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Description

It defines a compounded medication as a customized drug prepared by a licensed pharmacist or physician when a commercially available drug does not meet a patients specific need The core provision is a prohibition : no person or entity may sell, transfer, or distribute a compounded weight-loss medication in Florida unless they provide documentation to the Department of Business and Professional Regulation (DBPR) certifying a detailed set of conditions, including: The active pharmaceutical ingredient (API) used is identical to the API in an FDA-approved drug and manufactured according to the process specified on that drugs label The API is pharmaceutical-grade and accompanied by a valid certificate of analysis , including impurity identification and original manufacturer testing data The API was manufactured in a facility that is FDA-registered , inspected within the previous two years , and received a No Action Indicated (NAI) or Voluntary Action Indicated (VAI) inspection classification The seller conducted quality-control testing to confirm identity, content, and impurity justification before compounding Violations would carry $1,000 per dose in penalties and potential license or permit revocation , with DBPR authorized to conduct inspections and adopt implementing rules Why this matters: SB 860 does not simply mirror federal rules

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Peptides are fragile molecules that can degrade, aggregate, or lose their three-dimensional structure when exposed to pH fluctuations, temperature changes, light, or even the simple act of sitting in a vial for weeks at a time