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.

| WHY YOU SHOULD ATTEND

For years, OTC compliance decisions often followed familiar patterns. A product change was proposed, the monograph was reviewed, supporting documentation was assembled, and the business moved forward. The modernization of the OTC framework has introduced new processes, new obligations, and new decision points that now sit directly within routine product lifecycle activities. Organizations are finding that decisions once considered straightforward can now carry additional regulatory, operational, and financial consequences.

The impact is often felt long before a regulatory action occurs. Product teams, regulatory groups, quality units, and manufacturing organizations must align on how changes are evaluated, how responsibilities are assigned, and how decisions are documented. Small misunderstandings can create delays, unnecessary risk, or costly rework. This session explores the practical realities of operating within the modern OTC framework and the decisions manufacturers are increasingly being asked to make and defend.

| AREAS COVERED

• Determining Whether Product Changes Remain Within Monograph Conditions
• Managing Labeling, Claims, and Formula Changes Under the Modernized OTC Framework
• When OTC Product Modifications Create New Regulatory Questions
• Navigating Administrative Orders and Their Impact on Product Strategy
• Regulatory Responsibility Across Brand Owners, Manufacturers, and Distributors
• OMUFA II Compliance Decisions That Commonly Create Operational Challenges
• Documentation and Evidence Supporting Defensible OTC Regulatory Decisions
• Common OTC Assumptions That Create Compliance Risk Under the Modernized Framework

| WHO SHOULD ATTEND

• Regulatory Affairs Departments
• Quality Assurance (QA) Departments
• OTC Drug Manufacturers
• Compliance and Quality Systems Professionals
• Manufacturing Departments
• Operations Departments
• Product Development Teams
• Contract Manufacturing Organizations (CMOs)
• Pharmaceutical Regulatory and Compliance Consultants

Course Director: Meredith Crabtree

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.