CHA News Article

Final Prescription Labeling Rule for Pregnant Women Issued

The Food and Drug Administration (FDA) has published a final rule with new requirements for labeling prescription drugs and biological products when used during pregnancy and breastfeeding. Beginning June 30, the final rule will replace the current system of letter categories. According to the FDA, the new labeling will provide explanations about potential benefits and risks for the mother, fetus and breastfeeding child. The FDA has also published draft guidance on the final rule for manufacturers.