[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Page 75496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30347]


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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)(2) 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 21 CFR 1301.34(a), this is notice 
that on October 27, 2010, Meridian Medical Technologies, 2555 Hermelin 
Drive, St. Louis, Missouri 63144, made application by renewal to the 
Drug Enforcement Administration (DEA) to be registered as an importer 
of Morphine (9300), a basic class of controlled substance listed in 
schedule II.
    The company manufactures a product containing morphine in the 
United States. The company exports this product to customers around the 
world, including in Europe. The company has been asked to ensure that 
its product sold to European customers meets standards established by 
the European Pharmacopeia, which is administered by the Directorate for 
the Quality of Medicines (EDQM). In order to ensure that its product 
will meet European specifications, the company seeks to import morphine 
supplied by EDQM to use as reference standards. This is the sole 
purpose for which the company will be authorized by DEA to import 
morphine.
    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 January 3, 2011.
    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 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: November 19, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-30347 Filed 12-2-10; 8:45 am]
BILLING CODE 4410-09-P