The bill establishes a new section, 465.1903, in the Florida Statutes, which defines "bulk drug substance" or "active pharmaceutical ingredient (API)" and sets forth regulations for the sale, transfer, and distribution of compounded drugs. It specifies that only those compounded drugs using bulk drug substances that meet certain criteria—such as compliance with applicable United States Pharmacopoeia standards, FDA approval, and proper documentation—may be sold or distributed. The bill outlines the responsibilities of individuals or entities involved in compounding drugs, including maintaining records for at least two years and ensuring quality control testing of the bulk drug substances.

Additionally, the bill imposes penalties for violations, including fines and potential revocation of licenses. It grants the Board of Pharmacy the authority to conduct inspections and adopt necessary rules to enforce compliance with these regulations. The act is set to take effect upon becoming law, emphasizing the importance of safety and efficacy in the compounding of pharmaceuticals.