Drug Shortages Prevention and Quality Improvement Act

This bill aims to prevent drug shortages by requiring manufacturers of life-saving drugs to submit stability data to the FDA for potential expiration date extensions, with civil penalties for noncompliance. It mandates reporting of demand spikes that could cause shortages and imposes $50,000 fines for failure to report. The bill allocates $1 billion in grants to fund continuous manufacturing upgrades for sterile injectable drugs vulnerable to shortages, while allowing Medicare to use wholesale acquisition costs instead of average sales prices for drugs on shortage lists. These measures target specific drugs defined as life-supporting or critical for emergency care, affecting manufacturers, the FDA, and Medicare.