Duration: 75 Minutes


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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.

Definitions of prescription (Rx) and OTC drugs will be presented. The three ways that FDA regulates OTC drugs, Monographs, Applications and Rx to OTC switches, will be discussed. Labeling rules for OTC products will be reviewed. 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.


Areas Covered in the Session :

  • Rx versus OTC
  • How are OTC drugs regulated?
  • Monographs
  • NDA or ANDA
  • Rx to OTC Switch
  • Labeling
  • GMPs

Who Should Attend:

  • Quality Departments
  • Regulatory Affairs Departments
  • Marketing Departments
  • Labeling Experts

Course Director: DR. LOREN GELBER

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She then transitioned to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.