Over-the-counter (nonprescription) drug products play an increasingly vital role in America's health care system. OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional.FDA's review of OTC drugs is primarily handled by CDER's Office of Drug Evaluation IV. The Nonprescription Drug Advisory Committee meets regularly to assist the agency in evaluating issues surrounding these products. This committee has played a major role in the growth of prescription to OTC switches in recent years.
Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids, instead of individual drug products. For each category, an OTC drug monograph is developed and published in the Federal Register.