S2362-118

Introduced

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.

118th Congress Introduced Jul 18, 2023

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 provide for notification by manufacturers of critical drugs of increased demand, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Trade, Environment.

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 H3B69EBF5C33D4CE8845E2C84CB4D1DF3: 1. Short title This Act may be cited as the Drug Shortage Prevention Act of 2023.
  • Section HB4B8D0CA4F464D79B71EE5001C24A44E: 2. Improving notification procedures in case of increased demand for critical drugs Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c)...
  • Section id1c5cc281c0814475a4c8a76be06e9862: 3. Reporting on supply chains Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)(3)(A)) is amended— by striking annually to the...

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 provide for notification by manufacturers of critical drugs of increased demand, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.

Key Policy Areas

Healthcare, Trade, Environment

Primary Purpose

This 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., changes federal law or congressional policy affecting health care providers and patients.

Policy Domains

Healthcare Trade Environment

Whole bill

Identified Gains
  • health care providers and patients
Model: codex-gpt-5 | Version: bill_summary_v2 | Source: is
health care providers and patients: ,
Identified Costs
  • federal implementing agencies
  • health care providers and patients
Model: codex-gpt-5 | Version: bill_summary_v2 | Source: is
federal implementing agencies: ,
health care providers and patients: ,

Legislative Progress

Introduced
Introduced Committee Passed
Jul 18, 2023

Ms. Klobuchar (for herself, Ms. Collins, Ms. Smith, Ms. Murkowski, …

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?

Domains
Healthcare Trade Environment
Actor Mappings
"the_secretary"
→ The Secretary identified in the operative section

Key Definitions

Terms defined in this bill

1 term
"covered drug" §HB4B8D0CA4F464D79B71EE5001C24A44E

a drug that is intended for human use and that— is— life-supporting

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.

Learn more about our methodology