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DSCSA Compliance: Industry is still in the trenches

Nov. 27, 2018, was to be a red-letter day in the 10-year program to implement an end-to-end pharma traceability system. Did industry meet the deadline?
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FDA Guidance for DSCSA
On September 19, 2018, the USFDA published a Draft Guidance, Product Identifiers Under the Drug Supply Chain Security Act – Questions and Answers, [Docket Number FDA-2018-D-3175-0002]. This draft guidance introduced some recommendations that were, at the very least, confusing if not confounding to the pharmaceutical supply chain’s strategy, systems, and validated processes that have been widely adapted for compliance to the DSCSA regulation.
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OIG March 2018 Report: “Drug Supply Chain Security: Dispensers Received Most Tracing Information”
In March 2018, The Office of Inspector General (OIG) issued its second in a series of three anticipated examinations of drug supply chain security focusing on the implementation the Drug Supply Chain Security Act (DSCSA). The report focuses on the survey results of 40 healthcare/retail pharmacy organizations:
  • 20 independent/chain retail pharmacies
  • 20 small/large hospitals/health systems

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