Importer of Controlled Substances Registration: Fisher Clinical Services, Inc., 20418 [2016-07945]
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20418
Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices
The
Attorney General has delegated her
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on
February 12, 2016, Stepan Company,
Natural Products Dept., 100 W. Hunter
Avenue, Maywood, New Jersey 07607
applied to be registered as an importer
of coca leaves (9040), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed controlled substance in bulk for
the manufacture of controlled substance
for distribution to its customers.
SUPPLEMENTARY INFORMATION:
Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–07944 Filed 4–6–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Fisher Clinical Services,
Inc.
ACTION:
Notice of registration.
Fisher Clinical Services, Inc.
applied to be registered as an importer
of certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Fisher
Clinical Services, Inc. registration as an
importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated December 9, 2015, and published
in the Federal Register on December 17,
2015, 80 FR 78766, Fisher Clinical
Services, Inc., 7554 Schantz Road,
Allentown, Pennsylvania 18106 applied
to be registered as an importer of certain
basic classes of controlled substances.
No comments or objections were
submitted for this notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:35 Apr 06, 2016
Jkt 238001
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Fisher Clinical Services, 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. 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 the following basic classes
of controlled substances:
Controlled substance
Methylphenidate (1724) .............
Levorphanol (9220) ...................
Noroxymorphone (9668) ............
Tapentadol (9780) .....................
Schedule
II
II
II
II
The company plans to import the
listed substances for analytical research,
testing, and clinical trials. This
authorization does not extend to the
import of a finished FDA approved or
non-approved dosage form for
commercial distribution in the United
States.
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers. Placement
of these (this) drug code (s) 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.
Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–07945 Filed 4–6–16; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00100
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Navinta, LLC
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.33(a) on
or before June 6, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
The
Attorney General has delegated her
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
September 10, 2015, Navinta, LLC, 1499
Lower Ferry Road, Ewing, New Jersey
08618–1414 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Pentobarbital (2270) ...............
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333).
Remifentanil (9739) .................
Fentanyl (9801) .......................
Schedule
II
II
II
II
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.
E:\FR\FM\07APN1.SGM
07APN1
]]>Agencies
[Federal Register Volume 81, Number 67 (Thursday, April 7, 2016)]
[Notices]
[Page 20418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07945]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Fisher Clinical
Services, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Fisher Clinical Services, Inc. applied to be registered as an
importer of certain basic classes of controlled substances. The Drug
Enforcement Administration (DEA) grants Fisher Clinical Services, Inc.
registration as an importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated December 9, 2015, and
published in the Federal Register on December 17, 2015, 80 FR 78766,
Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown,
Pennsylvania 18106 applied to be registered as an importer 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, 952(a) and
958(a) and determined that the registration of Fisher Clinical
Services, 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. 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 the following basic classes of
controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Methylphenidate (1724).................... II
Levorphanol (9220)........................ II
Noroxymorphone (9668)..................... II
Tapentadol (9780)......................... II
------------------------------------------------------------------------
The company plans to import the listed substances for analytical
research, testing, and clinical trials. This authorization does not
extend to the import of a finished FDA approved or non-approved dosage
form for commercial distribution in the United States.
The company plans to import an intermediate form of tapentadol
(9780) to bulk manufacture tapentadol for distribution to its
customers. Placement of these (this) drug code (s) 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 non-
approved finished dosage forms for commercial sale.
Dated: March 28, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-07945 Filed 4-6-16; 8:45 am]
BILLING CODE 4410-09-P
