Manufacturer of Controlled Substances Registration: Euticals, Inc., 8246 [2016-03355]
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8246
Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
[Docket No. DEA–392]
controlled substance in bulk from a
domestic source in order to manufacture
other controlled substances in bulk for
distribution to its customers.
Manufacturer of Controlled
Substances Registration: Euticals, Inc.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cedarburg
Pharmaceuticals, Inc.
ACTION:
ACTION:
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 1301.33(a) on or before
April 18, 2016.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
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
November 4, 2015, Cedarburg
Pharmaceuticals, Inc., 870 Badger
Circle, Grafton, Wisconsin 53024
applied to be registered as a bulk
manufacturer of nabilone (7379), a basic
class of controlled substance listed in
schedule II.
The company plans to manufacturer
bulk active pharmaceutical ingredients
(API) for distribution to its customers.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–03350 Filed 2–17–16; 8:45 am]
BILLING CODE 4410–09–P
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19:03 Feb 17, 2016
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Euticals, Inc. applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Euticals, Inc. registration
as a manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated September 16, 2015, and
published in the Federal Register on
September 23, 2015, 80 FR 57391,
Euticals, Inc., 2460 W. Bennett Street,
Springfield, Missouri 65807–1229
applied to be registered as a
manufacturer 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(a) and determined that
the registration of Euticals, Inc. to
manufacture 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.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
BILLING CODE 4410–09–P
SUMMARY:
Notice of application.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–03355 Filed 2–17–16; 8:45 am]
Notice of registration.
Controlled substance
Gamma
Hydroxybutyric
Acid
(2010).
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Phenylacetone (8501) ..................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Oripavine (9330) ...........................
Tapentadol (9780) ........................
Schedule
I
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers.
In reference to oripavine (9330), the
company plans to acquire the listed
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Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Catalent Pharma
Solutions, LLC
ACTION:
Notice of registration.
Catalent Pharma Solutions,
LLC applied to be registered as an
importer of a certain basic class of
controlled substance. The Drug
Enforcement Administration (DEA)
grants Catalent Pharma Solutions, LLC
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated August 21, 2015, and published in
the Federal Register on August 31,
2015, 80 FR 52510, Catalent Pharma
Solutions, LLC, 3031 Red Lion Road,
Philadelphia, Pennsylvania 19114
applied to be registered as an importer
of a certain basic class of controlled
substance. 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
Catalent Pharma Solutions, LLC to
import the basic class of controlled
substance 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 hydromorphone (9150), a
basic class of controlled substance listed
in schedule II.
The company plans to import the
above listed controlled substance for a
clinical trial study. Approval of permit
applications will occur only when the
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Page 8246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03355]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Euticals,
Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Euticals, Inc. applied to be registered as a manufacturer of
certain basic classes of controlled substances. The Drug Enforcement
Administration (DEA) grants Euticals, Inc. registration as a
manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and
published in the Federal Register on September 23, 2015, 80 FR 57391,
Euticals, Inc., 2460 W. Bennett Street, Springfield, Missouri 65807-
1229 applied to be registered as a manufacturer 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(a) and
determined that the registration of Euticals, Inc. to manufacture 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. 823(a), and in accordance with 21
CFR 1301.33, the above-named company is granted registration as a bulk
manufacturer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)........... I
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Phenylacetone (8501)....................... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. II
Oripavine (9330)........................... II
Tapentadol (9780).......................... II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for distribution and sale to its customers.
In reference to oripavine (9330), the company plans to acquire the
listed controlled substance in bulk from a domestic source in order to
manufacture other controlled substances in bulk for distribution to its
customers.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03355 Filed 2-17-16; 8:45 am]
BILLING CODE 4410-09-P
