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# Drug Shortage Mitigation Guidance
- URL: https://www.fdaweb.com/drug-shortage-mitigation-guidance/
- Published: 2023-04-05T12:00:00.000Z
- Updated: 2026-09-14T18:24:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154140

FDA has published a draft guidance, *Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act*, to assist applicants and manufacturers to provide FDA timely, informative notifications about changes in the production of certain finished drugs and biological products and certain active pharmaceutical ingredients (API) that may help the agency’s efforts to prevent or mitigate drug shortages. The [document](https://www.federalregister.gov/public-inspection/2023-07238/guidance-permanent-discontinuance-or-interruption-in-manufacturing-under-the-federal-food-drug-and?utm%5Fmedium=email&utm%5Fsource=govdelivery) also explains how FDA communicates product shortage information to the public.

Current FDA regulations generally require applicants and manufacturers to notify the agency of:

- a permanent discontinuance in the manufacture of certain products;
- an interruption in the manufacture of certain products that is likely to lead to a meaningful disruption in the supply of the products in the U.S.;
- a permanent discontinuance in the manufacture of API for certain products; or
- an interruption in the manufacture of API for certain products that is likely to lead to a meaningful disruption in the supply of the API for those products.

When finalized, the agency says, the draft guidance would recommend that applicants and manufacturers provide additional details and follow additional procedures to ensure FDA has the specific information it needs to help prevent or mitigate shortages. The guidance would explain:

- who must notify FDA and what products are subject to notification requirements;
- when to notify FDA; and
- what details to include in notifications that will ensure FDA has information that would be helpful to assess the potential for a supply disruption or shortage.

When finalized, the draft will replace a 3/2020 guidance.