05/14/2026
OMUFA compliance is no longer just a regulatory detail for OTC drug manufacturers. It is a critical business risk.
In this article, we break down:
• What OMUFA is and why it was created
• The difference between MDF and CMO facility classifications
• How OMUFA fees impact OTC manufacturers and distributors
• What happens when companies miss payment deadlines
• Why the FDA Arrears List can disrupt market access and supply chains
If your company manufactures or distributes OTC monograph drugs, understanding OMUFA requirements is essential to maintaining compliance and protecting your U.S. market access.
Read the full article: https://hubs.li/Q04gBLfq0
A complete guide to OMUFA: Learn how OTC drug makers can manage FDA facility fees, OMORs, exemptions, and stay compliant under the CARES Act framework.