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Requires drug makers to notify the Secretary when they permanently stop or interrupt production of certain important drugs, when an active ingredient becomes unavailable, or when events (like sudden demand spikes) could meaningfully disrupt supply. Notices must include specific facts (sources of active ingredients, related devices, expected duration, etc.) on set timelines and the Secretary must share shortage information with relevant organizations. It also changes annual supply‑chain reporting so specified reports are submitted to the Secretary once in March and once in September each year.
Amend Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) by replacing the existing subsections (a), (b), and (c) with new notification, timing, and distribution rules and by updating cross-references in subsections (g) and (j).
Manufacturer notification: A manufacturer of a covered drug must notify the Secretary, in accordance with the timing rules in subsection (b), when any of the following occurs: (i) a permanent discontinuance or interruption in manufacture likely to lead to a meaningful disruption in supply of the drug in the United States; (ii) a permanent discontinuance or interruption in manufacture of an active pharmaceutical ingredient (API) likely to lead to a meaningful disruption in supply of that API; or (iii) any other circumstance (for example, an increase in demand or export restriction) likely to leave the manufacturer unable to meet demand without a meaningful shortfall or delay. The manufacturer must also include the reasons for the discontinuance, interruption, or other circumstance, if known.
Required contents of the notification: The notice must include (A) if an API is a reason or risk factor, the source of the API and any alternative sources known to the manufacturer; (B) whether any associated device used for preparation or administration is a reason or risk factor; (C) the expected duration of the interruption; and (D) any other information the Secretary may require.
Timing of notices: (1) For planned discontinuances or interruptions, notification must be submitted at least 6 months prior to the date of the discontinuance or interruption. (2) For circumstances described in paragraph (a)(1)(A)(iii) (e.g., increase in demand or export restriction), notice must be provided as soon as practicable, but not later than 10 business days after the onset of the circumstance. (3) If compliance with paragraphs (1) or (2) is not possible, notice must be provided as soon as practicable.
Secretary distribution duty: To the maximum extent practicable, the Secretary must distribute information about a discontinuance, interruption, or other circumstance described in subsection (a)(1)(A)(iii) that is likely to lead to a shortage or meaningful disruption in supply of covered drugs to appropriate organizations, including physician, health provider, and patient organizations, as described in section 506E.
Who is affected and how:
Drug manufacturers and contract manufacturers: Face new or clarified reporting duties when they permanently cease or interrupt production, when APIs are unavailable, or when other events threaten supply. They must collect and submit specified data on timelines, which may require new compliance systems, internal monitoring, and possible disclosure of supply‑chain sources.
API suppliers and other upstream suppliers: May be indirectly affected because manufacturers will need timely information about API availability and sources; contract and toll manufacturers may need to support reporting or change operations to avoid triggering notices.
Pharmacies, wholesalers, and hospitals: Should receive earlier and more detailed notice of impending shortages, enabling procurement adjustments, conservation strategies, and patient care planning.
Healthcare providers and patients: Potential for reduced clinical disruption if regulators and supply‑chain actors can act earlier to mitigate shortages; however, some shortfalls may still occur depending on supply realities.
Department of Health and Human Services / FDA (the Secretary): Will receive increased reporting and will be responsible for processing notices and sharing information with relevant stakeholders, which may require staffing or process changes.
Public health and supply‑chain resilience: The policy increases transparency and coordination tools that can reduce the severity and duration of drug shortages, but it may also raise concerns about proprietary supply‑chain information disclosure and impose administrative costs on manufacturers.
Overall effect: Improves early warning of potential shortages and standardizes biannual supply‑chain reporting, at the cost of additional compliance burden and potential concerns about confidential business information handling.
Modifies subsection (j)(3)(A) by replacing portions of the first sentence to require reporting to the Secretary once in March and once in September each year, inserting additional text before the terminal period of that sentence, and inserting additional text after the first sentence.
Revises section 506C of the Federal Food, Drug, and Cosmetic Act by replacing subsections (a)–(c) with new notification, content, timing, and distribution requirements; updating cross-references in subsections (g) and (j) to use the term 'covered drug'; and amending the definition of 'covered drug' in subsection (h)(1).
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced August 1, 2025 by Amy Klobuchar · Last progress August 1, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate