S. 2665 — Drug Shortage Prevention Act of 2025

This section revises FDA drug shortage notification requirements (21 U.S.C. 356c) for manufacturers of covered drugs—defined as human-use drugs that are life-supporting, life-sustaining, or used to prevent or treat debilitating diseases or conditions (including in emergencies, surgery, or public health emergencies), excluding radiopharmaceuticals, Secretary-designated products, and biological products (unless otherwise provided by regulation)—by (1) expanding required notifications to include, in addition to permanent discontinuances or interruptions likely to cause meaningful supply disruptions (including for active pharmaceutical ingredients), any other circumstances such as increased demand or export restrictions likely to result in a meaningful shortfall or delay; (2) requiring notifications at least six months prior to discontinuances or interruptions (unchanged), but as soon as practicable or within 10 business days after onset for the new circumstances; (3) mandating additional disclosure of reasons (if known), active pharmaceutical ingredient sources and alternatives (if relevant), associated devices, expected interruption duration, and other Secretary-required information; and (4) directing FDA, to the maximum extent practicable, to distribute information on all such events to physician, health provider, and patient organizations. (As background, these requirements enable FDA to mitigate shortages of critical drugs by coordinating with industry and stakeholders; the revisions broaden early-warning triggers and timelines to address demand-driven shortages.)

This section revises supply chain reporting requirements for persons registered with the FDA as drug establishments by (1) increasing the frequency of required reports to semi-annually (once in March and once in September, from annually); (2) requiring such reports to include the legal names of, and additional information specified by the Secretary regarding, suppliers of active pharmaceutical ingredients (APIs) and intermediate and in-process materials, as well as the amount of each drug manufactured, prepared, propagated, compounded, or processed using materials from each supplier; and (3) authorizing voluntary reporting of such supply chain information at other times specified by the Secretary. (Thus, the changes enhance FDA oversight of drug supply chains to support monitoring for shortages, quality issues, and adulteration risks.)