Over-the-counter (OTC) drug products are sold directly to consumers without the need of a prescription from a healthcare provider. In the US, these products are regulated by the Food and Drug Administration (FDA). Because of the large number of marketed OTC drug products, FDA reviews the active ingredients and labeling of over 80 therapeutic classes of drugs (e.g., analgesics) instead of individual drug products. This webinar will provide clarification on determining a regulatory pathway to bring your OTC drug product to market. OTC drug products are vital to the health care of America. Regulatory pathways for OTC products include utilizing the monograph system or gaining approval through the FDA New Drug Application (NDA) process. The Division of Nonprescription Regulation Development (DNRD) in the Office of Drug Evaluation is responsible for the development of OTC drug monographs. Data presented to support the safety and efficacy of different active ingredients in a particular drug monograph is reviewed by the appropriate scientific personnel. Although DNRD is considered to be the lead division in the development of an OTC drug monograph, reviewers (e.g., medical officers, statisticians, pharmacologists) from multiple divisions within the Office of New Drugs (OND) are involved. It is important to note that if a drug cannot comply with the drug monograph, an approved NDA is necessary before the drug product may be marketed.