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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Vaccines, Blood & Biologics
  3. Development & Approval Process (CBER)
  4. Labeling for CBER-Regulated Products
  5. Bar Code Label Requirements
  1. Labeling for CBER-Regulated Products

Blood 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.


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