The Food and Drug Administration (FDA) is cautioning against the compounding of remdesivir drug products due to the complexities and risks associated with the active pharmaceutical ingredient (API).
Remdesivir, marketed under the brand name Veklury, is indicated for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization in adults and pediatric patients 12 years of age and older and weighing at least 40kg. In a safety communication, the Agency urged health care providers to only use the FDA-approved product as “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.”
The FDA noted that because of the COVID-19 pandemic, there has been an increase in the interest of compounding remdesivir drugs, which given the complex nature of remdesivir, could result in the production of low quality product that may potentially be administered to a critically ill individual. Given these risks, the FDA is urging compounders not to compound remdesivir drug products.
Additionally, adverse events or quality problems experienced with the use of compounded drugs should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Veklury is supplied in single-dose vials containing 100mg of remdesivir in either lyophilized powder or aqueous-based solution.
FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products. [press release]. Silver Spring, MD; US Food and Drug Administration: February 4, 2021.