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 In this section:

                Labeling for CBER-Regulated Products

Labeling for CBER-Regulated Products

                        About the Advertising and Promotional Labeling Branch (APLB)
          Submitting Biologics Advertising & Promotional Labeling
          Compliance Actions on Biologics Advertising & Promotional Labeling
          Proprietary Name Review for Biologic Products
          Regulatory Information about Biologics Advertising & Promotional Labeling Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Labeling for CBER-Regulated Products
          Bar Code Label RequirementsLabeling for CBER-Regulated Products Bar Code Label Requirements
  
  	
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    PrintBlood and blood components must be labeled with with specific machine-readable bar code information by April 26th, 2006. The unit of blood or blood component label would contain the machine-readable information if the blood or blood component has any possibility of being transfused to a patient, whether or not the unit is actually transfused. The purpose of the bar coding rule is to reduce transfusion errors and increase patient safety.

Key Resources

Bar Code Label Requirements for Blood and Blood Components Questions and Answers
	Bar Code Label 2/26/04 Federal Register Notice
	Bar Code Label Requirements for Blood and Blood Components - ARCHIVED

                                                                                  Content current as of:
      01/24/2020
              
              
Regulated Product(s)
		 BiologicsLabeling for CBER-Regulated Products

          
                        About the Advertising and Promotional Labeling Branch (APLB)
          Submitting Biologics Advertising & Promotional Labeling
          Compliance Actions on Biologics Advertising & Promotional Labeling
          Proprietary Name Review for Biologic Products
          Regulatory Information about Biologics Advertising & Promotional Labeling
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