Bill > S0860

Introduced Session

An act relating to compounded drugs; creating s. 499.038, F.S.; defining the term “compounded medication”; prohibiting any person or entity from engaging in the sale, transfer, or distribution of compounded medications for weight loss unless they provide specified documentation to the Department of Business and Professional Regulation; providing administrative penalties; authorizing the department to adopt rules and conduct inspections as necessary to implement specified provisions; providing an effective date. WHEREAS, the Legislature finds that the safety and integrity of compounded medications are paramount for the health and well-being of the residents of this state, and WHEREAS, the Legislature recognizes that while the United States Food and Drug Administration (FDA) sets internationally recognized standards for drug approval and regulatory oversight, there have been increasing attempts by bad actors to circumvent these regulations, undermining public trust and patient safety, and WHEREAS, the Legislature further finds that foreign entities, including those from countries such as China, have exploited regulatory gaps to introduce inferior or contaminated active pharmaceutical ingredients into the supply chain for medications intended for compounding, and WHEREAS, recent cases, including those involving medications for weight loss, have demonstrated that high demand can lead to the proliferation of the use of illicit, substandard, and potentially harmful active pharmaceutical ingredients that jeopardize patient health and safety, and WHEREAS, while the FDA bears responsibility for enforcing federal laws to protect citizens from misbranded and adulterated pharmaceutical ingredients, its enforcement has proven insufficient to curtail the influx of these substances into this state, and despite FDA action to curb imports of active pharmaceutical ingredients for weight loss medications from entities that are not compliant with current good manufacturing practices, patients in our state remain at risk of receiving compounded medications containing such active pharmaceutical ingredients, and WHEREAS, the Legislature therefore finds it necessary for the state to take action to protect its residents by ensuring that all active pharmaceutical ingredients used in compounding are sourced from reputable, registered, and inspected establishments, and that only pharmaceutical-grade, safe, and unadulterated ingredients are used in medications for weight loss, NOW, THEREFORE,

AI Summary

Jennifer Bradley (R)*, 

Introduced (on 01/13/2026)

Official Document