Introduction to the new prescription drug labeling by the Food and Drug Administration

Abstract

The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. A new FDA final rule, "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," became effective in June 2006. The rule is part of FDA's initiative to manage the risks of medical product use and minimize adverse events. The new labeling reorders and reorganizes sections found in the previous labeling format. A label is now divided into highlights of prescribing information, contents of the full prescribing information (FPI), and the FPI. The highlights section is a half-page summary of the information that health care practitioners most commonly refer to and view as most important. This section contains cross-references to details in the FPI section. The contents section serves as a navigational tool that references all the sections in the FPI. The FPI section has been revised as to content, format, and order to make information clearer and more usable. FDA has instituted a flexible implementation schedule that phases in the new labeling requirements; more time to achieve compliance is provided for older products. The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA. The new requirements do not apply to nonprescription drug products. FDA has designed new labeling to help health care practitioners easily find, read, and convey information important for the safe and effective use of prescription drugs.