The FDA issued some updated guidance on the rollout of the Drug Supply Chain Security Act (DSCSA) today. Guidance for Industry (fda.gov). This updated guidance could be in response to pharmacy industry feedback from the National Community Pharmacists Association (NCPA), the National Association of Chain Drug Stores (NACDS) and the American Pharmacists Association (APhA) requesting a delay in implementation for the DSCSA.

In the new FDA guidance, there is decidedly NOT an extension for DSCSA implementation, but a delay in enforcement of certain provisions of the regulation. This is critical distinction. Don’t misconstrue that the DSCSA implementation is being delayed—it isn’t.

“While FDA generally expects trading partners to have the systems and processes in place to meet these requirements as of November 27, 2023, we recognize that some technical and operational issues, including issues involving trading partners and other affected stakeholders, may not be fully resolved by that time. The Agency also understands that additional time beyond November 27, 2023 may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”

The bottom line is that the endgame of the DSCSA—having interoperable, electronic product tracing at the package level—goes into effect on November 27, 2023. Per the new guidance, the FDA does not intend to take action to enforce the comprehensive set of new data-driven regulations on the industry until November 27, 2024. This delay applies across the board, to all manufacturers, wholesale distributors, dispensers and repackagers subject to these requirements for enhanced drug distribution security.

It is good news for many in the industry, especially the dispenser and pharmacy community. They were decidedly behind in establishing the data connections required and the on-premise product verification processes required for compliance. This is clearly evidenced by the cross-industry request for delay from the FDA and is likely one of the major reasons the enforcement delay was issued.

A second critical issue I firmly believe influenced the FDA to issue an enforcement delay which spans across the entire industry—data and product misalignment exceptions. I have written several articles about whether the industry is addressing exception handling enough. One example is this blog post in response to some great information on the topic from the Partnership for DSCSA Governance.

With over four billion prescriptions filled per year in the United States even 1% of medicines held up in quarantine due to data and product exception handling resolution is problematic. We simply do not know and have not tested end to end—from manufacturers to wholesalers to dispensers—the full “interoperable supply chain” DATA vision enough. This delay will give the entire industry room to breathe, and make sure we can handle all good and bad scenarios that the pharmaceutical supply chain, and its data, will face.

Systech is already providing solutions that enable the industry to be implemented and prepared for compliance by THIS November—many of our customers are ready to meet the requirements. We are looking forward to working with existing and new customers to continue testing thoroughly over the coming year, to make sure the overall industry is ready for enforcement in 2024.

This will likely spur many discussions at the upcoming HDA Traceability Seminar next week. Systech experts will be onsite at the event participating in the breakouts and available at our booth in the Exhibitor Hall. This event has all the pharmaceutical stakeholders represented, so we are excited to hear the industry’s feedback on the delay, and its overall readiness status—including the key gaps that are still outstanding.