Importer of Controlled Substances Registration: Catalent CTS, LLC, 3981 [2015-01316]
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3981
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices
[Docket No. DEA–392]
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers.
Importer of Controlled Substances
Registration: Cody Laboratories, Inc.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ACTION:
[FR Doc. 2015–01317 Filed 1–23–15; 8:45 am]
Notice of registration.
BILLING CODE P
Cody Laboratories, Inc.
applied to be registered as an importer
of certain basic classes of controlled
substances. The DEA grants Cody
Laboratories, Inc. registration as an
importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated August 27, 2014, and published in
the Federal Register on September 4,
2014, 79 FR 52762, Cody Laboratories,
Inc., 601 Yellowstone Avenue, Cody,
Wyoming 82414–9321, applied to be
registered as an importer of certain basic
classes of controlled substances. No
comments or objections were submitted
to this notice. Comments and requests
for hearings on applications to import
narcotic raw material are not
appropriate. 72 FR 3417 (January 25,
2007).
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 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, 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 the basic classes of
controlled substances listed:
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Catalent CTS, LLC
ACTION:
Notice of registration.
Catalent CTS, LLC applied to
be registered as an importer of certain
basic classes of controlled substances.
The DEA grants Catalent CTS, LLC
registration as an importer of those
controlled substances.
SUPPLEMENTARY INFORMATION:
By notice dated June 10, 2014, and
published in the Federal Register on
June 17, 2014, 79 FR 34551, Catalent
CTS, LLC, 10245 Hickman Mills Drive,
Kansas City, Missouri 64137, applied to
be registered as an importer of certain
basic classes of controlled substances.
One comment of objection was received
on this registration and a request for a
hearing was received on September 3,
2014. The objection was resolved.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007).
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 Catalent CTS, LLC 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
Controlled substance
Schedule
company’s maintenance of effective
Phenylacetone (8501) ..........
II controls against diversion by inspecting
and testing the company’s physical
Poppy Straw Concentrate
(9670) ................................
II security systems, verifying the
Tapentadol (9780) ................
II company’s compliance with state and
local laws, and reviewing the company’s
The company plans to import narcotic background and history.
raw materials for manufacturing and
Therefore, pursuant to 21 U.S.C.
further distribution to its customers.
952(a) and 958(a), and in accordance
The company is registered with the DEA with 21 CFR 1301.34, the above-named
as a manufacturer of several controlled
company is granted registration as an
substances that are manufactured from
importer of the basic classes of
poppy straw concentrate.
controlled substances listed:
VerDate Sep<11>2014
18:48 Jan 23, 2015
Jkt 235001
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Controlled substance
Schedule
Marihuana (7360) .................
Poppy Straw Concentrate
(9670) ................................
I
II
The company plans to import a
finished pharmaceutical product
containing cannabis extracts in dosage
form for a clinical trial study.
This compound is listed under drug
code 7360. No other activity for this
drug code is authorized for this
registration.
In addition, the company plans to
import an ointment for the treatment of
wounds which contain trace amounts of
the controlled substances normally
found in poppy straw concentrate for
packaging and labeling to be used in
clinical trials.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–01316 Filed 1–23–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: IRIX
Manufacturing, Inc.
ACTION:
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 1301.33(a) on
or before March 27, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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
DATES:
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Page 3981]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01316]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Catalent CTS, LLC
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Catalent CTS, LLC applied to be registered as an importer of
certain basic classes of controlled substances. The DEA grants Catalent
CTS, LLC registration as an importer of those controlled substances.
SUPPLEMENTARY INFORMATION:
By notice dated June 10, 2014, and published in the Federal
Register on June 17, 2014, 79 FR 34551, Catalent CTS, LLC, 10245
Hickman Mills Drive, Kansas City, Missouri 64137, applied to be
registered as an importer of certain basic classes of controlled
substances. One comment of objection was received on this registration
and a request for a hearing was received on September 3, 2014. The
objection was resolved. Comments and requests for hearings on
applications to import narcotic raw material are not appropriate. 72 FR
3417, (January 25, 2007).
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 Catalent CTS, LLC 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, 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 the basic classes of controlled
substances listed:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................................ I
Poppy Straw Concentrate (9670).......................... II
------------------------------------------------------------------------
The company plans to import a finished pharmaceutical product
containing cannabis extracts in dosage form for a clinical trial study.
This compound is listed under drug code 7360. No other activity for
this drug code is authorized for this registration.
In addition, the company plans to import an ointment for the
treatment of wounds which contain trace amounts of the controlled
substances normally found in poppy straw concentrate for packaging and
labeling to be used in clinical trials.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-01316 Filed 1-23-15; 8:45 am]
BILLING CODE 4410-09-P
