Sponsors (21)
Caps compounding of products that copy marketed drugs, adds out-of-state reporting, expands inspections/registration for high-volume outsourcing facilities, and lets HHS set a 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
The bill strengthens federal oversight, inspections, and funding to improve the safety and traceability of compounded drugs but does so by tightening limits, expanding reporting, and granting broader fee authority — trading improved product safety and regulatory clarity for higher costs, more administrative burden, and reduced access to some customized compounded therapies.
Patients who use compounded drugs: increases HHS/FDA oversight, inspections, and fee-funded compliance activities and tightens rules on duplicative compounded products, reducing risk of contaminated or unsafe formulations.
Pharmacies, physicians, and hospitals: clarifies when a product counts as a commercially available drug and expands device registration/traceability, giving providers clearer regulatory boundaries and improving product traceability.
Approved drug manufacturers: reduced substitution by compounders protects brand integrity and market share for commercially approved drugs.
Patients who need customized or compounded medications (including those with shortages or intolerances): caps and stricter 'commercially available' definitions make it harder to obtain compounded alternatives, risking reduced access to necessary therapies.
Small compounding pharmacies and some outsourcing facilities: more frequent inspections, registration, reporting, and potential higher fees increase compliance and operating costs, which could threaten business viability or reduce local supply.
Patients and taxpayers: broader HHS fee-setting authority creates the risk of higher base fees that could be passed through as higher prices for compounded medications or services.
Based on analysis of 5 sections of legislative text.
Limits how often pharmacies and physicians may compound drugs that are essentially copies of commercially available products, requires annual reporting when compounding for out-of-state patients, expands inspection and registration rules for high-volume outsourcing facilities, and lets the HHS Secretary set a base fee to fund compound-drug oversight. Some provisions take effect six months after enactment and the reporting rule applies beginning with calendar year 2025.