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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On September 19, 2018, the USFDA published a Draft Guidance, Product Identifiers Under the Drug Supply Chain Security Act – Questions and Answers, [Docket Number FDA-2018-D-3175-0002]. This draft guidance introduced some recommendations that were, at the very least, confusing if not confounding to the pharmaceutical supply chain’s strategy, systems, and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, and
  • 20 small/large hospitals/health systems

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DSCSA T3 Data Standardization & Documentation Practices
The FDA released the draft guidance which provides a significant amount of detail regarding the standardization of product tracing information, its specific data elements; and recommended documentation practices trading partners may utilize to satisfy their product tracing requirements. This guidance supplements the DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information guidance released in November 2014.

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