OTC Monograph Reform and OMUFA II: What FDA's Modernized OTC Framework Means for Manufacturers

The regulatory framework governing OTC monograph products has changed significantly following FDA's modernization of the OTC monograph system and the continued expansion of OMUFA requirements. While many manufacturers remain familiar with the historical OTC review process, growing attention is now being placed on administrative orders, facility obligations, user fee responsibilities, product changes, documentation expectations, and the practical impact of FDA's modernized oversight approach. Questions continue to emerge around how organizations should interpret these changes within daily regulatory, quality, manufacturing, and compliance activities.

This session examines the practical implications of OTC monograph reform and OMUFA II from a manufacturer's perspective. The discussion will focus on regulatory responsibilities, facility registration considerations, user fee obligations, product lifecycle impacts, change management expectations, and the operational decisions organizations must increasingly support within the modern OTC environment. Participants will gain a clearer understanding of how the framework functions in practice and where regulatory scrutiny may continue to increase.