Drugs

Temporary Propofol Repackaging, Combining Guidance

FDA has published an immediately-in-effect guidance, Temporary Policy on Repackaging or Combining Propofol Drug Products During the Covid-19 Public Health Emergency, to describe the enforcement discretion it will exercise on the repackaging or combining of propofol general anesthesia drug products by a licensed pharmacist in a state-licensed facility, a federal facility, or a registered outsourcing facility. The document says the policy will remain in effect for no longer than the duration of the public health emergency related to Covid-19 declared by HHS.

FDA notes that propofol is on its drug shortage list and says the agency has received reports that hospitals are having difficulty obtaining certain presentations that are needed in the care of critically ill Covid-19 patients. Other presentations may be available for repackaging or combining for this use, the guidance says.

“Having evaluated information regarding product availability, the physicochemical stability of approved propofol products, the inclusion of preservative systems in those products, and in a situation in which propofol is repackaged or combined under aseptic conditions, as a temporary measure, FDA has determined additional regulatory flexibility is appropriate,” the guidance says.

The document lists the specific circumstances that must be met for the agency to extend the enforcement discretion policy described in its repackaging guidance when a state-licensed pharmacy, federal facility, or outsourcing facility repackages an FDA-approved propofol injectable emulsion, 10 mg/mL product, or combines different FDA-approved propofol injectable emulsion, 10 mg/mL products in the same container.

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