Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc., 17622 [2023-05944]
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17622
Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on February 8, 2023,
Caliqor Coghlan Pharma Services, 1500
Business Park Drive, Unit B, Bastrop,
Texas 78602, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Controlled substance
Lysergic Acid
Diethylamide.
5-Methoxy-N, Ndimethyltryptamine.
Tapentadol ......................
Drug
code
Schedule
7315
I
7431
I
9780
II
The company plans to import the
listed controlled substances as finished
dosage units for use in clinical trials. No
other activities for these drug codes are
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on February 1, 2023,
Patheon Pharmaceuticals Inc., 2110 East
Galbraith Road, Cincinnati, Ohio 45237,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
ADDRESSES:
Controlled substance
Gamma-hydroxybutyric
acid.
Drug
code
Schedule
2010
I
Drug Enforcement Administration
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.
[Docket No. DEA–1166]
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–05938 Filed 3–22–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
[FR Doc. 2023–05944 Filed 3–22–23; 8:45 am]
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals Inc.
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 24, 2023. Such
persons may also file a written request
for a hearing on the application on or
before April 24, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 28, 2022,
Meridian Medical Technologies, LLC,
2555 Hermelin Drive, Saint Louis,
Missouri 63144, applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
DATES:
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1154]
Patheon Pharmaceuticals Inc.
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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 22, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 22, 2023.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:23 Mar 22, 2023
Jkt 259001
Importer of Controlled Substances
Application: Meridian Medical
Technologies, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Meridian Medical
Technologies, LLC has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTARY INFORMATION
listed below for further drug
information.
SUMMARY:
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
Morphine .........................
Drug
code
Schedule
9300
II
The company plans to import the
controlled substance for analytical and
research purposes. No other activities
for these drug codes are authorized for
this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or non-
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Page 17622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05944]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1166]
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 Supplementary Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
May 22, 2023. Such persons may also file a written request for a
hearing on the application on or before May 22, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 1, 2023, Patheon Pharmaceuticals Inc., 2110
East Galbraith Road, Cincinnati, Ohio 45237, applied to be registered
as a bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-05944 Filed 3-22-23; 8:45 am]
BILLING CODE P
