Importer of Controlled Substances Registration: STEPAN COMPANY, 34552-34553 [2014-14137]
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34552
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]
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[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:
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34553
Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated May 1, 2014, and published in the
Federal Register on May 15, 2014, FR
79 27935, Stepan Company, Natural
Products Department, 100 W. Hunter
Avenue, Maywood, New Jersey 07607,
applied to be registered as an importer
of a certain basic class of controlled
substance.
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the
registration of Stepan Company 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. The DEA investigated the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security systems, verifying the
company’s compliance with state and
local laws, and reviewing 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 Coca Leaves (9040), a basic
class of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance to
manufacture bulk controlled substance
for distribution to its customers.
Comments and request for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–14137 Filed 6–16–14; 8:45 am]
BILLING CODE 4410–09–P
accordance with 21 CFR 1301.33(a) on
or before August 18, 2014.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
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
1301.33(a), this is notice that on May 4,
2014, Cedarburg Pharmaceuticals, Inc.,
870 Badger Circle, Grafton, Wisconsin
53024, applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
4-Anilino-N-phenethyl-4-piperidine
(8333).
Remifentanil (9739) ......................
Fentanyl (9801) ............................
Schedule
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Regarding the drug code (8333), the
company plans to manufacture this
listed controlled substance for
commercial sale.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2014–14143 Filed 6–16–14; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
Bulk Manufacturer of Controlled
Substances Application: CEDARBURG
PHARMACEUTICALS, 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
VerDate Mar<15>2010
16:43 Jun 16, 2014
Jkt 232001
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
1301.33(a), this is notice that on May 21,
2014, AMPAC Fine Chemicals LLC,
Highway 50 and Hazel Avenue,
Building 05001, Rancho Cordova,
California 95670, applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Methylphenidate (1724) ................
Thebaine (9333) ...........................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
Schedule
II
II
II
II
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: AMPAC Fine
Chemicals LLC
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[Docket No. DEA–392]
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The company is a contract
manufacturer. In reference to Poppy
Straw Concentrate, the company will
manufacture Thebaine intermediates for
sale to its customers for further
manufacture. No other activity for this
drug code is authorized for this
registration.
BILLING CODE 4410–09–P
ACTION:
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 1301.33(a) on
or before August 18, 2014.
DATES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ACTION:
PO 00000
Notice of Application.
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]]>Agencies
[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Pages 34552-34553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14137]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: STEPAN COMPANY
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Stepan Company applied to be registered as an importer of a
basic class of a narcotic controlled substance. The DEA grants Stepan
Company
[[Page 34553]]
registration as an importer of this controlled substance.
SUPPLEMENTARY INFORMATION: By notice dated May 1, 2014, and published
in the Federal Register on May 15, 2014, FR 79 27935, Stepan Company,
Natural Products Department, 100 W. Hunter Avenue, Maywood, New Jersey
07607, applied to be registered as an importer of a certain basic class
of controlled substance.
The Drug Enforcement Administration (DEA) has considered the
factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the
registration of Stepan Company 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. The DEA investigated the company's maintenance
of effective controls against diversion by inspecting and testing the
company's physical security systems, verifying the company's compliance
with state and local laws, and reviewing 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 Coca Leaves (9040), a basic class of
controlled substance listed in schedule II.
The company plans to import the listed controlled substance to
manufacture bulk controlled substance for distribution to its
customers.
Comments and request for hearings on applications to import
narcotic raw material are not appropriate. 72 FR 3417 (January 25,
2007).
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-14137 Filed 6-16-14; 8:45 am]
BILLING CODE 4410-09-P
