Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC, 60899-60900 [2018-25862]
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60899
Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices
Company
FR Docket
Alcami Carolinas Corporation .............................................
83 FR 46758 ......................................................................
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrant to import the applicable
basic classes of schedule I 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
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 DEA has
granted a registration as an importer for
schedule I controlled substances to the
above listed company.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–25863 Filed 11–26–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: GE Healthcare
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 on
or before December 27, 2018. Such
persons may also file a written request
for a hearing on the application on or
before December 27, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
amozie on DSK3GDR082PROD with NOTICES1
DATES:
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/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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
September 5, 2018, GE Healthcare, 3350
North Ridge Avenue, Arlington Heights,
Illinois 60004, applied to be registered
as an importer of cocaine (9041), a basic
class of controlled substance listed in
schedule II.
The company plans to import small
quantities of Ioflupane, in the form of
three separate analogues of cocaine, to
validate production and quality control
systems, for a reference standard, and
for producing material for a future
investigational new drug (IND)
submission. Supplies of this particular
controlled substance are not available in
the form needed within the current
domestic supply of the United States.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–25864 Filed 11–26–18; 8:45 am]
Published
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Insys
Manufacturing, 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 on
or before January 28, 2019.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
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
delegated to the Assistant Administrator
of the DEA Diversion Control Division
(‘‘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 October
4, 2018, Insys Manufacturing, LLC, 811
Paloma Drive, Suite C, Round Rock,
Texas 78665, applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
Controlled substance
Drug code
Marihuana ................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................
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7370
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60900
Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices
The company plans to manufacture
bulk synthetic active pharmaceutical
ingredients (APIs) for product
development and distribution to its
customers. No other activity for these
drug codes are authorized for this
registration.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–25862 Filed 11–26–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
DATES:
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before December 27, 2018. Such
persons may also file a written request
for a hearing on the application on or
before December 27, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 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/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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
September 27, 2018, Fisher Clinical
Services, Inc., 700A–C Nestle Way,
Breinigsville, Pennsylvania 18031, has
applied to be registered as an importer
of the below listed basic classes of
controlled substances listed in schedule
I & II.
Controlled substance
Drug code
Psilocybin .................................................................................................................................................................
Methylphenidate .......................................................................................................................................................
Levorphanol .............................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Tapentadol ...............................................................................................................................................................
The company plans to import the
listed controlled 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.
DEPARTMENT OF JUSTICE
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
ACTION:
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cayman
Chemical Company
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 on
or before January 28, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
DATES:
[FR Doc. 2018–25872 Filed 11–26–18; 8:45 am]
BILLING CODE 4410–09–P
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Drug Enforcement Administration
Jkt 247001
PO 00000
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I
II
II
II
II
Drug code
3-Fluoro-N-methylcathinone (3–FMC) .......................................................................................................................
Cathinone ...................................................................................................................................................................
Methcathinone ............................................................................................................................................................
4-Fluoro-N-methylcathinone (4–FMC) .......................................................................................................................
17:45 Nov 26, 2018
7437
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9668
9780
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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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 25,
2018, Cayman Chemical Company, 1180
East Ellsworth Road, Ann Arbor,
Michigan 48108 applied to be registered
as a bulk manufacturer for the basic
classes of controlled substances:
Controlled substance
VerDate Sep<11>2014
Schedule
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1233
1235
1237
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]]>Agencies
[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60899-60900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25862]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Insys
Manufacturing, LLC
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 on or before January 28, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
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 delegated
to the Assistant Administrator of the DEA Diversion Control Division
(``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
October 4, 2018, Insys Manufacturing, LLC, 811 Paloma Drive, Suite C,
Round Rock, Texas 78665, applied to be registered as a bulk
manufacturer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
------------------------------------------------------------------------
[[Page 60900]]
The company plans to manufacture bulk synthetic active
pharmaceutical ingredients (APIs) for product development and
distribution to its customers. No other activity for these drug codes
are authorized for this registration.
Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25862 Filed 11-26-18; 8:45 am]
BILLING CODE 4410-09-P
