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FDA Releases New Prescription Labeling System for Pregnant and Nursing Women and Men and Women of Reproductive Potential

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According to the U.S. Food and Drug Administration (FDA), there are over six million pregnancies in the United States every year. These pregnant women take an average of three to five prescription drugs during pregnancy, whether it’s for a controlling pre-existing condition, such as asthma during pregnancy, or controlling pregnancy-related symptoms and conditions. The FDA required labeling prescriptions with product letter categories- A, B, C, D and X. These letters classified the risk of using a particular substance while pregnant or breastfeeding.

Recognizing the shortcomings of the existing letter labeling system, the FDA published a new “final rule” setting standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and other biological products.  This new labeling system aims to classify the risks of using prescription drugs during pregnancy with three detailed subsections that, “describe risks within the real-world context of caring for pregnant women who may need medication.”

The rule requires the use of three labels for reproductive concerns by using labeling titled “Pregnancy,” “Lactation” and “Females and Males of Reproductive Potential” that provide details about use of the drug or biological product. These subsections must include a summary of the risks of using a drug during pregnancy and breastfeeding, a discussion of the data supporting the summary and relevant information to help healthcare providers make prescribing and counseling decisions.

The new labeling format and requirement reorganizes information and is structured to help inform healthcare professionals to make proper decisions in prescribing.  Pharmaceutical companies will have access to guidance materials from the FDA to properly comply with the new labeling requirements.


This new labeling system will be effective June 30, 2015. Below is a comparison of the current labeling system with the new final rule published by the FDA. Visit the FDA website for a more detailed breakdown of the labeling categories.