Understand the practical regulatory, quality, and operational implications of FDA's modernized OTC monograph system and OMUFA II — from product lifecycle decisions to documentation requirements.
Includes live access & recording
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, and documentation expectations.
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 focuses 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.
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. 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.
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.
By the end of this session, participants will have a clear, practical understanding of how the modernized OTC framework applies to day-to-day regulatory, quality, and manufacturing decisions.
Understand the key regulatory changes introduced by OTC monograph reform and how they differ from the historical review process.
Determine whether product changes remain within monograph conditions or trigger new regulatory obligations.
Navigate administrative orders and understand their practical impact on product strategy and lifecycle decisions.
Understand OMUFA II user fee obligations, facility registration requirements, and their operational implications.
Recognize regulatory responsibilities across brand owners, contract manufacturers, and distributors under the modernized framework.
Manage labeling, claims, and formula changes in compliance with the modernized OTC framework requirements.
Build documentation practices that support defensible OTC regulatory decisions during inspections and reviews.
Identify common OTC compliance assumptions that now create risk under the modernized framework.
Four focused areas covering the regulatory, operational, and documentation dimensions of the modernized OTC framework.
Understand how administrative orders replaced the traditional OTC review process and what that means for product changes, approvals, and ongoing regulatory obligations.
Get clarity on user fee responsibilities, facility registration considerations, and the compliance decisions that commonly create operational challenges under OMUFA II.
Learn how labeling, formula, and claims changes are evaluated under the modernized framework and where product modifications may now trigger additional regulatory scrutiny.
Understand what documentation and evidence is needed to support OTC regulatory decisions — and where common assumptions create compliance gaps under the new framework.
Eight topics covering the complete practical landscape of OTC monograph reform and OMUFA II from a manufacturer's perspective.
Regulatory, quality, manufacturing, and compliance professionals in OTC drug manufacturing and related supply chain organizations.
Regulatory Affairs Departments
Quality Assurance (QA) Departments
OTC Drug Manufacturers
Compliance & Quality Systems Professionals
Manufacturing Departments
Operations Departments
Product Development Teams
Contract Manufacturing Organizations (CMOs)
Pharmaceutical Regulatory & Compliance Consultants
The modernization of the OTC monograph system represents one of the most significant structural changes to FDA's oversight of nonprescription drugs in decades. The CARES Act formalized this shift by replacing the longstanding rulemaking-based review process with an administrative order system — giving FDA greater flexibility and speed in updating monograph conditions, but also creating new obligations and decision points for manufacturers that were not previously part of routine compliance activities.
OMUFA II extended user fee authority specifically to OTC monograph products, introducing a structured funding mechanism that now intersects with facility registration, product reporting, and operational planning. For many organizations, particularly those that have historically viewed OTC compliance as a relatively stable area, these changes have required a reexamination of internal responsibilities, resource allocation, and regulatory workflows.
The practical impact is felt most acutely during product lifecycle decisions — when changes to formulas, labeling, or claims must be evaluated not only against existing monograph conditions but also within the context of any relevant administrative orders. Decisions that were once handled through straightforward monograph review now require more careful assessment of whether a modification falls within current conditions, creates new reporting obligations, or necessitates coordination with FDA's evolving administrative order framework.
This session addresses the applied dimension of these changes — what they mean for the people making day-to-day regulatory, quality, and manufacturing decisions. Participants will gain a working understanding of how the modernized OTC framework operates in practice, where the most common compliance gaps are emerging, and what manufacturers need to do to make and document decisions that will hold up under regulatory review.
Meredith Crabtree has over 30 years of experience in regulated industries, spanning Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. Her background encompasses manufacturing, packaging, labelling, and distribution operations across a broad range of regulated environments.
Meredith is the owner of MLKC Consulting, a Quality Consulting firm specializing in product label reviews, third-party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings for organizations across FDA-regulated industries.
Don't miss this essential session on FDA's modernized OTC framework. Get the practical clarity you need to navigate OMUFA II, administrative orders, and product lifecycle decisions.