FDA Takes First Step Towards "Track And Trace" As Final Guidance Lengthens Identifiers For Drug Packaging
This article was originally published in The Pink Sheet Daily
Agency had proposed an eight-digit system, but moved to 20 digits in final document after recommendation from PhRMA.
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As Congress considers how to ensure downstream supply chain security, industry groups are looking at a process to link drugs to their manufacturer. But in a recent communication with the Senate HELP Committee, FDA backs a “comprehensive national track-and-trace system.”
Standards were required in FDAAA; industry asked for them in part to avoid conflicts with California pedigree law that will be implemented in 2015.
Congress should empower FDA to enforce the track-and-trace standard for drugs that the agency already is tasked with developing, Deputy Commissioner for Global Regulatory Operations and Policy Deborah Autor told the Senate Health, Education, Labor and Pensions Committee Sept. 14.