Lexology June 10, 2025
The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves, stakeholders—including covered entities, pharmaceutical manufacturers, and pharmacies—must navigate an increasingly complex array of legal requirements and enforcement trends.
This blog post provides a comprehensive update on legislative developments, legal disputes, and emerging compliance issues within the Program.
Legislative Updates
The Program’s legal framework continues to evolve as states address pressing concerns surrounding contract pharmacy access, transparency, and distribution practices through legislation. Recent updates include efforts to protect contract pharmacy arrangements, impose revenue disclosure requirements, and restrict manufacturer use of limited distribution networks.
These legislative initiatives highlight the tension between...
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