2026 Distribution Management Conference (HDA) Key Highlights

The Healthcare Distribution Alliance’s Distribution Management Conference (DMC) in Austin underscored how rapidly the U.S. drug supply chain is shifting from policy design to day‑to‑day operations with proof of compliance. Across discussions on FDA oversight, state board activity, small‑dispenser readiness, and the coming 12‑digit NDC environment, one theme held steady: compliance, data quality, and operations can no longer be managed in silos.

FDA’s evolving posture: oversight with clear expectations

Aaron Weisbuch, Senior Regulatory Advisory, CDER, U.S. Food and Drug Administration, reinforced that DSCSA oversight is now baked into routine activity. Surveillance inspections coordinated with the Office of Inspections and Investigations (OII) continue to monitor both product quality and supply chain controls. While these visits may be triggered by manufacturing concerns, questions around DSCSA—particularly authorized trading partner (ATP) controls and suspect product handling—are becoming a normal part of the conversation.

Attendees were reminded that “for‑cause” inspections remain FDA’s sharpest tool, deployed when quality concerns, complaints, or intelligence suggest significant risk. A standout example: FDA’s first DSCSA inspection of a medical spa acting as a dispenser. Observations included gaps in ATP documentation, inventory that didn’t reconcile with order history, and a Botox vial lacking a product identifier. The message was clear: DSCSA expectations apply beyond traditional settings, and inventory controls, documentation, and recordkeeping are under real scrutiny.

Alongside inspections, Mr. Weisbuch highlighted broader investigative work—fact‑finding activities used even when there is no specific allegation of noncompliance. These efforts aim to clarify how the law is working in practice and where additional oversight or guidance is needed.

What regulators want to see: systems, evidence, and trained people

Both FDA and state boards of pharmacy emphasized that “paper compliance” is not enough. Trading partners should be ready to show:

• Documented systems and SOPs with clear roles and responsibilities

• Evidence that staff understand and can execute those SOPs in real time

• Robust ATP controls, including licensure/registration verification and records for transaction information and statements (or portal access)

• Clear, traceable processes for suspect and illegitimate product investigations and disposition

State board representatives, including Todd Dear from the Mississippi Board of Pharmacy, described how DSCSA has started showing up at the inspection level, but unevenly across states. Marty Hendrick from Oklahoma Board of Pharmacy stated that the board visits in‑state pharmacies/licensees annually and is actively communicating DSCSA expectations during those visits. Mark Hardy, representing the North Dakota Board of Pharmacy, noted that while states are placing greater emphasis on inspections, gaps remain—and he stressed that timely responses to regulators’ trace requests (supported by NABP tools) are critical to boards’ public-safety mission.

Small dispensers: where readiness and reality collide

Small dispensers emerged as a critical weak spot in DSCSA implementation. Conference discussions pointed to ongoing efforts to create guidance tailored to these entities, acknowledging that many lack the IT budgets, staffing depth, or formal change‑management structures common in larger systems.

For wholesalers and manufacturers, this isn’t a downstream footnote. When small dispensers struggle with system connectivity, data standards, or basic process discipline, the impact appears upstream as exceptions, delays, and verification headaches. Proactive support—education, practical playbooks, and simplified connectivity options—will be essential to keep product flowing smoothly.

Waivers, exceptions, and exemptions: narrow tools, not a plan

The conference also unpacked FDA’s approach to waivers, exceptions, and exemptions (WEERs). These mechanisms are meant to solve specific, documented barriers—not to substitute for long‑term compliance.

Common reasons for denial include:

• Requests outside FDA’s statutory authority (for example, for non‑trading partners)

• Hypothetical concerns rather than real, demonstrated obstacles

• Situations already covered by existing upstream WIEs

• Lack of demonstrated effort to build electronic connections with trading partners

• Overly broad or vague scope

• Weak internal controls or inventory management

Successful submissions tend to share traits: alignment with published guidance, a clearly defined and narrow ask, fact‑based justification, ongoing security controls, and a credible plan—including timelines—for exiting the WIE.

NDC12 and barcode convergence: data as infrastructure

Looking ahead, the DMC devoted substantial attention to FDA’s final rule standardizing the National Drug Code at 12 digits (6‑4‑2). The change addresses number exhaustion and simplifies today’s patchwork of 10‑digit formats and zero‑padding conventions.

Just as important, the rule pushes convergence between DSCSA and the older barcode rule. Allowing a 2D data matrix to satisfy both requirements reduces label crowding and eliminates conflicting barcode expectations—while accelerating the shift toward 2D scanning across the supply chain.

The timeline—a seven‑year effective date plus a three‑year coexistence period for 10‑ and 12‑digit NDCs—may appear generous, but speakers repeatedly warned against DSCSA‑style procrastination. NDC12 will touch:

• Master data and product catalogs

• Transaction systems, chargebacks, rebates, and pricing files

• Returns processing and historical crosswalks

• Front‑end and pharmacy‑level scanning capabilities

Bottom line: readiness as a core capability

From Austin, the takeaway for distribution leaders is less about any single rule—FDA enforcement posture, state board expectations, DSCSA operations, or NDC12—and more about building readiness as a durable capability. That means:

• Treating data and NDC governance as core infrastructure

• Investing in systems and people, not just policies

• Engaging trading partners early, with special attention to small dispensers

• Prioritizing ATP discipline, traceability, and real‑world inventory controls

The next phase of supply‑chain regulation will reward organizations that can prove what they do—not just describe it.

Drug pricing: where gross-to-net pressure meets data reality

Another thread running through DMC was drug pricing—especially the growing operational burden behind gross‑to‑net. In the 2026 Drug Pricing Trends Discussion: 340B and other Pricing Trends session, Heather Easterling (McKesson Professional & Advisory Services) mapped how multiple policy and market forces are converging to increase pricing complexity and the need for tighter data controls.

Key themes included:

• “MFN-style” pricing initiatives and reimbursement pressure. Several models and policy directions discussed target Medicare Part B and Part D drugs, using mechanisms such as global price benchmarking and alternative inflation rebate structures—each of which can shift financial exposure and compliance requirements for manufacturers.

• The Inflation Reduction Act (IRA) and negotiated pricing. The IRA Drug Negotiation Program was positioned as another driver pushing manufacturers toward more disciplined contracting and pricing execution.

• 340B evolution and data-sharing requirements. The discussion highlighted 340B policy activity and a clear direction toward more claims-level data to support eligibility, auditing, and reimbursement mechanics. That translates into heavier submission, validation, and reconciliation work across trading partners.

• WAC decreases and the “gross-to-net bubble.” A notable point: price decreases can relieve some gross-to-net pressure, but they also ripple into downstream calculations and obligations (e.g., reimbursement benchmarks and rebate dynamics), making clean, connected data even more important.

Taken together, the pricing conversation reinforced a reality many manufacturers feel every day: the hardest part isn’t choosing a pricing strategy—it’s operationalizing it across chargebacks, credits, returns, eligibility rules, data requests, and dispute cycles.

Turning serialization into ROI: why LSPedia launched three new products at DMC

At HDA DMC, the conversations we had weren’t about whether serialization matters anymore. That debate is over. What people are really asking now is:

“How do we make this investment actually pay off?”

That question is getting harder as gross‑to‑net pressure rises. Every policy shift, contract nuance, or 340B interpretation creates more edge cases to track, reconcile, and defend—and every one of those decisions depends on trusted, product-level data. Serialization already generates the most granular, verified data set manufacturers have; the opportunity now is to use it to tame pricing complexity, not just satisfy DSCSA.

That’s exactly why LSPedia released Serialized Lifecycle Management (SLM), Serialized Revenue Management (SRM), and Digital Link at the DMC—because the same data that powers DSCSA compliance can also reduce friction in the workflows that drive gross‑to‑net.

• Serialized Lifecycle Management (SLM) extends serialization beyond compliance to manage recalls, returns, expiries, and product disposition with full visibility and operational control. That same lifecycle view is critical when WAC changes, IRA negotiations, and MFN-style concepts create overlapping eligibility and pricing rules for the same physical unit.

• Serialized Revenue Management (SRM) connects physical product movements to financial workflows, helping automate reconciliation, chargebacks, credits, and fee calculations. By tying transactions to serialized events, SRM helps clarify “who is owed what, and why” across contracts, rebates, and discount programs—reducing manual research and dispute cycles that inflate gross‑to‑net noise.

• Digital Link enables real-time product engagement and data access across the supply chain using standardized, scan-enabled identifiers. As payers, providers, and contract pharmacies demand richer, claims-level and unit-level evidence, Digital Link becomes a bridge between the product in hand and the data needed to support eligibility, pricing, and audit trails.

These products aren’t “another layer of compliance.” They’re designed to help manufacturers, wholesalers, and dispensers finally connect the systems that have historically operated in parallel—serialization, operations, and revenue management—so teams can move from exception chasing to measurable outcomes.

What Now

‍If you’re seeing friction between compliance and operations—serialization data that never leaves the IT corner, pricing and contracting teams buried in disputes, or gross‑to‑net adjustments that are hard to explain—now is the moment to turn that around. LSPedia’s SLM, SRM, and Digital Link were built to transform serialization from a regulatory cost center into an operational and financial advantage. Let’s connect to map where serialized event data can simplify your pricing and gross‑to‑net workflows, and explore how these three products can help you unlock more value from the serialization investments you’ve already made.

We’re partnering with a select group of companies to pilot SLM, SRM, and Digital Link, and to explore these capabilities for tangible serialization ROI. Click here to receive  Pilot Information.  

Reach out to us at trace@lspedia.com or schedule time with our team. Click here to receive information about our Pilot Program.

Because at this stage, it’s no longer about getting compliant.

It’s about making it work.