FDA Regulations for OTC Drugs

Product Id : FDA155
Instructor : Loren Gelber
Jul 24, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes


The three ways that the FDA regulates OTC (Over-the-Counter) drugs. Monographs, Rx to OTC switches and NDA/ANDA submissions will be discussed in detail.  Labeling and advertising of OTC drugs will be covered.  Other requirements, including Registration, Drug Listing and Current Good Manufacturing Practice, will be covered.  Examples from recent Warning Letters and FDA Inspectional Observations (483s) will be used to show what not to do.

Both new and experiences OTC manufacturers will benefit from a review of the various FDA rules for OTC drugs. Knowledge of these rules and regulations is important for staying out of trouble with the FDA, which should be one of the main objectives of every drug manufacturer.

This webinar will discuss U.S. FDA and Consumer Product Safety Commission regulation of OTC drug products and strategic recommendations for mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available options for producing and selling an OTC drug product.

This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.

Areas Covered in the Webinar:

  • Claims for drugs, devices, medical foods and cosmetics
  • NDA, ANDA and OTC Monographs for OTC Drugs
  • Rx to OTC Switches
  • cGMPs for OTC drugs
  • Tamper Evidence and Poison Control
  • Branded Innovator, Branded Generic and Generics

Who Will Benefit:

  • Regulatory affairs managers, directors and associates
  • Compliance specialists
  • Marketing managers
  • Quality professionals
  • Document control specialists
  • Record retention specialists
Speaker Profile:

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory compliance. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

Available Options