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  4. Guidance | Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act
  1. Drug Safety and Availability

Guidance | Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act

Due to the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products in the U.S. The guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, is intended to help applicants and manufacturers provide the agency with timely and informative notifications about changes in the production of certain drugs and biological products. In urging the submission of these notifications, the guidance may assist in our efforts to prevent or mitigate shortages of such products, including under circumstances outside of the COVID-19 public health emergency.

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