Bulk Manufacturer of Controlled Substances Registration, 95641 [2016-31280]
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95641
Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
Lower Ferry Road, Ewing, New Jersey
08618–1414 applied to be registered as
a bulk manufacturer of the following
basic classes controlled substances:
Controlled substance
Drug code
Pentobarbital ....................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Remifentanil .....................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to initially to
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, then
eventually up FDA approval to produce
commercial size batches for distribution
to dosage form manufacturers.
Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
Drug Enforcement Administration
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
Bulk Manufacturer of Controlled
Substances Registration
Notice of registration.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Company
FR docket
National Center for Natural Products Research (NIDA MPROJECT) ..............
Cambrex Charles City .......................................................................................
Chemtos, LLC ....................................................................................................
Stepan Company ...............................................................................................
Chattem Chemicals ...........................................................................................
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants to
manufacture the applicable 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 each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed persons.
Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
80
81
81
81
81
FR
FR
FR
FR
FR
78766
46956
54604
54849
57932
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Synthcon,
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 February 27, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
BILLING CODE 4410–09–P
The Attorney General has delegated
her authority under the Controlled
Published
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............................................
............................................
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DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–31280 Filed 12–27–16; 8:45 am]
sradovich on DSK3GMQ082PROD with NOTICES
The
companies listed below applied to be
registered as manufacturers of various
basic classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
for these notices.
SUMMARY:
BILLING CODE 4410–09–P
Drug code
3-Fluoro-N-methylcathinone (3–FMC) .............................................................................................................................
Cathinone ........................................................................................................................................................................
Methcathinone .................................................................................................................................................................
4-Fluoro-N-methylcathinone (4–FMC) .............................................................................................................................
Pentedrone (a-methylaminovalerophenone) ...................................................................................................................
18:54 Dec 27, 2016
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Frm 00087
Fmt 4703
December 17, 2015.
July 19, 2016.
August 16, 2016.
August 17, 2016.
August 24, 2016.
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
December 16, 2015, Synthcon, LLC, 770
Wooten Road, Unit 101, Colorado
Springs, Colorado 80915 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
Controlled substance
VerDate Sep<11>2014
II
II
II
II
Administration (DEA) as bulk
manufacturers of various classes of
controlled substances.
DEPARTMENT OF JUSTICE
ACTION:
[FR Doc. 2016–31282 Filed 12–27–16; 8:45 am]
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8333
9739
9801
Schedule
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Schedule
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]]>Agencies
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Page 95641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31280]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Registration
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Registrants listed below have applied for and been granted
registration by the Drug Enforcement Administration (DEA) as bulk
manufacturers of various classes of controlled substances.
SUPPLEMENTARY INFORMATION: The companies listed below applied to be
registered as manufacturers of various basic classes of controlled
substances. Information on previously published notices is listed in
the table below. No comments or objections were submitted for these
notices.
----------------------------------------------------------------------------------------------------------------
Company FR docket Published
----------------------------------------------------------------------------------------------------------------
National Center for Natural Products 80 FR 78766................. December 17, 2015.
Research (NIDA MPROJECT).
Cambrex Charles City..................... 81 FR 46956................. July 19, 2016.
Chemtos, LLC............................. 81 FR 54604................. August 16, 2016.
Stepan Company........................... 81 FR 54849................. August 17, 2016.
Chattem Chemicals........................ 81 FR 57932................. August 24, 2016.
----------------------------------------------------------------------------------------------------------------
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of these registrants to manufacture
the applicable 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 each of the company's maintenance of
effective controls against diversion by inspecting and testing each
company's physical security systems, verifying each company's
compliance with state and local laws, and reviewing each company's
background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer
to the above listed persons.
Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-31280 Filed 12-27-16; 8:45 am]
BILLING CODE 4410-09-P
