ABSTRACT
Prior to the advent of the 1938 Food, Drug and Cosmetic Act (FD&C Act), technically all drugs could be marketed without a prescription. After passage of the Act, the U.S. Food and Drug Administration (FDA) decided on a case-by-case basis which drugs were to be considered prescription only and which could be sold over the counter (OTC), since the FD&C Act was silent on this matter. The usual key criterion used in
this decision-making process was whether or not adequate directions for safe use existed for the products in question.
