Friday, February 24, 2012

FDA changes to drug bar code rule could have significant impact on packaging lines

This is a good read, touching on several interesting aspects of bar codes on packages.

FDA changes to drug bar code rule could have significant impact on packaging lines | Anti-counterfeiting, track-and-trace, authentication | Healthcare Packaging:

"Manufacturers have been particularly outspoken about the need for the FDA to update the 2004 bar code rule. "Abbott recommends that FDA not require one specific bar code type but instead select GS1's approved data carriers," says Mark J. Goldberger MD, MPH, divisional vice president, regulatory policy & intelligence, Abbott Laboratories. "Using GS1 standards, manufacturers could choose the appropriate data carrier type for the package size and market."

GS1, the international standards organization, allows for serialization within its Global Trade Identification Number (GTIN), provides a 2D standard called GS1 DataMatrix and a stacked, linear bar code called GS1 DataBar. Very few American pharmaceutical manufacturers are printing GS1 DataMatrix labels today and even fewer are serializing them, as California will require. Some are printing GS1 DataBar, which is a small pyramid of stacked linear codes, referred to as a "composite" code. It is rarely serialized but could be."

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