The U.S. Food and Drug Administration’s is responsible for regulating the Over-the-Counter Drug market. In this webinar, attendees will learn what is required to market and sell an OTC drug in the U.S. It will provide information on what is an OTC drug, how they are regulated, the different types of products, how to read a Monograph, whether or not a certain ingredient can be used, the parts of a proper label, and a variety of other important requirements needed to be successful.

Why Should You Attend

  • Do you know how to properly market and sell an OTC drug in the U.S.?
  • Are the ingredients in your product safe? Does your label comply with the regulations?
  • If you are already selling OTC drugs, are you ready for an FDA facility inspection?

Areas Covered in the Webinar

  • Participants who attend this course will:
    • Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S.
    • Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
    • Recognize the difference between the various pathways for commercializing an OTC Drug Product.
    • Understand how to identify and successfully navigate an OTC Drug Monograph.
    • Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
    • Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC Drug and understand the difference between Category I, II and II Ingredient designations.
    • Identify the required elements of a compliant OTC Drug Label.
    • Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
    • Possess a working knowledge of the Rx-to-OTC Switch Process.
    • Review and evaluate several of FDA’s current OTC Monographs with a focus on the Cold & Cough and Oral Healthcare monographs.

Who Will Benefit

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Labelers and Private Labelers
  • Contract Manufacturers
  • Importers and Custom Agents
  • U.S. Agents of Foreign Corporations
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal Professionals
  • Financial Advisors and Institutional Investors
  • Consultants, Inspectors and cGMP Experts

  • From the following sectors:
    • OTC drugs
    • Pharmaceuticals
    • Drugs
    • Dietary supplements
    • Ingredient manufacturers
    • Distributors
    • Foreign drug companies