FDA targets remdesivir, thymosin in compounding concerns

FDA has revised information on compounding drugs during the COVID-19 pandemic, citing “concerns about the use of certain drugs prepared by compounders to treat COVID-19.” Regarding thymosin-alpha 1, FDA wrote: “The agency is aware of drug products containing thymosin being offered to patients for the treatment of COVID-19.” FDA warned that thymosin is not approved to treat any condition and as a result does not meet conditions for compounding under the relevant provisions of the Food, Drug & Cosmetic Act. Regarding remdesivir (Veklury—Gilead), FDA noted the antiviral was authorized to treat hospitalized patients with COVID-19, but “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.” FDA has concerns that patient harm could result if the compounding process affected drug quality. FDA advises hospitals to turn first to outsourcing facilities for compounded drugs, because those facilities have “more robust quality standards” than pharmacies or federal facilities that are not registered as outsourcing facilities. FDA’s website also clarifies: “Although federal law specifies a 5% limit on distribution out of state of drugs compounded by pharmacies and physicians regulated under section 503A of the Federal Food, Drug & Cosmetic Act, the agency does not intend to enforce the 5% limit” until states have had an opportunity to sign a memorandum of understanding.