Females and Males of Reproductive Potential

The 2014 amendment to the FDA’s regulations governing the content and format of labeling for human prescription drugs and biological products also requires the inclusion of a “Females and Males of Reproductive Potential” subsection.2,3 The subsection provides guidance when pregnancy testing or contraception is required or recommended before, during, or after drug therapy; or when there are human or animal data that suggest drug-associated fertility effects.