FDA Lays Out Stakeholder Engagement Plan for Nonprescription Drug Switches
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The FDA has issued a 2025-2026 stakeholder engagement plan for bringing nonprescription drug products to market. The plan implements new section 505(b)(7) of the FD&C Act, added by a law passed in 2025, and aims to identify prescription drugs that are promising candidates for nonprescription availability. Its components include a request for information, two public meetings, a 2026 pilot program, and planned draft guidance. The plan also describes the two regulatory pathways for marketing nonprescription drugs, defines full and partial prescription-to-nonprescription switches, and introduces the concept of Additional Conditions for Nonprescription Use (ACNU). The pilot program and draft guidance are still ahead, and which drug candidates will be selected remains open.
Written by a model from the reports · updated 4 hours ago
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- U.S. FDAEngaging with Stakeholders to Bring Nonprescription Drug Products to Market
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to market, comprising a request for information, two public meetings, a pilot program starting in 2026, and planned draft guidance.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).
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