FDA Refining "Track And Trace" Standards For Rx Drugs
This article was originally published in The Pink Sheet Daily
The agency is holding a two-day workshop on the next steps to take to secure the supply chain and protect consumers from counterfeit drugs; industry stakeholders discussing formation of consortium.
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Standards were required in FDAAA; industry asked for them in part to avoid conflicts with California pedigree law that will be implemented in 2015.
With many new technologies to combat counterfeiting, agency appears to want more time to get the implementation of quality control legislation right, say some sources.
FDA Takes First Step Towards "Track And Trace" As Final Guidance Lengthens Identifiers For Drug Packaging
Agency had proposed an eight-digit system, but moved to 20 digits in final document after recommendation from PhRMA.