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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.

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Approvals & Clearances

 

Contact FDA

(800) 835-4709
(301) 827-1800
Manufacturers Assistance and Technical Training Branch (CBER)

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
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