ABSTRACT

Overview and objectives The Federal Food, Drug, and Cosmetic Act (FDCA) of 1938, as described in Chapter 2, was formulated as a reaction to instances that occurred because of lack of governmental controls. Although people do not want governments to control their lives more than necessary, certain things can be done only by government actions. Protecting each citizen from adulterated or misbranded drugs is one of those things; no one person has the ability or the resources to make such determinations independently, so the FDCA and its amendments are meant to provide this protection through the actions of the Food and Drug Administration (FDA) as it administers the FDCA.