Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling

This information collection supports Food and Drug Administration (FDA) regulations. Specifically, regulations found at 21 CFR 201.57 governing the content and format of labeling requirements for “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential” individuals. The regulations are intended to improve the content and format of prescription drug labeling by creating a consistent format for providing information about the risks and benefits of drug use during pregnancy and lactation by patients included within specific populations. The regulations also require the removal of the pregnancy categories A, B, C, D, and X from all drug product labeling.

The latest form for Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling expires 2021-04-30 and can be found here.

Supplements to Applications Approved 6/30/01 to Effective Date

Federal Enterprise Architecture: Health - Public Health Monitoring