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FDA targets remdesivir, thymosin in compounding concerns

Posted 24 February 2021 | By Kari Oakes 

FDA targets remdesivir, thymosin in compounding concerns

The US Food and Drug Administration has updated information on compounding drugs during the COVID-19 pandemic, focusing on some specific compounded drugs related to COVID-19.
“FDA has concerns about the use of certain drugs prepared by compounders to treat COVID-19,” wrote the agency on its web page addressing compounding during the pandemic.
The first drug called into question by FDA is thymosin-alpha 1. “The agency is aware of drug products containing thymosin being offered to patients for the treatment of COVID-19,” wrote FDA, going on to note that thymosin is not approved to treat any condition and thus does not meet conditions for compounding under the relevant provisions of the Food, Drug & Cosmetic act.
A brief internet search on 24 February revealed several firms marketing thymosin; a representative claim for thymosin tells prospective customers that thymosin injections will “boost your immune system and protect yourself from COVID-19.” One website advises that injections of thymosin alpha-1 are being used “to combat the effects of damaged cells due to coronaviruses, including the new COVID-19.”
The agency expressed different concerns about compounding of drug products containing the antiviral Veklury (remdesivir, Gilead). That antiviral has been 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,” according to the FDA web page. FDA therefore has concerns that patient harm could result if the compounding process compromised drug quality.
In recognition of the shortages some hospitals have faced during the public health emergency of the pandemic, FDA issued a guidance in April 2020 to communicate its temporary policy related to compounding by outsourcing facilities. The guidance, last updated in May 2020, allows for extra flexibility “to ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with COVID-19.” During the pandemic, FDA is exercising enforcement discretion when hospitals outsource compounded drugs needed to treat hospitalized patients with COVID-19. (RELATED: FDA allows compounding of needed hospital drugs for COVID-19, Regulatory Focus 16 April 2020)
The compounding guidance applies only to drugs in shortage if they are used for hospitalized patients with COVID-19. In the guidance, FDA advises hospitals to turn first to outsourcing facilities for compounded drugs, since those facilities have “more robust quality standards” than pharmacies or federal facilities that are not registered as outsourcing facilities.
FDA’s guidance for hospital and health system compounding has been in draft form since April 2016, and has not yet been implemented.
FDA’s website also clarifies that “Although federal law specifies a 5 percent limit on distribution out of state of drugs compounded by pharmacies and physicians regulated under section 503A of the Federal Food, Drug and Cosmetic Act, the agency does not intend to enforce the 5 percent limit” until states have had an opportunity to sign the MOU. (RELATED: FDA-state compounding MOU now available for signing, Regulatory Focus 26 October 2020)


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