FDA Updates Labeling Requirements Regarding Pregnancy and Lactation

Effective June 30, 2015, FDA-approved products will face new labeling requirements. The five existing pregnancy risk categories (A, B, C, D, and X) will be replaced with condensed summaries of relevant studies and organized into three sections: A new section called “Females and Males of Reproductive Potential” will be added to the sections entitled “Pregnancy” and “Lactation.” Labels must be updated “when new information becomes available that causes the labeling to become inaccurate, false, or misleading.” Labeling for prescription drugs approved after July 2001 will be gradually updated; however, labeling for over-the-counter medicines will not change.