Drug Shortages Shelf Life Extension Act
12/29/2022, 11:48 PMSummary of Bill HR 7669
Bill 117 hr 7669, also known as the Drug Shortages Shelf Life Extension Act, is a piece of legislation currently being considered by the US Congress. The purpose of this bill is to address the issue of drug shortages by allowing for the extension of the shelf life of certain medications.The bill proposes that the Food and Drug Administration (FDA) be given the authority to extend the expiration dates of drugs that are in short supply. This would help to ensure that patients have access to the medications they need, even if they have been on the market for longer than originally intended.
The Drug Shortages Shelf Life Extension Act aims to prevent situations where patients are unable to access life-saving medications due to shortages. By allowing for the extension of expiration dates, the bill seeks to alleviate the strain on the healthcare system and ensure that patients receive the care they need. Overall, the Drug Shortages Shelf Life Extension Act is a bipartisan effort to address the issue of drug shortages and ensure that patients have access to the medications they need. It is currently being debated in Congress and may be voted on in the near future.
Congressional Summary of HR 7669
Drug Shortages Shelf Life Extension Act
This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates.
Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; (2) establishing on drug labels the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages and affect product quality; and (3) using innovative approaches to stability modeling to support initial product expiration dates and expiration date extensions.
The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.
Read the Full Bill
Current Status of Bill HR 7669
Bill HR 7669 is currently in the status of Bill Introduced since May 6, 2022. Bill HR 7669 was introduced during Congress 117 and was introduced to the House on May 6, 2022. Bill HR 7669's most recent activity was Referred to the House Committee on Energy and Commerce. as of May 6, 2022Bipartisan Support of Bill HR 7669
Total Number of Sponsors
1Democrat Sponsors
1Republican Sponsors
0Unaffiliated Sponsors
0Total Number of Cosponsors
6Democrat Cosponsors
4Republican Cosponsors
2Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 7669
Primary Policy Focus
HealthPotential Impact Areas
Congressional oversightDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesManufacturingAlternate Title(s) of Bill HR 7669
Drug Shortages Shelf Life Extension ActDrug Shortages Shelf Life Extension ActTo require guidance on extending expiration dates for certain drugs, and for other purposes.Comments
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Sponsors and Cosponsors of HR 7669
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