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 notification of discontinuances, interruptions, or surges in demand for drugs.
Mandates that notifications for discontinuances or interruptions be made at least 6 months in advance, or as soon as practicable if not possible.
Requires notifications for surges in demand to be made as soon as practicable.
Updates definitions related to drug shortages and surges in demand.
Includes provisions for outsourcing facilities in the notification process.
Requires the Secretary of Health and Human Services to publicly update the list of identified 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.