APC: FDA issues warning on thymosin and remdesivir

February 26, 2021

FDA issues warning on thymosin and remdesivir

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.