Manufacturer of Controlled Substances Registration: Navinta, LLC, 75690 [2015-30558]
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75690
Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
Schedule
Controlled substance
Methamphetamine (1105) ............
Phenmetrazine (1631) ..................
Methylphenidate (1724) ................
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
Glutethimide (2550) ......................
Phencyclidine (7471) ....................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Phenylacetone (8501) ..................
Alphaprodine (9010) .....................
Anileridine (9020) .........................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Meperidine (9230) ........................
Methadone (9250) ........................
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Sufentanil (9740) ..........................
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Navinta, LLC
ACTION:
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Lhorne on DSK5TPTVN1PROD with NOTICES
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.
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under to 21 U.S.C 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
[FR Doc. 2015–30552 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
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.
SUPPLEMENTARY INFORMATION: By notice
dated June 25, 2015, and published in
the Federal Register on July 6, 2015, 80
FR 38471, 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 following basic
classes of controlled substances:
SUMMARY:
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Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
Notice of registration.
Controlled substance
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Fentanyl (9801) ............................
Schedule
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The company plans initially to
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, then
eventually upon FDA approval to
produce commercial size batches for
distribution to dosage form
manufacturers.
Importer of Controlled Substances
Registration: Akorn, Inc.
ACTION:
Notice of registration.
Akorn, Inc. applied to be
registered as an importer of a certain
basic class of controlled substance. The
Drug Enforcement Administration
(DEA) grants Akorn, Inc. registration as
an importer of this controlled substance.
SUMMARY:
SUPPLEMENTARY INFORMATION:
By notice dated September 1, 2015,
and published in the Federal Register
on September 9, 2015, 80 FR 54327
Akorn, Inc., 1222 W. Grand Avenue,
Decatur, Illinois 62522 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
Akorn, 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 remifentanil (9739), a basic
class of controlled substance listed in
schedule II.
The company plans to import
remifentanil in dosage form for
distribution.
Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30559 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30558 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
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[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Page 75690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30558]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Navinta, LLC
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: 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.
SUPPLEMENTARY INFORMATION: By notice dated June 25, 2015, and published
in the Federal Register on July 6, 2015, 80 FR 38471, 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 following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Fentanyl (9801)............................ II
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The company plans initially to manufacture API quantities of the
listed controlled substances for validation purposes and FDA approval,
then eventually upon FDA approval to produce commercial size batches
for distribution to dosage form manufacturers.
Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30558 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P
