Healthcare Documents

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The FDA released the draft guidance which provides a significant amount of detail regarding the standardization of product tracing information, its specific data elements; and recommended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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FDA Key Definitions for Suspect & Illegitimate Product Verification

The FDA released its draft guidance which provides FDA’s interpretation of the terms counterfeit, diverted, fraudulent transaction, and unfit for distribution to aid trading partners in their determination of whether a given product is suspect and/or illegitimate.
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OIG September 2017 Summary:
“Drug Supply Chain Security: Wholesalers Exchange Most Tracing Information”

The Office of Inspector General (OIG) issued its first in a series of examinations of drug supply chain security that will outline provisions for the implementation the Drug Supply Chain Security Act (DSCSA). This Report Discusses:

  • The Office of Inspector General’s methodology
  • Key findings from the report
  • Recommendations based on The FDA & The OIG’s findings
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