This 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 U.S. 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 are only required to obtain the outsourcing facility permit, while those that do engage in such activities must also secure the appropriate pharmacy permit.

Furthermore, the bill emphasizes the reliance on federal inspection reports for both initial permitting and renewals, thereby exempting permitted outsourcing facilities from separate licensure or permitting requirements under the Florida Drug and Cosmetic Act for activities within the scope of their permit. The Board of Pharmacy is designated as the sole regulatory authority for these facilities, and the bill includes provisions for rulemaking to implement its requirements. The act is set to take effect on July 1, 2026, and it includes a provision that outsourcing facilities holding a valid permit before this date will be deemed compliant with the new requirements.