The FDA clarified Thursday that it won’t take action against GLP-1 compounders for certain violations while it reevaluates Eli Lilly’s weight loss and diabetes drug tirzepatide’s removal from its national shortage list.
Last week, the agency revealed in court documents that it was reconsidering whether tirzepatide should have been removed from the shortage list. On Thursday, the agency went a step further, saying it “intends to treat compounders consistently at this time, meaning that FDA does not intend to take action against compounders for violations” related to certain conditions under the Federal Food, Drug, and Cosmetic Act.
The agency’s step-back is a significant win for compounding pharmacies and many of the online medical companies that prescribe the drugs. While Novo Nordisk’s drug semaglutide remains in shortage, the removal of tirzepatide from the list accelerated the possibility that compounders would no longer be able to make the treatments, which are often sold for less than the brand-name versions and have been in great demand by people seeking them for weight loss.
Trade associations for compounders have argued that a shortage of tirzepatide persists, despite the FDA’s decision to remove the drug from its shortage list. Earlier this month, the Outsourcing Facilities Association filed a lawsuit against the agency, and the Alliance for Pharmacy Compounding (APC) this week urged the agency in a letter to put tirzepatide back on the shortage list and called for clarity.
The APC applauded Thursday’s announcement, calling it a “win for continued patient access to compounded versions of Eli Lilly’s Mounjaro and Zepbound.”
“The abruptness of FDA’s resolution of the tirzepatide injection shortage left thousands and thousands of patients stranded with a prescription that could no longer be filled — and no speedy means of transitioning to the FDA-approved drug,” APC CEO Scott Brunner said in a news release “For those patients and their providers, today’s clarification by FDA is wonderful news.”
However, Brunner said the clarification “is not a checkered flag allowing unrestrained compounding.” The FDA’s announcement doesn’t, for example, protect compounders from actions by state boards of pharmacy or from potential challenges by Lilly.
Lilly didn’t respond to a request for comment as of press time, nor did the FDA.
APC urged compounding pharmacies to check with their state boards of pharmacy before resuming distribution of compounded tirzepatide.