The FDA is alerting healthcare professionals and compounders of potential risks associated with compounding remdesivir drug products.
Compounded drugs are not FDA-approved, the agency said, and it does not verify the safety, effectiveness, or quality of compounded drugs.
“FDA understands that some compounders might be interested in compounding remdesivir drug products. However, FDA cautions against compounding remdesivir drug products and recommends that health care providers utilize the FDA-approved drug for patients who are prescribed remdesivir,” the agency said in an alert.
The agency recommends healthcare providers utilize the FDA-approved drug for patients who are prescribed remdesivir. Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.
“Because it is challenging to formulate remdesivir as a stable drug, the agency is concerned that compounded remdesivir drug products could be of low quality potentially resulting in patient harm,” the FDA said.