DSCSA 2023 Requirements

The traceability requirements in effect from 2015 to 2023 generally require products to be traceable at the lot level. A second phase of requirements will go into effect November 27, 2023 to allow the interoperable, electronic tracing of products at the package level. However, the statute provides much less detail with regard to 2023 interoperability requirements for the tracing of products at the package level than was provided for the lot level tracing requirements. The DSCSA 2023 requirements are comprised of three specific, but highly interrelated statutory components that go into effect on November 27, 2023:

  • Interoperable Exchange. Trading partners must exchange required transaction information (TI) and transaction statements (TS) in a secure, electronic, interoperable manner, and the TI must include the product identifier at the package level.
  • Interoperable Verification. Trading partners must be able to verify the product identifier on a package or sealed homogenous case in a secure, electronic, interoperable manner.
  • Interoperable Tracing. Trading partners must maintain secure, electronic, interoperable systems and processes to provide TI and TS in response to a request for it and to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.

A Plan to Set Up A Track and Trace System 

Efficient implementation requires an intentional implementation plan that builds toward a shared vision for 2023 interoperability. As an independent, balanced, and sector-neutral governance body, PDG is working to establish an implementation plan and will provide certainty and longevity that benefits the effective, efficient implementation of the DSCSA. Each trading partner will be committing significant resources to implementation of the DSCSA 2023 requirements. The formal structure of PDG, with well-understood, agreed upon rules for governance will provide confidence and predictability in the allocation of those resources.

PDG has developed this informal guide to assist trading partners develop their internal standard operating procedures (SOPs) for DSCSA tracing procedures.

A Need for Governance

The ability to gather and use serialization data among trading partners is essential to the effective and efficient implementation of the DSCSA requirements for electronic interoperable verification and tracing. Interoperability in 2023 and beyond will require a level of cooperation, coordination, and interconnection at the unit level not present today. Stakeholders throughout the supply chain, including FDA, have broadly recognized that governance is critical to the successful implementation of DSCSA 2023 interoperability.