ABSTRACT
Package inserts were originally intended to provide drug information to practicing physicians. Drug labeling regulations began in 1906 with the enactment of the Pure Food and Drug Act and were expanded in 1938 with the passage of the Federal Food, Drug and Cosmetic Act. The latter act required all drugs be dispensed with information regarding method and duration of use, as well as warning information about unsafe dosages. After the thalidomide tragedy in Europe, labeling requirements in the United States were strengthened in 1962 by amendments to the act. The warning labels were required to include information regarding the active ingredients, the indications and directions for use, the mechanism for drug action, and potential adverse effects of the drug. Over the years, these warning labels have expanded in their content and scope, and are commonly referred to as package inserts.
