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

This 90-minute webinar provides a comprehensive overview of the FDA's regulation of Over-the-Counter (OTC) drugs, covering key aspects such as regulatory frameworks, approval processes, labeling requirements, and compliance considerations. Participants will gain a clear understanding of the regulatory requirements governing OTC drugs, including the OTC Monograph System, labeling guidelines, and compliance with current Good Manufacturing Practices (cGMP). The webinar will explore the differences between OTC Monograph submissions and New Drug Applications (NDA), as well as the timeline and requirements for OTC drug approval. Additionally, participants will learn about important considerations for OTC drug development, including nonclinical and clinical studies, establishing product safety and efficacy profiles, and ensuring clear and accurate communication with consumers through labeling and marketing. Compliance and enforcement aspects, including FDA inspections and common compliance issues, will also be discussed. By attending this webinar, participants will gain practical insights and strategies to navigate the regulatory landscape effectively and ensure compliance with FDA regulations for OTC drug products.

Why You Should Attend:

This training offers numerous benefits for professionals involved in the development, manufacturing, regulatory affairs, and marketing of Over-the-Counter (OTC) drugs. Attendees will gain a comprehensive understanding of the FDA's regulatory requirements governing OTC drugs, including the OTC Monograph System, labeling guidelines, and compliance with current Good Manufacturing Practices (cGMP). By mastering key concepts such as the OTC drug approval process, participants will be equipped to navigate regulatory pathways effectively, ensuring timely market entry and compliance with FDA regulations. Additionally, attendees will learn about important considerations for OTC drug development, including nonclinical and clinical studies, product safety and efficacy evaluation, and communication strategies for consumers. Compliance and enforcement aspects, such as FDA inspections and common compliance issues, will also be covered, enabling participants to mitigate risks and maintain regulatory compliance throughout the product lifecycle. This training is ideal for professionals in regulatory affairs, product development, quality assurance, clinical research, legal, and marketing roles within the pharmaceutical and healthcare industries who seek to enhance their understanding of FDA regulations for OTC drugs and ensure successful market entry and compliance with regulatory requirements.

 Areas Covered in the Session :

• Regulatory Framework for OTC Drugs:
  • Overview of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • FDA's OTC Drug Monograph System
  • Labeling requirements for OTC drugs
  • Compliance with current Good Manufacturing Practices (cGMP)
• OTC Drug Approval Process:
  • Differences between OTC Monograph submissions and New Drug Applications (NDA)
  • Timeline and requirements for OTC drug approval
  • Post-market surveillance and reporting obligations
• Key Considerations for OTC Drug Development:
  • Active ingredients and OTC monographs
  • OTC drug categories and therapeutic classes
  • Nonclinical and clinical studies requirements
  • Establishing product safety and efficacy profiles
• Labeling and Marketing Requirements:
  • OTC drug labeling guidelines
  • Drug Facts Label format and content
  • Compliance with advertising and promotional materials
  • Ensuring clear and accurate communication with consumers
• Compliance and Enforcement:
  • FDA inspections and audits of OTC drug manufacturers
  • Common compliance issues and enforcement actions
  • Strategies for maintaining compliance with FDA regulations
• Resources and Support for OTC Drug Manufacturers:
  • FDA guidance documents and resources
  • Industry associations and collaborative initiatives
  • Training and educational opportunities for OTC drug professionals

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Labeling Experts
• Marketing Departments
• Compliance Departments
• Clinical Affairs Departments
• Product Development Teams

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.