FDA Provides Specific Compounded Drug Concerns Related to COVID-19

The U.S. Food and Drug Administration (FDA) is advising compounders and health care providers the agency has concerns about the use of certain drugs prepared by compounders to treat patients with COVID-19:

Thymosin-alpha 1 is not a component of an approved drug, and thymosin does not meet the conditions for compounding under sections 503A and 503B of the FD&C Act. FDA 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. However, thymosin is not approved to treat any condition, including COVID-19.

The FDA recommends that FDA-approved drug Veklury (remdesivir) be used to treat patients who are prescribed remdesivir. FDA is concerned that 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. The agency is concerned patients may receive substandard or low-quality compounded remdesivir drugs which could result in patient harm.

Compounded drugs are not FDA-approved. This means they have not undergone premarket review for safety, effectiveness or manufacturing quality. Because they are subject to a lower regulatory standard, compounded drugs should only be used to meet the needs of patients whose medical needs cannot be met by an FDA-approved drug. The agency recommends FDA-approved drugs be used to treat patients whenever possible.