As previously communicated, the FDA has been monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. 

A manufacturer has alerted the FDA to a shortage of a drug that was recently added to the drug shortages list. The manufacturer just notified the FDA that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient (API) used in the drug. The FDA notes that there are other alternatives that can be used by patients and that it is working with the manufacturer, as well as other manufacturers, to mitigate the shortage.  

Since January 24, the FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including APIs and other components manufactured in China. 

As part of the FDA’s efforts, it has identified about 20 other drugs, which solely source their APIs or finished drug products from China. The FDA says it has been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. These drugs are considered non-critical drugs.