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  4. FDA Public Meeting on Increasing Access to Nonprescription Drugs - 04/23/2026
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Event Title
FDA Public Meeting on Increasing Access to Nonprescription Drugs
April 23, 2026

Date:
April 23, 2026
Time:
12:30 p.m. - 5:00 p.m. ET
Location:
Event Location
National Press Club
Holeman Lounge

529 14th Street NW
Washington, DC 20045
United States


The Food and Drug Administration is announcing a public meeting and comment period, “Increasing Access to Nonprescription Drugs.” The meeting will bring together experts to discuss perspectives on expanding access to nonprescription or over-the-counter (OTC) drugs. Making more drugs available over the counter can decrease medication costs and improve access to important treatments. 

The public meeting will discuss perspectives on increasing access to nonprescription drugs from interested parties, including drug developers, healthcare professionals, and consumers, among others. FDA is particularly interested in practical considerations that shape nonprescription drug access.

The meeting will focus on the following topics:

  • Specific diseases or conditions that have not been treated with nonprescription drugs for which nonprescription drugs could be safely and effectively used. 
  • Challenges industry may face in developing such nonprescription drugs.
  • Opportunities to improve access.
  • Opportunities for stakeholder collaboration to increase cost-effective access to safe and effective nonprescription drugs.

FDA approves drugs as either prescription or nonprescription under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A drug must be prescribed when it is not safe for use except under medical supervision due to its toxicity, potential for harmful effects, method of use, or additional measures necessary to its use. 

If a drug does not meet prescription-only criteria, it may be marketed as nonprescription through the new drug application (NDA) process. Nonprescription drugs can also be marketed without an approved NDA if they meet conditions of an OTC monograph. An OTC monograph includes parameters such as active ingredients, uses, doses, routes of administration, labeling, and testing, that a drug in a given therapeutic category (e.g., sunscreen, antacid) must meet to be generally recognized as safe and effective (GRASE). 

A request for information for the April 23, 2026, meeting was issued in the Federal Register on Dec. 2, 2025 (90 FR 55316). Comments received by Feb. 2, 2026, will inform discussion during the public meeting.

A comment period will reopen in conjunction with this meeting for additional public input. Duke-Margolis will publish a discussion guide approximately one week before the meeting, and FDA will post the agenda and meeting materials approximately three business days in advance.

Meeting Registration and Event Materials

Please visit the following link: https://healthpolicy.duke.edu/events/increasing-access-nonprescription-drugs

Submit Comments

Comments on Increasing Access to Nonprescription Drugs must be submitted on or before May 8, 2026. Submit electronic comments to www.regulations.gov to docket number FDA-2025-N-4731. Written comments should be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should identify the docket number FDA-2025-N-4731.

For Further Information

For general questions about the public meeting, please contact margolisevents@duke.edu.
 

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