Impact of the pregnancy and lactation labeling rule (PLLR) on practicing dermatologists

Abstract

On June 30th 2015, the FDA instituted a new system for the categorization of drug safety during pregnancy and lactation, known as the Pregnancy and Lactation Labeling Rule (PLLR), which replaces the “A, B, C, D, X” pregnancy labeling categories. The new rule will apply to all newly approved prescription medications, with a staggered phase-in for prescription drugs approved prior to the effective date. In this article, we provide a brief description of the major changes introduced by the PLLR and discuss the major implication of this new categorization system for clinical dermatologists.