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USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"

Yesterday (06 February 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance for the industry entitled “Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.”


Manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) play a critical role in ensuring a stable supply of safe and effective medications. However, unforeseen circumstances or strategic decisions may lead to discontinuances or interruptions in manufacturing. To address such situations, the U.S. Food and Drug Administration (FDA) has provided this guidance.


The draft guidance aims to help applicants and manufacturers promptly inform the FDA with comprehensive notifications regarding alterations in the manufacturing of specific finished drugs, biological products, and active pharmaceutical ingredients (API), which could aid the Agency in its endeavors to prevent or alleviate shortages.


Timely notifications that include specific information about the situation allow the Agency to evaluate the situation and determine an appropriate course of action, when FDA does not receive timely, informative notifications, the Agency’s ability to respond appropriately is limited.


According to section 506C of the FD&C Act and FDA regulations, specific individuals are required to notify the FDA

  1. a permanent discontinuance in the manufacture of certain finished drug and biological products,

  2. an interruption in the manufacture of certain finished drug and biological products that is likely to lead to a meaningful disruption (or, in the case of blood or blood components intended for transfusion, a significant disruption in supply of those products in the United States,

  3. a permanent discontinuance in the manufacture of API for certain finished drugs and biological products, or

  4. an interruption in the manufacture of API for certain finished drugs and biological products that is likely to lead to a meaningful disruption in the supply of the API for those products


This guidance helps ensure the continuity of drug supply, allowing patients to access necessary medications without significant disruptions. It also enables the FDA to assess the potential impact of a discontinuance or interruption and take appropriate actions to mitigate any shortages.


To know Who Must Notify FDA, when to notify and What Information To be Included in Notifications, click this LINK.


Also check CDER's updated final guidance on "Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act" to assist registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).



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