Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc, 13586 [2021-04809]
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Federal Register / Vol. 86, No. 44 / Tuesday, March 9, 2021 / Notices
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Procedures, available on the
Commission’s website at https://
www.usitc.gov/documents/handbook_
on_filing_procedures.pdf, elaborates
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upon the Commission’s procedures with
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Authority: These investigations are being
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pursuant to § 207.21 of the Commission’s
rules.
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 2, 2021,
Patheon Pharmaceuticals Inc, 2110 East
Galbraith Road, Cincinnati, Ohio
45237–1625, applied to be registered as
a bulk manufacturer of the following
basic class of controlled substance:
SUPPLEMENTARY INFORMATION:
Controlled substance
Gamma Hydroxybutyric
Acid.
Drug
code
Schedule
2010
I
The company plans to manufacture
the above-listed controlled substance as
Active Pharmaceutical Ingredient (API)
that will be further synthesized into
Food and Drug Administrationapproved dosage forms. No other
activities for this drug code are
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–04809 Filed 3–8–21; 8:45 am]
By order of the Commission.
Issued: March 4, 2021.
Lisa Barton,
Secretary to the Commission.
BILLING CODE 4410–09–P
[FR Doc. 2021–04860 Filed 3–8–21; 8:45 am]
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
BILLING CODE 7020–02–P
[Docket No. DEA–804]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Patheon Pharmaceuticals Inc
has applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplemental Information listed below
for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before May 10, 2021. Such persons
may also file a written request for a
hearing on the application on or before
May 10, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
Frm 00068
Fmt 4703
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[Docket No. DEA–802]
PO 00000
Bulk Manufacturer of Controlled
Substances Application: Stepan
Company
Sfmt 4703
Stepan Company has applied
to be registered as a bulk manufacturer
of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before May 10, 2021. Such persons
may also file a written request for a
hearing on the application on or before
May 10, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 8, 2021,
Stepan Company, 100 West Hunter
Avenue, Maywood, New Jersey 07607–
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09MRN1.SGM
09MRN1
Agencies
[Federal Register Volume 86, Number 44 (Tuesday, March 9, 2021)]
[Notices]
[Page 13586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04809]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-802]
Bulk Manufacturer of Controlled Substances Application: Patheon
Pharmaceuticals Inc
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Patheon Pharmaceuticals Inc has applied to be registered as a
bulk manufacturer of basic class(es) of controlled substance(s). Refer
to Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before May 10, 2021.
Such persons may also file a written request for a hearing on the
application on or before May 10, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 2, 2021, Patheon Pharmaceuticals Inc, 2110
East Galbraith Road, Cincinnati, Ohio 45237-1625, applied to be
registered as a bulk manufacturer of the following basic class of
controlled substance:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............... 2010 I
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substance as Active Pharmaceutical Ingredient (API) that will be
further synthesized into Food and Drug Administration-approved dosage
forms. No other activities for this drug code are authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-04809 Filed 3-8-21; 8:45 am]
BILLING CODE 4410-09-P