Drug Shortage Compounding Patient Access Act of 2025
The Drug Shortage Compounding Patient Access Act of 2025 would amend the Federal Food, Drug, and Cosmetic Act to improve access to shortage- and urgent-use medications through expanded pharmacy compounding, enhanced reporting of shortages and surges in demand, and updated labeling and recordkeeping. The bill creates new conditions under which compounding pharmacists or licensed physicians may prepare and distribute non-patient-specific medications for urgent administration in hospitals or clinical settings when a drug is on a shortage list. It also strengthens the oversight of outsourcing facilities (503B) and expands public reporting on drug shortages and bulk drug substances. In short, the bill aims to speed access to critical compounded medicines during shortages while increasing transparency and accountability around shortages and adverse events. Key elements include allowing urgent-use, shortage-related compounding outside a specific patient prescription under defined safeguards; clarifying what counts as “essentially a copy” of a commercially available product; expanding the reporting requirements for drug shortages (including surges in demand) and including outsourcing facilities in those requirements; updating the public list of bulk drug substances; and adding labeling and recordkeeping requirements to ensure clarity about compounded products and to support traceability and safety.
Key Points
- 1Expedited urgent-use compounding under 503A: Allows a licensed pharmacist or licensed physician to compound a drug for distribution to a hospital or clinical setting for urgent administration, even without a specific identified patient, if:
- 2- The drug appeared on the drug shortage list within the prior 60 days; and
- 3- The prescriber certifies via the order that reasonable attempts were made to obtain an outsourcing facility product with the same active ingredient and route; and
- 4- The product is properly labeled with a beyond-use date; and
- 5- The packaging is marked to indicate urgent-use and a records request is made for patient identifiers within 7 days of administration or discharge; and
- 6- Records are linked to the corresponding order and adverse events are reported to MedWatch within 15 days of awareness.
- 7Clarification of “essentially a copy”: Redefines when a compounded product is not considered an essentially copy of a commercially available drug, including scenarios where a product is altered for an identified patient or where shortages trigger labeling and documentation requirements for non-identified-patient compounding.
- 8Expanded drug shortage reporting (506C): Requires notices to cover disruptions in manufacture and surges in demand, with earlier or expedited notices, and broadens reporting to include outsourcing facilities and patient organizations; introduces a definition of “surge” and updates related terms.
- 9Outsourcing facility updates (503B): Makes targeted technical changes to 503B provisions and requires annual public updates on evaluation of bulk drug substances for the list of identified bulk drug substances.
- 10Labeling and clarifications (503A): Replaces certain labeling guidance to require a statement that the medication is compounded for dispensing to an individual patient and not FDA-approved; updates terminology related to monographs to reference National Formulary drug or dietary supplement monographs.
- 11Public health transparency: Creates public updates and more transparent information about bulk drug substances and shortages to improve planning and patient access.