No. SB 860
Filed under Healthcare.
Compounded Drugs; 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, etc.
Plain English Summary
AI-GENERATEDNobody may sell, transfer, or distribute a compounded weight-loss medication without first certifying to state regulators that its active ingredient matches an FDA-approved drug's ingredient, comes from an FDA-inspected facility, and passed in-house quality testing.
The required paperwork includes a certificate of analysis identifying every impurity, backed by the original manufacturer's own testing data, plus proof the ingredient's manufacturing facility passed an FDA inspection within the last two years.
Violators face a $1,000 fine for every single dose sold, dispensed, transferred, or distributed, plus revocation of their license or permit. The law takes effect immediately once signed, with no phase-in period.
AINobody may sell, transfer, or distribute a compounded weight-loss medication unless they first certify to the department that the active ingredient's identity, sourcing, testing, and manufacturing facility all meet the standards this section lists.
AIWhen a pharmacist relies on the federal exemption for compounding using a component of an approved drug, the active ingredient must be identical to, and made by the same manufacturing process as, the ingredient in an FDA-approved drug.
AIThe facility that manufactured the active ingredient must be FDA-registered and must have passed an FDA inspection within the last two years, with only the two best possible inspection outcomes qualifying.
AIAnyone who violates this section faces a fine of $1,000 for every single dose sold, dispensed, transferred, or distributed, and can have their license or permit revoked by the Board of Pharmacy or the department.
AIThe active ingredient must come with a certificate of analysis identifying every impurity by chemical name and amount, and that certificate is invalid unless it is backed by the original manufacturer's own testing data.
AIBeyond any certificate from the ingredient's manufacturer, the compounding pharmacist or physician must independently test the active ingredient to confirm its identity and content and to justify any impurities found.
AIThe department gets explicit authority to adopt rules and conduct inspections to enforce this new section, on top of whatever general authority it already had over compounding pharmacies.