, powdered9639II
    Oxymorphone9652II
    Noroxymorphone9668II
    Alfentanil9737II
    Remifentanil9739II
    Sufentanil9740II
    Tapentadol9780II
    Fentanyl9801II
    Start Printed Page 13137

    The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers.

    Start Signature

    Louis J. Milione,

    Assistant Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2017-04645 Filed 3-8-17; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Published:
03/09/2017
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2017-04645
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 in accordance with 21 CFR 1301.33(a) on or before May 8, 2017.
Pages:
13136-13137 (2 pages)
Docket Numbers:
Docket No. DEA-392
PDF File:
2017-04645.Pdf