summary
Introduced
06/05/2023
06/05/2023
In Committee
06/09/2023
06/09/2023
Crossed Over
Passed
Dead
01/03/2025
01/03/2025
Introduced Session
118th Congress
Bill Summary
A BILL To amend the Federal Food, Drug, and Cosmetic Act to require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes.
AI Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to require manufacturers of life-saving drugs to submit data and information to the Secretary of Health and Human Services to assess the stability of the drugs and determine their longest supported expiration date. The bill defines "life-saving drugs" as those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of debilitating diseases, including drugs used in emergency medical care or during public health emergencies. The bill also allows the Secretary to order manufacturers to conduct studies and make labeling changes regarding the expiration date or storage and handling of these drugs. The bill imposes civil penalties of up to $10,000 per day for manufacturers who fail to comply with these requirements.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (3)
Last Action
Referred to the Subcommittee on Health. (on 06/09/2023)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/118th-congress/house-bill/3793/all-info |
| BillText | https://www.congress.gov/118/bills/hr3793/BILLS-118hr3793ih.pdf |
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