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# Drug Manufacturing Discontinuance Guide
- URL: https://www.fdaweb.com/drug-manufacturing-discontinuance-guide/
- Published: 2024-02-06T12:00:00.000Z
- Updated: 2026-09-14T14:22:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156296

FDA has published a draft guidance, *Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act*, to assist manufacturers and applicants in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients that may help agency efforts to prevent and mitigate shortages. The [document](mailto:https://www.fda.gov/media/166837/download) discusses provisions of the Federal Food, Drug, and Cosmetic Act that require applicants and manufacturers of certain finished drugs and biological products to notify the agency of:

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

The guidance recommends 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. It also explains how the agency communicates information about product shortages to the public.