[Federal Register Volume 64, Number 62 (Thursday, April 1, 1999)]
[Notices]
[Page 15811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8055]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importation of Controlled Substances; Notice of Application
Pursuant to section 1008 of the Controlled Substances Import and
Export Act (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 Section 1002(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 section 1301.34 of Title 21, Code of
Federal Regulations (CFR), notice is hereby given that on November 30,
1998, Taro Pharmaceuticals U.S.A., Inc., 5 Skyline Drive, Hawthorne,
New York 10532, made application to the Drug Enforcement Administration
to be registered as a importer of the basic classes of controlled
substances listed below:
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Drug Schedule
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Pentobarbital (2270)....................... II
Codeine (9050)............................. II
Oxycodone (9143)........................... II
Hydrocodone (9193)......................... II
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The firm plans to import finished product sample for evaluation and
conducting clinical/Bio-equivalence testing.
Any manufacturer holding, or applying for, registration as a bulk
manufacturer of these basic classes of controlled substances may file
written comments on or objections to the application described above
and may, at the same time, file a written request for a hearing on such
application in accordance with 21 CFR 1301.43 in such form as
prescribed by 21 CFR 1316.47.
Any such comments, objections or requests for a hearing may be
addressed, in quintuplicate, to the Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration, United
States Department of Justice, Washington, D.C. 20537, Attention: DEA
Federal Register Representative (CCF), and must be filed no later than
May 3, 1999.
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 at 40 FR 43745-46
(September 23, 1975), 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(a), (b), (c),
(d), (e), and (f) are satisfied.
Dated: January 27, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 99-8055 Filed 3-31-99; 8:45 am]
BILLING CODE 4410-09-M
