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Home » 2019 Issues » 84 FR (12/16/2019) » 2019-27094. Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.

  2019-27094. Importer of Controlled Substances Application: Mylan Pharmaceuticals 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 January 15, 2020. Such persons may also file a written request for a hearing on the application on or before January 15, 2020

    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.

    End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    In accordance with 21 CFR 1301.34(a), this is notice that on October 17, 2019, Mylan Pharmaceuticals Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505 applied to be registered as an importer of the following basic classes of controlled substances:

    Controlled substanceDrug codeSchedule
    Amphetamine1100II
    Methylphenidate1724II
    Oxycodone9143II
    Hydromorphone9150II
    Methadone9250II
    Morphine9300II
    Fentanyl9801II

    The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically-manufactured FDF to foreign markets.

    Authorization will not extend to the import of Food and Drug Administration approved or non-approved finished dosage forms for commercial sale.

    Start Signature

    Dated: November 14, 2019.

    William T. McDermott,

    Assistant Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2019-27094 Filed 12-13-19; 8:45 am]

    BILLING CODE 4410-09-P

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Document Information

Published:
12/16/2019
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2019-27094
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 January 15, 2020. Such persons may also file a written request for a hearing on the application on or before January 15, 2020
Pages:
68474-68474 (1 pages)
Docket Numbers:
Docket No. DEA-553
PDF File:
2019-27094.pdf