FDA allows compounders to repackage, combine propofol amid COVID-19
After allowing compounders and outsourcing facilities to compound 13 drugs needed to treat patients on ventilators during the coronavirus disease (COVID-19) public health emergency, the US Food and Drug Administration (FDA) says it will allow compounders to repackage or combine propofol to meet hospitals’ needs.(RELATED: FDA allows compounding of needed hospital drugs for COVID-19, Regulatory Focus 16 April 2020, FDA expands COVID-19 drug compounding policy to smaller pharmacies, Regulatory Focus 21 April 2020).
“FDA has received reports from some hospitals that they are having difficulty obtaining adequate supplies of FDA-approved propofol injectable emulsion (propofol) products, 10 milligram (mg) per milliliter (mL), in the presentations used to support COVID-19 patients who have been sedated and intubated, or for other procedures involved in the care of such patients,” FDA writes.
Five manufacturers are currently reporting shortages of propofol in various presentations due to increased demand for the drug or supply chain issues.
Specifically, FDA says it is extending the enforcement discretion policy laid out in its repackaging guidance to compounders who repackage or combine FDA-approved 10 mg/mL propofol products. (RELATED: FDA Finalizes Repackaging Guidance, Revises Draft on Biologics Mixing, Diluting and Repackaging, Regulatory Focus 16 January 2017).
FDA explains that it is issuing the guidance to address issues “that fall outside” its repackaging guidance. Under the repackaging guidance, FDA requires repackaged drugs to be “repackaged, stored, and shipped in a way that does not conflict with [their] approved labeling.” Because the approved labeling for propofol states that the drug “undergoes oxidative degradation in the presence of oxygen and is therefore packaged under nitrogen to eliminate this degradation path,” FDA says repackaging the drug under oxygen would be in conflict with the requirements laid out in the repackaging guidance.
However, because outsourcing facilities and pharmacies may not have the capability of repackaging under nitrogen, FDA says it will allow them to forgo that requirement on an emergency basis.
Another issue addressed by the policy has to do with combining different propofol formulations, which FDA says, “may result in a final product with a less effective antimicrobial preservative system.” As such, FDA includes different requirements for combining propofol products based on whether they contain matching preservatives or antioxidants.
The guidance also sets parameters for containers, tubing and beyond use dates for repackaged or combined propofol.
As with the agency’s other compounding policies during the COVID-19 public health emergency, FDA says hospitals must inform compounders that they are treating patients with COVID-19 and have made reasonable attempts to obtain FDA-approved versions of the drugs.
Additionally, FDA says that any repackaged or combined propofol must be discarded “if there is any change in appearance such as color [or if] visible separation of the water and oil occurs such as the formation of any visible oil droplets, or particulate matter.”
FDA