‍

It was an eventful and informative HDA DMC (Distribution Management Conference) last week in Tampa, FL!

Aside from some incredible networking and seeing old friends and new, we learned a lot on the latest things DSCSA. Here is our top 10 things we learned in 2025 HDA DMC:

‍

Number 1- FDA DSCSA Inspections- We heard from 2 of the largest manufacturers that the FDA has been active in performing DSCSA related audits and has a DSCSA inspection process that sounds comprehensive. Manufacturers should be sure they are fully ready for DSCSA related questions from both federal and state inspections or in the event of any internal or external conducted suspect/illegitimate product investigations. We had already reported on the growing trend of FDA 483s in our 2024 recap. Ten Count is proud to offer comprehensive assessment solutions that can be leveraged no matter where you are in your DSCSA readiness journey from implementation to a final external independent assessment.

‍

Number 2- State Regulators Are Engaging- The trend we saw in 2024 of state regulators engaging continues to increase. We heard from 3 more states as members of a state regulator panel (AR, ID, NC) who explained the importance of DSCSA and how they are incorporating in inspections and utilizing tools in investigations. A real world example was shown of how Arkansas recently leveraged product verification as evidence in a recent counterfeit/diversion investigation by leveraging the HDA managed VRS network through Pulse by NABP.

Number 3- Most Manufacturers Reported Being Ready- We heard there has been steady improvement in EPCIS and portal sharing of Transaction Information to their distributor and dispenser direct customers with most reporting 90 to 95% success rate and improving. The focus appears to have moved mostly to improving consistency of data flow and exception handling to resolve clerical or other issues in movement of data. We did hear of challenges still remaining with some 3PL and CMO providers but understand these are now leading to manufacturers looking at contingency plans for alternate providers. It was good to see, independent consultant, Connie Jung as a panelist discussing the end of the connected trading partner efforts.

‍

Number 4- VRS is Here to Stay- It appears some manufacturers have not yet listed GTINs in the VRS lookup directory and possibly either avoiding VRS or planning to present alternative compliance methods to handling verification requests in a secure, interoperable, and globally recognized way. Based on the growing indication of VRS usage from regulators (states and most recently DEA), we believe VRS is here to stay. The recent example in Arkansas gives a clear example of the power of VRS and why manufacturers should be embracing this industry coordinated effort. Contact your DSCSA solution provider or see the HDA VRS Provider Network page to learn more.

‍

Number 5- FDA PDG Listening Session- We heard confirmation that the FDA is still planning to participate in the townhall session that has been arranged through their Public Private Partnership with PDG (Partnership for DSCSA Governance). The first event related to the approaching May end of exemption for manufacturers will be held virtually on March 26th, 2025 and has an open registration link.

Number 6- Exception Handling Is the Key- All sectors mentioned the importance of robust efforts to ensure your organization has solid procedures, processes, ticket systems, and other tools in place to handle any data or product movement exceptions related to DSCSA. We covered the topic along with some of the key workgroups and document that can be used to familiarize yourself with these in the related post from our 2024 Top 10.

‍

Number 7- NDC12 is Coming!- The round tables session included insights from GS1, HDA, and Pfizer about the draft rule related to NDC 12 and the expected future sunset of NDC 10 (and 11). This will have a substantial impact on the industry as it will involve updating all levels of packaging, systems across distribution, and a significant involvement through dispensing and payment processes across the industry. An overview of the NDC 12 draft rule can be found at this link.

‍

Number 8- Decommissioning- It is encouraging to see the industry continue to explore patient safety potential beyond compliance that is developing through the data and tools of DSCSA. Recent counterfeit and diversion events have shown that bad actors have a preference to target high value and high demand products and leverage techniques that go beyond the scope of DSCSA. We reported on NABP's Decommissioning Pilot Report efforts last year and we are excited to share they recently provided a part 2 Decommissioning Report that included input from a recent cross industry workshop that included trading partners from all sectors.

‍

Number 9- Daily Breakdowns- We were excited to provide quick video recaps of the event through our daily LinkedIn Posts. Be sure to check out our Day 1 and Day 2 posts and follow us on LinkedIn !

‍

Number 10- Ten Count Consulting is On-site!- We were excited to have so many people stop by our booth to talk about DSCSA, our services, and take a shot at our putting challenge! Be sure to reach out to us for all your DSCSA questions or needs at info@tencountconsulting.com or

‍Connect with us for a free consultation to discuss how your company is finishing DSCSA 2025 strong!

‍