The FDA has published its concerns about compounding during the pandemic, specifically regarding two drugs: thymosin and remdesivir.
Per the agency:
- 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”. (It also points out that “thymosin is not approved to treat any condition, including CovidD-19.”)
- Remdesivir may be “particularly challenging to compound” and thus “The agency is concerned patients may receive substandard or low-quality compounded remdesivir drugs which could result in patient harm.”
Visit FDA’s COVID-19 Compounding Activities webpage for more information or contact compounding@fda.hhs.gov with any questions.
