Back to: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
Presenter
CDR Tramara Dam, PharmD, MBA, BCSCP, GWCPM
Senior Program Management Officer
Division of User Fee Management (DUFM)
Policy and Operations Branch (POB)
Office of Management (OM)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Abstract
Commander Tramara Dam introduces the OTC Monograph Drug User Fee Program (OMUFA), established by the CARES Act to modernize OTC drug regulation and fund regulatory activities through fees from qualifying manufacturers and OMAR requesters. Key terms defined included MDF (OTC Monograph Drug Facility) and CMO (Contract Manufacturing Organization), with CMOs paying two-thirds of the MDF fee. Proper facility registration in eDRLS using appropriate SPL codes is essential for fee assessment. The FY 2025 facility fee liability is triggered by engaging in manufacturing or processing activities any time between January 1, 2024, and December 31, 2024. Commander Dam emphasized that there are no statutory waivers or reductions available for OMUFA facility fees.