Drug Shortage Compounding Patient Access Act of 2025

Summary

Creates a temporary, limited pathway for pharmacists and physicians to compound and distribute certain drugs that are on the FDA drug shortage list so licensed prescribers can urgently administer them in hospitals or clinical settings without an individual patient prescription. It also expands manufacturer reporting requirements to include surges in demand, tightens definitions of ‘drug shortage,’ requires public annual updates on bulk drug substance evaluations for outsourcing facilities, and adds or revises labeling and documentation rules for compounded products.

• Permits pharmacists and physicians to compound and distribute certain FDA-listed shortage drugs for urgent hospital use without an individual patient prescription when the drug appeared on the FDA shortage list within the prior 60 days.
• Requires prescriber certification that reasonable attempts to obtain an equivalent outsourcing facility (503B) product failed before using a compounded shortage product.
• Mandates labeling, patient-record linkage, and adverse-event reporting (15-day MedWatch deadline) for shortage-based compounded products.
• Expands manufacturer reporting obligations to include surges in demand and requires 6-month advance notice of discontinuances when possible.
• Revises the statutory definition of drug shortage to include active pharmaceutical ingredients and to define shortage by demand exceeding supply for a specific dosage form/route.
• Requires HHS/FDA to publish annual updates about evaluations of bulk drug substances for the 503B bulk-substance list.
• Adds a required label statement for all compounded products that they were compounded for an individual patient and are not FDA-approved.
• Makes narrower, targeted exceptions to usual compounding restrictions rather than broadly changing approval or distribution pathways.