Packaging Serialization Update
FDA reviews obsolete 2004 barcode rule — One drug packaging consultant doesn’t mince words in describing how drug manufacturers would be affected if the Food and Drug Administration (FDA) requires them to serialize their drug packages. “The [stuff] will hit the fan,” said this long-term industry advisor who has worked extensively with GS1 Healthcare, the industry standards group that has approved a number of drug packaging data standards, including GS1 DataMatrix, designed for tiny, two-dimensional (2D) barcodes that can fit on unit-of-use drug packages as small as ampules.