2025 in Compounding: Key Takeaways and What to Expect in 2026

By: Philip Smyth, CPhT | Director, Global Public Affairs at Medisca

Looking back, 2025 was a defining year for compounding — not because of one product category or one policy fight, but because of the industry’s expanding impact and visibility.

Yes, GLP-1s dominated headlines. They drove lawsuits, media attention, and public debate at a scale not seen in years. But focusing solely on GLP-1s misses the larger story. What truly defined 2025 was a structural shift: compounding moved closer to the center of the healthcare conversation at a moment when the system itself is under increasing strain. With this visibility comes both significant opportunity and heightened responsibility.

What 2025 Really Showed Us

GLP-1s shone a light on a broader dynamic. When shortages emerged, compounders stepped in to help patients maintain continuity of care. Courts enforced the laws throughout the year, clarifying that shortage-based compounding is not a loophole but an integral part of the system Congress created. In one case, a federal judge captured this reality plainly: “For patients with allergies or unique needs that make FDA-approved medications unsuitable, compounded drugs are a godsend.” That observation resonated because it reflected lived experience, not theory.

These decisions mattered beyond the immediate cases. They reinforced confidence that the statutory framework works as intended and that litigation is not a substitute for thoughtful policy. Key outcomes from such experiences leads to a deeper understanding of compounding, both its role and its limits.

At the same time, 2025 made the reality of drug shortages impossible to overlook. Neither isolated nor rare, these events persisted across all therapeutic areas. The discussion shifted from emergency response to a more challenging reality that shortages are structural, rooted in concentrated manufacturing, fragile global supply chains, and limited redundancy. Compounding found itself squarely in the discussion, recognized as a key solution for maintaining patient access.

Within the industry, change was happening as well. Governance, documentation, quality systems, and risk management moved to the forefront. For many organizations, 2025 was a year of continued change and evolution, a process that was at times uncomfortable but necessary.

The 503B outsourcing facility sector continued to mature this year. Facilities invested in analytics, automation, and more robust quality systems. Hospital partnerships became more strategic, and 503Bs increasingly supplied products to 503A pharmacies. This evolution reflects a more segmented and collaborative ecosystem, one that is likely to continue as roles become clearer.

This was also a year where we’ve seen continued engagement between regulators and policymakers with industry.  The focus increasingly centered on how compounding fits into healthcare, rather than whether it should exist at all.

The Cost of Supply Chain Fragility

In 2025, rising input costs had a measurable impact across healthcare supply chains. Increases affecting APIs, excipients, consumables, and manufacturing inputs placed added pressure on sourcing, production planning, and long-term reliability. These pressures are not abstract — they show up in tighter sourcing options, longer lead times, and reduced operational flexibility. Even when costs are temporarily absorbed, underlying fragility within the system becomes more pronounced.

These dynamics did not create disruptions and shortages on their own, but they exposed and intensified existing vulnerabilities. Looking ahead to 2026, strengthening supply chain resilience will remain critical to maintaining continuity of care and patient access.

Three Things to Watch in 2026

1. Peptides will remain under the spotlight
   Regulatory guidance around certain peptide ingredients continues to evolve, and compounders are closely watching how access may develop. Any path forward is likely to involve appropriately strict quality and control expectations. There is real opportunity here for the industry to demonstrate discipline, transparency, and adherence to high standards.
2. State-level legislation will intensify
   Although federal courts clarified several key issues in 2025, regulatory momentum is now moving decisively to the state level. Florida’s newly introduced SB 860, targeting compounded medications for weight loss, offers an early indication of what is likely to become a broader trend. Should more states consider legislation that touches compounding, there will be opportunity for industry to continue to grow, particularly around education, alignment, and proactive engagement. Industry must continue to articulate its role clearly and consistently: compounders exist to expand patient options, and they do so safely, responsibly, and within appropriate safeguards.
3. Drug shortages will continue to grow, even if they do not dominate headlines
   While shortages may not be the most visible issue in 2026, the conditions that drive them are becoming more pronounced. Global market dynamics and cost pressures can particularly affect older, essential generic therapies with thin margins. As a result, fewer overseas manufacturers may operate in or enter the U.S. market, quietly tightening supply. When traditional supply falters, compounders continue to provide safe, reliable access to essential therapies, stepping in wherever patients need them.

Looking Ahead

If 2025 was about demonstrating relevance to bridging gaps in patient access, 2026 will be about continuing the efforts in demonstrating a reliable and responsible structure. The industry is navigating rising expectations, political pressure, and real supply chain challenges. How compounding responds through quality, discipline, and transparency will determine whether future headlines focus on controversy or on the patients being helped every day.

Compounding is no longer on the sidelines of healthcare— it is at the heart of it. What happens next will contribute to defining its role for years to come.

Disclaimer: This blog is for general informational and educational purposes only and does not constitute professional, regulatory, or medical advice. Any third-party sites referenced in this blog are not monitored or controlled by Medisca and Medisca shall not be held responsible or liable for any content resulting therefrom. Any statements or opinions made in this blog are strictly those of the authors and not of Medisca. Medisca is not liable for any loss or damage arising from the use of or reliance on this content. Medisca makes no guarantees regarding the accuracy or completeness of the information contained herein.