Sponsors (2)
The bill strengthens safety oversight of high-volume compounding (reporting, registration, inspections, and fee-funded FDA activity) to reduce patient risk, but does so at the cost of reduced access for some patients, higher compliance and operational costs for small compounding providers, and added privacy and implementation burdens.
Patients (including those with chronic conditions) and hospitals: tighter limits on large-scale compounding plus standardized reporting, registration, inspections, and fee-supported FDA activity reduce the risk that contaminated, substandard, or improperly duplicated compounded drugs reach patients.
Licensed pharmacists, physicians, hospitals, and regulators: clearer definitions of when a compounded product is an 'essentially a copy' and standardized reporting create more consistent legal boundaries and data for targeted enforcement and oversight.
Hospitals and health systems: clearer registration rules and risk-based inspection requirements for large compounding/outsourcing facilities improve supply-chain transparency and make facility status and inspection expectations more predictable.
Patients who need customized compounded drugs (e.g., allergies, special dosing) and hospitals: production caps, tighter definitions favoring commercial products, and new inspection/registration timing can reduce availability, cause delays, and shift patients to costlier commercial alternatives.
Independent compounding pharmacies and small providers: monthly production limits, additional reporting, potential IT/data-format compliance costs, and variable fees increase administrative burden and can reduce revenue or push small operators out of the market.
Pharmacies, physicians, and hospitals: mandatory reporting of product types and monthly volumes raises privacy and business-competition concerns by forcing disclosure of sensitive business information to HHS.
Based on analysis of 5 sections of legislative text.
Sets monthly and annual limits and reporting on compounding copies of commercial drugs, creates inspection/registration rules for high-volume compounders, and lets HHS set a base fee to fund safety.
Official title: Amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes.
Introduced February 5, 2026 by James E. Banks · Last progress February 5, 2026
Limits how often pharmacies and physicians may compound copies of commercially available drugs, creates new reporting requirements for out-of-state compounding, establishes inspection and registration rules for high-volume outsourcing compounding facilities, and lets the HHS Secretary set a new base fee to fund compounded-drug safety activities. Key changes include a monthly cap of 20 copies of commercially available products per compounder, annual reporting for certain out-of-state compounding above that cap, required risk-based inspections for ‘‘large-scale’’ outsourcing facilities (those compounding >100 times/year) with biennial reinspections, and replacement of a fixed statutory fee phrase with a Secretary-determined base establishment fee to fund safety activities. The bill tightens when compounding is treated as an exempt compounded drug, narrows the definition of ‘‘commercially available drug product,’’ and phases in inspections/registration changes six months after enactment while requiring annual data collection beginning for calendar year 2025 and continuing thereafter.