OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration

May 20, 2025

This webinar will provide an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and describe the key elements of the program as it relates to OMUFA user fees. Topics to be discussed include:

• Update for facilities that first registered with FDA on or after the declaration of the COVID-19 Public Health Emergency (PHE) for the sole purpose of producing hand sanitizer products during the COVID-19 PHE
• Registration process for over-the-counter monograph drug facilities
• Different fee types for OMUFA
• Fiscal year 2025 target revenue, fee rates, and timelines
• Penalties associated with failure to pay OMUFA user fees
• Overview of the fee payment process
• OMUFA refund eligibility

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 Program known as OMUFA. 
• General public with an interest in over-the-counter monograph drug products and/or non-prescription drugs.
• Researchers testing over-the-counter monograph drug products and/or non-prescription drugs.
• Foreign regulators of 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. 
• Healthcare professionals specializing in over-the-counter monograph drug products and/or non-prescription drugs.
• Importers of over-the-counter monograph drug products and/or non-prescription drugs.
• Supply chain of over-the-counter monograph drug products and/or non-prescription drugs.

Topics Covered

• Develop knowledge on the fees associated with the Over-the-Counter Monograph Drug User Fee Program (OMUFA).
• Describe the registration process for over-the-counter monograph drug facilities.
• Outline the different fee types for OMUFA. 
• Explain the fee collection and payment process for OMUFA.  
• Define the timelines for OMUFA.
• Clarify the process for entities that registered with FDA during the Coronavirus Disease 2019 (COVID-19) pandemic whose sole activity with respect to OTC monograph drugs consisted of manufacturing OTC hand sanitizer products

Resources

• Over-The-Counter Monograph User Fee Program (OMUFA)  
• November 2, 2022: OMUFA draft guidance for industry titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program 
• February 1, 2022: OMUFA Draft guidance Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs 
• Updated Over-the-Counter Monograph User Fee Program Performance Goals Dates– Fiscal Years 2021-2025  
• OMUFA Cover Sheet and Payment Information 
• Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act 

visit the FDA.gov webpage