Drug Shortage Prevention Act of 2023

HR 3008, the Drug Shortage Prevention Act of 2023, requires manufacturers of critical essential medicines (like life-saving or emergency drugs) to notify the FDA earlier about potential supply disruptions. Specifically, manufacturers must report permanent production stops, interruptions, or unexpected demand spikes (not seasonal) at least six months in advance for production issues, or within 48 hours for sustained demand increases. The notification must include reasons, ingredient sources, alternative suppliers, and expected duration. The FDA will then share this information with healthcare providers and patient groups to help manage shortages. This law applies to drugs critical for life-sustaining care, excluding certain radio pharmaceuticals.