This Act streamlines pharmacy compounding during drug shortages, improves FDA reporting requirements for manufacturers to anticipate supply issues, and updates labeling and regulatory language for compounded and outsourced drugs.
Diana Harshbarger
Representative
TN-1
The Drug Shortage Compounding Patient Access Act of 2025 aims to improve patient access to necessary medications during drug shortages. It allows pharmacists and physicians to compound urgent batches of drugs without an individual prescription if the drug is on the shortage list and commercial alternatives are unavailable. Furthermore, the bill enhances drug shortage mitigation by requiring manufacturers to report sudden surges in demand to the FDA, alongside existing reporting for manufacturing interruptions. Finally, it clarifies compounding regulations and adds specific labeling requirements for patient-specific compounded drugs.
New Bill Allows Hospitals to Compound Urgent Shortage Drugs Without Patient Prescriptions, Adds 'Demand Surge' Reporting
The Drug Shortage Compounding Patient Access Act of 2025 is a direct response to the frustrating reality of drug shortages, aiming to give hospitals and clinics a faster way to get essential medications when the supply chain breaks down. The core change here is that it creates a legal exception allowing licensed pharmacists or physicians to compound certain drugs—mix them up on the spot—for urgent use in a hospital setting without a specific prescription for an individual patient. Normally, compounding requires that patient-specific prescription.
This exception only kicks in if the drug has been on the official shortage list within the last 60 days. There’s a catch, though: the ordering doctor must certify that they first "tried hard" to get the drug from a large-scale compounding facility (called a 503B outsourcing facility) but couldn't. If they go this route, they have to label the batch for "urgent administration only" and then track down which patients received the drug within seven days of administration or discharge. This is all about speed and access when the clock is ticking, but it means those specific batches are bypassing the usual patient-specific oversight.
The Supply Chain Gets a New Alarm Bell
For anyone who has ever waited for a crucial medication because the manufacturer couldn't keep up, Section 3 is a big deal. It updates the FDA’s reporting requirements for drug manufacturers, making them responsible for reporting not just production interruptions or discontinuations, but also a "surge in demand." This means if a manufacturer sees demand suddenly spike beyond what they can handle without causing delays, they have to notify the FDA "as soon as practicable." This is a crucial shift because sometimes the shortage isn't about the factory breaking down; it's about unexpected demand (like a new flu strain or a sudden trend) overwhelming the system. The bill also clarifies the definition of a "drug shortage" to explicitly include situations where demand exceeds available supply, taking into account things like dosage and administration methods.
Labeling and the Fine Print
Section 5 tackles transparency in compounding. If a drug is compounded specifically for a patient, the label must now include a very direct warning: "This medication has been compounded for dispensing to an individual patient and has not been approved by the Food and Drug Administration." While this is meant to be transparent, it could cause confusion or anxiety for patients. Imagine picking up a necessary medication and seeing that warning—it might make you question the safety, even if the drug is being compounded safely under strict pharmacy guidelines. It’s a necessary legal clarification, but one that could require healthcare providers to do more explaining.
What About the Big Compounders?
Finally, the bill adds new requirements for outsourcing facilities (the 503B facilities that compound drugs in bulk). The Secretary of Health and Human Services must now publicly release annual updates detailing how they are evaluating the bulk drug substances these facilities use. For regular people, this means more public transparency about the ingredients being used in large-scale compounded drugs. It’s a move toward better oversight, ensuring that the raw materials used to make these essential medicines are being properly reviewed.