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FDA Releases Final Rule on Bar Coding

Kate Traynor

The Food and Drug Administration (FDA) this morning released a final rule, to be published in tomorrow's Federal Register, that mandates bar coding for most packages of prescription drugs, biologicals, and blood products.

The bar-code rule, which FDA first proposed in March 2003, is designed to reduce preventable medication errors in hospitals and encourage hospitals to adopt advanced technology systems, such as electronic medical records. FDA requires that the bar code contain a product's National Drug Code, or NDC number, which represents the product's name, dosage form, and strength.

The bar-coding requirement applies to "most prescription drugs" and "certain over-the-counter drugs that are commonly used in hospitals and dispensed pursuant to" a medication order, according to an FDA press release.

In Department of Veterans Affairs hospitals, medication-error rates are "practically zero," thanks in part to widespread implementation of bar coding, said Tom McGinnis, FDA's director of pharmacy affairs.

During a teleconference held this morning, McGinnis said that using bar codes to reduce medication errors by 50 percent over the next 20 years—a conservative figure—will save the nation $93 billion in costs associated with the errors, according to FDA estimates.

But hospitals have a way to go before they reach this point, McGinnis said.

"Currently, we have about 10 percent of the hospitals in the United States with a bar-code system," McGinnis said. In such hospitals, he said, a nurse scans a patient's bar-coded wristband to identify the patient, finds the patient's electronic medical record, scans the bar code on the unit of medication, and administers the drug only if the computer confirms that the dose is scheduled to be given then.

In the final rule, FDA did not require that manufacturers include a product's lot number and expiration date in the bar code, as ASHP had requested in comments on last year's proposed rule.

"We couldn't find any information, and nor did commenters provide us with any information, about that lot number or expiration date being able to reduce patient errors, reduce any type of problems occurring with a patient taking an outdated drug or a recalled drug," McGinnis explained. "We couldn't find any harmful effects that we could equate economically to offset the high costs to the industry of mandating such a requirement of including lot number and expiration date."

He added that FDA encourages manufacturers to include a product's lot number and expiration date in the bar code.

The rule is effective 60 days from tomorrow. At that time, McGinnis said, any new drug products approved by FDA will require a bar code within 60 days of marketing approval. This is a substantial change from the proposed rule, which had given manufacturers three years from the date of approval to put bar codes on the new products.

Products that are already on the market will require bar codes within two years of the rule's effective date instead of the three years proposed last March.

"We expect many firms to do that much faster than two years," McGinnis said.

McGinnis emphasized that the bar-coding requirement applies only to "those entities that FDA regulates," such as "manufacturers, repackagers, or distributors."

"Pharmacy operations would be exempt from this rule," McGinnis noted.

Although hospital pharmacies that use bar-code-scanning systems will still need to place the codes on products compounded internally, McGinnis said, the new rule means that "the majority of medications coming from anybody who has registered with FDA will be bar-coded already."

McGinnis said that FDA is aware of developing technology, such as radio-frequency identification, that could one day be used in place of bar coding.

"But bar coding is here today," McGinnis said. "Bar coding is the only thing that's here and now proven technology" to improve patient safety.