S 2529
A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.
Jurisdiction
US Congress
Session
119th Congress (2025-2026)
Last updated at
Jun 14, 2026, 7:37 AM
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Sign in to take action- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
This bill aims to make the process for switching prescription drugs to over-the-counter (OTC) status clearer and more predictable. It requires the Food and Drug Administration (FDA) to issue guidance on how to evaluate applications for these switches, considering factors like medical literature, previous safety data, and consumer understanding. The bill also mandates the FDA to create a plan for engaging with stakeholders and to have the Government Accountability Office (GAO) assess the efficiency and effectiveness of the current Rx-to-nonprescription switch process.
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