Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process

Increasing over-the-counter switches in the US will add “ACNU” to regulatory jargon and flexibility to the Food and Drug Administration’s drug approval process, allowing the same ingredient at the same dose to remain available for prescription after being approved for nonprescription sales, according to a proposed rule.

The FDA’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule published on 27 June – its first proposal after a decade of considering changes to...