Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under 21 U.S.C. 952(a) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing.
Therefore, in accordance with Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on January 31, 2010, Meda Pharmaceuticals Inc., 705 Eldorado Street, Decatur, Illinois 62523, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of Nabilone (7379), a basic class of controlled substance listed in schedule II.
The company plans to import the listed controlled substance as a finished drug product in dosage form only for distribution to its customers. The company does not import the listed controlled substance in bulk active pharmaceutical ingredient (API) form.
There are no domestic sources of Nabilone in finished drug product form available in the United States. The U.S. Food and Drug Administration has approved this product for medical use in the United States.
Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may 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 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 8, 2010.
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 class of any controlled substance listed in schedule 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.Start Signature
Dated: May 28, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2010-13756 Filed 6-7-10; 8:45 am]
BILLING CODE 4410-09-P