In 2014, United States Food and Drug Administration (USFDA) released a new format of labeling called “Pregnancy and Lactation Labeling Rule” (PLLR or final rule) for Human Prescription Drug and Biological Products; and Requirements for Pregnancy and Lactation Labeling. The rule came into effect from 30th June 2015.

The changes in the format and content of Physician Labeling Rule (PLR) are a step forward to ensure that the health professionals can better identify the benefits and risks of the drugs and the pregnant women and nursing mothers can make an informed decision for themselves and their children. The final rule also withdraws the pregnancy letter category – A, B, C, D, and X. The rule also requires to be updated once the information becomes outdated.

PLLR requirements have the following changes:

  1. Subsection 8.1 – The Pregnancy subsection contains information regarding the pregnancy exposure registry, once the drug is available for use. It also includes information related to Risk Summary, Clinical considerations, and their corresponding Data. In the final rule, the information related to “Labor and Delivery” is now merged in the pregnancy section.
  2. Subsection 8.2 – The nursing section has now been renamed as Lactation subsection. Information related to the impact of the drugs on breastfeeding, such as the amount of drug in breast milk and its effects on the breastfed infant, can be found under this section.
  3. Subsection 8.3 – The latest addition to the PLLR is subsection 8.3, Females and Males of Reproductive Potential. This subsection gives information regarding the necessity of pregnancy testing, contraception recommendations, and information related to infertility as a consequence of the drug.

The rule only applies to products approved under a New Drug Application (NDA), Biologics Licensing Application (BLA) or efficacy supplement (ES) between 2001 and 30 June 2006, as well as all products thereafter.

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