Bar Coding Deadline Looms

The unit-dose bar coding rule requires integration of bar code technology, printing, quality control, data collection and transmission, and recordkeeping.

We are now less than a year aw ay from the April 24, 2006, de adline that requ i res bar coded labels on approx i m a tely 153,500 packaging units of prescription and over- t h e - counter (OTC) dru gs dispen s ed in hospitals. Drug products approved for use after the ru l e’s April 24, 2004, ef fective date must be bar coded within 60 days of approval. FDA’s final rule requires a linear bar code repre senting the produ ct’s nati onal drug code (NDC ) to be placed on the immed i a te container label and the outer wra pper that appe a rs on most pre s c ri pti on and certain OTC dru gs com m on ly used in hospitals, or abo ut 75% of OTC produ ct s .

The lot nu m ber and ex p i ra ti on date do not have to be inclu ded , but drug makers may do so, if desired . Th e rule applies to most drug manufacturers, as well as rep ackers , relabelers , priva te label distri butors , and bl ood establishments (www.fda.gov/OHRMS/ DOCKETS/98fr/04-4249.htm). The goal is to reduce med i c a ti on errors by providing an autom a ted means to confirm the ri gh t dose is given to the ri ght pati ent at the ri ght ti m e vi a the correct administration ro ute. In use, the bar code on the unit dose pack is scanned at the ti m e of administration. For a more complete record, bar codes on the pati ent’s wrist band and caregiver’s i dentificati on bad ge also could be scanned .

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