As the pharmaceutical and medical device industries move into 2026, compliance teams are facing a familiar reality with a new level of intensity. Regulatory expectations continue to expand, supply chains are more complex than ever, and state-level compliance requirements are becoming increasingly active. While many companies focus on meeting immediate deadlines, those that take a proactive approach now will be better positioned to manage risk and avoid disruption throughout the year.
Below are several key compliance areas pharmaceutical and medical device companies should be prioritizing as they plan for 2026.
A More Fragmented Supply Chain Means Greater State Licensing Exposure
The modern pharmaceutical supply chain rarely follows a straight line. Manufacturers, virtual manufacturers, repackagers, relabelers, 3PLs, own label warehouses, and reverse distributors are deeply interconnected. Each additional partner introduces new state licensing requirements and compliance considerations.
In 2026, companies should expect continued scrutiny around whether all trading partners hold the appropriate licenses for the activities they perform and the states in which they operate. Assumptions based on historical practices or outdated interpretations of state rules can leave organizations exposed.
This is where many companies benefit from regular license reviews and centralized oversight. Having a clear view of licensing obligations across all facilities and partners helps reduce gaps before they turn into enforcement issues.
State Licensing Enforcement Is Becoming Less Forgiving
State boards of pharmacy are not simply issuing licenses, they are actively enforcing them. Inspections, audits, and data requests tied to licensure status are increasing, and regulators are less tolerant of expired licenses, incorrect license types, or incomplete records.
For compliance teams, this means shifting away from a renewal-only mindset. License management in 2026 should include ongoing visibility into changing state requirements, timely updates to company and facility information, and documentation that can withstand regulator review at any time.
Many organizations are re-evaluating how they track license status and regulatory changes across jurisdictions. Proactive monitoring and expert support can help teams stay ahead of shifting requirements rather than reacting under pressure.
DSCSA Compliance Expectations Continue Beyond Stabilization
While much of the industry has been focused on DSCSA stabilization and interoperability, 2026 marks a period where regulators expect operational maturity. DSCSA compliance now extends beyond implementation and into sustained execution.
Trading partner authorization remains a foundational requirement and companies should anticipate questions around how trading partner verification processes are maintained, documented, and audited over time. Relying on one-time checks or manual processes increases risk.
Ongoing license verification and consistent due diligence help demonstrate that DSCSA controls are not just in place but actively managed. This is increasingly important as inspections and audits look for proof of continuous compliance.
Drug Price Transparency Reporting Remains a Moving Target
Drug price transparency reporting continues to evolve at the state level, with varying thresholds, definitions, and timelines. In 2026, companies should be prepared for more rigorous enforcement and less flexibility around missed or incomplete submissions.
The challenge is not just understanding individual state requirements but managing them collectively. Centralized tracking, clear internal ownership, and advance preparation are key to avoiding last-minute reporting issues that can draw unwanted regulatory attention.
Companies that treat price transparency reporting as an ongoing compliance function, rather than an annual exercise, are better positioned to keep pace with changes and reduce risk.
Technology and Self-Service Tools Are Becoming Compliance Essentials
As regulatory requirements grow more complex, manual research and spreadsheet-based tracking become harder to sustain. In 2026, compliance teams are increasingly relying on technology to centralize licensing rules, monitor regulatory changes, and support informed decision-making.
Self-service compliance platforms allow teams to quickly access state requirements, assess licensing needs for new business activities, and stay current as rules change. These tools are especially valuable for organizations managing multi-state operations with limited internal resources.
When paired with expert guidance, technology can help compliance teams operate more efficiently while maintaining confidence in their regulatory decisions.
Preparing Now Sets the Tone for the Year Ahead
Compliance in 2026 will reward preparation. Companies that invest time now in reviewing state license compliance, strengthening DSCSA processes, and improving internal oversight will be better equipped to handle regulatory change with confidence.
Rather than reacting to issues as they arise, forward-thinking organizations are building connected, proactive compliance frameworks. The result is fewer surprises, smoother operations, and a stronger foundation for growth in an increasingly regulated environment.
If your team is looking to better understand where potential compliance gaps may exist or how to strengthen your licensing and regulatory strategy ahead of 2026, now is the time to start the conversation.
Contact our team to discuss how proactive planning, expert support, and the right compliance tools can help position your organization for a more confident year ahead.