Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act

5 April 2023 – the FDA published draft guidance on notifications of changes in the production of finished products or API.

This draft guidance assists applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and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 (API) that may, in turn, help the Agency in its efforts to prevent or mitigate shortages. The guidance also explains how FDA communicates information about products in shortage to the public.