Sponsors (4)
Creates an urgent compounding pathway for recent FDA‑listed shortages, expands manufacturer shortage reporting (including demand surges), narrows outsourcing bulk-substance timing, and adds labeling/reporting requirements.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain shortage and urgent-use compounded medications, and for other purposes.
Introduced September 11, 2025 by Diana Harshbarger · Last progress September 11, 2025
The bill improves timely access and FDA visibility during drug supply stresses—helping hospitals and patients obtain compounded alternatives and giving regulators earlier warning—while increasing safety risks from broader, non‑patient‑specific compounding and imposing new compliance and reporting burdens that could raise costs and affect market incentives.
Hospitals, clinicians, and patients can get faster access to compounded drugs during recent shortages because compounding pharmacies/outsourcing facilities may supply limited quantities to clinical settings without an individual patient prescription and have clearer, time-limited eligibility to use certain bulk substances.
Manufacturers must report demand 'surges' (including for APIs) and FDA gets a clearer statutory definition of 'drug shortage,' giving FDA, hospitals, and clinicians earlier warnings and coordinated information to plan and mitigate supply stress.
Patient safety monitoring and informed choice are improved by required tracking and adverse‑event reporting for urgent-use compounded products plus clearer labeling that the product is not FDA‑approved.
Patients could face safety risks because non‑patient‑specific compounded products bypass some standard prescription safeguards and broader allowed monographs could permit bulk substances with different (potentially lower) standards, increasing variability in safety and efficacy.
Clinicians, hospitals, and compounding facilities will face added administrative and compliance burdens—documenting attempts to obtain 503B products, providing patient IDs, expanded labeling/recordkeeping and MedWatch reporting, and related procedural steps—which could raise costs and strain staff time.
Manufacturers and API suppliers face faster reporting timelines and new reporting obligations that may raise compliance costs and be difficult for small or foreign suppliers to meet, potentially limiting actionable foresight for FDA in some cases.
Based on analysis of 5 sections of legislative text.
Allows licensed pharmacists or physicians to compound and deliver limited quantities of drugs for urgent administration in hospitals and clinical settings when a drug has been on the FDA shortage list recently and certain documentation, labeling, and reporting requirements are met. It also expands FDA shortage reporting rules to require manufacturers to notify the agency about demand surges, tightens the time window for outsourcing facilities to rely on the shortage list for bulk substances, and adds explicit labeling and monograph references for compounded products.