Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Biologics Rules

Biologics Rules

                        Blood Notices, Proposed and Final Orders, Proposed and Final Rules
          General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules
          Tissue Notices, Proposed and Final Rules
          Vaccine Notices, Proposed and Final Rules Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics Rules
          Pregnancy and Lactation Labeling Final RuleBiologics Rules Pregnancy and Lactation Labeling Final Rule
  
  	
    Share
    Post
    Linkedin

    Email
    PrintOn 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

Pregnant? Breastfeeding? Better Drug Information Is Coming
	Questions and Answers on the Pregnancy and Lactation Labeling Rule
	Outline of Section 8.1 - 8.3 on Drug LabelingPLLR Final Rule and Labeling Requirements

Pregnancy and Lactation Labeling Rule
	Draft Guidance for Industry: Pregnancy, Lactation, and Reproductive Potential--Labeling for Human Prescription Drug and Biological Products--Content and Format
	Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and FormatAdditional Guidance Documents

Evaluating the Risks of Drug Exposure in Human Pregnancies

                                                                                  Content current as of:
      03/15/2021Biologics Rules

          
                        Blood Notices, Proposed and Final Orders, Proposed and Final Rules
          General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules
          Tissue Notices, Proposed and Final Rules
          Vaccine Notices, Proposed and Final Rules
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop