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www.fdanews.com/articles/211144-fda-withdraws-early-covid-19-era-guidance-on-propofol-drug-products

FDA Withdraws Early COVID-19 Era Guidance on Propofol Drug Products

February 13, 2023

The FDA has announced the withdrawal of its guidance that allowed repackaging or combining propofol drug products during the COVID-19 public health emergency.

An anesthetic and sedative, propofol is used to sedate COVID-19 patients who need mechanical ventilation. It is also used to help prepare patients for surgery or other medical procedures.

The agency said the conditions that created the need for the policy described in the document have evolved and the policy is no longer needed.

The agency issued the guidance in April 2020 to temporarily allow for the repackaging or combining of propofol drug products when there was a shortage. The shortage has since ended.

The withdrawal date is March 13.

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