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Lannett Company Incorporated
FR Doc E7-18497 [Federal Register: September 19, 2007 (Volume 72, Number
181)] [Notices] [Page 53605-53606] From the Federal Register Online via GPO
Access [wais.access.gpo.gov] [DOCID:fr19se07-119]
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 registration under 21
U.S.C. 952(a) authorizing the importation of such substances, 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 10, 2006, Lannett Company Incorporated, 9001 Torresdale Avenue,
Philadelphia, Pennsylvania 19136, made application by letter and subsequent
renewal on February 19, 2007 to the Drug Enforcement Administration (DEA) for
registration as an importer of the basic classes of controlled substances:
Drug
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Schedule
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Tetrahydrocannabinols (7370)
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I
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Methylphenidate (1724)
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II
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Morphine (9300)
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II
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The company plans to import the basic classes of controlled substances for
analytical testing on a formulated product for submission to U.S. Food and
Drug Administration (FDA) for generic product approval.
Any manufacturer who is presently, or is applying to be, registered with
DEA to manufacture such basic classes of
[[Page 53606]]
controlled substances 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 being sent via regular mail should be
addressed, in quintuplicate, to the Drug Enforcement Administration, Office of
Diversion Control, Federal Register Representative (ODL), Washington, DC
20537, or any being sent via express mail should be sent to Drug Enforcement
Administration, Office of Diversion Control, Federal Register Representative (ODL),
2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no
later than October 19, 2007.
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 43745-43746), all applicants for registration to import a basic
class of any controlled substances 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: September 12, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion
Control, Drug Enforcement Administration.
[FR Doc. E7-18497 Filed 9-18-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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