Pregnancy and lactation drug labeling

Background

• The 2015 FDA Pregnancy and Lactation Labeling Rule (PLLR) replaces the previously used pregnancy categories (A, B, C, D, X) and creates new labeling categories
  • Drugs approved by the FDA after the PLLR final rule will no longer be assigned a pregnancy category letter
• New drug labeling categories:
  • 8.1 - Pregnancy (including labor and delivery)
  • 8.2 - Lactation (including nursing mothers)
  • 8.3 - Females and Males of reproductive potential
• Labels will provide a narrative summary of risk and will summarize available human and animal risk data.

See Also

• Drug pregnancy categories

External Links

• FDA Pregnancy and Lactation Rule
• FDA PLLR Final Rule PDF
• Zepatier Drug Label (Conforms to PLLR standards)