[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Page 68474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27094]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-553]


Importer of Controlled Substances Application: Mylan 
Pharmaceuticals Inc.

ACTION: Notice of application.

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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.

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:

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                                           Drug
          Controlled substance             code          Schedule
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Amphetamine............................    1100   II
Methylphenidate........................    1724   II
Oxycodone..............................    9143   II
Hydromorphone..........................    9150   II
Methadone..............................    9250   II
Morphine...............................    9300   II
Fentanyl...............................    9801   II
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    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.

    Dated: November 14, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-27094 Filed 12-13-19; 8:45 am]
 BILLING CODE 4410-09-P