Drug Shortage Compounding Patient Access Act of 2025
The Drug Shortage Compounding Patient Access Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to expand and clarify how compounded medications can be used to address drug shortages and urgent medical needs. It creates new pathways for urgent-use compounding in hospitals and other clinical settings, provided the drug is on the shortage list and is prepared by a licensed pharmacist or physician with specific documentation, labeling, and record-keeping requirements. The bill also strengthens reporting around drug shortages and surges in demand, expands the role and transparency of outsourcing facilities (503B), and tightens labeling standards for compounded drugs to improve safety and traceability. Overall, it aims to improve patient access to shortage-related compounded medicines while increasing oversight and data sharing related to shortages and adverse events.
Key Points
- 1Urgent-use compounding for shortage meds (new 503A pathway): Allows limited-quantity compounding for distribution to a licensed prescriber for urgent administration in hospitals or clinical settings, if
- 2- the drug appeared on the FDA drug shortage list within the prior 60 days, and
- 3- the prescriber certifies attempts to obtain a similar product made by an outsourcing facility (503B) with the same active ingredient and route, and
- 4- the compounded product is labeled with a beyond-use date, packaged for urgent use, and the hospital/clinic is able to provide patient records to the pharmacist/physician within specified timeframes, with those records linked to the order, and adverse events reported to MedWatch within 15 days of awareness.
- 5Redefinition related to “essentially a copy”: Expands and clarifies when a compounded product is considered essentially a copy of a commercially available drug, excluding modifications that provide a significant patient-specific difference, and setting conditions for shortage-related, non-identifiable-patient compounding to be properly labeled and documented.
- 6Expanded surge and shortage reporting (new 506C language): Adds “surge in demand” to the drug shortage framework, requiring notice for discontinuance or interruption (ideally 6 months in advance) and, for surges, notice as soon as practicable; requires reporting that includes surges in demand and includes outsourcing facilities in the reporting framework.
- 7Outsourcing facilities—bulk substances and transparency: Requires annual public updates on bulk drug substances used for identified substances and adjusts certain 503B definitions; broadens the list-building process for substances that may be used in bulk by outsourcing facilities.
- 8Strengthened labeling and FDA-notice language (503A labeling): Requires a clear labeling statement on compounded products indicating they have been compounded for dispensing to an individual patient and have not been FDA-approved; updates reference language for monographs to include National Formulary drug or dietary supplement monographs.