FDA bar code rule for drugs takes effect

The Food and Drug Administration's requirements for bar codes on the labels of thousands of drugs and biological products took effect today as part of an agency effort to improve patient safety.

Companies had two years to comply with the measure, which aims to protect patients from preventable medication errors by helping ensure that health professionals give patients the right drugs at the appropriate dosages.

Health care professionals, however, must use bar-code scanning equipment and computerized databases to verify that the patient is receiving the right drug in the right dose at the right time.

The FDA requires the bar codes, which are similar to those on food packages and other consumer goods, 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. Drugs that the FDA approves after today will have 60 days in which to comply.

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.

The rule applies to drug manufacturers, re-packers, re-labelers and private-label distributors, but not hospitals, clinics and public health agencies.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.


  • business meeting (Monkey Business Images/Shutterstock.com)

    Civic tech volunteers help states with legacy systems

    As COVID-19 exposed vulnerabilities in state and local government IT systems, the newly formed U.S. Digital Response stepped in to help. Its successes offer insight into existing barriers and the future of the civic tech movement.

  • data analytics (Shutterstock.com)

    More visible data helps drive DOD decision-making

    CDOs in the Defense Department are opening up their data to take advantage of artificial intelligence and machine learning tools that help surface insights and improve decision-making.

Stay Connected