The End Drug Shortages Act amends federal drug regulation to expand how manufacturers must report supply problems to the Food and Drug Administration. Under current law, manufacturers must notify the FDA about discontinuances and manufacturing interruptions, but this bill adds a new requirement to report sudden surges in demand that the manufacturer cannot meet without significant delays or shortages. Manufacturers must provide at least six months advance notice for discontinuances or interruptions, but must report demand surges as soon as practicable. The legislation also requires the FDA to publish annual updates on its evaluation of bulk drug substances used in compounding and directs the agency to finalize guidance on hospital and health system compounding practices within one year of the bill's enactment. This bill affects pharmaceutical manufacturers, compounding facilities, healthcare providers, and patients who depend on consistent access to medications.
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