FDA Releases Guidance on Reporting Potential Disruptions in Supply During COVID-19 Pandemic

FDA Releases Guidance on Reporting Potential Disruptions in Supply During COVID-19 Pandemic

March 30, 2020, Covington Alert

On Friday, March 27, 2020, the U.S. Food and Drug Administration (FDA) released updated guidance to ensure that drug manufacturers notify FDA as soon as possible of potential interruptions in manufacturing that could lead to drug shortages. The Guidance, titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act,” was published for immediate implementation, in light of the importance of working with FDA on potential supply disruptions and drug shortages during the COVID-19 pandemic.