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FDA Proposes Bar Codes on Drugs

Donna Young

More than a year after the Food and Drug Administration (FDA) announced in December 2001 intentions to develop a proposed rule that would require machine-readable codes on drug and biological product packaging, federal officials today announced release of that proposal.

Health and Human Services Secretary Tommy G. Thompson made the announcement at the National Patient Safety Foundation’s 5th Annual Patient Safety Congress in Washington, D.C.

FDA Commissioner Mark B. McClellan, in a statement released today, said the proposed rule is "the start of a comprehensive strategy to build a medical patient protection system for the 21st Century."

According to FDA, hospitals that have used bar-code technology have seen significant decreases in medication error rates ranging from 71% to 86%.

In its proposed rule, FDA is requiring makers of drug and biological products to include the National Drug Code (NDC) number in a linear bar code on product labels.

An NDC number is the unique 10-digit, three-segment number that identifies the manufacturer, product, and package size. 

Most groups attending a public meeting held last July agreed that bar coding should, at a minimum, contain NDC numbers.

Several groups, including ASHP, suggested that FDA require the addition of lot numbers and expiration dates in bar codes.

But the agency is declining to require drug makers to do so.

ASHP Executive Vice President Henri R. Manasse Jr., Ph.D., Sc.D., declared that inclusion of lot numbers and expiration dates in bar coding on drug products "is a critical element to protect patients from medications that may have been recalled or are past their expiration date."

FDA acknowledged in its proposal that adding a product’s lot number and expiration date to bar coding on labels would make it easier to identify recalled or expired drugs.

But the agency said it "neither found nor received data to show that the benefits of bar coding lot number and expiration date information would exceed the costs of putting that information in the bar code."

FDA noted that some drug companies had complained that adding lot numbers and expiration dates to bar codes would adversely affect production line speed and raise production costs.

Inclusion of lot number and expiration date, the agency added, might require the use of a different machine-readable format such as two-dimensional symbology, or reduced space symbology (RSS).

"Use of nonlinear bar code formats could require the purchase of a different scanning or reading device and also increase a hospital’s equipment costs," FDA stated.

FDA is continuing to study inclusion of lot number and expiration date in bar coding.

The proposed rule is open for public comment for 90 days. Comments should be directed to FDA.

"If comments provide information and data to support requiring lot number and expiration date information, we may consider requiring that information with the bar coded NDC number as part of a final rule," FDA said.

The proposed rule, which would apply to prescription drugs and also to nonprescription drug products that are commonly used in hospitals and dispensed pursuant to a medication order, does not prohibit drug companies from including a product’s lot number and expiration date information in bar codes on labels.

For blood and blood components, FDA’s proposal would require the use of machine-readable information in a format approved by the director of FDA’s Center for Biologics and Evaluation and Research.

The agency is proposing that machine-readable information on labels for blood and blood components must contain a unique facility identifier, a lot number relating to the donor, a product code, and the blood type of the donor.

Makers of medical devices are exempt from the bar code requirement.

"We recognize that different issues arise for devices than for drugs, so further consideration is needed regarding the need for putting bar codes on medical devices," the proposal states.

FDA intends to make the rule effective three years after it publishes its final rule.