Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc., 22560 [2015-09324]
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22560
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
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
December 23, 2014, Johnson Matthey
Pharmaceutical Materials, Inc.,
Pharmaceutical Service, 25 Patton Road,
Devens, Massachusetts 01434 applied to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
Controlled substance
Schedule
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Nabilone (7379) ............................
Hydrocodone (9193) .....................
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
II
II
II
II
II
II
II
The company plans to utilize this
facility to manufacture small quantities
of the listed controlled substances in
bulk and to conduct analytical testing in
support of the company’s primary
manufacturing facility in West Deptford,
New Jersey. The controlled substances
manufactured in bulk at this facility will
be distributed to its company’s
customers.
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09330 Filed 4–21–15; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: AMRI
Rensselaer, Inc.
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 22, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
asabaliauskas on DSK5VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
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.
The
Attorney General has delegated his
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 of subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on June
10, 2013, AMRI Rensselaer, Inc., 33
Riverside Avenue, Rensselaer, New
York 12144 applied to be registered as
a bulk manufacturer of the following
basic classes controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
4-Anilino-N-phenethyl-4-piperidine
(8333).
Meperidine (9230) ........................
Fentanyl (9801) ............................
Schedule
I
I
II
II
II
II
II
II
II
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: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09324 Filed 4–21–15; 8:45 am]
BILLING CODE 4410–09–P
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Frm 00088
Fmt 4703
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cody
Laboratories, Inc.
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 22, 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 his
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 July 3,
2014, Cody Laboratories, Inc., Steve
Hartman—Vice President of
Compliance, 601 Yellowstone Avenue,
Cody, Wyoming 82414 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
DATES:
Controlled substance
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Phenylacetone (8501) ..................
E:\FR\FM\22APN1.SGM
22APN1
Schedule
I
II
II
II
II
II
II
II
Agencies
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Page 22560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09324]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: AMRI
Rensselaer, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: 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 22, 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 his
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 of subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on June
10, 2013, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New
York 12144 applied to be registered as a bulk manufacturer of the
following basic classes controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
4-Anilino-N-phenethyl-4-piperidine (8333).. II
Meperidine (9230).......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
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: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-09324 Filed 4-21-15; 8:45 am]
BILLING CODE 4410-09-P