S 4256
Protecting Infants from Formula Shortages Act of 2022
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Sign in to take action- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
The Protecting Infants from Formula Shortages Act of 2022 aims to prevent disruptions in the supply of infant formula and certain medical foods for individuals with inborn errors of metabolism. It requires manufacturers to notify the FDA of any planned production changes, at least six months in advance or as soon as possible, and to develop redundancy risk management plans. The bill also establishes a process for the FDA to enforce compliance and allows for expedited action during public health emergencies, including the potential for ordering manufacturers to provide notifications. Finally, it modifies existing regulations to allow for remote record assessments in lieu of factory inspections.
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Primary sponsor
Robert P., Jr. Casey
Cosponsors
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