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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 [248 KB]
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. [319 KB]
See also the comments from GS1 UK (formerly e.centre UK).
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