80 FR 128 pgs. 38471-38472 - Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc.
Type: NOTICEVolume: 80Number: 128Pages: 38471 - 38472
Pages: 38471, 38472Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2015-16453 Filed 7-2-15; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc.
ACTION:
Notice of registration.
SUMMARY:
Mylan Pharmaceuticals, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mylan Pharmaceuticals, Inc. registration as an importer of those controlled substances.
SUPPLEMENTARY INFORMATION:
[top] By notice dated March 20, 2015, and published in the Federal Register on March 27, 2015, 80 FR 16436, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505 applied to be registered as an importer
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Mylan Pharmaceuticals, Inc. 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 of controlled substances:
| Controlled substance | 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.
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16453 Filed 7-2-15; 8:45 am]
BILLING CODE 4410-09-P