Stakeholder Requirements: Drug Supply Chain Security Act

Title II, Drug Quality and Security Act

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Projects: Drug Safety
Stakeholder Requirements: Drug Supply Chain Security Act

The Drug Supply Chain Security Act (Title II, Drug Quality and Security Act, 2013) addresses risks in the pharmaceutical distribution supply chain by establishing a national system that allows stakeholders and regulators to trace each package of product. The serialization and traceability requirements will be phased in over the next 10 years. The law requires sectors in the supply chain—manufacturers, repackagers, wholesale distributors, and dispensers—to comply with statutory requirements under the following categories.

  • Product serialization
  • Authorized trading partners
  • General product tracing
  • Product tracing (salable and nonsalable returns)
  • Product tracing (request for information
  • Investigation of suspect product
  • Removal and notification of illegitimate product
  • Verification (request for verification)
  • Verification (salable returned product and nonsalable returned product)
  • Verification (electronic database)
  • Enhanced drug distribution security (unit-level traceability)

Download the PDF

December 2014 update: FDA announced that it will exercise enforcement discretion and allow a four-month grace period for certain information exchange requirements. (PDF)

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