Importer of Controlled Substances; Notice of Application, 32505 [2010-13756]
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Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
emcdonald on DSK2BSOYB1PROD with NOTICES
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
VerDate Mar<15>2010
16:31 Jun 07, 2010
Jkt 220001
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]
32505
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic classes of controlled
substances listed.
Dated: May 28, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–13737 Filed 6–7–10; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated October 21, 2009, and
published in the Federal Register on
October 29, 2009 (74 FR 55858),
Johnson Matthey, Inc., Pharmaceutical
Materials, 2003 Nolte Drive, West
Deptford, New Jersey 08066–1742, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
Schedule
Phenylacetone (8501) ..................
Coca Leaves (9040) .....................
Thebaine (9333) ...........................
Opium, raw (9600) .......................
Noroxymorphone (9668) ..............
Poppy Straw Concentrate (9670)
II
II
II
II
II
II
The company plans to import the
listed controlled substances as raw
materials for use in the manufacture of
bulk controlled substances for
distribution to its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
Johnson Matthey, Inc. to import the
basic classes of controlled substances is
consistent with the public interest, and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971, at
this time. DEA has investigated Johnson
Matthey, Inc. to ensure that the
company’s registration is consistent
with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
PO 00000
Frm 00151
Fmt 4703
Sfmt 4703
Importer of Controlled Substances;
Notice of Registration
By Notice dated January 27, 2010, and
published in the Federal Register on
February 5, 2010, (75 FR 6062), Wildlife
Laboratories, 1401 Duff Drive, Suite 400,
Fort Collins, Colorado 80524, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of
Etorphine Hydrochloride (9059), a basic
class of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance for sale to its
customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
Wildlife Laboratories to import the basic
class of controlled substance is
consistent with the public interest, and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971, at
this time. DEA has investigated Wildlife
Laboratories to ensure that the
company’s registration is consistent
with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic class of controlled substance
listed.
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Page 32505]
From the Federal Register Online via the Government Printing 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
