Drug Shortage Compounding Patient Access Act of 2025

Summary

Creates a temporary pathway that lets licensed pharmacists or physicians prepare and deliver limited quantities of compounded drugs for urgent in-hospital clinical use when a product has been on FDA’s shortage list within the prior 60 days, subject to documentation, labeling, record-sharing, and adverse-event reporting requirements. It also expands manufacturer reporting rules to require notice for surges in demand as well as discontinuances or interruptions, broadens the list of covered substances (including active pharmaceutical ingredients), requires FDA to publish annual updates on bulk drug substance evaluations, and adjusts certain labeling and monograph references for compounded products.

• Permits limited non-patient-specific compounding for urgent in-hospital use when the drug was on FDA's shortage list within the prior 60 days, subject to conditions.
• Requires prescribers to document attempts to obtain an outsourcing-facility-compounded product before using the shortage exception.
• Labels compounded products for urgent use and requires patient-identifying administration records within 7 days; compounders must link those records to orders.
• Mandates adverse-event reporting to FDA's MedWatch within 15 days of awareness for products distributed under the exception.
• Expands manufacturer reporting obligations to include "surges in demand" and shortens timing language to require notice as soon as practicable for surges.
• Broadens covered substances in reporting rules to include active pharmaceutical ingredients and defines "drug shortage" and "surge."
• Requires the Secretary to publish annual public updates about evaluations of bulk drug substances for the outsourcing (503B) list.
• Adds a required label stating compounded products were prepared for an individual patient and are not FDA-approved, and updates a National Formulary reference.