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78 FR 126 pgs. 39336-39337 - Importer of Controlled Substances; Notice of Application; Mylan Pharmaceuticals, Inc.

Type: NOTICEVolume: 78Number: 126Pages: 39336 - 39337
FR document: [FR Doc. 2013-15587 Filed 6-28-13; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version:  PDF Version
Pages: 39336, 39337

[top] page 39336

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Importer of Controlled Substances; Notice of Application; Mylan Pharmaceuticals, Inc.

Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on March 8, 2013, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances:

Drug Schedule
Amphetamine (1100) II
Lisdexamfetamine (1205) II
Methylphenidate (1724) II
Pentobarbital (2270) II
Oxycodone (9143) II
Hydromorphone (9150) II
Hydrocodone (9193) II
Levorphanol (9220) II
Morphine (9300) II
Oxymorphone (9652) II
Remifentanil (9739) 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.


[top] Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled page 39337 substances listed in schedule II, which falls under the authority of section 1002(a)(2)(B) of the Act 21 U.S.C. 952(a)(2)(B) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47.

Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than July 31, 2013.

This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745-46, all applicants for registration to import a basic classes of any controlled substances in schedules I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration,that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.

Dated: June 18, 2013.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

[FR Doc. 2013-15587 Filed 6-28-13; 8:45 am]

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