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 reviewed. 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 are important for staying out of trouble with the FDA, which should be one of the main objectives of every drug manufacturer.
Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.