What Are Drugs?

Abstract

FDA defines a drug in the following three ways: (1) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; (2) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (3) articles recognized in the official United States Pharmacopeia, Homeopathic Pharmacopeia of the United States or National Formulary or any supplement to any of them (Table 2.1). FDA-approved drugs are classified as either non-prescription – so-called Over-the-Counter (OTC) drugs – or prescription drugs. The latter are mainly either New Drugs, including Biological Drugs (Biologics), or Generic Drugs. However, prescription drugs may also be in the Botanical or DESI (Drug Efficacy Study Implementation) category. FDA regulation of human drugs is by its Center for Drug Evaluation and Research (CDER) while veterinary drugs are regulated through its Center for Veterinary Medicine. By FDA definition all drugs, in contrast to devices (Table 2.2), work, that is, achieve their intended purpose by chemical action in or on the body or through being metabolized.