FDA advises against using compounded remdesivir products

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FDA advises against using compounded remdesivir products
tjordan_drupal
Feb 5, 2021

The Food and Drug Administration yesterday cautioned health care providers against using compounded remdesivir drug products due to the potential for patient exposure to substandard or adulterated products.

“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 agency said. “Furthermore, heightened interest in remdesivir due to its use in COVID-19 patients may increase the risk that a substandard or counterfeit [active pharmaceutical ingredient] is sold to compounders.”

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FDA advises against using compounded remdesivir products
tjordan_drupal
Feb 5, 2021

The Food and Drug Administration yesterday cautioned health care providers against using compounded remdesivir drug products due to the potential for patient exposure to substandard or adulterated products.

“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 agency said. “Furthermore, heightened interest in remdesivir due to its use in COVID-19 patients may increase the risk that a substandard or counterfeit [active pharmaceutical ingredient] is sold to compounders.”

COVID-19: Vaccines and Therapeutics
COVID-19: CDC, FDA and CMS Guidance

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