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NOTE TO CORRESPONDENTS Print Media: 301-827-6242
July 10, 2002 Consumer Inquiries: 888-INFO-FDA

 

FDA TO HOLD MEETING ON BAR CODE LABELING FOR HUMAN DRUG PRODUCTS

The Food and Drug Administration will hold a public meeting on July 26, 2002, to solicit comments about developing a regulation requiring bar code labeling for human drug and biologic products. The meeting will also cover bar codes for medical devices.

The purpose of the regulation is to reduce the number of adverse drug events, including deaths, which occur every year due to medication errors. It is hoped that bar code labeling for human drug products can minimize errors due to drug mix-ups and also provide crucial information for prescribers.

A 1999 Institute of Medicine (IOM) Report estimated that 770,000 adverse drug events leading to injury or death occur yearly in the United States hospitals. According to the report, between 28 to 95 percent of these events result from preventable errors. In response to the IOM Report, the Secretary of Health and Human Services directed FDA to explore possible approaches to reduce these preventable errors, including the use of bar codes. .

The meeting will be held from 9 a.m. to 5 p.m. at the Natcher Auditorium, Building 45, National Institutes of Health (NIH), Bethesda, Maryland.

Any interested party may attend the meeting but pre-meeting registration is required. The registration deadline is July 12, 2002. To register contact Elizabeth French by mail at: Office of Policy, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, rm. 14-101, Rockville, MD 20857; by phone, 301-827-3360, or FAX 301-827-6777; by e-mail, efrench@oc.fda.gov. More information is available on the internet at http://www.fda.gov/oc/meetings/barcodemtg.html.

 

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