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With DSCSA becoming fully in effect for most of the supply chain, trading partners are realizing the importance of governance and effectiveness checks to ensure their organization avoids any compliance readiness gaps.

As organizations complete the implementation and stabilization of DSCSA, there is a logical point to ensure that a plan for long term operations is in place. Often heavy focus is put on the seemingly endless activities related to launching, with less attention given the important tasks of ensuring continuous readiness to demonstrate compliance.

Shared Governance of DSCSA is becoming a common approach to structuring support. DSCSA continues to impact many departments which means ownership can often become confusing or lacking. Typical organizational departments to own DSCSA long-term include: Quality, Product Protection, Supply Chain, or Operations. With these or any departments taking ownership, there is a need to have a clear structure in place for share governance to ensure consistency and clarity. Each department that is a direct stakeholder in requirements should be represented in the governance. Changes for the assessment around DSCSA should be expected to continue to happen for at least the next 1 to 2 years and we advise clients to watch for changes that require assessment.

Effectiveness checks are also an important part of ensuring continued compliance. These checks should include having the assigned shared governance members gather on a regular bases such as monthly or quarterly to review if compliance is being maintained and address any changes that may require actions. While these checks can be conducted within the organization, it is best to ensure there is resources involved who are aware of changes that have happened in the industry. Much of DSCSA is based on industry adoption and complying in a interoperable fashion which means staying aligned. We find that mid to larger manufacturers often have a resource that is significantly to fully allocated to DSCSA. Bringing in a independent contracted resource is a viable alternative as we keep intentional focus on happenings in the industry and learning how trading partners are adopting.

Some events to keep in mind as reasons for creating shared governance and holding regular effectiveness checks: 

1. The expected finalization of the National Standards for the Licensure of Wholesale Drug Distributors Third–Party Logistics Providers
2. DSCSA guidance that remain in draft mode and are expected to go final on the FDA DSCSA Law and Policies site.
3. Any GS1 US DSCSA Implementation Guide updates and related GS1 Global Standards that change as the standards evolve. Note: GS1 expects to sunrise an adoption of guide version 1.3 in 2026 as noted below.
4. Expected impacts in DSCSA labeling and data integration related to the transition from NDC10 to NDC12 once the proposed rule is finalized.
5. Lessons learned from exception handling, stabilization, and trading partner requirements.

It is hard to predict what things will look like in the next few years, but it is clear we still have hurdles to cross in bringing the largest sector of the supply chain to fully operational and organizations across the supply chain demonstrating interoperability and full readiness. We are proud to be a trusted partner to many organizations across the pharmaceutical supply chain and remain committed to helping the industry ensure it is implemented effectively.

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Ten Count continues to offer a free consultation to help trading partners of any size or sector understand their requirements, comply, and have processes independently pressure tested while minimizing wasted spend.

Reach out to us through info@tencountconsulting.com

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