Is your company ready for the enhanced product tracing requirements of the Drug Supply Chain Security Act (DSCSA) to go into effect on November 27, 2023?

FDA CDER Office of Compliance, Office of Drug Security, Integrity, and Response (ODSIR) Senior Advisor for Policy, Connie Jung, addressed these requirements in the Oct. 5 webinar, “Enhanced Drug Distribution Security in 2023 Under the DSCSA.”

  • Enables secure tracing of product at the package level
  • Uses product identifiers to verify product at the package level
  • Enables a prompt response to suspect/illegitimate products when identified
  • Improves efficiency of recalls

Of note, requirements for a full transaction history sunset on November 27, 2023. Instead, manufacturers must be able to promptly provide transaction information for each transaction going back to the manufacturer. Product tracing will have to include transaction information (TI) and a transaction statement (TS). The latter is a paper or electronic statement from the original owner authorizing transferring the product to the partner. 

Also beginning November 27, 2023, transaction information must include the product identifier at the package level. Additional information will be required as part of the transaction information:

  • National Drug Code number of the product
  • Lot number
  • Serial number
  • Expiration date

Further DSCSA guidances and documents will become available over the next three years. Interested stakeholders can sign up on this page for alerts.

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