DSCSA Implementation & Readiness Efforts for 2023

2023 is a crucial year for pharmaceutical trading partners as the Drug Supply Chain Security Act (DSCSA) deadline for full traceability approaches in November. To allow supply chain stakeholders an opportunity to share their perspectives, the FDA held a 2-day virtual public meeting. DSCSA Implementation and Readiness Efforts for 2023 was a collaborative session to discuss:

  • Implementation experiences and overall readiness for meeting the upcoming requirements;
  • The FDA’s mechanism to request product tracing information and verification during investigations of suspect or illegitimate product or in response to a recall;
  • Steps the pharmaceutical distribution supply chain has taken to build capacity for package-level tracing.

Over 500 manufacturers, dispensers, distributors, and solution providers participated to share their perspectives. They were joined by collaboration groups such as PDG, AAM, PhRMA, OCI, IWLA, and PDSA.

Todd Applebaum is Managing Director at Converge and has been supporting biopharma companies with serialization and DSCSA compliance for close to 20 years.

Ulpiano Flores is a Serialization consultant who specializes in serialization implementations and related efforts. He has worked with a variety pharmaceutical manufacturing organizations ensuring DSCSA compliance.

Feroz Khan is a former Serialization consultant with Converge.

Why Are Implementation & Readiness Efforts Important?

The DSCSA established a set of product tracing, product identifier, authorized trading partner, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers. The requirements were phased in across the pharmaceutical supply chain over a 10-year timeframe, with the final enforcement date for full end-to-end traceability set at November 27, 2023. As that enforcement date nears, stakeholders across the supply chain are preparing to ensure compliance. They are also monitoring developments closely to understand whether the FDA will delay enforcement or hold to the current timeline.

Important Topics Covered

Many conversations during the event revolved around the latest DSCSA requirements:

Serialized outbound shipments

Larger manufacturers reported significant progress in preparing for outbound EPCIS, noting that 75% of outbound shipments are serialized well ahead of deadlines. However, smaller manufacturers and specialty distributors lag the bigger players due to a lack of infrastructure and identifiers.

Removing suspect product from commerce

Major players also indicated progress in establishing the capability to remove suspect product from commerce. However, while advances have been evident, there is still significant work to ensure adherence to stringent data requirements across the entire supply chain, as well as to hire and retain critical skills.

Salable returns verification

Although the enabling infrastructure is in place (as part of VRS), many manufacturers, especially smaller and specialty pharma manufacturers, are opting to destroy returned product rather than accept salable returns where verification is required.

Dispenser verification

Suspect product verification requests from specialty distributors and dispensers are expected to increase the need for strict adherence to data requirements. This would also increase the workload for manufacturers to manage and resolve these requests. Manufacturers should enable VRS capabilities as a key enabler to support dispenser verification. Again, the larger industry players appear confident in their infrastructure and processes to meet this requirement.

Key Takeaways

  • Time is short. If not already complete, manufacturers should start now to enable outbound serialization that ensures compliance by November 26. Stress test your existing process and identify both process gaps and staffing shortages in specific areas.
  • No deferrals in sight. Unlike earlier DSCSA requirement enforcement deadlines, talk of ‘deferred enforcement’ was non-existent. Larger players appear to be confident in having the infrastructure, processes, and staffing in place.
  • Data quality and standards are critical. New requirements for exception management and the capability to prevent/remove suspect product from commerce will impose stringent data quality requirements across the entire supply chain to capture, manage and handle data accurately.
  • Resources are scarce. Skilled staffing continues to be a challenge, so manufacturers should prepare for internal or external resources to support exception management and product verification requests. Lessons from European implementations with mandatory dispenser verification showed the need for additional hiring and training to support the new activities.