Pharmacists can continue making compounded versions of generic tirzepatide, the active ingredient in popular medications Mounjaro and Zepbound, the Food and Drug Administration said in a recent court filing.
The agency will revisit its decision to remove the drug from its nationwide shortage list earlier this month in response to the lawsuit filed by a trade group of compounding pharmacies claiming the drug was still in short supply.
When a drug is on the FDA’s shortage list, it allows compounding pharmacies to legally make generic, copied versions of the medications by ordering ingredients in bulk and producing the medications themselves. But when the FDA announced on Oct. 2 that the shortage of tirzepatide had ended, that meant compounding pharmacies had to stop making it.
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For now though, according to the recent court filing, the FDA said it will not “take action” against the pharmacies making the drug while it looks into potentially adding it back to its shortage list.
Tirzepatide had been on the FDA’s drug shortage list for nearly two years before the agency and the manufacturer of the brand-name versions, Eli Lilly, claimed it was in good supply.
The demand for the injectable medication skyrocketed after doctors started prescribing Mounjaro, a diabetes drug, to patients for off-label weight loss use. Now, under the name Zepbound, patients can get it prescribed for weight loss.
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Shortages for similar drugs, like semaglutide under the brand names Ozempic and Wegovy, continue.
