Bill > S0732

This bill permits Class II institutional pharmacies, which are pharmacies located within hospitals or other healthcare facilities, to include biologics, biosimilars, and biosimilar interchangeables in their approved drug lists, known as formularies. A biologic is a large-molecule drug derived from living organisms, while a biosimilar is a biologic that is highly similar to an already approved biologic with no clinically meaningful differences. A biosimilar interchangeable means that the biosimilar can be substituted for the reference biologic by a pharmacist. The bill outlines requirements for pharmacists to dispense a substitute biological product, ensuring it has been determined by the U.S. Food and Drug Administration (FDA) to be biosimilar and interchangeable with the prescribed product, and that the prescribing healthcare provider has not prohibited substitution. Pharmacists must also notify the patient of the substitution, similar to how they handle generic drug substitutions, and maintain records of these substitutions for at least two years. For pharmacists in Class II or modified Class II institutional pharmacies, this notification must be documented within the institution's medical records. Additionally, the Board of Pharmacy will be responsible for maintaining a publicly accessible list of all biological products that the FDA has deemed biosimilar and interchangeable.