FDA Wants Your Data to Tweak Over-the-Counter Rules
Published Date: 7/16/2026
Notice
Summary
The FDA is rolling out a clear process to ask the public for data to help update rules about over-the-counter (OTC) drugs. This means anyone interested in OTC drug safety and use can share info that might change how these medicines are regulated. The new process starts now and aims to make drug updates smarter and faster, with no direct costs to the public but big benefits for safer medicines.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Public data submissions for OTC monographs
Starting July 16, 2026, FDA will announce Data Requests on the OTC Monographs@FDA portal (https://www.accessdata.fda.gov/scripts/cder/omuf/). The public may submit data and information in response to those Data Requests to help inform certain future over‑the‑counter (OTC) monograph drug activities.
Submission confidentiality and notification process
Each Data Request will include instructions on how to submit data, how confidential information will be handled, and how submissions may be viewed by the public. FDA also intends to list planned Data Requests in its Annual Forecast for Planned Monograph Activities (a nonbinding 3‑year list) and offers an email mailing list on the OTC Monographs@FDA portal for alerts.
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Key Dates
Department and Agencies
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