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.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This 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., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Agriculture, Transportation.
Who Benefits and How
health care providers and patients may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.
Who Bears the Burden and How
federal implementing agencies, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section H2CF0E95751404B2184D7F386BCBCF936: 1. Short title This Act may be cited as the Ensuring Access to Lifesaving Drugs Act of 2023.
- Section HEF9CD88BA6E04B1A904461CD57DACAD8: 2. Extended expiration dates for life-saving drugs The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after section 506L...
- Section HBAD2E883A187481FAFC058FEE9CB7137: 506M. Extended expiration dates for life-saving drugs A manufacturer of a life-saving drug shall— submit to the Secretary data and information as required by...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
This 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., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Agriculture, Transportation
Primary Purpose
This 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., changes federal law or congressional policy affecting health care providers and patients.
Policy Domains
Whole bill
Identified Gains
- health care providers and patients
Identified Costs
- federal implementing agencies
- health care providers and patients
Legislative Progress
IntroducedMs. Slotkin introduced the following bill; which was referred to …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → The Secretary identified in the operative section
Key Definitions
Terms defined in this bill
a drug, that is— a medical countermeasure
a drug, that is— a medical countermeasure
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
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