Magazine article Drug Topics

FDA Plans Rx Bar-Code Mandate to Cut Drug Errors

Magazine article Drug Topics

FDA Plans Rx Bar-Code Mandate to Cut Drug Errors

Article excerpt


Food & Drug Administration official announced at ASHP's recent midyear meeting in New Orleans that the agency plans to develop a rule requiring drug manufacturers to put bar codes on their products as a way to reduce medication errors.

As part of a Health & Human Services effort to cut medical errors, the FDA published a notice in the Federal Register that the agency is proposing to require bar codes on human drugs and biologicals. The bar code would have to include certain information about the product, such as the NDC number. The FDA is considering whether to also require the expiration date and lot number. The agency has not determined whether the bar-coding rule will extend beyond the hospital setting, said an FDA spokeswoman.

The bar-coding price tag for drug manufacturers and repackagers could range anywhere from $500 million to $1.4 billion over a 10-year period, according to the FDA. The wide variance stems from unknowns, such as how much it would cost to require various pieces of information, whether all or just some drugs and biologicals would have to be bar-coded, and possible changes in labeling operations.

The Pharmaceutical Research & Manufacturers of America has adopted a wait-and-see attitude. "We are eagerly awaiting publication of the proposed rule so we can go over it," said spokesman Jeff Trewhitt. "There certainly is the potential, depending on the details of the proposed rule, to reduce the number of medical errors with bar-coding, but the devil is always in the details. We need to see the details, and we need to go over those details very carefully because this is going to be a time-consuming proposition, a technically challenging proposition, and potentially a very expensive proposition."

The FDA announcement was good news to pharmacy leaders who have been advocating bar codes as a way to reduce medication errors. …

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