Sponsor
Buddy Carter
Representative · R-GA
Representative · R-GA
The bill increases near‑term access to compounded alternatives by using a 180‑day shortage lookback—helping hospitals and patients—but raises safety risks, could weaken manufacturers' incentives to remedy shortages, and adds oversight burdens.
Hospitals, clinics, and patients (including those with chronic conditions) will have greater access to needed compounded drugs because outsourcing facilities could compound and distribute products that were on the FDA shortage list within the prior 180 days, reducing gaps in care and supply interruptions.
Patients who rely on compounded medications are less likely to experience treatment interruptions because the 180-day lookback lets facilities produce alternatives when a product was recently on the shortage list.
Outsourcing facilities and the FDA get clearer, more predictable regulatory rules by replacing an ambiguous 'at the time' standard with a concrete 180-day window, which helps planning and compliance.
Patients could face increased safety and quality risks because expanded eligibility would allow more use of compounded products that have not gone through full FDA premarket review.
Manufacturers may have reduced market incentives to resolve shortages quickly if demand shifts toward compounded alternatives, potentially prolonging shortages of commercially manufactured, FDA‑approved products.
The FDA and outsourcing facilities may face increased regulatory and administrative workload to track the 180-day lookback, monitor compliance, and manage oversight, raising costs for regulators and firms.
Based on analysis of 2 sections of legislative text.
Replaces a single-point "at the time" test with a 180-calendar-day window for the drug-shortage exception applicable to outsourcing facilities.
Official title: To amend section 503B of the Federal Food, Drug, and Cosmetic Act to enhance the ability of outsourcing facilities to mitigate drug shortages by allowing a short-term period to continue supplying the market after a drug is in shortage.
Introduced February 12, 2026 by Buddy Carter · Last progress February 12, 2026
Amends the Federal Food, Drug, and Cosmetic Act to change how an outsourcing facility determines whether a compounded drug meets the drug-shortage exception. Instead of checking whether a bulk drug substance was on the drug shortage list at a single instant (“at the time”), the bill allows the facility to rely on whether the drug appeared on the shortage list at any point during a specified 180-calendar-day window. The change applies in two places in the outsourcing facility statute and effectively expands the time period during which compounding and distribution can rely on the shortage-list exception.