S 2665 119th Congress
Drug Shortage Prevention Act of 2025
A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical drugs of increased demand, and for other purposes.
Official Title as Introduced Congress.gov
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Bill journey
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Introduction Congress.gov
Introduced
Introduced in the Senate.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Open bill recordOfficial action Congress.gov
Introduced in Senate
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Introduced in Senate
A dated text-version record is available.
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| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Health, Education, Labor, and Pensions. | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov |
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Congressional Research Service
CRS summary
Drug Shortage Prevention Act of 2025This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand, export restriction, or other circumstance that may result in a shortage of certain critical drugs.Currently, drug manufacturers are required to notify the FDA in the event of a discontinuation or interruption in the supply of prescription drugs that are life-supporting, life-sustaining, or used for a debilitating disease or condition, including those used in medical emergencies, surgeries, or public health emergencies.The bill requires drug manufacturers to also notify the FDA if there is an increased demand, export restriction, or other circumstance that may result in a meaningful shortfall or delay in meeting the demand for such drugs. Manufacturers must notify the FDA as soon as possible but no later than 10 days after the onset of the relevant circumstance. The notice must include the reasons for the increased demand, the expected duration, and any other information the FDA requires. The bill's requirements apply to both prescription and nonprescription drugs.Drug manufacturers must also report twice a year (rather than annually) information on the quantities of drugs produced; manufacturers must also provide the names of the suppliers of corresponding active ingredients.
Official documents
Text versions
- Introduced in SenateAug 1, 2025