Bulk Manufacturer of Controlled Substances Application: Pharmacore, Inc., 31987 [2014-12797]
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31987
Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Notices
Controlled substance
Schedule
Tetrahydrocannabinols (7370) .....
Codeine-N-oxide (9053) ...............
Dihydromorphine (9145) ...............
Difenoxin (9168) ...........................
Morphine-N-oxide (9307) .............
Normorphine (9313) .....................
Norlevorphanol (9634) ..................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Phenylacetone (8501) ..................
Methylphenidate (1724) ................
Nabilone (7379) ............................
4-Anilino-N-phenethyl-4-piperidine
(8333).
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Thebaine (9333) ...........................
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
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The company plans to manufacture
the listed controlled substances for
internal use and for distribution to other
companies.
Dated: May 28, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Drug Enforcement Administration
[Docket No. DEA–392]
DEPARTMENT OF JUSTICE
Manufacturer of Controlled
Substances Registration: Cody
Laboratories, Inc.
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Pharmacore,
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 1301.33(a) on
or before August 4, 2014.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
sroberts on DSK4SPTVN1PROD with NOTICES
DATES:
17:35 Jun 02, 2014
[FR Doc. 2014–12797 Filed 6–2–14; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
VerDate Mar<15>2010
Dated: May 28, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
[FR Doc. 2014–12794 Filed 6–2–14; 8:45 am]
ACTION:
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 part 0,
subpart R, App.
In accordance with 21 CFR
1301.33(a), this is notice that on March
20, 2014, Pharmacore, Inc., 4180
Mendenhall Oaks Parkway, High Point,
North Carolina 27265, applied to be
registered as a bulk manufacturer of
Noroxymorphone (9668), a basic class of
narcotic controlled substance listed in
schedule II.
The company plans to manufacture
the listed controlled substance as an
active pharmaceutical ingredient (API)
for clinical trials.
Jkt 232001
ACTION:
Notice of registration.
Cody Laboratories, Inc.
applied to be registered as a
manufacturer of certain basic classes of
narcotic or non-narcotic controlled
substances. The DEA grants Cody
Laboratories, Inc. registration as a
manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated December 31, 2013, and
published in the Federal Register on
January 10, 2014, 79 FR 1890, Cody
Laboratories, Inc., 601 Yellowstone
Avenue, Cody, Wyoming 82414–9321,
SUMMARY:
PO 00000
Frm 00072
Fmt 4703
Sfmt 9990
applied to be registered as a
manufacturer 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(a) and
determined that the registration of Cody
Laboratories, Inc. to manufacture 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.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the basic classes of
narcotic or non-narcotic controlled
substances listed:
Controlled Substance
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Methylphenidate (1724) ................
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
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The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
No comments or objections have been
received.
Dated: May 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–12799 Filed 6–2–14; 8:45 am]
BILLING CODE 4410–09–P
E:\FR\FM\03JNN1.SGM
03JNN1
]]>Agencies
[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Page 31987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12797]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application:
Pharmacore, 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
1301.33(a) on or before August 4, 2014.
ADDRESSES: 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
part 0, subpart R, App.
In accordance with 21 CFR 1301.33(a), this is notice that on March
20, 2014, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point,
North Carolina 27265, applied to be registered as a bulk manufacturer
of Noroxymorphone (9668), a basic class of narcotic controlled
substance listed in schedule II.
The company plans to manufacture the listed controlled substance as
an active pharmaceutical ingredient (API) for clinical trials.
Dated: May 28, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-12797 Filed 6-2-14; 8:45 am]
BILLING CODE 4410-09-P
