This bill amends the definition of "interchangeable biological product" and establishes guidelines for pharmacists regarding the substitution of biological products. It introduces new definitions, including "biosimilar" and "interchangeable biological product," which clarify the criteria for a biological product to be considered interchangeable with a reference product. Specifically, an interchangeable biological product must meet the standards set by the federal Food and Drug Administration (FDA) and be deemed therapeutically equivalent. The bill also mandates that pharmacists inform patients when dispensing an interchangeable biological product and outlines conditions under which substitution is not permitted, such as when a prescriber indicates that a specific product is medically necessary or when a patient declines the interchangeable product.

Additionally, the bill requires pharmacists to document the specific biological product dispensed within three business days, ensuring that this information is accessible to the prescriber through various electronic systems. The label on all dispensed biological products must include the proper name and manufacturer information. The act is set to take effect 60 days after its passage, with an effective date of September 13, 2025.

Statutes affected:
Introduced: 318:47-dd
As Amended by the Senate: 318:47-dd
Version adopted by both bodies: 318:47-dd
CHAPTERED FINAL VERSION: 318:47-dd