Senate Bill 1414 amends Tennessee Code Annotated to enhance protections for 340B entities, which are organizations participating in the federal 340B drug discount program. The bill specifically revises Section 56-7-3119 by deleting subsection (d) and replacing it with new provisions that prohibit drug manufacturers and their affiliates from denying or limiting the acquisition and delivery of 340B drugs to these entities. It also restricts manufacturers from imposing additional requirements, such as data submissions or audit conditions, that are not applicable to non-340B entities. Violations of these provisions can result in civil penalties of $50,000 per violation.
Additionally, the bill introduces new subdivisions to Sections 56-8-104 and 47-18-104, making violations of the newly established rules under Section 56-7-3119(d) subject to enforcement actions. The bill clarifies that it should not conflict with federal laws or other compatible state laws. The act is set to take effect on July 1, 2025, ensuring that the rights of 340B entities are upheld in their dealings with drug manufacturers.
Statutes affected: Introduced: 56-7-3119, 56-8-104, 47-18-104(b), 47-18-104