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FDA requires digital drug labeling

Ambulatory Safety Monitor, November 17, 2005

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The U.S. Food and Drug Administration (FDA) is now requiring drug makers to submit electronic versions of their drug labels to allow patients and doctors to search online for changes or warnings, according to Reuters.

The labels will be uploaded onto DailyMed, the new searchable database. "With this information, physicians will be able to quickly search and access specific information they need before prescribing a treatment, allowing for fewer prescribing errors, and better informed decision making," the FDA said in a statement, according to Reuters.

The FDA has promised that new labels will appear on the Internet within one business day of any FDA-approved change. These labels include warnings, information on how the drug works, side effects, and dosage instructions.

It is estimated by the FDA that it will take a year for the roughly 9,000 U.S. approved drugs to have their labels made available online.

DailyMed will eventually include labels for nonprescription drugs, medical devices, and animal drugs, according to Reuters.

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