The 2014 FDA amendment to regulations governing the content and format of labeling for human prescription drugs and biological products, which became effective on 30 June 2015, also requires the inclusion of a “Lactation” subsection in the package insert.65 Information about LA-related risks to a breastfeeding child and recommendations on how to minimize drug exposure when a drug is administered to the mother can be found in the “Lactation” subsection of specific package inserts.21-25
