Crunch Time: 3 DSCSA Takeaways from HDA’s 2025 Traceability Seminar

As a service provider member of the Healthcare Distribution Alliance (HDA), I had the opportunity to attend the HDA’s Traceability Seminar 2025, which took place from August 4-6 in Washington, DC. This was HDA's last event before the Drug Supply Chain Security Act (DSCSA) enforcement deadline of August 27, the end of the exemption period for wholesale distributors. From speaking to attendees and attending the expert-led sessions, here are my top three takeaways on what the immediate and long-term future has to hold when it comes to DSCSA compliance in the warehouse: 

DSCSA compliance is not a project 

DSCSA compliance should not be viewed as a project to be completed and forgotten. It is a program that must be integrated into your daily operations as a continuous, ongoing part of your business. This means embedding supply chain traceability, verification and data exchange standards into every workflow, from receiving and tracking shipments to managing data across teams. 

Compliance should be part of standard operating procedures (SOPs), with every team member accountable for maintaining it and a clear chain of command. Speakers at HDA’s 2025 Traceability Seminar stressed that the evolving nature of the regulations requires ongoing monitoring and system adjustments. Technology plays a key role here, helping to automatically update and integrate systems, ensuring compliance remains streamlined and not a reactive task. 

Embedding compliance into your operations not only avoids penalties but also futureproofs your business, ensuring resilience to regulatory changes, improving efficiency and building trust with customers and regulators alike. DSCSA compliance needs to be a seamless, built-in part of your business processes for long-term success.  

The FDA is acting 

Whether the FDA decides to postpone (again) the DSCSA deadline is anyone’s guess. However, considering it stuck with the manufacturer deadline in May, I’d put my money on August 27 remaining firm. What does that mean for distributors? It means if the FDA shows up at your warehouse for inspection (or schedules a virtual inspection), you need to be ready. We’ve heard of record/data requests and inspections at manufacturers already taking place, so it stands to reason distributors are next. Make sure all your documentation and records are complete and readily available. It’s also possible that an end customer of a pharmaceutical can incite an inspection just by raising a concern with the FDA, so preparedness is key. One of the most memorable stories circulating at HDA’s 2025 Traceability Seminar was how the FDA had actually sent a warning letter to a distributor for violating DSCSA. Considering the ponderous and deliberate nature of the FDA, its streamlined approach to issuing the warning may say something about how it will act in the future. 

A data storm is coming 

As DSCSA compliance evolves, pharmaceutical distributors will be required to manage large volumes of data transmitted from upstream trading partners. Serialization, transaction histories and product traceability are central to the law, and data will need to be captured and tracked at every step to enable supply chain traceability. Some of the key data challenges for distributors will be ensuring that: 

• Upstream data is accurate and aligns to the physical product being delivered and the bar code data on the container 

• Inventory data is traceable and verifiable when exceptions occur, to streamline resolution 
• Data sent downstream is accurate and aligns to the physical product being delivered and the bar code data on the container 

With the complexity of managing this information across multiple systems, distributors will need clear internal processes for data handling and verification. As the amount of data grows, staying compliant will require ongoing attention to internal processes and regular monitoring. Distributors will need to be prepared to demonstrate compliance when required, with data accessible for inspection and verification at any given point. 

Continuity of care is what it’s all about 

Ultimately, the core responsibility of pharmaceutical distributors — and all authorized trading partners — is to ensure the welfare and wellbeing of patients at the end of the supply chain. DSCSA compliance is not merely about fulfilling regulatory requirements; it is a critical safeguard to maintain the integrity of the supply chain. By prioritizing patient safety through robust compliance, distributors help ensure that only safe, verified products reach those who rely on them, reinforcing trust in the healthcare system as a whole.