Drug Shortage Compounding Patient Access Act of 2025

This bill aims to improve patient access to compounded medications, particularly during drug shortages, by amending the Federal Food, Drug, and Cosmetic Act. It allows licensed pharmacists or physicians to compound drug products for urgent administration to patients in hospitals or clinical settings, even without an initial individual prescription. This is permissible if the drug has been on the drug shortage list within the last 60 days, and the prescriber certifies they could not obtain an equivalent outsourcing facility-compounded drug to meet the urgent medical need. Compounding pharmacists or physicians must adhere to specific conditions, including labeling the product for urgent use, requesting patient administration records, and reporting adverse events to the FDA's MedWatch program. The bill also clarifies that a compounded drug is not considered "essentially a copy" of a commercially available product if it addresses a significant patient difference or if it is a shortage drug meeting these urgent administration criteria. Additionally, the legislation strengthens drug shortage mitigation by requiring manufacturers to report not only discontinuances or interruptions but also a "surge in demand" for a drug. The definition of "drug shortage" is expanded to mean when demand or projected demand exceeds supply. For outsourcing facilities, the look-back period for drugs on the shortage list is extended to 180 days, and the Secretary must provide public annual updates on bulk drug substance evaluations.