Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide)

Issue Date: June 10, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Final

Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide)

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).

Download the Guidance Document