Drug Applications for Over-the-Counter (OTC) Drugs
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 IV1. The Nonprescription Drug Advisory Committee2 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 developed3 and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Many of these monographs are found in section 300 of the Code of Federal Regulations4.
Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.
New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application5 process. A drug company may also petition to change a final monograph to include additional ingredients or to modify labeling.
Thanks for the information about the OTC potential of Z-160. I am a long term holder of Z and it has been a difficult ride to say the least. I need to keep hearing any positive news in order to keep me from giving up on Z.