Anyone with a view on whether drug and biologics packaging should carry identifying bar codes has less than 90 days to forward comments to the FDA.
The agency published a proposed rule that would require prescription drugs and biologics, vaccines (except for samples for physicians) and certain over-the-counter drugs commonly used in hospitals to include bar codes, which at minimum would contain the product's National Drug Code, a number that identifies each drug, its dosage form and strength. Medical devices were not included in the rule.
Over the next 90 days, the agency will seek comments on whether the bar code should include other information such as the lot number (a code that identifies when and where the product was made) and the expiration date.
Backed by the Department of Health and Human Services, the FDA was prompted to mandate the codes as a way of helping health care workers cut down on medical errors. The government began pursuing a solution upon the release of the 1999 Institute of Medicine report, "To Err is Human: Building a Safer Health System," that said upward of 100,000 people die every year in U.S. hospitals due to preventable medical errors, oftentime related to drugs.
FDA officials told BioWorld Today the agency expects to give manufacturers up to three years to comply with the new rule. The clock likely will begin ticking once the 90-day comment period expires in June.
In a public meeting held last summer to solicit comments on the proposal, the FDA was greeted with representatives from various industry groups who seemed to support a coding system of some form.
For example, John Combes, a senior medical adviser with the American Hospital Association, said many U.S. hospitals are in various stages of setting up scanning systems for a number of uses. Already, he said, systems are in place for inventory control purposes as well as for scanning lab specimens and blood products. The same scanning systems could be used to read bar codes. However, the FDA does not regulate the hospital industry and cannot force it to implement a bar-coding system. (See BioWorld Today, July 30, 2002.)
Beyond use in hospitals, the FDA believes bar codes would provide benefits in other scenarios. In the retail setting, pharmacists could use bar codes in conjunction with computerized prescription orders to confirm that the right drug is being dispensed to the right patient. Meanwhile, the agency said drug manufacturers would benefit from uniform standards rather than having to worry about conflicting requirements from different purchasers that would add to the cost of adopting bar coding.
To view the proposed rule, visit the FDA's web site at https://www.fda.gov/oc/initiatives/barcode-sadr/
Written comments should be sent to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852.