This guidance is intended to help small businesses better understand and comply with the new content and format requirements of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products. On December 4, 2014, we published the final rule “Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling,” referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR, or final rule, 79 FR 72064). The final rule requires that the former “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the USE IN SPECIFIC POPULATIONS section of the labeling for human prescription drug and biological products be replaced by the three subsections entitled Pregnancy, Lactation, and Females and Males of Reproductive Potential.
FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).