Bob Celeste, C4SCS

Nov.27, 2023, was the date that the US pharmaceutical supply chain fully implemented all stages of the Drug Supply Chain Security Act (DSCSA). Well, not quite. Turning a ship as big as the US drug supply chain takes a lot. It’s turning, but it's not complete. On Aug. 30, 2023, the FDA established a one-year stabilization period for implementing electronic systems.

The final stages (DSCSA SEC 203. Enhanced Drug Distribution Security), among other requirements, call for all trading partners to implement four major data exchange capabilities. Those include serialized transaction information exchange between buying and selling trade partners, product information verification between owners of drugs and the manufacturers or repackagers, product ownership tracing, and, for lack of better words, authentication and authorization of authorized trade partners in those interactions.

The transition from lot-level data transactions to serialized is an order-of-magnitude change for trading partners and their supporting systems. With it comes accountability for each package moving through the supply chain by each authorized trading partner that holds ownership. Serialization brings with it recordkeeping of aggregation of packages into cases, inferring (based on aggregation data) information about those packages, and being able to unwind and correct exceptions among multiple trading partners in the supply chain.

Besides the inertia of such a large supply chain and the effects of serialized recordkeeping, the final stage of DSCSA brings interactions and challenges that few supply chains encounter. Typical business transactions take place between two known trading partners. Authentication (who am I interacting with?) and authorization (are they authorized trading partners?) of trading partners, transactions, and exceptions are managed between immediate trading partners without including or affecting others in the supply chain.

Trading partners engaged in DSCSA transaction information exchange can rely on existing authentication and authorization practices. However, product information verification and product ownership tracing processes are another animal. These two interactions occur ad-hoc, typically involving many intermediaries and potentially between trading partners that do not have existing relationships. Like all other information exchanges companies are involved with, both parties need to authenticate and authorize each other within each capability's regulatory and industry-defined performance time constraints.

A last challenge we’ll see worked out through the stabilization period is ramping up the flow of serialized transaction information throughout the system. This is a stop-and-go process; as manufacturers initiate and increase flow with their customers, wholesalers deal with incomplete data needed for their customers and implement their programs to ramp up to full data flow, and finally, dispensers get the chance to see and manage serialized transaction information.

The FDA has been clear in its intent for the DSCSA stabilization period. Data must flow, issues must be worked out, and systems must be production-ready. The timeline compression resulting in all trading partners needing to implement in unison has created challenges for trading partners and their solution providers. It’s going to take time. Maybe more time than the 12 months given, but the DSCSA ship will continue to turn, challenges will be overcome, significant progress will be made in 2024, and it won’t be 2023 déjà vu.

Bob Celeste is the founder of Center for Supply Chain Studies (C4SCS) and executive director of the Open Credentialing Initiative (OCI).

Articles

A look at the challenges that need to be addressed during the FDA stabilization period.