The Drug Supply Chain Security Act – Summarizing the Act and Its Effect on FDA Practice

March 10, 2015 4:45pm

Michael Walsh
Principal and International Managing Partner
Midgard Consulting Inc.

  • The executive branch’s strategy and FDA’s pathway for global product supply chain security, safety, and quality
  • Overview of the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act of 2013)
  • FDA’s Implementation Plan, including timeline for Guidance
  • Identifying the scope of the DSCSA
  • Outlining the specifics:
    • obligations to create a unique product identifier;
    • establishing tracing and monitoring systems;
    • developing detection and response protocols regarding counterfeit materials;
    • understanding notification obligations;
    • evaluating the effect of the act on the recall process; and
    • penalties.