Amends the Federal Food, Drug, and Cosmetic Act to enhance drug shortage notification practices.
Expands the definition of drug shortages to include surges in demand for drugs.
Requires manufacturers to notify about discontinuances or interruptions in drug production at least 6 months in advance, or as soon as practicable if that is not possible.
Mandates notification of surges in demand for drugs as soon as practicable.
Updates definitions related to drug shortages, including how demand is assessed based on preparation, dispensing, and reported information.
Introduces a definition for “surge” as an increase in demand that manufacturers may struggle to meet.
Requires the Secretary of Health and Human Services to publicly update the list of evaluated bulk drug substances annually.
Directs the Secretary to finalize guidance on hospital and health system compounding within one year of enactment, ensuring it aligns with current research and best practices.
