US Is Experiencing its First Shortage Drug as a Result of the Effects of COVID-19

04 March 2020

GMP News

In a statement from the US Food and Drug Administration (FDA) commissioner Stephen Hahn, the organisation has announced that a shortage of a drug in the US supply chain has been caused as a result of the coronavirus COVID-19. The FDA has not disclosed the name of the drug or its manufacturer.

According to the regulatory body, the manufacturer has alerted the FDA that their site is directly affected by COVID-19, impacting the production of an active pharmaceutical ingredient (API). The FDA has announced that there are alternatives to the drug available and that it is working with the manufacturer as well as others to mitigate the shortage.

The organisation has said that since January 24, it has been in touch with more than 180 manufacturers of 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 their efforts, the FDA has identified about 20 other drugs, which solely source their APIs or finished drug products from China. It says it has made 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.



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