Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency

Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency

Today, FDA issued a guidance explaining a temporary policy regarding repackaging or combining propofol injectable emulsion, 10 milligram (mg) per milliliter (mL) (propofol) products for treating and managing hospitalized patients during the COVID-19 public health emergency. FDA has received reports that hospitals are having difficulty obtaining adequate supplies of FDA-approved propofol products that are needed to care for critically ill COVID-19 patients. Today’s guidance provides regulatory flexibility when state-licensed pharmacies (including hospital pharmacies), federal facilities and outsourcing facilities repackage or combine propofol for use in hospitals that are having difficulty obtaining adequate supplies of an FDA-approved propofol product. FDA previously issued guidance for pharmacies, federal facilities and outsourcing facilities that repackage certain nonbiological drugs. FDA is issuing today’s temporary guidance to address the repackaging and combining of propofol during the pandemic, including certain practices that fall outside the repackaging guidance. As a temporary measure during the COVID-19 public health emergency, FDA does not intend to object to a state-licensed pharmacy, federal facility or outsourcing facility that repackages an FDA-approved propofol product or combines different FDA-approved propofol products in the same container, under the circumstances outlined in today’s guidance. View guidance

For more information, please visit FDA's Human Drug Compounding web site.