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.

Approvals & Clearances

Contact FDA

(800) 835-4709
(240) 402-8010
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 12/04/2014
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