FDA Publishes Pregnancy and Lactation Labeling Final Rule (PLLR)

The Pregnancy and Lactation Labeling Rule, formally known as the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (PLLR) has been published by the FDA.

The PLLR has been put into place in order to assist health care providers in assessing the benefit versus risk for pregnant women who need to take medication. The changes will allow practitioners and pregnant women to make more informed and educated decisions.

The new labeling is effective June 30, 2015.

A summary of the changes is provided below:

Section 8.1 (Pregnancy) will include Section 8.2 (Labor and Delivery) from the current labeling. This will also include information for a pregnancy exposure registry which collects and maintains data on the effects of approved drugs on pregnant women. Section 8.3 of the current labeling will be re-named to “Section 8.2 Lactation”  and will include information about use and effects of use while breastfeeding. A new section, Section 8.3 Females and Males of Reproductive Potential, has been added. This section will include information on the need for pregnancy testing, contraception recommendations and infertility.

Prescription drugs and biologic products submitted after June 30, 2015 will use the new format immediately and drugs and biologics that were approved on or after June 30, 2001 will be phased in gradually.

For the official release of Content and Format of Labeling of Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, please click here:
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-28241.pdf

The FDA has also issued a draft guidance for industry to assist with compliance of the new labeling content and format.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425398.pdf

An updated Questions and Answers resource has also been released, available here:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093311.htm

Share Button