The 2025 HDA Traceability Conference convened industry leaders, regulators, and supply chain experts to address the evolving landscape of DSCSA compliance. With enforcement now in full swing, the conference underscored the urgency of readiness, the complexity of operational alignment, and the shared responsibility across manufacturers, wholesalers, dispensers, and regulators.
Among the many discussions, several themes stood out as especially pressing in this new era of enforcement, highlighting both persistent challenges and emerging priorities across the pharmaceutical supply chain.
Regulatory Enforcement: A New Era Begins
The FDA’s transition to active enforcement marks a pivotal shift in pharmaceutical logistics and compliance. Attendees learned that inspections and communications are likely to be more frequent and rigorous. While the FDA did not formally present, as in years past, former FDA staffers shared that federal licensure standards for wholesale distributors is under review and electronic compliance pathways are being explored for small dispensers.
Their message was clear: industry readiness is needed for all stakeholders by having robust exception management and proactive data monitoring systems, and be ready to demonstrate how they are able to achieve compliance through robust documentation.
Supply Chain Readiness: Challenges and Adjustments
Each segment of the supply chain is grappling with its own set of challenges.
- Manufacturers are tightening procedures to ensure data integrity, as even minor discrepancies can now trigger product holds. Training, SOP evolution, and collaboration across the supply chain are essential for on-going compliance.
- Wholesalers face a high-volume impact from a small percentage of transactions lacking “good” serialization data, with the wholesalers reporting that 2% of all products received still have a “data problem.” Furthermore, exception resolution is taking weeks, not hours, as they need.
- Dispensers are scaling their systems to handle increasing inbound data, but continue to struggle with integration bottlenecks in pharmacy management platforms that will hamper their efficiency in getting products available to patients.
The root cause is often an overreliance on technology without equal investment in process and people. Effective SOPs ensure every employee — not just regulatory specialists — knows how to identify and escalate suspect product concerns. Just as adverse event reporting requires broad staff training, DSCSA compliance demands that anyone who might encounter a suspicious product can act immediately and in accordance with documented procedures.
Industry Updates: Standards, Services, and Strategic Shifts
The conference also addressed broader industry developments. The topic of 340B rose to a prominent talking point, as the lack of clarity or additional guidance documents “on the docket” from the FDA is suggesting that no further clarification is forthcoming from the agency. Stakeholders are being asked to align as best as they can with existing information and approaches, while several work groups, including PDG and GS1, are investing time into helping provide more clarity around the options of data transmission that exist for 340B transactions.
It is also becoming more apparent that regulatory agencies, namely the State Boards of Pharmacy, are leaning into the usage of the Verification Router Service (VRS) as they conduct investigations or to “audit” the readiness of wholesalers or pharmacies in their compliance of DSCSA. However, in the same vein, major wholesalers have indicated utilizing other means for verifications and are looking to sunset VRS usage, which has created a ‘tug of war’ feel in the industry, which has fostered an environment of confusion about whether the VRS networks will sustain. It is important to note that the industry is reporting that verification failures are often due to data or system issues—not counterfeit products—highlighting the need for improved infrastructure rather than panic.
Public comments on national standards for third-party logistics providers and wholesale drug distributors are under review, but no timeline for implementation has been set. These documents have been pending and quite late from the FDA (by nearly 10 years).
Meanwhile, the FDA’s authority to issue Wholesale Exemptions for Emergency Requests (WEERs) remains intact, though requests will be scrutinized more closely, and no centralized repository is planned.
Counterfeit Drugs and Med Spa Risks: A Growing Threat
One of the key discussions from the conference that underscored the importance of drug safety tools, like DSCSA, centered on the rise of counterfeit and grey-market drugs, particularly in unregulated settings like med spas. The counterfeit market surged in 2024 and 2025, with expired labeling often serving as a red flag. Sophisticated counterfeits — such as those mimicking GLP-1’s — are increasingly difficult to detect, making visual inspection insufficient. In some cases, the counterfeiters are properly mimicking how a product needs to be serialized, using randomized sequences bumped up against a legitimate lot number – further reinforcing the important role of DSCSA traceability in identifying and preventing counterfeit drugs.
Compounding practices also drew concern, particularly in the wake of ongoing issues with GLP-1 products. Despite official declarations that shortages have ended, unapproved compounded versions are still being manufactured and distributed. Med spas—often referred to as the “Wild West” of drug administration due to their lack of oversight compared to pharmacies and physician offices—remain a key area of risk. More than 80 cases have been opened involving GLP-1 and Botox products, including instances where products labeled “for research use only” were nonetheless administered to patients.
Barcode Integrity and Labeling Compliance
Barcode quality challenges re-emerged as a notable topic– echoing concerns first raised over a decade ago when serialization was first being brought on-line. The wholesale distributor community reported persistent systemic errors that, while less disruptive in earlier enforcement periods, are now leading to quarantined products and delayed shipments. Many attendees were surprised by the extent of these ongoing issues, as barcode compliance was assumed to have been resolved with the 2017 serialization requirements going into effect.
For manufacturers, the message was clear: barcode integrity remains a critical compliance priority. Partners must adhere to GS1 and HDA standards, and barcode quality should be validated consistently throughout packaging runs and future batches. Common errors—such as unreadable labels, incorrect formatting, or improper placement—can halt shipments and even trigger recalls. Best practices include using laser ablation over ink printing for cold chain durability, ensuring ink–substrate compatibility, and testing barcodes at multiple points across packaging runs.
The FDA evaluates barcode durability using USP standards, with non-compliant labeling—especially around expiration dates—posing significant regulatory risks. Ultimately, manufacturers must enforce disciplined, standardized processes with CMOs and 3PLs to validate barcode structures and safeguard compliance.
Data Governance and Operational Controls
Timely and accurate data is not just a compliance issue—it’s a patient safety imperative. Inaccuracies in GTIN, lot, or expiry data can result in unsupported products entering the supply chain, creating risks for end users. Weak master data governance and gaps in partner communication—particularly during CMO or 3PL transitions—remain key contributors to these issues.
To mitigate risks, manufacturers were urged to strengthen data governance, improve system integration, and enhance operational controls. This includes quarantining inbound products until data is complete, standardizing reconciliation processes, and training staff to detect issues early. Aggregation errors and improperly marked returns can disrupt downstream operations, making proactive management essential.
NDC-12 Transition: Planning for the Future
The FDA’s plan to transition all companies to a six-digit labeler code—resulting in a 12-digit NDC format—is imminent and non-negotiable. With an estimated eight-year transition window (five years for implementation and three years for sell-through), the industry must begin budgeting and resource planning now.
This shift will impact labeling, packaging, distribution, and even government programs. UPC-A barcodes and the original GTIN-14 structure orchestrated by the industry to “embed” the NDC into the GTIN can no longer accommodate because of the increase in length. This will necessitate industry collaboration around the use of a new AI Code 715 (which is for the NDC) within barcodes and EPCIS files.
The industry will not only need to update systems and standards but also ensure the entire ecosystem remains “backwards compatible,” supporting both legacy and new NDC formats simultaneously to avoid product shortages and protect patient safety. Implementing these changes will require updates across thousands of platforms spanning the healthcare sector. While DSCSA teams within many organizations are already aware of the transition through recent labeling and data system updates, the impact extends far beyond the DSCSA compliance groups. Broader executive-level education is essential to raise awareness of this industry-wide “sea change” and to prepare companies for the scale of operational adjustments ahead.
Inspection Readiness: Proactive Preparation
Finally, the conference emphasized the importance of preparing for traceability-focused inspections. Cross-agency involvement—including the DEA, FDA, and state regulators—is expected. Companies should conduct mock inspections, maintain training records, and be ready to present organizational charts, risk assessments, and program overviews.
Documentation is key: verifications, suspect drug investigations, 3911s, and exception logs must be well-maintained. DSCSA requirements should be embedded in contracts and clearly understood by suppliers and customers alike.
The 2025 HDA Traceability Conference underscored a critical reality: DSCSA compliance is no longer on the horizon—it is here, and it demands action. As enforcement accelerates and operational challenges mount, success will depend on how effectively the industry embraces collaboration, strengthens data integrity, and builds resilience across the supply chain. For manufacturers, wholesalers, and dispensers alike, the path forward requires not only meeting regulatory requirements but also viewing compliance as a cornerstone of patient safety and long-term market stability.
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Authors
Greg Makin, Manager, DSCSA/Serialization Services
Amanda Addezio, Consultant, DSCSA/Serialization Services