Notice of Application - 2010
[Federal Register: December 3, 2010 (Volume 75, Number 232)]
[Notices]
[Page 75496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de10-75]
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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
