U.S. FDA· FDA·· 4 hours agoScore52
Engaging with Stakeholders to Bring Nonprescription Drug Products to Market
In brief
FDA has issued a 2025-2026 stakeholder engagement plan for bringing nonprescription drug products to market, comprising a request for information, two public meetings, a pilot program starting in 2026, and planned draft guidance. The plan follows a law passed in 2025 that added section 505(b)(7) to the FD&C Act to identify prescription drugs that are promising candidates for nonprescription availability. The article also outlines two regulatory pathways for nonprescription marketing, definitions of full and partial prescription-to-nonprescription switches, and the concept of Additional Conditions for Nonprescription Use (ACNU).
Source: U.S. FDA