Notice2025-16007
Bulk Manufacturer of Controlled Substances Application: Continuus Pharmaceuticals
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 21, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Notices]
[Page 40859]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16007]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1589]
Bulk Manufacturer of Controlled Substances Application: Continuus
Pharmaceuticals
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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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 20, 2025. Such persons may also file a written request for a
hearing on the application on or before October 20, 2025.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 14, 2025, 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):
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Drug
Controlled substance code Schedule
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Fentanyl............................... 9801 II
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The company plans to bulk manufacture the listed controlled
substance for research and development purposes only. No other activity
for this drug code is authorized for this registration.
Justin Wood,
Acting Deputy Assistant Administrator.
[FR Doc. 2025-16007 Filed 8-20-25; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on August 21, 2025.
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