Importer of Controlled Substances Registration: Fisher Clinical Services, Inc., 57388-57389 [2015-24121]
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57388
Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
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:
Controlled substance
Schedule
Marihuana (7360) .......................
Tetrahydrocannabinols (7370) ....
Amphetamine (1100) ..................
Lisdexamfetamine (1205) ...........
Methylphenidate (1724) ..............
Pentobarbital (2270) ...................
4-Anilino-N-phenethyl-4-piperidine (8333).
Meperidine (9230) ......................
Fentanyl (9801) ..........................
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The company plans to manufacture
bulk controlled substances for use in
product development and for
distribution to its customers.
In reference to drug code 7360
(marihuana), and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetic. No other
activity for this drug code is authorized
for this registration.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–24122 Filed 9–22–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Mallinckrodt
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 November 23, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated her
authority under the Controlled
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:00 Sep 22, 2015
Jkt 235001
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 July 21,
2015, Mallinckrodt LLC, 3600 North
Second Street, Saint. Louis, Missouri
63147 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Gamma
Hydroxybutyric
Acid
(2010).
Tetrahydrocannabinols (7370) .....
Codeine-N-oxide (9053) ...............
Dihydromorphine (9145) ...............
Difenoxin (9168) ...........................
Morphine-N-oxide (9307) .............
Normorphine (9313) .....................
Norlevorphanol (9634) ..................
Acetyl
Fentanyl
(N-(1phenethylpiperidin-4-yl)-Nphenylacetamide) (9821).
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
4-Anilino-N-phenethyl-4-piperidine
(8333).
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Schedule
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The company plans to manufacturer
bulk active pharmaceutical ingredients
(API) for distribution its customers.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–24125 Filed 9–22–15; 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 August 27, 2014, and published in
the Federal Register on September 4,
2014, 79 FR 52762, Fisher Clinical
Services, Inc., 700A–C Nestle Way,
Breinigsville, Pennsylvania 18031–1522
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 basic classes of
controlled substances:
SUMMARY:
Controlled substance
Methylphenidate (1724) ................
Levorphanol (9220) ......................
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
E:\FR\FM\23SEN1.SGM
23SEN1
Schedule
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Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
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.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–24121 Filed 9–22–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Chemtos,
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 November 23, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:00 Sep 22, 2015
Jkt 235001
In accordance with 21 CFR
1301.33(a), this is notice that on May 28,
2015, Chemtos, LLC, 14101 W. Highway
290, Building 2000B, Austin, Texas
78737–9331 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
Marihuana (7360) .........................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Etorphine HCI (9059) ...................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Ecgonine (9180) ...........................
Ethylmorphine (9190) ...................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Isomethadone (9226) ...................
Meperidine (9230) ........................
Meperidine intermediate-A (9232)
Meperidine intermediate-B (9233)
Meperidine intermediate-C (9234)
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Dihydroetorphine (9334) ...............
Levo-alphacetylmethadol (9648) ..
Oxymorphone (9652) ...................
Racemethorphan (9732) ..............
Racemorphan (9733) ...................
Schedule
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The company plans to manufacture
small quantities of the listed controlled
substances in bulk for distribution to its
customers for use as reference
standards.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
57389
also file a written request for a hearing
on the application pursuant to 21 CFR
1301.43 on or before October 23, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: 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 June
16, 2015, Fresenius Kabi USA, LLC,
3159 Staley Road, Grand Island, New
York 14072 applied to be registered as
an importer of remifentanil (9739), a
basic class of controlled substance listed
in schedule II.
The company plans to import the
listed controlled substance for product
development and preparation of
stability batches.
[FR Doc. 2015–24123 Filed 9–22–15; 8:45 am]
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
[FR Doc. 2015–24118 Filed 9–22–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
Importer of Controlled Substances
Application: Fresenius Kabi USA, LLC
[Docket No. DEA–392]
ACTION:
Importer of Controlled Substances
Registration: Rhodes Technologies
Notice of application.
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.34(a) on or before
October 23, 2015. Such persons may
DATES:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
ACTION:
Notice of registration.
Rhodes Technologies applied
to be registered as an importer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Rhodes Technologies
SUMMARY:
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Pages 57388-57389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24121]
-----------------------------------------------------------------------
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 August 27, 2014, and
published in the Federal Register on September 4, 2014, 79 FR 52762,
Fisher Clinical Services, Inc., 700A-C Nestle Way, Breinigsville,
Pennsylvania 18031-1522 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 basic classes of controlled
substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Methylphenidate (1724)..................... II
Levorphanol (9220)......................... II
Noroxymorphone (9668)...................... II
Tapentadol (9780).......................... II
------------------------------------------------------------------------
[[Page 57389]]
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.
Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-24121 Filed 9-22-15; 8:45 am]
BILLING CODE 4410-09-P
