Final rule on bar code labeling

FDA Consumer, May-June, 2004

The FDA has issued a final rule requiring that bar codes be placed on the labeling of most prescription drugs and certain over-the-counter drags. The measure, issued in February 2004, is designed to support the widespread adoption of information systems that have reduced medication error rates by as much as 85 percent in some hospitals.

In hospitals currently using bar codes, patients receive a bar-coded identification bracelet. A health care professional scans the bar codes on the patient and on the drug. The information system then verifies that the right patient is getting the right drug at the right time, and in the right dose and method of administration.

In accordance with the FDA rule, each bar code must contain the drug's National Drug Code number, a unique 10-digit identifier for human drugs. The code indicates the product, its labeler, vendor, and the package size. Companies may also include information about lot numbers and expiration dates. The final rule applies to most drug manufacturers, repackers, relabelers, private label distributors, and blood establishments.

New medications covered by the rule are required to have bar codes within 60 days of their approval. Most products that were previously approved will have to comply with the new requirements within two years.