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USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API

Today (o5 April 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance on "Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act" that helps to prevent and mitigate drug shortage.

The FDA is issuing this guidance in order to help applicants and manufacturers provide FDA with timely, informative notifications about changes in the production of certain finished drugs, biological products, and active pharmaceutical ingredients (API), which may aid the Agency in preventing and mitigating shortages.


According to section 506C of the FD&C Act, applicants and manufacturers must notify the FDA of certain finished drugs and biological products to notify FDA on

  1. a permanent discontinuance in the manufacture of such products.

  2. an interruption in the manufacture of such products that are likely to lead to a meaningful disruption in the supply of those products in the United States.

  3. a permanent discontinuance in the manufacture of API for such products, or

  4. an interruption in the manufacture of API for such products that are likely to lead to a meaningful disruption in the supply of API for those products.

By notifying the agency, an appropriate course of action can be determined based on an evaluation of the situation. The guidance recommends that applicants and manufacturers provide additional details and follow additional procedures to establish the specific information FDA needs to prevent or mitigate shortages.


If you are looking to know more information on Who Must Notify FDA When To Notify, What Information To Include in Notifications, How To Notify FDA, and what will be the outcome if you Fail To Notify click this LINK.




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