FDA Rule Requires Bar Codes on Drugs and Blood to Help Reduce Errors

WASHINGTON, D.C. -- As part of a wide-ranging effort to improve patient safety, today the Food and Drug Administration (FDA) finalized a rule requiring bar codes on the labels of thousands of human drugs and biological products. The measure aims to protect patients from preventable medication errors by helping ensure that health professionals give patients the right drugs at the appropriate dosages.

The bar codes -- similar to those on food packages and other consumer goods -- will be required on most prescription drugs and certain over-the-counter drugs. The rule also requires machine-readable information on container labels of blood and blood components intended for transfusion.

FDA estimates that the rule will help prevent nearly 500,000 adverse events and transfusion errors while saving $93 billion in health costs over 20 years.

In March 2003, FDA also proposed a rule designed to improve reporting requirements for safety problems involving medicines.

Source: FDA