Importer of Controlled Substances; Notice of Registration; United States Pharmacopeial Convention, 54913-54914 [2013-21742]
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54913
Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices
Commission may also be obtained by
accessing its internet server (https://
www.usitc.gov). The public record for
these investigations may be viewed on
the Commission’s electronic docket
(EDIS) at https://edis.usitc.gov.
Authority: These investigations are being
terminated under authority of title VII of the
Tariff Act of 1930; this notice is published
pursuant to section 201.10 of the
Commission’s rules (19 CFR 201.10).
By order of the Commission.
Issued: September 3, 2013.
Lisa R. Barton,
Acting Secretary to the Commission.
[FR Doc. 2013–21725 Filed 9–5–13; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Clinical Supplies
Management, Inc.
Pursuant to Title 21 Code of Federal
Regulations 1301.34 (a), this is notice
that on July 22, 2013, Clinical Supplies
Management, Inc., 342 42nd Street
South, Fargo, North Dakota 58103, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of
Sufentanil (9740), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed controlled substance with the sole
purpose of packaging, labeling, and
distributing to customers which are
qualified clinical sites, conducting FDAapproved clinical trials.
Any bulk manufacturer who is
presently, or is applying to be,
registered with D listed in schedule II,
which falls under the authority of
section 1002(a)(2)(B) of the Act 21
U.S.C. 952 (a)(2)(B) may, in the
circumstances set forth in 21 U.S.C.
958(i), file comments or objections to
the issuance of the proposed registration
and may, at the same time, file a written
request for a hearing on such
application pursuant to 21 CFR 1301.43,
and in such form as prescribed by 21
CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than October 7, 2013.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
§ 1301.34(b), (c), (d), (e), and (f). As
noted in a previous notice published in
the Federal Register on September 23,
1975, 40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substance in schedules I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: August 29, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–21735 Filed 9–5–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; United States
Pharmacopeial Convention
By Notice dated May 22, 2013, and
published in the Federal Register on
May 30, 2013, 78 FR 32457, United
States Pharmacopeial Convention,
12601 Twinbrook Parkway, Rockville,
Maryland 20852, made application by
renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the following basic
classes of controlled substances:
mstockstill on DSK4VPTVN1PROD with NOTICES
Drug
Schedule
Cathinone (1235) .........................................................................................................................................................................................
Methaqualone (2565) ..................................................................................................................................................................................
Lysergic acid diethylamide (7315) ...............................................................................................................................................................
Marihuana (7360) ........................................................................................................................................................................................
Tetrahydrocannabinols (7370) .....................................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (7395) ..............................................................................................................................................
3,4-Methylenedioxyamphetamine (7400) ....................................................................................................................................................
Codeine-N-oxide (9053) ..............................................................................................................................................................................
Difenoxin (9168) ..........................................................................................................................................................................................
Heroin (9200) ...............................................................................................................................................................................................
Morphine-N-oxide (9307) .............................................................................................................................................................................
Norlevorphanol (9634) .................................................................................................................................................................................
Amphetamine (1100) ...................................................................................................................................................................................
Methamphetamine (1105) ...........................................................................................................................................................................
Phenmetrazine (1631) .................................................................................................................................................................................
Methylphenidate (1724) ...............................................................................................................................................................................
Amobarbital (2125) ......................................................................................................................................................................................
Pentobarbital (2270) ....................................................................................................................................................................................
Secobarbital (2315) .....................................................................................................................................................................................
Glutethimide (2550) .....................................................................................................................................................................................
Phencyclidine (7471) ...................................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (8333) ...................................................................................................................................................
Phenylacetone (8501) .................................................................................................................................................................................
Alphaprodine (9010) ....................................................................................................................................................................................
Anileridine (9020) ........................................................................................................................................................................................
Cocaine (9041) ............................................................................................................................................................................................
Codeine (9050) ............................................................................................................................................................................................
Dihydrocodeine (9120) ................................................................................................................................................................................
Oxycodone (9143) .......................................................................................................................................................................................
Hydromorphone (9150) ...............................................................................................................................................................................
Diphenoxylate (9170) ..................................................................................................................................................................................
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54914
Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices
Drug
Schedule
Hydrocodone (9193) ....................................................................................................................................................................................
Levomethorphan (9210) ..............................................................................................................................................................................
Levorphanol (9220) .....................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Methadone (9250) .......................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................
Morphine (9300) ..........................................................................................................................................................................................
Thebaine (9333) ..........................................................................................................................................................................................
Oxymorphone (9652) ...................................................................................................................................................................................
Alfentanil (9737) ..........................................................................................................................................................................................
Sufentanil (9740) .........................................................................................................................................................................................
The company plans to import
reference standards for sale to
researchers and analytical labs.
The company plans to import the
listed controlled substances in bulk
powder form from foreign sources for
the manufacture of analytical reference
standards for sale to their customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
United States Pharmacopeial
Convention 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. DEA has
investigated United States
Pharmacopeial Convention to ensure
that the company’s registration is
consistent with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of 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.
Dated: August 29, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–21742 Filed 9–5–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; GE Healthcare
By Notice dated June 7, 2013, and
published in the Federal Register on
June 18, 2013, 78 FR 36594, GE
Healthcare, 3350 North Ridge Avenue,
Arlington Heights, Illinois 60004–1412,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
Cocaine (9041), a basic class of
controlled substance listed in schedule
II.
The company plans to import small
quantities of ioflupane, in the form of
three separate analogues of Cocaine, to
validate production and quality control
systems, for a reference standard, and
for producing material for a future
investigational new drug (IND)
submission.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
GE Healthcare 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. DEA has
investigated GE Healthcare to ensure
that the company’s registration is
consistent with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of 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 class of controlled substance
listed.
Dated: August 29, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–21743 Filed 9–5–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Lipomed, Inc.
By Notice dated June 7, 2013, and
published in the Federal Register on
June 18, 2013, 78 FR 36591, Lipomed,
Inc., One Broadway, Cambridge,
Massachusetts 02142, made application
by renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the following basic
classes of controlled substances:
mstockstill on DSK4VPTVN1PROD with NOTICES
Drug
Schedule
Cathinone (1235) .........................................................................................................................................................................................
Methcathinone (1237) ..................................................................................................................................................................................
4-Mephedrone (1248) ..................................................................................................................................................................................
N-Ethylamphetamine (1475) ........................................................................................................................................................................
N,N-Dimethylamphetamine (1480) ..............................................................................................................................................................
Fenethylline (1503) ......................................................................................................................................................................................
Aminorex (1585) ..........................................................................................................................................................................................
4-Methylaminorex (cis isomer) (1590) .........................................................................................................................................................
Gamma Hydroxybutyric Acid (2010) ...........................................................................................................................................................
Methaqualone (2565) ..................................................................................................................................................................................
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]]>Agencies
[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Pages 54913-54914]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21742]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration; United
States Pharmacopeial Convention
By Notice dated May 22, 2013, and published in the Federal Register
on May 30, 2013, 78 FR 32457, United States Pharmacopeial Convention,
12601 Twinbrook Parkway, Rockville, Maryland 20852, made application by
renewal to the Drug Enforcement Administration (DEA) to be registered
as an importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Cathinone (1235)............................ I
Methaqualone (2565)......................... I
Lysergic acid diethylamide (7315)........... I
Marihuana (7360)............................ I
Tetrahydrocannabinols (7370)................ I
4-Methyl-2,5-dimethoxyamphetamine (7395).... I
3,4-Methylenedioxyamphetamine (7400)........ I
Codeine-N-oxide (9053)...................... I
Difenoxin (9168)............................ I
Heroin (9200)............................... I
Morphine-N-oxide (9307)..................... I
Norlevorphanol (9634)....................... I
Amphetamine (1100).......................... II
Methamphetamine (1105)...................... II
Phenmetrazine (1631)........................ II
Methylphenidate (1724)...................... II
Amobarbital (2125).......................... II
Pentobarbital (2270)........................ II
Secobarbital (2315)......................... II
Glutethimide (2550)......................... II
Phencyclidine (7471)........................ II
4-Anilino-N-phenethyl-4-piperidine (8333)... II
Phenylacetone (8501)........................ II
Alphaprodine (9010)......................... II
Anileridine (9020).......................... II
Cocaine (9041).............................. II
Codeine (9050).............................. II
Dihydrocodeine (9120)....................... II
Oxycodone (9143)............................ II
Hydromorphone (9150)........................ II
Diphenoxylate (9170)........................ II
[[Page 54914]]
Hydrocodone (9193).......................... II
Levomethorphan (9210)....................... II
Levorphanol (9220).......................... II
Meperidine (9230)........................... II
Methadone (9250)............................ II
Dextropropoxyphene, bulk (non-dosage forms) II
(9273).
Morphine (9300)............................. II
Thebaine (9333)............................. II
Oxymorphone (9652).......................... II
Alfentanil (9737)........................... II
Sufentanil (9740)........................... II
------------------------------------------------------------------------
The company plans to import reference standards for sale to
researchers and analytical labs.
The company plans to import the listed controlled substances in
bulk powder form from foreign sources for the manufacture of analytical
reference standards for sale to their customers.
No comments or objections have been received. DEA has considered
the factors in 21 U.S.C. 823(a) and 952(a) and determined that the
registration of United States Pharmacopeial Convention 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. DEA has
investigated United States Pharmacopeial Convention to ensure that the
company's registration is consistent with the public interest. The
investigation has included inspection and testing of the company's
physical security systems, verification of the company's compliance
with state and local laws, and a review of the company's background and
history.
Therefore, pursuant to 21 U.S.C. 952(a) and Sec. 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.
Dated: August 29, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-21742 Filed 9-5-13; 8:45 am]
BILLING CODE 4410-09-P
