ABSTRACT
This chapter discusses the evolution of and regulatory requirements for assessment of the efficacy of over-the-counter (OTC) antiseptic drug products. The discussion begins with a summary of the salient concepts proposed in the 1974 Federal Register Notice of rule making and concludes with the 1994 Tentative Final Monograph (TFM) [1,2]. The discussion also addresses the relationship that exists between the OTC and New Drug Application (NDA) antiseptic drug product regulatory process and how these processes influence each other. Finally, the chapter concludes with a discussion of the technical issues facing the FDA and the scientific community regarding protocol standardization, interpretation of the data derived from these studies, and the relationship of these outcomes with those in the clinical setting.
