FDA Mandates Bar Codes

FDA-registered firms with existing products have two years to comply

Daphne Allen

In hopes of reducing medical errors, FDA has finalized its rule requiring bar codes on most prescription and over-the-counter drugs used in hospitals. The agency published its landmark regulation on February 26 in the Federal Register. It takes effect April 26, 2004. The rule applies to all manufacturers, repackers, relabelers, and private-label distributors registered with FDA. Hospitals and pharmacies are not subject to the requirements. 

Tommy Thompson, secretary of Health and Human Services, announced the rule during a press conference on February 25, along with FDA commissioner Mark B. McClellan. �We are changing the way we produce medicines here in the United States to improve the quality of healthcare,� said Thompson. �Nearly 50% of medical mistakes are caused because drugs are wrong or given in the wrong amount, at the wrong time, or to the wrong patient. Our rule is a giant step forward to protect American citizens.�

McClellan explained that no fundamental changes were made to the proposal, which was published in the Federal Register on March 14, 2003. However, �We have cut the implementation period from three years to two for existing drugs, and all drugs approved after the effective date have 60 days to comply,� he said. 

The rule will require most drug packages produced for hospitals to bear a linear bar code. This code will need to incorporate the drug�s National Drug Code (NDC); any additional data, such as lot codes or expiration dates, are not required. The code will need to meet standards put forth by either the Uniform Code Council (UCC) or the Health Industry Business Communications Council (HIBCC). 

Much of FDA�s published rule is dedicated to responding to many of the nearly 200 comments the agency received on the proposal. Of particular note are these decisions justified in response to the comments:

� Vaccines are subject to the rule. 
� Investigational new drugs are not covered by the rule, as they have not been assigned an NDC.
� Allergenic extracts are excluded from the rule.
� Diluents are subject to the rule. FDA notes that errors have occurred during the administration of diluents, such as the use of the incorrect product or incorrect amount or use of the diluent alone.
� LDPE form-fill-seal (also known as blow-fill-seal) containers without overwraps are exempt, as the bar code labels could present a risk of leaching impurities. However, if an overwrap is used, it must bear a bar code.
� FDA has declined to exempt small vials or containers, including suppository packages and prefilled syringes. FDA will, however, grant exemptions, but only after firms have demonstrated that they have exhausted all attempts to include bar codes.
� Medical devices are not covered in the rule. The agency cites the device industry�s lack of a common classification system, such the NDC system for drugs. 
� While FDA believes that a linear bar code is currently the most established and cost-effective code, the agency will consider revising the rule to accommodate new technologies. At the press conference, McClellan stated that, given the agency�s interest in RFID to combat counterfeit drugs, RFID might one day be employed to combat medical errors, too.
� The rule requires the bar code to remain intact under normal conditions of use. Partial, incomplete, or poorly printed bar codes will be considered misbranded.
� While unit-of-use and unit-dose packages are not required under the rule, if they are used, they must bear bar codes. The codes must appear on all packaging levels, so if a unit-dose blister package is used, each unit must bear a code. 

FDA reported in the rule that industry was generally supportive of the proposal. Joe Mase, senior marketing manager for Baxter Healthcare, says his firm is �extremely supportive� of the rule. �It took a lot of time, but FDA did the right thing. Coding standards are needed for improving patient safety, so that�s what FDA did.� Baxter, along with Pfizer, Abbott, and a few other industry leaders, began investigating unit-of-use bar coding well before FDA�s 2003 proposal. Baxter currently uses linear bar codes including lot number and expiration date using its proprietary Enlightened high-resolution bar coding printing technology. �We spent a lot of time looking for the common denominator in hospitals, and it was the linear code. So we decided to start with that. We can, though, move to 2-D codes or RFID, if necessary.�

Mase sums up FDA�s rule this way: �Bar codes by themselves don�t improve patient safety, but they are a very important part of the foundation.� 

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