The implementation of safe logistic processes in the marketplace is to use proper identification of sales and logistic units and locations. In the healthcare market, this has a strong influence on the quality of care. This has been recognised by the US Food and Drug Administration which initiated in late 2001 a rule making process. The FDA based its approach on the need to reduce the number of medication errors - the 1999 Report of the Institute of Medicine 'to err is human' is one of the sources - and opened a consultation about a 'barcoding rule' in November 2001. The consultation process lasted until Summer 2002, and the proposed rule was published in the Federal Register in March 2003. 26 February 2004 : The US Food and Drug Administration announces its final ruling on the label marking at the unit of use for pharmaceuticals and biological products. The rule imposes the use of a linear barcode, including EAN's Reduced Space Symbology (RSS) for very samll healthcare items such as ampoules and blister packs. You can download here the official FDA rule. See also the comments from GS1 UK (formerly e.centre UK).
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