[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Page 32505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13756]





[[Page 32505]]



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DEPARTMENT OF JUSTICE



Drug Enforcement Administration




Importer of Controlled Substances; Notice of Application



    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.



     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