Sponsors
The bill increases short-term access to compounded drugs by allowing a 180-day shortage lookback, improving availability for hospitals and patients but raising safety, economic, and administrative risks associated with broader use of compounded products.
Hospitals and health systems will have increased availability of needed drugs because outsourcing facilities can compound and distribute products that were on the FDA shortage list within the prior 180 days.
Patients who rely on compounded drugs (including many with chronic conditions) will face fewer gaps in access because facilities may lawfully produce alternatives based on a 180-day shortage lookback.
Outsourcing facilities and the FDA (and indirectly health providers) gain clearer regulatory rules because the bill defines a concrete 180-day period instead of an ambiguous 'at the time' standard, improving predictability for compliance and planning.
Patients (including those with chronic conditions) may face higher safety and quality risks because expanded eligibility increases use of compounded products that have not undergone full FDA premarket review.
Medicaid beneficiaries and other payers could indirectly suffer if demand shifts away from FDA-approved, commercially manufactured drugs, reducing manufacturers' incentives to resolve shortages quickly.
FDA, outsourcing facilities, and health systems may incur increased regulatory tracking and administrative workload to implement and monitor the 180-day lookback, raising compliance costs.
Based on analysis of 2 sections of legislative text.
Allows an outsourcing facility to rely on a drug being on the shortage list if it appeared at any time within the prior 180 calendar days, instead of only "at the time."
Amends the Federal Food, Drug, and Cosmetic Act to change when a drug is treated as being on the federal drug shortage list for purposes of compounding by outsourcing facilities. Instead of requiring the drug to be on the shortage list at a single instant, the bill makes the shortage-list condition true if the drug appeared on the list at any time within the prior 180 calendar days. This expands the time window that outsourcing facilities can rely on to compound and distribute drugs using bulk drug substances under the shortage exception.
Introduced February 12, 2026 by Buddy Carter · Last progress February 12, 2026