eLaws | eCases | United States Code | Federal Courts |
Home » 2015 Issues » 80 FR (05/21/2015) » 2015-12329. Importer of Controlled Substances Registration: Myoderm

  2015-12329. Importer of Controlled Substances Registration: Myoderm  

  • Start Preamble

    ACTION:

    Notice of registration.

    SUMMARY:

    Myoderm applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Myoderm registration as an importer of those controlled substances.

    End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    By notice dated February 5, 2015, and published in the Federal Register on February 11, Start Printed Page 293372015, 80 FR 7633, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice.

    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Myoderm to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the basic classes controlled substances:

    Controlled substanceSchedule
    Amphetamine (1100)II
    Lisdexamfetamine (1205)II
    Methylphenidate (1724)II
    Pentobarbital (2270)II
    Nabilone (7379)II
    Codeine (9050)II
    Oxycodone (9143)II
    Hydromorphone (9150)II
    Hydrocodone (9193)II
    Levomethorphan (9210)II
    Meperidine (9230)II
    Methadone (9250)II
    Methadone intermediate (9254)II
    Morphine (9300)II
    Oxymorphone (9652)II
    Fentanyl (9801)II

    The company plans to import the listed controlled substances in finished dosage form for clinical trials, and research.

    The import of the above listed basic classes of controlled substances will be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale.

    Start Signature

    Dated: May 15, 2015.

    Joseph T. Rannazzisi,

    Deputy Assistant Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2015-12329 Filed 5-20-15; 8:45 am]

    BILLING CODE 4410-09-P

Visit the Official Version
Leave a Comment

Document Information

Published:
05/21/2015
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of registration.
Document Number:
2015-12329
Pages:
29336-29337 (2 pages)
Docket Numbers:
Docket No. DEA-392
PDF File:
2015-12329.pdf