Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act." The draft guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs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 The draft guidance also explains how FDA communicates information about products in shortage to the public. This draft guidance is not final nor is it in effect at this time.