Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Importers Notice of Application - 2019

[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]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-553]

Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.

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.

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 Substance Drug Code Schedule
Amphetamine 1100 II
Methylphenidate 1724 II
Oxycodone 9143 II
Hydromorphone 9150 II
Methadone 9250 II
Morphine 9300 II
Fentanyl 9801 II

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

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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