Importer of Controlled Substances Registration: Akorn, Inc., 52764 [2014-21063]
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52764
Federal Register / Vol. 79, No. 171 / Thursday, September 4, 2014 / Notices
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–392]
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals, Inc.
Importer of Controlled Substances
Registration: Akorn, Inc.
ACTION:
ACTION:
Notice of registration.
Akorn, Inc., applied to be
registered as an importer of a certain
basic class of controlled substance. The
DEA grants Akorn, Inc., registration as
an importer of this controlled substance.
SUMMARY:
By notice
dated May 28, 2014, and published in
the Federal Register on June 4, 2014, 79
FR 32317, Akorn, Inc., 1222 W. Grand
Avenue, Decatur, Illinois 62522, applied
to be registered as an importer of a
certain basic class of controlled
substance. No comments or objections
were reviewed for this notice.
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 Akorn, Inc., 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 Remifentanil (9739), a basic
class of controlled substance listed in
schedule II.
The company plans to import
Remifentanil in bulk for use in dosage
form manufacturing.
SUPPLEMENTARY INFORMATION:
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[FR Doc. 2014–21063 Filed 9–3–14; 8:45 am]
BILLING CODE 4410–09–P
18:14 Sep 03, 2014
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 November 3, 2014.
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
(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 section 7 of 28 CFR pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.33(a), this is notice that on June
23, 2014, Chattem Chemicals, Inc., 3801
St. Elmo Avenue, Chattanooga,
Tennessee 37409, applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
DATES:
Controlled substance
Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
VerDate Mar<15>2010
Notice of application.
Jkt 232001
Gamma
Hydroxybutyric
Acid
(2010).
4-Methoxyamphetamine (7411) ...
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
PO 00000
Frm 00140
Fmt 4703
Sfmt 4703
Schedule
I
I
I
II
II
II
II
II
II
II
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Meperidine intermediate-A (9232)
Meperidine intermediate-B (9233)
Meperidine intermediate-C (9234)
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers. Regarding (9640) the
company plans to manufacture another
controlled substance for sale to its
customers.
Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–21062 Filed 9–3–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Organix, Inc.
ACTION:
Notice of registration.
Organix, Inc. applied to be
registered as a manufacturer of certain
basic classes of narcotic and nonnarcotic controlled substances. The DEA
grants Organix, Inc. registration as a
manufacturer of those controlled
substances.
SUMMARY:
By notice
dated April 21, 2014, and published in
the Federal Register on April 28, 2014,
79 FR 23376, Organix, Inc., 240 Salem
Street, Woburn, Massachusetts 01801,
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections have been received.
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823(a) and
determined that the registration of
Organix, Inc. to manufacture the basic
classes of controlled substances is
SUPPLEMENTARY INFORMATION:
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Page 52764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21063]
[[Page 52764]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Akorn, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Akorn, Inc., applied to be registered as an importer of a
certain basic class of controlled substance. The DEA grants Akorn,
Inc., registration as an importer of this controlled substance.
SUPPLEMENTARY INFORMATION: By notice dated May 28, 2014, and published
in the Federal Register on June 4, 2014, 79 FR 32317, Akorn, Inc., 1222
W. Grand Avenue, Decatur, Illinois 62522, applied to be registered as
an importer of a certain basic class of controlled substance. No
comments or objections were reviewed for this notice.
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 Akorn, Inc., 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 Remifentanil (9739), a basic class of
controlled substance listed in schedule II.
The company plans to import Remifentanil in bulk for use in dosage
form manufacturing.
Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-21063 Filed 9-3-14; 8:45 am]
BILLING CODE 4410-09-P
