Bulk Manufacturer of Controlled Substances Application: Continuus Pharmaceuticals, 54353 [2023-17136]
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54353
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
Controlled substance
Lysergic acid diethylamide ....
5-Methoxy-N,Ndimethyltryptamine.
Tapentadol ............................
Drug
code
Schedule
7315
7431
I
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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17138 Filed 8–9–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1242]
Bulk Manufacturer of Controlled
Substances Application: Continuus
Pharmaceuticals
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 July 6, 2023, Continuus
Pharmaceuticals, 256 West Cummings
Park, Woburn, Massachusetts 01801,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Fentanyl ........................
Drug
code
9801
Schedule
II
The company plans to bulk
manufacture the above listed controlled
substance for research and development
purposes 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.
Claude Redd,
Acting Deputy Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[FR Doc. 2023–17136 Filed 8–9–23; 8:45 am]
BILLING CODE 4410–09–P
Continuus 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 October 10, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 10, 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:28 Aug 09, 2023
Jkt 259001
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–1244]
Importer of Controlled Substances
Application: Chattem Chemicals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Chattem Chemicals 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 September 11, 2023. Such
persons may also file a written request
for a hearing on the application on or
before September 11, 2023.
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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 July 14, 2023, Chattem
Chemicals, 3801 Saint Elmo Avenue,
Chattanooga, Tennessee 37409–1237,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
ADDRESSES:
Methamphetamine ........
4-Anilino-N-phenethyl-4piperidine (ANPP).
Phenylacetone ..............
Cocaine ........................
Poppy Straw Concentrate.
Tapentadol ....................
Drug
code
Schedule
1105
8333
II
II
8501
9041
9670
II
II
II
9780
II
The company plans to import the
listed controlled substances to
manufacture bulk controlled substances
for sale to its customers. The company
plans to import an intermediate of
Tapentadol (9780), to bulk manufacture
Tapentadol for distribution to its
customers. 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
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Page 54353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17136]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1242]
Bulk Manufacturer of Controlled Substances Application: Continuus
Pharmaceuticals
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Continuus 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
October 10, 2023. Such persons may also file a written request for a
hearing on the application on or before October 10, 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 July 6, 2023, Continuus Pharmaceuticals, 256 West
Cummings Park, Woburn, Massachusetts 01801, applied to be registered as
a bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the above listed controlled
substance for research and development purposes 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 non-approved finished
dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-17136 Filed 8-9-23; 8:45 am]
BILLING CODE 4410-09-P
