This bill allows pharmacists and physicians to compound and distribute limited amounts of recently short-listed drugs to hospitals or clinics for urgent use, without prescriptions for every patient—only when FDA-approved or outsourced alternatives aren’t available despite reasonable attempts. It sets new labeling requirements, mandates prompt adverse event reporting and patient record tracking, and requires earlier, more thorough reporting of drug shortages and demand spikes. By loosening some restrictions during shortages, the bill allows the use of compounded drugs that haven’t undergone full FDA approval, while maintaining some safeguards for oversight and patient safety.
