An early historical perspective on the FDA's regulation of OTC drugs.

Abstract

From a variety of contacts with hospital infection control personnel, it has become clear to us that the historical perspective about and internal workings of the Food and Drug Administration (FDA) are confusing and deserve clarification. The accompanying article in this issue (“Regulation of Topical Antimicrobials: History, Current Status and Future Perspective,” pp. 505-508) details the regulation of topical antimicrobial drugs administered by the FDA. We believe it is necessary to provide a special context for this article.