OTC Monograph Drug User Fee Amendments (OMUFA)

May 5, 2026

Understanding FY 2026 User Fees and Registration

The webinar provides an overview of the Over-the-Counter Drug User Fee Amendments (OMUFA) and describes the key elements of the amendments as it relates to OMUFA user fees. Topics to be discussed include:

Overview of OMUFA as it relates to user fees, fees liable period and due dates
Registration process for over-the-counter monograph drug facilities
Different fee types for OMUFA
Fiscal year 2026 target revenue, fee rates, and timelines
Penalties associated with failure to pay OMUFA user fees
Fee payment process.
OMUFA refund eligibility
OMUFA frequently asked questions

Intended Audience

Regulatory affairs professionals working on over-the-counter monograph drug products and/or non-prescription drugs or who submit over-the-counter monograph order requests
Industry partners following the FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Amendments known as OMUFA
Researchers and Foreign Regulators testing over-the-counter monograph drug products and/or non-prescription drugs
Consultants focused on processing, manufacturing, developing of over-the-counter monograph drug products and/or non-prescription drugs
Clinical research coordinators
Importers and supply chains of over-the-counter monograph drug products and/or non-prescription drugs
Healthcare professionals specializing in over-the-counter monograph drug products and/or non-prescription drugs
General public with an interest in over-the-counter monograph drug products and/or non-prescription drugs

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