Lifestyle and Over‐the‐Counter Drugs

Abstract

This chapter attempts to show how lifestyle drugs and over‐the counter (OTC) drugs relate to each other and the challenges that they face. It also traces the history of OTC drugs and regulations, shows how the OTC Review process works, and shows how the United States, Europe, and Japan classify OTC drugs. It briefly explains the three major criteria for Rx‐to‐OTC switch—safety, labeling, and effectiveness. The chapter also provides an overview and a generalized definition of lifestyle drugs. Four examples of lifestyle drugs are provided: hair growth drugs, smoking cessation drugs, sexual disorder drugs, and sunscreens. The selected examples cover both prescription only and OTC lifestyle drugs. The chapter ends with a look into the future for OTC and lifestyle drugs.