OTC Monograph Reform and OMUFA II: What FDA’s Modernized OTC Framework Means for Manufacturers
A practical session on OTC product responsibilities, monograph change decisions, OMUFA obligations, and documentation expectations under FDA’s modernized framework.
GROUP SAVINGS: Get your team to attend for just $390.
Individual registrations available too.
OTC monograph decisions now carry operational consequences.
OTC manufacturers now face product, facility, fee, and documentation choices that affect routine lifecycle decisions across regulatory, quality, and manufacturing functions.
The session connects monograph status, product modifications, facility obligations, OMUFA requirements, and supporting documentation to the decisions OTC teams must make across the product lifecycle.
The discussion moves from framework changes to operational application, showing how monograph status, product modifications, facility responsibilities, user fees, and documentation expectations intersect in everyday OTC decision-making. Emphasis is placed on how teams evaluate, assign, and record responsibilities before issues become costly or difficult to resolve.
- Determine whether product changes remain within monograph conditions
- Assess labeling, claims, and formula changes under the modern OTC framework
- Recognize when OTC modifications raise new regulatory questions
- Understand administrative orders and their product strategy impact
- Clarify responsibilities across brand owners, manufacturers, and distributors
- Evaluate OMUFA II decisions that create operational challenges
- Document evidence supporting OTC regulatory positions
- Identify common OTC assumptions that create compliance exposure
Designed for professionals responsible for OTC product decisions, quality systems, manufacturing execution, regulatory review, and lifecycle documentation.
Meredith Crabtree
Meredith Crabtree’s 30 years across regulated manufacturing, packaging, labeling, distribution, inspections, recalls, consent decree support, and regulatory assessments give her direct perspective on OTC compliance decisions. Her work in label reviews, quality consulting, and regulatory training aligns closely with the monograph, OMUFA, documentation, and operational responsibilities covered in this session.
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Customized training is also available through TalkFDA Elite Training Labs.
This topic can also be delivered as a customized session for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.
TalkFDA Elite Training Labs