The bill establishes a new section, 465.191, in the Florida Statutes, specifically addressing compounding pharmacies. It defines key terms such as "chronically ill patient," "terminally ill patient," and "compounding pharmacy," and allows these patients to work with their healthcare providers to determine individualized treatment plans using medications from compounding pharmacies. The bill also permits licensed compounding pharmacies to access active pharmaceutical ingredients that lack a specific monograph, provided they are sourced from FDA-registered manufacturers and comply with quality specifications.
Additionally, the bill outlines restrictions on the use of certain ingredients, stating that compounding pharmacies cannot use ingredients that have been withdrawn from the market for safety reasons or are listed as category II or III by the FDA unless they meet specific criteria. Importantly, the legislation clarifies that it does not permit any treatments intended to cause a patient's death. The act is set to take effect on July 1, 2025.