FDA issues alert about potential risks associated with the compounding of remdesivir

Feb. 8, 2021

The U.S. Food and Drug Administration (FDA) issued an alert, warning providers about using compounded remdesivir drug products. Instead, they should use the branded product, Veklury, from Gilead Sciences, which received emergency use authorization (EUA) from the FDA in November 2020 for treatment in hospitalized patients with COVID-19, the agency said.

“The FDA is aware of various entities (separate from the suppliers named in the approved remdesivir NDA) selling what they claim to be remdesivir API. FDA often lacks detailed information about the composition and quality of the API that suppliers sell to compounders,” the agency wrote in the alert.

In describing why purchasing a version of remdesivir from outside suppliers is risky, the agency said, “complexities related to the quality and sourcing of the remdesivir-active pharmaceutical ingredient (API) and formulation of remdesivir drug products may make these drugs particularly challenging to compound. Remdesivir API is complex and neither a United States Pharmacopeia (USP) monograph nor other public quality standard for the API used in FDA-approved remdesivir is available. Remdesivir API has six stereocenters and has multiple polymorphic forms. Using API forms that differ from the API in the FDA-approved drug may affect the compounded drug’s quality, including the solubility of the API in the compounded drug.”

In addition, the agency warned that “remdesivir drug products are complex to produce. It may be challenging for compounders to formulate remdesivir drug products that will remain stable over time and have an appropriate pH. FDA-approved remdesivir is administered intravenously as an aqueous solution and remdesivir has limited aqueous solubility. FDA is concerned that compounders may have difficulty identifying an appropriate solubilizing agent and sourcing one of sufficient quality.”

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