This bill amends the definition of "interchangeable biological product" and establishes guidelines for pharmacists regarding the substitution of biological products. It introduces new definitions for "biosimilar" and "interchangeable biological product," specifying that an interchangeable biological product must meet the criteria set forth in federal law, particularly under 42 U.S.C. section 262(i)(3). The bill also mandates that pharmacists can only substitute a biological product for the prescribed one if it meets the definition of an interchangeable biological product. Additionally, it requires pharmacists to inform patients when an interchangeable product is dispensed and to document the specific product provided, ensuring that this information is accessible to the prescriber.

Key changes include the insertion of definitions for "biosimilar" and "interchangeable biological product," which clarify the standards for these products. The bill also outlines conditions under which a pharmacist cannot substitute an interchangeable biological product, such as when the prescriber indicates that substitution is not authorized or when the patient expresses a preference against receiving an interchangeable product. Furthermore, it emphasizes the importance of communication between pharmacists and prescribers regarding the dispensed products, ensuring that all relevant information is documented and shared appropriately. The act is set to take effect 60 days after its passage.

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