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