The bill establishes a new section, 465.0199, in the Florida Statutes, which outlines the requirements for outsourcing facilities to obtain a permit from the Department of Health before engaging in activities related to compounded drug products. The bill mandates that these facilities must apply using a form prescribed by the Board of Pharmacy and provides that permits will only be issued to those certified by the board as meeting specific criteria. The initial application must include documentation of a recent inspection by the United States Food and Drug Administration (FDA) demonstrating compliance with federal good manufacturing practices. Additionally, the bill specifies that outsourcing facilities not involved in patient-specific sterile compounding need only the outsourcing facility permit, while those that do must also obtain the appropriate pharmacy permit.

Furthermore, the bill emphasizes the reliance on federal inspection reports to satisfy state inspection requirements for both initial permitting and renewals, thereby reducing duplicative regulatory burdens. The Board of Pharmacy is designated as the sole regulatory authority for these facilities, which are exempt from separate licensure under the Florida Drug and Cosmetic Act for activities within the scope of their outsourcing permit. The bill also includes a provision that allows existing outsourcing facilities with valid permits issued before July 1, 2026, to continue operating under those permits until they expire or are revoked. The act is set to take effect on July 1, 2026.