Vaccines, Blood & Biologics
Bar Code Label Requirements
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.
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 Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels Guideline for the Uniform Labeling of Blood and Blood Components (PDF - 1.2MB)International Society of Blood Transfusion (ISBT)
Contact FDA
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-41
Rockville, MD 20852-1448