Highlights from Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline Webinar

By Zachary Ogorzalek

2024 is a crucial year for the life science industry. November marks the end of the DSCSA stabilization period and the start of definitive enforcement for commercial drug traceability requirements. Manufacturers, 3PLs, wholesalers, and other partners continue working diligently to establish connections, ensure data quality, exchange data, and establish verification processes. Although great progress has been made to prepare for the deadline, a lot of effort remains to fully establish the processes that manage data exceptions and end-to-end traceability.

Converge Consulting recently hosted Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline. The webinar discussion ranged across topics from industry efforts to achieve DSCSA compliance so far and critical aspects of the new requirements to best practices for dealing with trading partner requests and data exceptions, as well as efficiently and effectively managing the current challenges of serialization programs.

Insights on Life Science Serialization Readiness

Converge serialization consultant Ulpiano Flores opened the webinar by presenting DSCSA historical context and offering insight on life science serialization readiness, including:

• FDA offered a deadline extension, but only to small dispensers. This indicates that the agency recognizes the challenges still faced by the downstream supply chain in becoming DSCSA ready.
• Implementing VRS is a big milestone for many companies and has dramatically increased the efficiency to respond to verification requests.
• Exceptions management is a serialization hot topic in 2024. Trading partners are now reviewing shared data. They are identifying errors that need to be solved to avoid product return or quarantine that would prevent delivery to the patient.

Serialization Recommendations for Emerging Companies

Building on Ulpiano’s insights, Brian Recchione, Supply Chain Director at ImmunoGen (now AbbVie) shared his own experience building ImmunoGen’s serialization capability from vendor selection and implementation to the more recent challenges in managing serialization for their first commercial product.

ImmunoGen initially outsourced their outbound serialization operations to a 3PL to avoid building internal serialization capabilities for onboarding and managing trading partners. However, as they recently started to share transaction data with downstream trading partners, they lack visibility into data at the 3PL. This has become a challenge for exception management and issue resolution.

As an emerging life science company with internal resource constraints, Brian sought external consulting support to manage complex issues such as a dropship distribution model, direct ongoing serialization operations, and maintain DSCSA compliance over time.

Traceability efforts don’t end after a system implementation. The effort required often grows as a company’s business objectives change. For ImmunoGen, this involved adding a new 3PL location, expanding to global markets, and navigating acquisition by AbbVie.

For other emerging companies navigating their serialization compliance journey for the first time, Brian recommended:

• Acknowledging your internal team’s strengths and limitations with respect to serialization expertise
• Maintaining visibility to and control of your serialized data rather than relying solely on your 3PL for outbound serialization
• Leveraging external expertise to understand international market requirements
• Coordinating closely with your trading partners on serialization needs

Key Takeaways

• DSCSA compliance is your responsibility: Brand owners should take responsibility for product traceability and not assume that trading partners will resolve errors. Avoid putting your patients and brand at risk!
• Be proactive rather than reactive: Have conversations with your trading partners early and often. Staff your company adequately to ensure readiness.
• Think strategically: Identify which activities are needed for compliance and evaluate your internal resources. Then determine ways to leverage those resources to ensure activity execution.
• Define internal procedures: Ensure roles and responsibilities are clear both internally and amongst all of your partners.

For support on your serialization program, contact our team at info@convergeconsulting.com today.