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

“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

Increasing OTC 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 Rx 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 –...