Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc., 8114 [2019-04029]
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Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices
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 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: February 22, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–04026 Filed 3–5–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals, 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 on
or before April 5, 2019. Such persons
may also file a written request for a
DATES:
hearing on the application on or before
April 5, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
into a new product for development.
The company plans to manufacture the
above listed controlled substance as
Active Pharmaceutical Ingredient (API)
that will be further synthesized into
dosage forms of a new product. No other
activities for this drug code are
authorized for this registration.
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
December 24, 2018, Patheon
Pharmaceuticals, Inc., 2110 E Galbraith
Road, Cincinnati, Ohio 45237, has reapplied to be registered as a bulk
manufacturer of the Schedule I
controlled substance Gamma
Hydroxybutyric Acid (2010), a basic
class of controlled substance.
The Gamma Hydroxybutyric Acid
will be produced during the process of
converting gamma-butyrolactone (GBL)
Dated: February 18, 2019.
John J. Martin,
Assistant Administrator.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–04029 Filed 3–5–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
Notice of registration.
The registrant listed below
has applied for and has been granted a
registration by the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of various classes of
schedule I and II controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as a bulk manufacturer of
various basic classes of controlled
substances. Information on the
previously published notice is listed in
the table below. No comments or
objections were submitted for this
notice.
SUMMARY:
Company
FR Docket
Cambrex Charles City ...........................................................
83 FR 49579 ........................................................................
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of this registrant 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 the company’s maintenance
of effective controls against diversion by
inspecting and testing their physical
security systems, verifying their
compliance with state and local laws,
and reviewing their 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
VerDate Sep<11>2014
18:35 Mar 05, 2019
Jkt 247001
registration as a bulk manufacturer to
the above listed company.
Dated: February 22, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–04027 Filed 3–5–19; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
PO 00000
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as bulk
manufacturers of schedule I or schedule
II controlled substances.
SUMMARY:
The
companies listed below applied to be
registered as bulk manufacturers of
schedule I or schedule II controlled
substances. Information on previously
published notices is listed in the table
below. No comments or objections were
submitted for these notices.
Notice of registration.
Frm 00044
Fmt 4703
October 2, 2018.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
ACTION:
Published
Sfmt 4703
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Page 8114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04029]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Patheon
Pharmaceuticals, 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 on or before April 5, 2019. Such
persons may also file a written request for a hearing on the
application on or before April 5, 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 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
December 24, 2018, Patheon Pharmaceuticals, Inc., 2110 E Galbraith
Road, Cincinnati, Ohio 45237, has re-applied to be registered as a bulk
manufacturer of the Schedule I controlled substance Gamma
Hydroxybutyric Acid (2010), a basic class of controlled substance.
The Gamma Hydroxybutyric Acid will be produced during the process
of converting gamma-butyrolactone (GBL) into a new product for
development. The company plans to manufacture the above listed
controlled substance as Active Pharmaceutical Ingredient (API) that
will be further synthesized into dosage forms of a new product. No
other activities for this drug code are authorized for this
registration.
Dated: February 18, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-04029 Filed 3-5-19; 8:45 am]
BILLING CODE 4410-09-P
