FDA Regulation for Over-the-Counter (OTC) Drug Products

  • Instructor : Meredith Crabtree
  • Level : Intermediate
  • Study time : 82 minutes
  • Course ID: TF3614
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ABOUT THE COURSE

Are you confident your OTC products follow the right FDA regulatory pathway?
Do you know when an NDA, ANDA, or monograph applies to your product?
Could your team be making labeling or GMP mistakes that risk a 483 or Warning Letter?


This training cuts through the complexity of OTC drug regulation-from Rx switches to monographs to GMPs-so you stay compliant, market faster, and avoid costly mistakes.


WHAT WILL YOU GAIN
  • A complete understanding of how FDA classifies and regulates OTC drugs.
  • Clarity on when NDAs, ANDAs, or monographs apply-and what to do next.
  • Actionable insights from recent FDA enforcement cases and labeling missteps.


WHY TAKE THIS COURSE
  • Protect your brand by avoiding preventable regulatory pitfalls.
  • Get every department aligned on the right compliance framework.
  • Use real examples to strengthen your labeling, filing, and GMP practices.


KEY AREAS COVERED
  • Definitions and distinctions between Rx and OTC drugs.
  • Three FDA pathways for regulating OTC products.
  • When to file NDA or ANDA vs. follow an OTC monograph.
  • Labeling requirements specific to OTC drug products.
  • Registration, listing, and GMP obligations for manufacturers.
  • FDA 483s and Warning Letters-recent real-world examples.

Quality training, expert insights, and answers that matter. Know your Expert

MEREDITH CRABTREE

Meredith Crabtree brings over 30 years of leadership in regulated industries including Pharma, Biologics, and Medical Devices. As the founder of MLKC Consulting, she’s known for her sharp regulatory acumen, hands-on approach to quality systems, and expertise in inspections, recalls, and compliance remediation. Her real-world insight makes her the ideal mentor for mastering aseptic processing and validation practices.

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