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  1. Biologics Rules

Pregnancy and Lactation Labeling Final Rule

On December 3, 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule).

The final rule applies to biological products subject to the Physician Labeling Rule. This rule also applies to products regulated by the Center for Biologics Evaluation and Research, including, but not limited to: vaccines, allergenics and cellular and gene therapies.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic product applications submitted after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

The PLLR requires changes to the content and format of information presented in prescription drug labeling in the Physician Labeling Rule (PLR) format to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children. The PLLR removes pregnancy letter categories – A, B, C, D and X. The PLLR also requires the label to be updated when information becomes outdated.

Below is a comparison of the current prescription drug labeling with the new PLLR labeling requirements. 

Pregnancy and Lactation Labeling graphic

The Pregnancy subsection (8.1) includes information for a pregnancy exposure registry for the drug when one is available. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. Information about the existence of any pregnancy registries in drug labeling has been recommended but not required until now. Information in the Pregnancy sub-section includes a Risk Summary, Clinical considerations, and Data. Information formerly found in the “Labor and delivery” subsection is now included in the “Pregnancy” subsection.

The Nursing mothers subsection was renamed, the Lactation subsection (8.2), and provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

The Females and Males of Reproductive Potential subsection (8.3), a new addition to the labeling, includes information, when necessary, about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

Concurrently with publishing the PLLR, FDA also issued draft guidance for industry to assist manufacturers in complying with the new labeling content and format requirements.

Additional Information

PLLR Final Rule and Labeling Requirements

Additional Guidance Documents

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