Importer of Controlled Substances; Notice of Registration; Cambrex Charles City, Inc., 4973-4974 [2014-01707]
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Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices
Tapia, M.D., 52 FR 30458, 30459 (1987)
(considering evidence that a physician
did not perform physical exams and
issued medically unnecessary
prescriptions under factor two); Thomas
Parker Elliott, D.O., 52 FR 36312, 36313
(1987) (adopting ALJ’s conclusion that
physician’s ‘‘experience in the handling
[of] controlled substances clearly
warrants finding that his continued
registration is inconsistent with the
public interest,’’ based on the
physician’s having ‘‘prescribed
enormous quantities of highly addictive
drugs to [ten] individuals’’ without
adequate medical justification).
Under agency precedent, ‘‘where a
registrant [or applicant] has committed
acts inconsistent with the public
interest, [he] must accept responsibility
for his . . . actions and demonstrate
that he . . . will not engage in future
misconduct.’’ Jayam Krishna-Iyer, 74 FR
459, 463 (2009); see also Medicine
Shoppe-Jonesborough, 73 FR 364, 387
(2008). Here, because Applicant waived
his right to a hearing (as well as his right
to submit a written statement in lieu of
a hearing), GX 4, at 2, the only evidence
in the record to refute the conclusion
that his continued registration is
‘‘inconsistent with the public interest’’
is that he apparently completed the
courses required by the Florida Board of
Medicine as evidenced by the fact that
his medical license remains current and
active.
There is, however, no evidence that
Applicant acknowledges his
misconduct, which is egregious, and
accepts responsibility for it. Indeed, the
Expert’s report identifies dozens of
patients (beyond the seven specifically
discussed above) to whom Applicant
diverted controlled substances.
Accordingly, Applicant’s application
will be denied.22 See Krishna-Iyer, 74 FR
464 (‘‘[E]ven where the Agency’s proof
establishes that a practitioner has
committed only a few acts of diversion,
this Agency will not grant [an
application for] registration unless he
accepts responsibility for his
misconduct.’’); see also MacKay v. DEA,
664 F.3d 808, 822 (10th Cir. 2011)
(sustaining agency order revoking
practitioner’s registration based on proof
physician knowingly diverted drugs to
two patients).
22 As found above, because Applicant did not
submit his renewal application at least 45 days
before the expiration of his registration, and had
been served previously with the Order to Show
Cause, pursuant to 21 CFR 1301.36(i), his
registration expired on August 25, 2013. Had his
registration not expired per the Agency’s rule, I
would have revoked it.
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Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b) and 0.104, I order that the
pending application of Ralph J.
Chambers, M.D., for a DEA Certificate of
Registration be, and it hereby is, denied.
This Order is effective immediately.
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 September 27, 2013,
and published in the Federal Register
on October 25, 2013, 78 FR 64014,
United States Pharmacopeial
Convention, 12601 Twinbrook Parkway,
Rockville, Maryland 20852, made
application to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Noroxymorphone (9668),
a basic class of controlled substance
listed in schedule II.
The company plans to import
reference standards for sale to
researchers and analytical labs.
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 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 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 class of controlled substance
listed.
Fmt 4703
Sfmt 4703
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Drug Enforcement Administration
[FR Doc. 2014–01797 Filed 1–29–14; 8:45 am]
Frm 00110
[FR Doc. 2014–01784 Filed 1–29–14; 8:45 am]
DEPARTMENT OF JUSTICE
Dated: January 17, 2014.
Thomas M. Harrigan,
Deputy Administrator.
PO 00000
Dated: January 15, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Importer of Controlled Substances;
Notice of Registration; Cambrex
Charles City, Inc.
By Notice dated September 27, 2013,
and published in the Federal Register
on October 25, 2013, 78 FR 64013,
Cambrex Charles City, Inc., 1205 11th
Street, Charles City, Iowa 50616–3466,
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
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Schedule
II
II
II
II
II
The company plans to import the
listed controlled substances for internal
use, and to manufacture bulk
intermediates for sale to its customers.
Comments and requests for hearings
on application to import narcotic raw
material are not appropriate. 72 FR 3417
(2007).
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
Cambrex Charles City, 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. DEA has investigated
Cambrex Charles City, Inc., 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
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Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices
the basic classes of controlled
substances listed.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Dated: January 16, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Drug Enforcement Administration
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration;
Halo Pharmaceutical, Inc.
Manufacturer of Controlled
Substances; Notice of Registration;
Chattem Chemicals, Inc.
By Notice dated August 14, 2013, and
published in the Federal Register on
August 20, 2013, 78 FR 51210, Halo
Pharmaceutical, Inc., 30 North Jefferson
Road, Whippany, New Jersey 07981,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
By Notice dated August 14, 2013, and
published in the Federal Register on
August 20, 2013, 78 FR 51210, Chattem
Chemicals, Inc., 3801 St. Elmo Avenue,
Chattanooga, Tennessee 37409, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
[FR Doc. 2014–01707 Filed 1–29–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
Importer of Controlled Substances;
Notice of Registration; Clinical
Supplies Management, Inc.
By Notice dated August 29, 2013, and
published in the Federal Register on
September 6, 2013, 78 FR 54913,
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.
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
Clinical Supplies Management, 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. DEA has investigated
Clinical Supplies Management, Inc., 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: January 14, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Drug
Drug
Dihydromorphine (9145) ...............
Hydromorphone (9150) ................
Dated: January 15, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–01785 Filed 1–29–14; 8:45 am]
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I
II
Dihydromorphine is an intermediate
in the manufacture of Hydromorphone
and is not for commercial distribution.
The company plans to manufacture
Hydromorphone for sale to other
manufacturers and to manufacture other
controlled substances for distribution to
its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a), and
determined that the registration of Halo
Pharmaceutical, Inc., to manufacture the
listed basic classes of controlled
substances is consistent with the public
interest at this time. DEA has
investigated Halo Pharmaceutical, Inc.,
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.
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
controlled substances listed.
[FR Doc. 2014–01788 Filed 1–29–14; 8:45 am]
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Frm 00111
Fmt 4703
Schedule
Schedule
Sfmt 4703
Gamma
Hydroxybutyric
Acid
(2010).
4-Methoxyamphetamine (7411) ...
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
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) ............................
I
I
I
II
II
II
II
II
II
II
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.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a), and
determined that the registration of
Chattem Chemicals, Inc., to manufacture
the listed basic classes of controlled
substances is consistent with the public
interest at this time. DEA has
investigated Chattem Chemicals, Inc., 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
E:\FR\FM\30JAN1.SGM
30JAN1
]]>Agencies
[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4973-4974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01707]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration;
Cambrex Charles City, Inc.
By Notice dated September 27, 2013, and published in the Federal
Register on October 25, 2013, 78 FR 64013, Cambrex Charles City, Inc.,
1205 11th Street, Charles City, Iowa 50616-3466, 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
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine (8333).. II
Phenylacetone (8501)....................... II
Cocaine (9041)............................. II
Opium, raw (9600).......................... II
Poppy Straw Concentrate (9670)............. II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
internal use, and to manufacture bulk intermediates for sale to its
customers.
Comments and requests for hearings on application to import
narcotic raw material are not appropriate. 72 FR 3417 (2007).
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 Cambrex Charles City, 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. DEA has
investigated Cambrex Charles City, Inc., 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
[[Page 4974]]
the basic classes of controlled substances listed.
Dated: January 16, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2014-01707 Filed 1-29-14; 8:45 am]
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