Importer of Controlled Substances Application: MEDA PHARMACEUTICALS, INC., 34552 [2014-14150]
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Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices
dispensers of controlled substances
(other than final orders in connection
with suspension, denial, or revocation
of registration) has been redelegated to
the Deputy Assistant Administrator of
the DEA Office of Diversion Control
(‘‘Deputy Assistant Administrator’’)
pursuant to sec. 7(g) of 28 CFR pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.34(a), this is notice that on May 8,
2014, Alkermes Gainesville LLC, 1300
Gould Drive, Gainesville, Georgia
30504, applied to be registered as an
importer of Noroxymorphone (9668), a
basic class of controlled substance listed
in schedule II.
The company plans to import the
above listed controlled substance for
analytical research and testing.
The import of the above listed basic
class of controlled substance would be
granted only for analytical testing and
clinical testing. This authorization does
not extend to the import of a finished
Food and Drug Administration
approved or non-approved dosage form
for commercial distribution in the
United States.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, and
dispensers of controlled substances
(other than final orders in connection
with suspension, denial, or revocation
of registration) has been redelegated to
the Deputy Assistant Administrator of
the DEA Office of Diversion Control
(‘‘Deputy Assistant Administrator’’)
pursuant to sec. 7(g) of 28 CFR pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.34(a), this is notice that on
December 9, 2013, Meda
Pharmaceuticals, Inc., 705 Eldorado
Street, Decatur, Illinois 62523, applied
to be registered as an importer of
Nabilone (7379), a basic class of nonnarcotic controlled substance listed in
schedule II.
The company plans to import the
FDA approved listed controlled
substance as a finished drug product in
dosage form for distribution to its
customers.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–14145 Filed 6–16–14; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2014–14150 Filed 6–16–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
Importer of Controlled Substances
Application: MEDA
PHARMACEUTICALS, INC.
[Docket No. DEA–392]
ACTION:
Importer of Controlled Substances
Registration: CODY LABORATORIES,
INC.
Notice of Application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before July 17, 2014. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before July 17,
2014.
DATES:
Written comments should be
sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
tkelley on DSK3SPTVN1PROD with NOTICES
ADDRESS:
The
Attorney General has delegated his
authority under the Controlled
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
16:43 Jun 16, 2014
Jkt 232001
ACTION:
Notice of Registration.
Cody Laboratories, Inc.
applied to be registered as an importer
of certain basic classes of narcotic or
non-narcotic controlled substances. The
DEA grants Cody Laboratories, Inc.
registration as an importer of those
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated December 31, 2013, and
published in the Federal Register on
January 10, 2014, 79 FR 1888, Cody
Laboratories, Inc., 601 Yellowstone
Avenue, Cody, Wyoming 82414–9321,
applied to be registered as an importer
of certain basic classes of narcotic or
non-narcotic controlled substances.
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
SUMMARY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
958(a) and determined that the
registration of Cody Laboratories, 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. The DEA investigated the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security systems, verified the company’s
compliance with state and local laws,
and reviewed 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 narcotic
or non-narcotic controlled substances
listed:
Controlled substance
Phenylacetone (8501) ..................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
Schedule
II
II
II
The company plans to import narcotic
raw materials for manufacturing and
further distribution to its customers.
The company is registered with the DEA
as a manufacturer of several controlled
substances that are manufactured from
poppy straw concentrate.
The company plans to import an
intermediate form of tapentadol (9780),
to bulk manufacture tapentadol for
distribution to its customers.
Comments and request for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(2007).
In reference to the non-narcotic raw
material, no comments or objections
have been received.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–14151 Filed 6–16–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: STEPAN COMPANY
ACTION:
Notice of registration.
Stepan Company applied to
be registered as an importer of a basic
class of a narcotic controlled substance.
The DEA grants Stepan Company
SUMMARY:
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Page 34552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14150]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: MEDA
PHARMACEUTICALS, INC.
ACTION: Notice of Application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration in accordance with 21 CFR
1301.34(a) on or before July 17, 2014. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before July 17, 2014.
ADDRESS: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, and dispensers of controlled substances
(other than final orders in connection with suspension, denial, or
revocation of registration) has been redelegated to the Deputy
Assistant Administrator of the DEA Office of Diversion Control
(``Deputy Assistant Administrator'') pursuant to sec. 7(g) of 28 CFR
pt. 0, subpt. R, App.
In accordance with 21 CFR 1301.34(a), this is notice that on
December 9, 2013, Meda Pharmaceuticals, Inc., 705 Eldorado Street,
Decatur, Illinois 62523, applied to be registered as an importer of
Nabilone (7379), a basic class of non-narcotic controlled substance
listed in schedule II.
The company plans to import the FDA approved listed controlled
substance as a finished drug product in dosage form for distribution to
its customers.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-14150 Filed 6-16-14; 8:45 am]
BILLING CODE 4410-09-P
