Bill > H0877

This bill creates a new section of Florida law that establishes comprehensive regulations for the use of active pharmaceutical ingredients (APIs) in drug compounding. The bill defines an API as a substance intended to provide pharmacological activity in medical treatments and sets strict requirements for its use in compounded drugs. Specifically, pharmacies and drug compounders must ensure that any bulk drug substance used meets rigorous standards, including compliance with United States Pharmacopoeia monographs, FDA approval, pharmaceutical grade quality, and accompanied by a detailed certificate of analysis. The bill mandates that drug substance manufacturers must be FDA-registered, have undergone recent inspections, and meet current good manufacturing practices. Compounders must conduct and document quality control testing and maintain detailed records for at least two years. Violations of these provisions can result in significant penalties, including a $1,000 fine per illegally compounded drug dose and potential license revocation. The bill also authorizes the Board of Pharmacy to conduct inspections and adopt rules to implement these requirements, with the goal of ensuring the safety and quality of compounded pharmaceutical products.

Health and Social Services

https://www.flsenate.gov/Session/Bill/2026/877