Bill > S2665

This bill amends the Federal Food, Drug, and Cosmetic Act to improve drug shortage prevention and notification procedures. It requires manufacturers of critical drugs (defined as life-supporting, life-sustaining, or used for preventing or treating debilitating conditions) to notify the Secretary of Health and Human Services about potential drug supply disruptions at least 6 months in advance, or as soon as possible if advance notice is not feasible. The notification must include details such as reasons for potential discontinuation, the expected duration of interruption, sources of active pharmaceutical ingredients, and any associated medical devices that might impact drug production. The bill also mandates that manufacturers report their supply chain information twice annually, specifically in March and September, including details about suppliers of active pharmaceutical ingredients and intermediate materials. Additionally, the bill allows manufacturers to voluntarily provide additional supply chain information at other times as specified by the Secretary. The goal of these provisions is to enhance transparency, improve early warning systems for potential drug shortages, and help prevent disruptions in the supply of critical medications.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/2665/all-info