[Federal Register Volume 91, Number 122 (Friday, June 26, 2026)]
[Notices]
[Pages 38719-38720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-12937]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3240]
List of Bulk Drug Substances for Which There Is a Clinical Need
Under Section 503B of the Federal Food, Drug, and Cosmetic Act;
Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice entitled ``List of Bulk
Drug Substances for Which There Is a Clinical Need Under Section 503B
of the Federal Food, Drug, and Cosmetic Act'' that appeared in the
Federal Register of May 1, 2026. In the Federal Register notice, FDA
requested comments on FDA's proposal not to include semaglutide,
tirzepatide, or liraglutide on a list of bulk drug substances (active
pharmaceutical ingredients) for which there is a clinical need for
outsourcing facilities to use in compounding (the 503B Bulks List). The
Agency is taking this action in response to a request for an extension
to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the notice published in
the Federal Register of May 1, 2026 (91 FR 23431). Either electronic or
written comments must be submitted by July 30, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 30, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3240 for ``List of Bulk Drug Substances for Which There Is a
Clinical Need Under Section 503B of the Federal Food, Drug, and
Cosmetic Act.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management
[[Page 38720]]
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Tracy Rupp, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 240-402-0260, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of May 1, 2026, FDA
published a notice with a 60-day comment period to request comments on
FDA's proposal not to include semaglutide, tirzepatide, or liraglutide
on the 503B Bulks List. Comments on the proposal will inform FDA's
final determination whether to include these substances on the 503B
Bulks List.
The Agency has received a request for a 60-day extension of the
comment period for the May 1, 2026 Federal Register notice. The request
conveyed concern that the current 60-day comment period does not allow
sufficient time to develop a meaningful or thoughtful response to the
Federal Register notice. The request states that the additional time
will allow interested parties to develop rigorous and comprehensive
comments that will address complex clinical, public health, and legal
issues; engage thoughtfully with a complicated regulatory landscape;
and thoroughly address issues around patient safety and access to high-
quality medications.
FDA has considered the request and is extending the comment period
for the Federal Register notice for 30 days, until July 30, 2026. The
Agency believes that a 30-day extension, rather than 60 days,
appropriately balances allowing adequate time for interested persons to
submit comments with avoiding significant delay of Agency action on
these important issues. FDA encourages comments to address the clinical
need standard provided by the statute and FDA's rationale in the May 1,
2026 Federal Register notice.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-12937 Filed 6-25-26; 8:45 am]
BILLING CODE 4164-01-P