Track and Trace Standards Coming Shortly, FDA Says

Standards were required in FDAAA; industry asked for them in part to avoid conflicts with California pedigree law that will be implemented in 2015.

FDA expects to issue new standards soon for tracking drug products through the supply chain, which could foreshadow congressional moves to strengthen the system intended to fight drug adulteration and counterfeiting.

According to Ilisa Bernstein, acting director of the CDER Office of Compliance, the standards are “pretty far along” in development...

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