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# Do More to Capture Nonprescription Drug Use Info: Meeting
- URL: https://www.fdaweb.com/do-more-to-capture-nonprescription-drug-use-info-meeting/
- Published: 2026-08-26T12:00:00.000Z
- Updated: 2026-09-14T12:05:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161687

One of the key takeaways from a 4/23 meeting convened by FDA and the Duke Margolis Institute for Health Policy to discuss increasing access to nonprescription drugs was the recognition that additional efforts may be necessary to capture information on nonprescription drug use in electronic health records or via other means. A [meeting summary](https://healthpolicy.duke.edu/sites/default/files/2026-08/Meeting%20Summary%5FIncreasing%20Access%20to%20Nonprescription%20Drugs.pdf?ref=fdaweb.com) was just released by the Duke Institute.

The summary says that speakers at the event discussed the potential value of increased access to nonprescription drugs as well as innovative ways to generate the necessary evidence about nonprescription drug candidates’ safety and effectiveness in the nonprescription setting.

The takeaways listed in the summary are:

- an overview of the current regulatory landscape for nonprescription drugs and prescription-to-nonprescription switches, including the option for nonprescription drug products with an additional condition for nonprescription use (ACNU), and what evidence about consumer comprehension and behavior is generally needed to inform regulatory decisions;
- for prescription-to-nonprescription switches without an ACNU, sponsors must communicate the clinically significant information from the prescription drug label in the much smaller Drug Facts label;
- real-world data could provide useful context to help sponsors and regulators anticipate or observe how consumers use nonprescription products, but data collection and evidence generation is limited in the nonprescription drug space compared to the prescription drug space; and
- the ACNU pathway is intended to enable nonprescription access to products for which labeling alone is inadequate for safe and effective consumer use, and participants were generally optimistic about the opportunities this may provide.