Importer of Controlled Substances Registration: Meda Pharmaceuticals, Inc., 42544-42545 [2015-17514]
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42544
Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
Proposed 2016
quotas
(g)
Basic class
Methadone (for sale) .....................................................................................................................................................................
Methadone Intermediate ................................................................................................................................................................
Methamphetamine .........................................................................................................................................................................
31,875,000
34,375,000
2,061,375
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]
Methylphenidate .............................................................................................................................................................................
Morphine (for conversion) ..............................................................................................................................................................
Morphine (for sale) ........................................................................................................................................................................
Nabilone .........................................................................................................................................................................................
Noroxymorphone (for conversion) .................................................................................................................................................
Noroxymorphone (for sale) ............................................................................................................................................................
Opium (powder) .............................................................................................................................................................................
Opium (tincture) .............................................................................................................................................................................
Oripavine ........................................................................................................................................................................................
Oxycodone (for conversion) ..........................................................................................................................................................
Oxycodone (for sale) .....................................................................................................................................................................
Oxymorphone (for conversion) ......................................................................................................................................................
Oxymorphone (for sale) .................................................................................................................................................................
Pentobarbital ..................................................................................................................................................................................
Phenazocine ..................................................................................................................................................................................
Phencyclidine .................................................................................................................................................................................
Phenmetrazine ...............................................................................................................................................................................
Phenylacetone ...............................................................................................................................................................................
Racemethorphan ...........................................................................................................................................................................
Remifentanil ...................................................................................................................................................................................
Secobarbital ...................................................................................................................................................................................
Sufentanil .......................................................................................................................................................................................
Tapentadol .....................................................................................................................................................................................
Thebaine ........................................................................................................................................................................................
87,500,000
91,250,000
62,500,000
18,750
17,500,000
1,475,000
112,500
687,500
30,000,000
6,250,000
139,150,000
29,000,000
7,750,000
38,125,000
6
50
3
50
3
3,750
215,003
6,255
25,500,000
125,000,000
List I Chemicals
Ephedrine (for conversion) ............................................................................................................................................................
Ephedrine (for sale) .......................................................................................................................................................................
Phenylpropanolamine (for conversion) ..........................................................................................................................................
Phenylpropanolamine (for sale) .....................................................................................................................................................
Pseudoephedrine (for conversion) ................................................................................................................................................
Pseudoephedrine (for sale) ...........................................................................................................................................................
The Administrator further proposes
that the aggregate production quotas for
all other basic classes of schedule I and
II controlled substances included in 21
CFR 1308.11 and 1308.12 remain at
zero. In accordance with 21 CFR
1303.13 and 21 CFR 1315.13, upon
consideration of the relevant factors, the
Administrator may adjust the 2016
aggregate production quotas and
assessment of annual needs as
necessary.
Dated: July 13, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015–17561 Filed 7–16–15; 8:45 am]
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20:59 Jul 16, 2015
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Meda Pharmaceuticals,
Inc.
ACTION:
Notice of registration.
Meda Pharmaceuticals, Inc.
applied to be registered as an importer
of a certain basic class of controlled
substance. The Drug Enforcement
Administration (DEA) grants Meda
Pharmaceuticals, Inc. registration as an
importer of this controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated March 20, 2015, and published in
the Federal Register on March 27, 2015,
80 FR 16426, Meda Pharmaceuticals,
Inc., 705 Eldorado Street, Decatur,
Illinois 62523 applied to be registered as
an importer of a certain basic class of
controlled substance. No comments or
SUMMARY:
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100,000
4,000,000
22,400,000
8,500,000
7,000
224,500,000
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(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. 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 nabilone (7379) a basic class
of controlled substance listed in
schedule II.
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42545
Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
The company plans to import the
FDA approved drug product in finished
dosage form for distribution to its
customers.
Tapentadol (9780) ........................
Dated: July 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
The company plans to manufacturer
bulk active pharmaceutical ingredients
(API) for distribution and product
development to its customers.
[FR Doc. 2015–17514 Filed 7–16–15; 8:45 am]
Controlled substance
Schedule
II
Dated: July 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[FR Doc. 2015–17523 Filed 7–16–15; 8:45 am]
Drug Enforcement Administration
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Manufacturer of Controlled
Substances Registration: Mallinckrodt,
LLC
Notice of registration.
Mallinckrodt, LLC applied to
be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants
Mallinckrodt, LLC registration as a
manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated January 21, 2015, and published
in the Federal Register on January 28,
2015, 80 FR 4592, Mallinckrodt LLC,
3600 North Second Street, St. Louis,
Missouri 63147 applied to be registered
as a manufacturer of certain basic
classes of controlled substances. No
comments or objections were submitted
to this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Mallinckrodt, LLC 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, 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.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
srobinson on DSK5SPTVN1PROD with NOTICES
SUMMARY:
Controlled substance
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Lisdexamfetamine (1205) .............
Oripavine (9330) ...........................
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Remifentanil (9739) ......................
Schedule
II
The company plans to initially
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, and then
produce commercial size batches for
distribution to dosage form
manufacturers upon FDA approval.
Dated: July 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–17525 Filed 7–16–15; 8:45 am]
[Docket No. DEA–392]
ACTION:
Controlled substance
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–392]
DEPARTMENT OF JUSTICE
Manufacturer of Controlled
Substances Registration: Navinta LLC
Drug Enforcement Administration
ACTION:
Notice of registration.
Navinta LLC applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Navinta LLC registration as
a manufacturer of those controlled
substances.
SUMMARY:
By notice
dated February 11, 2015, and published
in the Federal Register on February 19,
2015, 80 FR 8901, Navinta LLC, 1499
Lower Ferry Road, Ewing, New Jersey
08618–1414 applied to be registered as
a manufacturer of certain basic classes
of controlled substances. No comments
or objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Navinta LLC 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, 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.
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:
SUPPLEMENTARY INFORMATION:
I
Controlled substance
II
II
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Pentobarbital (2270) .....................
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Schedule
II
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Siegfried USA, LLC
ACTION:
Notice of registration.
Siegfried USA, LLC applied to
be registered as an importer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Siegfried USA, LLC
registration as an importer of those
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22561, Siegfried USA, LLC, 33
Industrial Park Road, Pennsville, New
Jersey 08070 applied to be registered as
an importer of certain basic classes of
controlled substances. Comments and
requests for hearings on applications to
import narcotic raw material are not
appropriate. 72 FR 3417 (January 25,
2007).
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Siegfried USA, LLC 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. 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
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42544-42545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17514]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Meda
Pharmaceuticals, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Meda Pharmaceuticals, Inc. applied to be registered as an
importer of a certain basic class of controlled substance. The Drug
Enforcement Administration (DEA) grants Meda Pharmaceuticals, Inc.
registration as an importer of this controlled substance.
SUPPLEMENTARY INFORMATION: By notice dated March 20, 2015, and
published in the Federal Register on March 27, 2015, 80 FR 16426, Meda
Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523
applied to be registered as an importer of a certain basic class of
controlled substance. No comments or objections were submitted for this
notice.
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and
958(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. 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 nabilone (7379) a basic class of
controlled substance listed in schedule II.
[[Page 42545]]
The company plans to import the FDA approved drug product in
finished dosage form for distribution to its customers.
Dated: July 10, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-17514 Filed 7-16-15; 8:45 am]
BILLING CODE 4410-09-P
