Vaccines, Blood & Biologics
Resources for You
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: Bar Code Label Requirements - Questions and Answers
- 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 - 1189KB)
- International Society of Blood Transfusion (ISBT)
Recalls & Alerts
Contact Us
Manufacturers Assistance and Technical Training Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- matt@fda.hhs.gov
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

