Notice2025-21728
Increasing Access to Nonprescription Drugs; Request for Information
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
December 2, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a request for information from interested parties and the public to share their perspectives with FDA on how to increase access to nonprescription drugs. The Agency intends to use the information submitted to inform plans for a public meeting intended to be held in calendar year 2026.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 229 (Tuesday, December 2, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 229 (Tuesday, December 2, 2025)]
[Notices]
[Pages 55316-55318]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21728]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-4731]
Increasing Access to Nonprescription Drugs; Request for
Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a request for information from interested parties and the
public to share their perspectives with FDA on how to increase access
to nonprescription drugs. The Agency intends to use the information
submitted to inform plans for a public meeting intended to be held in
calendar year 2026.
DATES: Either electronic or written comments on the notice must be
submitted by February 2, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 2, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
[[Page 55317]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2025-N-4731 for ``Increasing Access to Nonprescription Drugs;
Request for Information.'' 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Nikia Morris, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., White Oak Building 22, Room 5134, Silver Spring, MD
20993, 240-402-6625, <a href="/cdn-cgi/l/email-protection#b8f6d1d3d1d996f5d7cacad1cbf8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="ca84a3a1a3abe487a5b8b8a3b98aacaeabe4a2a2b9e4ada5bc">[email protected]</span></a> with the subject line
``Increasing Access to Nonprescription Drugs CDER''.
SUPPLEMENTARY INFORMATION:
I. Background
Nonprescription drug products are important for the treatment of
many conditions and diseases. Unlike prescription drug products,
nonprescription drug products are accessible to consumers without a
prescription and may be accessed and used safely and effectively by
consumers without the supervision of a practitioner licensed by law to
administer such drugs for their intended use. At present, the majority
of nonprescription drug products are intended to provide temporary
relief of minor symptoms or to treat self-limited conditions and
diseases. Nonprescription drug products are usually accessible to
consumers to purchase at pharmacies, supermarkets, or other retail
locations, and from online retailers.
FDA approves drugs as either prescription or nonprescription drug
products under section 505 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355). A drug must be dispensed by prescription
when it is not safe for use except under the supervision of a
practitioner licensed by law to administer such drug product because of
its toxicity or other potentiality for harmful effect, or the method of
its use, or the collateral measures necessary to its use (see section
503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1))).
If the drug does not meet the criteria for prescription-only
dispensing, it may be marketed as nonprescription. There are two
regulatory pathways to bring a nonprescription drug product to market
in the United States.\1\ This request for information is focused on the
new drug application (NDA) process under section 505 of the FD&C Act.
An applicant seeking to market a nonprescription drug under an NDA must
submit data to satisfy the applicable statutory and regulatory
requirements for approval of an NDA. Among other things, an NDA must
include adequate tests to show that the drug is safe for use under the
conditions prescribed, recommended, or suggested in the proposed
labeling,\2\ and there must be substantial evidence that the drug will
have the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
labeling.\3\ Often, consumer studies are required to demonstrate that
products can be used safely and effectively in a nonprescription
setting. Label comprehension studies, self-selection studies, actual
use studies, human factors studies, and other types of studies may be
required to evaluate proposed nonprescription drug product labeling and
to demonstrate that the drug is safe and effective for use in self-
medication, as directed in proposed labeling as required under 21 CFR
310.200(b).\4\ The less that is known about the use of a medication
without the intervention of a health care practitioner, the more data
that typically will be required.
---------------------------------------------------------------------------
\1\ The two regulatory pathways to bring a nonprescription drug
product to market in the United States are: (1) the over-the-counter
(OTC) monograph drug review process under section 505G of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h);
and (2) the application process under section 505 of the FD&C Act.
\2\ See section 505(d)(l) and (2) of the FD&C Act.
\3\ See section 505(d)(5) of the FD&C Act.
\4\ See, for example, the guidance for industry ``Self-Selection
Studies for Nonprescription Drug Products,'' available at <a href="https://www.fda.gov/media/81141/download">https://www.fda.gov/media/81141/download</a>; and the guidance for industry
``Label Comprehension Studies for Nonprescription Drug Products,''
available at <a href="https://www.fda.gov/media/75626/download">https://www.fda.gov/media/75626/download</a>.
---------------------------------------------------------------------------
II. Purpose of Request for Information
This request for information provides an opportunity for interested
parties and the public--including commercial drug developers, health
care providers, consumers, and other relevant groups--to share their
perspectives with FDA on increasing access to nonprescription drugs.
Specifically, FDA is interested in perspectives on the scientific,
regulatory, and practical considerations that shape nonprescription
drug access. The collected input will help inform
[[Page 55318]]
topics for a public meeting planned for calendar year 2026.
III. Questions for Consideration
We seek input on the questions presented below. While the questions
are aimed at gathering information most pertinent to increasing access
to nonprescription drugs, we welcome any additional data and
information regarding access to nonprescription drugs that may improve
our understanding and advance our public health mission. To help FDA
review comments efficiently, please identify the question to which you
are responding by its associated category and number. If you are
responding to more than one question, please identify each question to
which you are responding, and categorize each response by question.
General
1. What are challenges faced in the development of drugs for
nonprescription use?
2. What are the biggest opportunities to improve access to
nonprescription drugs?
3. How could interested parties--including, but not limited to,
drug developers, health care providers, patients, consumers, and
retailers--work together to increase access to safe and effective
nonprescription drugs?
4. Looking ahead to a 2026 public meeting, what specific topics or
questions would you like to see on the agenda for public discussion?
Scientific Considerations
5. What scientific barriers most limit progress in increasing
access to nonprescription drugs?
6. What additional scientific tools, technologies, or data sources
could support access to nonprescription drugs?
7. Are there specific diseases or conditions that have not,
traditionally, been treated with nonprescription drugs for which
nonprescription drugs could be safely and effectively used without the
supervision of a licensed healthcare practitioner? If so, what
information would support such use under the applicable statutory and
regulatory requirements for nonprescription drugs?
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-21728 Filed 12-1-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 2, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.