Bulk Manufacturer of Controlled Substances Application: Isosciences, 61249-61250 [2016-21241]
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61249
Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before October 6, 2016. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before October 6,
2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/ODW, 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
17, 2016, Fisher Clinical Services, Inc.,
7554 Schantz Road, Allentown,
Pennsylvania 18106 applied to be
registered as an importer of the
following basic classes of controlled
substances:
mstockstill on DSK3G9T082PROD with NOTICES
Controlled substance
Schedule
Methylphenidate (1724) ................
Levorphanol (9220) ......................
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
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 finished FDA approved or
non-approved dosage form for
VerDate Sep<11>2014
17:04 Sep 02, 2016
Jkt 238001
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 this drug code 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.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–21240 Filed 9–2–16; 8:45 am]
BILLING CODE 4410–09–P
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 November 7, 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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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 May 18,
2016, Cody Laboratories, Inc., 601
Yellowstone Avenue, Cody, Wyoming
82414 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–21238 Filed 9–2–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Isosciences
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 7, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
DATES:
E:\FR\FM\06SEN1.SGM
06SEN1
61250
Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DEPARTMENT OF JUSTICE
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 May 3,
2016, Isosciences, LLC, 1017 West Ninth
Avenue, Building 10, Suite B, King of
Prussia, Pennsylvania 19406 applied to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Cathinone (1235) ..........................
Methcathinone (1237) ..................
Lysergic acid diethylamide (7315)
3,4-Methylenedioxyamphetamine
(7400).
3,4-Methylenedioxy-Nethylamphetamine (7404).
3,4Methylenedioxymethamphetamine (7405).
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Codeine (9050) .............................
Morphine (9300) ...........................
I
I
I
I
I
I
II
II
II
II
The company plans to manufacture
small quantities of the listed controlled
substances to make reference standards
which will be distributed to their
customers.
Louis J. Milione,
Deputy Assistant Administrator.
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–21241 Filed 9–2–16; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
17:04 Sep 02, 2016
Jkt 238001
Drug Enforcement Administration
Importer of Controlled Substances
Application: Unither Manufacturing,
LLC
ACTION:
Notice of application.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–21239 Filed 9–2–16; 8:45 am]
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 1301.34(a) on
or before October 6, 2016. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before October 6,
2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/ODW, 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 May 6,
2016, Unither Manufacturing, LLC., 331
Clay Road, Rochester, New York 14623
applied to be registered as an importer
of methylphenidate (1724), a basic class
of controlled substance listed in
schedule II.
DATES:
The company plans to import the
listed substance solely for updated
analytical testing purposes for EU
customer requirements.
This analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
BILLING CODE 4410–09–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 November 7, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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
1301.33(a), this is notice that on May 19,
2016, AMRI Rensselaer, Inc., 33
Riverside Avenue, Rensselaer, New
York 12144 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
DATES:
Controlled substance
Marihuana (7360) .........................
E:\FR\FM\06SEN1.SGM
06SEN1
Schedule
I
]]>Agencies
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61249-61250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21241]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application:
Isosciences
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 November 7, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal
[[Page 61250]]
Register Representative/ODW, 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 1301.33(a), this is notice that on May 3,
2016, Isosciences, LLC, 1017 West Ninth Avenue, Building 10, Suite B,
King of Prussia, Pennsylvania 19406 applied to be registered as a bulk
manufacturer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Cathinone (1235)........................... I
Methcathinone (1237)....................... I
Lysergic acid diethylamide (7315).......... I
3,4-Methylenedioxyamphetamine (7400)....... I
3,4-Methylenedioxy-N-ethylamphetamine I
(7404).
3,4-Methylenedioxymethamphetamine (7405)... I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Codeine (9050)............................. II
Morphine (9300)............................ II
------------------------------------------------------------------------
The company plans to manufacture small quantities of the listed
controlled substances to make reference standards which will be
distributed to their customers.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-21241 Filed 9-2-16; 8:45 am]
BILLING CODE 4410-09-P
