theuniformcodecouncilsresponse.docVIP

The Uniform Code Council’s Response To the FDA’s Bar Code Label Requirements For Human Drug Products General Questions Related to Drugs and Biologics: Question Which medical products should carry a bar code? For example, should all prescription and over-the-counter (OTC) drugs be bar coded? Should blood products and vaccines carry a barcode? Answer All medical products should carry a bar code. The technology exists now to bar code down to the smallest package. Instead of selection of a particular bar code, the FDA should select a system. The EAN.UCC system is a proven globally accepted system. Its selection will cause the least amount of disruption to the supply chain. For the FDA to select none would create chaos. The EAN.UCC system is the one that the FDA must select for healthcare. Every major pharmaceutical manufacturer already uses it globally. To have the FDA create its own system or to select another standard would have grave implications in cost and in acceptance in other countries. All OTC products sold in retail carry a bar code, the globally recognized UPC. It would require some effort and expense but the lot number and expiration date can be encoded in a Composite Code Symbology over the UPC. The Composite code was designed to work with any of the EAN.UCC system symbologies. Bar codes are the first step in medication error reduction but are not a cure all. The coming year will see the wide spread bar coding of unit dose products globally as industry follows the early adopters. Medication errors will not be reduced significantly until the hospitals develop a software infrastructure to take advantage of this new data. The market place will drive change as it has in the past in other sectors. The Uniform Code Council Inc. is a voluntary standards organization. It has 260,000 members in North America. (18,000 have identified themselves as healthcare and approximately 75 to 97 more healthcare companies (medical surgical. OTC, prescri