End Drug Shortages Act: Mandatory Reporting of Demand Surges for Drugs
This Act aims to enhance the security of drug supplies by requiring manufacturers to report not only production interruptions but also sudden, significant surges in demand. This allows authorities and hospitals to react faster to potential shortages, which is crucial for patients requiring continuous access to medication. These changes are designed to improve transparency and stability in the pharmaceutical market, minimizing the risk of essential medicines running out in pharmacies and medical facilities.
Key points
Drug manufacturers must notify the FDA of anticipated surges in demand that could lead to shortages, in addition to manufacturing discontinuances or interruptions.
The definition of 'drug shortage' is expanded to mean a period when demand or projected demand exceeds supply, considering how the drug is prepared or dispensed.
The Secretary must publicly release annual updates on the evaluation of bulk drug substances for outsourcing facilities.
Requires the finalization of guidance on hospital and health system compounding within one year, ensuring consistency with current research and best clinical practices.
Expired
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