FDA warns of potential risks associated with compounding remdesivir products

In October 2020, the agency approved remdesivir for treatment of COVID-19 when adult and pediatric patients ages 12 years and older require hospitalization. In a new alert, FDA said it “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.”

Compounded drugs are neither FDA approved nor evaluated by the agency for safety, effectiveness, or quality. FDA cautioned that “compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.” According to the agency, complexities related to the quality and sourcing of remdesivir active pharmaceutical ingredient (API) and formulation of remdesivir drug products could make these drugs especially challenging to compound. The agency said it is aware of entities (separate from the suppliers named in the approved remdesivir new drug application) selling what they claim to be remdesivir API and noted the challenges of compounding remdesivir products that remain stable over time and with an appropriate pH.

In addition, FDA expressed concern “about the compounding of remdesivir drug products with dosage forms or routes of administration that are different from the FDA-approved drug.” Because of the challenges of formulating remdesivir as a stable drug, FDA said it “is concerned that compounded remdesivir drug products could be of low quality, potentially resulting in patient harm,” and warned that “heightened interest in remdesivir due to its use in COVID-19 patients may increase the risk that a substandard or counterfeit API is sold to compounders.”

APhA staff