Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals, Inc., 46371 [2013-18332]
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Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices
Drug
Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
Meperidine (9230) ........................
Meperidine intermediate-A (9232)
Meperidine intermediate-B (9233)
Meperidine intermediate-C (9234)
Metazocine (9240) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Methamphetamine (1105) ............
Methylphenidate (1724) ................
Metopon (9260) ............................
Moramide intermediate (9802) .....
Morphine (9300) ...........................
Nabilone (7379) ............................
Opium, raw (9600) .......................
Opium extracts (9610) ..................
Opium fluid extract (9620) ............
Opium tincture (9630) ..................
Opium poppy/Poppy Straw (9650)
Oripavine (9330) ...........................
Poppy Straw Concentrate (9670)
Opium, granulated (9640) ............
Oxycodone (9143) ........................
Oxymorphone (9652) ...................
Pentobarbital (2270) .....................
Phenazocine (9715) .....................
Phencyclidine (7471) ....................
Phenmetrazine (1631) ..................
Phenylacetone (8501) ..................
Piminodine (9730) ........................
Powdered opium (9639) ...............
Racemethorphan (9732) ..............
Racemorphan (9733) ...................
Remifentanil (9739) ......................
Secobarbital (2315) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Thebaine (9333) ...........................
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II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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Dated: July 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–18330 Filed 7–30–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Meda
Pharmaceuticals, Inc.
The company plans to import small
quantities of the listed controlled
substances for the National Institute on
Drug Abuse (NIDA) for research
activities.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR 3417
(2007).
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedule I or II,
which fall 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 August 30, 2013.
VerDate Mar<15>2010
16:14 Jul 30, 2013
Jkt 229001
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 substances in schedule 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.
By Notice dated February 8, 2013, and
published in the Federal Register on
February 21, 2013, 78 FR 12101, Meda
Pharmaceuticals, Inc., 705 Eldorado
Street, Decatur, Illinois 62523, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of Nabilone
(7379), a basic class of controlled
substance listed in schedule II.
The company plans to import the
listed controlled substance as a finished
drug product in dosage form 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 952(a),
and determined that the registration of
Meda Pharmaceuticals 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 Meda Pharmaceuticals
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)
PO 00000
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Sfmt 4703
46371
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: July 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–18332 Filed 7–30–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Almac Clinical
Services, Inc.
By Notice dated April 10, 2013, and
published in the Federal Register on
April 19, 2013, 78 FR 23594, Almac
Clinical Services, Inc., (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964,
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
Oxycodone (9143) .........................
Hydromorphone (9150) .................
Tapentadol (9780) .........................
Fentanyl (9801) .............................
Schedule
II
II
II
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
The import of the above listed basic
classes of controlled substances will be
granted only for analytical testing and
clinical trials. This authorization does
not extend to the import of a finished
FDA approved or non-approved dosage
forms for commercial distribution in the
United States.
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
Almac Clinical Services, Inc., (ACSI) 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
Almac Clinical Services, Inc., (ACSI) 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
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]]>Agencies
[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Page 46371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18332]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration; Meda
Pharmaceuticals, Inc.
By Notice dated February 8, 2013, and published in the Federal
Register on February 21, 2013, 78 FR 12101, Meda Pharmaceuticals, Inc.,
705 Eldorado Street, Decatur, Illinois 62523, made application by
renewal to the Drug Enforcement Administration (DEA) to be registered
as an importer of Nabilone (7379), a basic class of controlled
substance listed in schedule II.
The company plans to import the listed controlled substance as a
finished drug product in dosage form 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 952(a), and determined that the
registration of Meda Pharmaceuticals 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 Meda
Pharmaceuticals 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: July 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-18332 Filed 7-30-13; 8:45 am]
BILLING CODE 4410-09-P
