As we turn the calendar to 2026 and see DSCSA becoming fully operational across the supply chain, Ten Count Consulting rewinds for the topics you may have missed with our DSCSA 2025 Ten Count. Ten Count Consulting's list of top DSCSA moments and stories from the year.

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The End of DSCSA Connected

Trading Partner Exemptions.

All but "small dispensers" must be fully compliant!

After a few extensions granted through exemptions by the FDA, 2025 brought the end of the broad exemptions that were available for each sector while they completed connections with trading partners. The exemption expirations happened in a staggered fashion this year and were grouped into manufacturers/repackagers, then distributors, and finally large dispensers. This meant a significant push by those not yet fully compliant to DSCSA to complete both internal changes as well as ensuring their direct trading partners were able to receive or send data as required.

The key expiration events that required readiness for each sector included:

• Manufacturers/Repackagers  (May 27th, 2025): The PDG (Partnership for DSCSA Governance) and the FDA held a joint public meeting on March 26th where it was reported that significant progress had been made based on various industry surveys. Stakeholders were leveraging the FDA WEER (Waivers, Exemptions,     Exception) process to handle the remaining risks.
• ‍Distributors     (August 27th, 2025): The next PDG/FDA joint public meeting held on June 25th highlighted the progress from the larger distributors while also raising awareness on challenges being faced by secondary distributors as well as the need to exhaust product received prior to compliance readiness date.
• Large Dispensers (November27th, 2025): For pharmacy organizations with greater than 25 pharmacist and pharmacist tech employees, being at the end of the supply chain exposed the heavy dependency on ready and stable supplying trading partners from the distributor and manufacturer sectors. Most reported readiness of major components and connections but highlighted the inconsistencies and various levels of supporting readiness from suppliers. The PDF/FDA joint public meeting held on September 24th proved to be a valuable platform to raise concerns for a broader audience

In the month following the last milestone, industry forums highlighted areas that require further efforts to stabilize and ensure DSCSA related data continues to move with the product while ensuring no interruptions to access to medicines for the patients being served. Some of those highlighted included:

• Technical challenges in electronic EPCIS file transmissions and receipts
• Lack of aggregation or GS1 standard compliance from a few supplying manufacturers and distributors
• Confusion on the proper choice and correct use of the GS1 GLN identifier requested by the receiver
• The need for more informed and experienced long term training that includes both business and technical aspects

We are excited to see DSCSA coming into full effect as it provides significant capabilities for those preventing and investigating dangerous product. While it is clear that systems and processes will take years to fully stabilize, the industry came together in a big way in 2025 to help make DSCSA a reality. We appreciate efforts by all trading partners, solutionproviders, trade organizations, standards groups, consulting peers, andregulators working daily on DSCSA.

Contact Ten Count Consulting to learn how we can help you navigate DSCSA requirements and protect the health of your customers.

Stay tuned to our blog over the coming days as we share theremaining 9 highlights of 2025!

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