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# FDA Raises Covid-19 Compounded Drug Concerns
- URL: https://www.fdaweb.com/fda-raises-covid-19-compounded-drug-concerns/
- Published: 2021-02-24T12:00:00.000Z
- Updated: 2026-09-14T16:48:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148743

An online FDA post says the agency is advising compounders and healthcare providers that it has concerns about the use of certain drugs prepared by compounders to treat patients with Covid-19\. The [post](https://content.govdelivery.com/accounts/USFDA/bulletins/2c3b1f7?ref=fdaweb.com) lists these concerns: 

- Thymosin-alpha 1 is not a component of an approved drug and thymosin does not meet the regulatory conditions for compounding. FDA says it will take appropriate action against compounders that produce thymosin. “The agency is aware of drug products containing thymosin being offered to patients for the treatment of Covid-19,” the notice says. “However, thymosin is not approved to treat any condition, including Covid-19.”
- FDA recommends that the FDA-approved drug Veklury (remdesivir) be used to treat patients who are prescribed remdesivir. The post says the agency is concerned that complexities related to the quality and sourcing of the remdesivir active pharmaceutical ingredient and formulation of remdesivir drug products may make these drugs particularly challenging to compound. “The agency is concerned patients may receive substandard or low-quality compounded remdesivir drugs which could result in patient harm,” it says.

The post concludes with a reminder that compounded drugs are not FDA-approved and thus have not undergone premarket review for safety, effectiveness, or manufacturing quality. FDA says it recommends that FDA-approved drugs be used to treat patients whenever possible.