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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Pregnancy and Lactation Medication Information for the Healthcare Provider

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Tue, 6/21/22: 12:00 AM EDT
Ends On: Tue, 12/31/24: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: FDA implemented a revised pregnancy and lactation labeling system. The updated labeling system replaces the pregnancy letter categories – A, B, C, D and X – used to classify prescription drugs used during pregnancy with a description of risks within the real-world context of caring for pregnant people who may need medication. This presentation provides an overview of the current pregnancy and lactation labeling system, also known as the Pregnancy and Lactation Labeling Rule (PLLR), lessons learned, and feedback received from healthcare providers. Further, it will help learners examine how prescription drug labeling can be used to inform prescribing in pregnant and lactating individuals.
Objectives:
  • Discuss the history of pregnancy and lactation labeling.
  • Explain the current prescription drug labeling for pregnancy, lactation, and females and males of reproductive potential.
  • Describe the FDA review process for incorporating information in prescription labeling on drug use in pregnancy and lactation.
  • Identify the limitations of prescription drug labeling recommendations (i.e., lack of data, quality of limited data).
  • Examine how prescription drug labeling can be used to inform prescribing in pregnant and lactating individuals.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES