This bill amends the definition of "interchangeable biological product" and establishes guidelines for pharmacists regarding the substitution of biological products. The new legal language specifies that an "interchangeable biological product" is one that the federal Food and Drug Administration (FDA) has licensed and determined does not require an interchangeable study to be therapeutically equivalent. Additionally, the bill mandates that pharmacists can only substitute a biological product for the prescribed one if it meets the definition of an interchangeable biological product. The bill also requires pharmacists to inform patients when dispensing an interchangeable biological product and outlines conditions under which substitution is not permitted, such as when the prescriber indicates that substitution is not authorized or when the patient expresses a preference against receiving an interchangeable product.

Furthermore, the bill introduces a requirement for pharmacists to document the specific biological product dispensed, including the product name and manufacturer, within three business days. This information must be made electronically accessible to the prescriber through various systems, ensuring proper communication regarding the dispensed product. The label of all biological products dispensed must also include the proper name and manufacturer. The act will take effect 60 days after its passage.

Statutes affected:
Introduced: 318:47-dd