On Wednesday, March 26th, the Partnership for DSCSA Governance did an effective job of coordinating a public meeting with the FDA through their Public-Private Partnership. While many of the messages and themes were similar to past forums and recent industry events such as HDA DMC, there were some notable takeaways.

While a readout and summary is expected to be produced, we wanted to share our key takeaways. (Update April 17th, PDG link to meeting summary, recording and survey results)

• #1 The Focus Has Moved From Connections to Exception Handling. There is an evolutionary nature of moving DSCSA data. With labeling and data well established, connections now largely made, the focus is now on identifying, handling, and resolving exceptions. AAM referenced that their members have over 5,800 SKU with only a 2 of those not fully complying with labeling and transaction data sending.

• #2 The Good, The OK, and The Ugly.
  • Good The feedback from HDA and the distributors who commented, highlighted that the majority of manufacturers are now connected and sending quality data.
  • OK There was a similar focus on working through exceptions and continuous improvement. HDA highlighted that accurate data transmissions have risen to just above 90%, meaning roughly 9% of PO lines face some type of data transmission or content issue.
  • Ugly It was noted that some manufacturers are still not connected and are sending inconsistent data. Cencora mentioned that approximately 12 to 15 out of around 500 manufacturers (roughly 2 to 3%) are in this lagging state.

• #3 Teamwork Makes the Dream Work. Novartis and Genentech expressed readiness and highlighted the significant work and engagement that it takes for manufacturers to reach a state of readiness. Genentech referenced having over 20 teams working across many time zones for years to reach an effective point of readiness. It is clear that this also included significant work to handle the related change management to ensure any groups in an organization that might interact or receive issues related to DSCSA are effectively trained with up-to-date procedures.

• #4 Stay With The Pack. NABP shared the growing use of product verification by state and federal regulators and how they are already aiding investigations. "The good news is that the tools of DSCSA work!" NABP also shared that around 10-15% of verification scans do not have listed GTINs in the industry Verification Router Service lookup directory (governed by an HDA group). It was recommended that manufacturers check with their solution providers or IT associates to ensure their GTINs are listed and that they have DSCSA contact information being returned in verification responses.
• #5 Does Your Trade Group Have Statistics? Several of the trade organizations had useful statistics that spanned quarters or years to help show the trends that are appearing. Some segments did not have these statistics from their trade organization, which makes it difficult to know if the experiences being shared are reflective of the industry as a whole. We appreciated that PDG had great questions and repeated an earlier survey but was limited in the number of respondents. We are hopeful that trade organizations for limited information sectors that include manufacturers, repackagers, 3PLs, secondary distributors, and dispensers can help improve statistics going forward. An alternative might be to have those agencies help encourage trading partners to participate in PDG or other organizations' next surveys.

• #6 Who Lets The Dogs Out? Vetsource shared its experience as an organization that handles a significant number of human prescription products being distributed in the veterinary supply chain. While it seems reasonably clear that veterinary pharmacies are not dispensers under DSCSA since they are not dispensing any products to humans, it is not so clear for the distributors of those products who supply them. This has been a consistent challenge over the past years of DSCSA with many distributors of human drugs in the animal use supply chain believing that they need to fully comply with DSCSA in all area including buying and selling. We hope the FDA might consider a broad exemption for any such distributors if the distributor can ensure that no product handled is ever intended to be further distributed by any a DSCSA Authorized Trading Partner. DSCSA would clearly apply if these distributors sell to pharmacies or distributors who may eventually dispense them to humans.

• #7 Areas of Further Alignment. Several areas were highlighted as needing further alignment, communication, or training across the industry and with state/federal regulators. These included transactions related to 340B products, replacement products, drop ship products, and approved drug products used in clinical trials (new drug indication trials).
• #8 The Phase Approach Works. Several of the groups thanked the FDA for the Connected Trading Partner Exemption phase that allowed for the cascading readiness with manufacturers expected May 27th, 2025, followed by distributors on August 27th, 2025, large dispensers on November 27th, 2025, and small dispensers on November 27th, 2026. It is clear that this approach has allowed trading partners downstream to help encourage and press manufacturers and repackagers to send quality data that is now facilitating their ability to be ready for further downstream trading partners.
• #9 Expect the Unexpected. AAM shared, "we don't know what we don't know yet" while explaining the complex nature of the movement of DSCSA aggregated transactional data means that much of the journey ahead is still uncharted waters. This means that trading partners should ensure they have robust exception management and contingency plans which will enable them to respond quickly to challenges and develop acceptable workarounds as issues arise.

• #10 The Industry is Ready for Manufacturer DSCSA Deadline Day on May 27th Are You? The tone of this public meeting was significantly different from past updates, and it is clear that the industry is largely suggesting a cautious but clear message of readiness. If you are a manufacturer or repackager without quality aggregated data going with every shipment, you should already be working on contingency plans, including the submission of DSCSA WEE requests. Keep in mind that these requests can take several months to process, and approval is not guaranteed. This means that your organization could be at a significant risk of being unable to legally manufacture or repackage products in the US, and we recommend handling this at the executive leadership level with a strong plan to mitigate.

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