Sponsors (20)
The bill increases federal oversight, inspections, reporting, and fee funding to improve safety and traceability of compounded drugs, but does so at the cost of added fees, administrative burdens, and tighter limits that could raise provider costs and reduce patient access to certain customized compounded therapies.
Patients who use compounded drugs and hospitals: facilities that compound a product frequently will face required inspections and increased FDA oversight, lowering the risk of contamination and improving overall product quality.
Patients and regulators: clearer limits on when a product counts as a 'commercially available' drug plus better HHS data on out‑of‑state compounding reduce the chance that compounded products will duplicate approved commercial drugs, helping detect and prevent large‑scale circumvention and protecting patient safety.
Hospitals, pharmacies, and patients: giving HHS fee‑setting authority creates a funding stream that can be used to support inspections and compliance activities, making oversight more predictable and better funded.
Patients who need customized or alternative formulations (including those with intolerances or facing shortages): access could be reduced if compounding is restricted when a product is deemed 'commercially available' or if facilities limit compounding to avoid thresholds.
Small and independent compounding pharmacies: monthly caps, higher inspection/registration thresholds, and new reporting requirements could reduce revenue, raise operating costs, or force business changes.
Patients and taxpayers: giving the Secretary broad fee‑setting authority (and allowing base fees above prior levels) creates a real risk that higher fees will be imposed, which could be passed through as higher prices for compounded medications or services and raises accountability concerns.
Based on analysis of 5 sections of legislative text.
Caps repetitive compounding of drugs that copy commercial products, adds annual out-of-state compounding reports, expands inspections/registration for outsourcing facilities, and lets HHS set the base oversight fee.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes.
Introduced December 9, 2025 by Rudy Yakym · Last progress December 9, 2025
Restricts how often pharmacies and physicians can compound drugs that are essentially copies of commercially available products, requires annual reporting when compounding for out-of-state patients, strengthens inspection and registration rules for large outsourcing compounding facilities, and lets the HHS Secretary set a base establishment fee to fund oversight. Some changes take effect immediately, the reporting rule begins for calendar year 2025, and new inspection/registration rules take effect six months after enactment.