This legislation amends federal drug shortage reporting requirements to include situations where demand for a drug surges unexpectedly, not just when manufacturers discontinue or interrupt production. Pharmaceutical manufacturers would be required to notify the Food and Drug Administration as soon as practicable when they identify a surge in demand they cannot meet without meaningful shortfalls or delays, while maintaining the existing six-month advance notice requirement for planned discontinuances or production interruptions. The bill also directs the FDA to provide annual public updates on its evaluation of bulk drug substances used by compounding facilities and requires the Secretary of Health and Human Services to finalize guidance on hospital and health system compounding practices within one year of the law's enactment. The changes are designed to give the federal government and healthcare system earlier visibility into potential drug supply problems so they can take preventive action. The bill was introduced in November 2024 by Senators Kaine and Cotton and referred to the Senate Health, Education, Labor, and Pensions Committee.
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