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As we fast approach the upcoming November 27th, 2025 end of the "Connected Trading Partner" exemption period for DSCSA, large pharmacies (greater than 25 pharmacists/pharmacy techs in 2024) should be moving through final preparations and into exception process readiness. The only wide exemption remaining after this November will be the small dispenser exemption which extends full readiness to November 27th, 2026 for pharmacies with fewer than 25 pharmacists/pharmacy techs.

All pharmacies should already be complying with aspects of DSCSA that are already in effect, as these exemptions apply only to aspects outlined in the FDA Guidance Enhanced Drug Distribution Security at the Package Level that include full interoperability requirements of DSCSA. If you need further insights on DSCSA requirements for dispensers, we recommend reviewing the Resources Page of DSCSA.Pharmacy which is managed in partnership between APhA, AHSP, HDA, NABP, NCPA, PDG, and PDSA.

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What Should My Organization Be Doing?

1. Develop an Assessment of Readiness for November 27th, 2025 requirements. This can be done through a detailed review of the law, guidance, and learning the best practices of the industry based on guidelines, blueprints, and other documents. Ten Count offers various assessment or effectiveness check options that can help your organization, whether you are a manufacturer, repackager, distributor, dispenser, or 3PL. We have completed over 40 such checks across the industry at a large variety of clients. We also offer a variety of options for more or less DSCSA-experienced organizations.
2. Analyzing the Need for a WEE (Wavier, Exception, Exemption) Request. Some have highlighted that this should be a last resort, but the reality is the FDA expects WEERs to be filed to inform the industry of concerns. The data flow in itself is the biggest challenge to readiness, including processes to set up, test, onboard, and stabilize the exponential amount of data involved in DSCA compliance. We recommend working with industry groups and checking with peers as industry alignment remains critical. Ten Count can help you in evaluating this option and provide support options along the way.
3. Plan for Exception Handling. Early adopters in EPCIS, who have been exchanging files with partners for several years, are suggesting not to underestimate the effort to send or receive serialization data. Every connection with a trading partner brings a variety of challenges that may require either or both organizations to troubleshoot. Since DSCSA requires your organization to ensure you have matching serialized transactional data with all non-exempt products, it is paramount to ensure you are ready to handle exceptions to avoid products becoming quarantined or considered potentially suspect. We can help your organization review the industry-developed scenarios and ensure you are connecting with the right peers and partners.
4. Connect and Stay Aligned with the Industry. There are a variety of industry groups that are working in business and technical areas to help ensure alignment on interoperability and other aspects of this important patient safety law. Ten Count offers a DSCSA orientation that includes a basic understanding for leadership or secondary stakeholders, as well as detailed training for alignment with industry technical and functional best practices. We also stay connected with leaders in each sector to understand the latest developments in DSCSA.

It is hard to predict what things will look like in the next few months, but it is clear we still have a hurdle 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.

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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