Notice of Registration - 2013
[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Page 5498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01540]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances, Notice of Registration,
Myoderm
By Notice dated June 28, 2012, and published in the Federal
Register on July 5, 2012, 77 FR 39741, Myoderm, 48 East Main Street,
Norristown, Pennsylvania 19401, 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 |
| 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 is 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 distribution in the
United States.
No comments or objections have been received. DEA has considered
the factors in 21 U.S.C. 823(a) and 952(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, at this time. DEA has investigated
Myoderm, to ensure that the company's registration is consistent with
the public interest. The investigation has included inspection and
testing of the company's physical security systems, verification of the
company's compliance with state and local laws, and a review of 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 listed.
Dated: January 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-01540 Filed 1-24-13; 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 Printing Office (GPO). |
