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Expert Analysis

The FDA's Track And Trace Enforcement Delay: Stay Alert

Law360, New York (July 13, 2015, 10:36 AM EDT) -- On June 30, 2015, just one day ahead of the effective date for additional Drug Supply Chain Security Act (DSCSA) requirements, the U.S. Food and Drug Administration announced a temporary suspension of enforcement of one of those requirements. Specifically, the FDA will not enforce dispensers' obligations to receive and maintain product tracing information until Nov. 1, 2015. This provides dispensers a welcome reprieve, but it still leaves them with exposure to DSCSA violations, since the FDA did not include any other new dispenser requirements (or any other entities in the pharmaceutical distribution chain) in this temporary delay....

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