Notifying FDA of Drug Shortages During the Pandemic: FDA Offers Guidance

Regulatory NewsRegulatory News | 27 March 2020 |  By 

With an eye on drug supply disruptions, the US Food and Drug Administration (FDA) on Friday published new guidance on how manufacturers should notify FDA of permanent halts or interruptions to manufacturing certain products that are likely to lead to a meaningful disruption in supply.

An FDA spokesman told Focus that so far, only one firm is reporting a shortage of one human drug. FDA previously declined to name the firm or the drug, citing confidential commercial information.

“We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage. We will remain in contact with manufacturers so that we can continue to assist them with any potential issues in the fastest way,” the spokesman said.

FDA staff also have been proactively reaching out to manufacturers to identify potential disruptions or shortages of drugs. And although the shutdown of certain areas in China heightened concerns because the US relies heavily on products and active ingredients manufactured there, Chinese manufacturers seem to be coming back online now.

Marc Kikuchi, CEO of North America Generics at Dr. Reddy's Laboratories, told Bernstein biotech analysts recently that China is operating at about 40% capacity now. Sandoz President Carol Lynch also said the Chinese are back to manufacturing, but not back to full scale yet.


FDA says that companies should submit notifications of disruptions or shortages as soon as possible but no later than five business days after the discontinuance or interruption occurs. After the initial notification of an interruption in manufacturing, the guidance recommends updates every two weeks, including information on the expected timeline for recovery, even if the status remains unchanged.

“FDA should not first learn of a supply disruption resulting from an interruption in manufacturing from a purchaser whose order could not be filled by the manufacturer,” the guidance says.

In terms of what to include in such notifications, FDA says manufacturers should consider whether it’s an unavoidable supply disruption, the root cause of the shortage, the estimated duration of a disruption and the current inventory, among other factors.

The guidance also discusses how to notify FDA of a shortage, what happens if a firm does not notify FDA and how FDA communicates shortages to the public.

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


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy