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FDA Issues Draft Guidance on Bar-Code Label Requirements

June 15, 2005

Products with low medication error rates aren't exempt from the FDA's final bar-code rule implemented early last year, according to a draft guidance.

Numerous drugmakers have queried the FDA about exemptions to its bar-code labeling rule, but the agency clarified in a recent draft guidance that products won't be exempted for having few medication errors.

"If the type of medication error is serious, such as an error that results in death, it would be difficult to justify an exemption on the grounds that few deaths occur," states the draft guidance. "We also have no basis to establish a threshold or baseline number of medication errors that would determine whether a drug should or should not be subject to the bar-code requirement."

The guidance, titled "Bar-Code Label Requirements: Questions and Answers," addresses a variety of questions posed by manufacturers since the bar-code labeling rule was released last February. Created to reduce medication errors in healthcare facilities, the rule requires drugmakers to put linear bar codes on both exterior labeling and interior unit-dose packaging. The rule applies to drug products, biological products and OTC drug products commonly used in hospitals.

To view the draft guidance, go to ()a href="http://www.fda.gov/cder/guidance/6383dft.htm" target="_blank">http://www.fda.gov/cder/guidance/6383dft.htm.