When an FDA-approved drug is in shortage, FDA policy has long allowed state-licensed compounding pharmacies to prepare "essentially copies” of those drugs based on prescriptions from licensed prescribers. It is intentional policy meant to assure patients have access to medications they need, even when the supply chain breaks down. During drug shortages these compounded copies serve a critical lifeline to patients by filling the gap in supply. The Senate is considering a bill to eliminate that policy, and that puts patients at risk.

The so-called "SAFE Drugs Act" (S.3794), would severely limit compounding of drugs on FDA Shortage List and make it harder for patients to receive needed medications when FDA-approved products are unavailable. This includes all medications – from pediatric amoxicillin to treat infections to lidocaine as an anesthetic.

Shortage-drug compounding is not a loophole. It is an essential lifeline when the regular drug supply chain fails patients.

Congress needs to hear about the real-world impacts of changing that longstanding and effective policy.