Importer of Controlled Substances Application: Quagen Pharmaceuticals LLC, 46905 [2024-11892]
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46905
Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices
of the following basic class(es) of
controlled substance(s):
Controlled substance
Marihuana Extract ...........
Tetrahydrocannabinols ....
Drug
code
Schedule
7350
I
I 7370 II
The company plans to import finished
dosage unit products containing the
above listed controlled substances for
research and clinical trial studies only.
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.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–11795 Filed 5–29–24; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1368]
Bulk Manufacturer of Controlled
Substances Application: Royal
Emerald Pharmaceuticals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
ddrumheller on DSK120RN23PROD with NOTICES1
Jkt 262001
I
Schedule
7350
7360
7370
I
I
I
I
[FR Doc. 2024–11786 Filed 5–29–24; 8:45 am]
BILLING CODE P
Royal Emerald
Pharmaceuticals 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 July 29, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 29, 2024.
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
20:03 May 29, 2024
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
Drug
code
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
AGENCY:
VerDate Sep<11>2014
Controlled substance
The company plans to bulk
manufacture the listed controlled
substances to provide Marihuana
(Cannabis) as botanical raw material
and/or active pharmaceutical
ingredients (API) to Drug Enforcement
Administration-registered researchers
and manufacturers. No other activities
for these drug codes are authorized for
this registration.
BILLING CODE 4410–09–P
SUMMARY:
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 April 10, 2024, Royal
Emerald Pharmaceuticals, 14011 Palm
Drive, Building B, Desert Hot Springs,
California 92240–6845, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
hearing on the application on or before
July 1, 2024.
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on April 16, 2024, Quagen
Pharmaceuticals LLC, 37 Fairfield Place,
West Caldwell, New Jersey 07006,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
[Docket No. DEA–1381]
Importer of Controlled Substances
Application: Quagen Pharmaceuticals
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Quagen Pharmaceuticals 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.
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 July 1, 2024. Such persons
may also file a written request for a
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Diphenoxylate ..................
Drug
code
Schedule
I 9170 III
The company plans to import the
listed controlled substance for
distribution to its customer. No other
activity for this drug code is 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 J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–11892 Filed 5–29–24; 8:45 am]
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E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Page 46905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11892]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1381]
Importer of Controlled Substances Application: Quagen
Pharmaceuticals LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Quagen Pharmaceuticals 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.
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
July 1, 2024. Such persons may also file a written request for a
hearing on the application on or before July 1, 2024.
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 April 16, 2024, Quagen Pharmaceuticals LLC, 37
Fairfield Place, West Caldwell, New Jersey 07006, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Diphenoxylate........................... 9170 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance for
distribution to its customer. No other activity for this drug code is
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-approved finished
dosage forms for commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-11892 Filed 5-29-24; 8:45 am]
BILLING CODE P
