October 2, 2024
FDA says tirzepatide shortage “resolved”
Pharmacies must immediately cease preparing and dispensing compounded copies of Mounjaro, Zepbound
October 2, 2024 – As of this afternoon, the FDA Drug Shortage List is showing that the shortage of tirzepatide injection is “resolved.” Pharmacies must immediately cease preparing and dispensing compounded copies of Mounjaro and Zepbound, the FDA-approved injectable drugs for which tirzepatide is the active pharmaceutical ingredient.
Pharmacies are generally prohibited from compounding copies of FDA-approved drugs. But FDA’s Guidance for Industry “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” does allow pharmacies to prepare copies when an FDA-approved drug is listed as “currently in shortage” on the FDA Drug Shortage List. It’s an intentional policy designed to assure patients can continue to access essential medications even when the drug supply chain breaks down. Tirzepatide injection has been listed “currently in shortage” since December 2022.
“For Lilly, this is surely progress, but for many patients, at least in the near term, I’m not so sure,” said Alliance for Pharmacy Compounding CEO Scott Brunner. “I suspect plenty of patients taking compounded tirzepatide are going to be caught flat-footed by this. They are being cut-off cold-turkey, their prescription no longer fillable. They’ll need to get in to see their provider to get a new prescription, and that will take some time. It’s possible that so many patients presently taking compounded GLP1s will be eventually switched to the FDA-approved versions – if they can afford them, of course – that it will push tirzepatide injection back into shortage. We’ll see.”
Via informal channels, two months ago APC communicated to FDA its concerns about just such a circumstance as this and asked the agency to consider an informal “off-ramp” for patients taking compounded GLP1s after the drug came off shortage. “A 60-day period during which a patient could continue compounded GLP1 therapy while their prescriber transitioned them to the FDA-approved versions would have been helpful for assuring continuation of care for those patients,” said Brunner. “Unfortunately, the agency hasn’t responded.”
As for how quickly pharmacies can access the newly available FDA-approved tirzepatide drugs, Brunner notes that it often takes much longer for FDA-approved versions of the drug to become widely available to wholesalers, hospitals, and clinics. “The slowness with which Eli Lilly’s Zepbound has been attainable from wholesalers by pharmacies for dispensing, even after the company’s recent and much-heralded announcement of its newfound ‘availability,’ is evidence of that. Even now, for most pharmacies, they’re lucky to get two or three boxes of Zepbound a day from their wholesaler – for a patient waiting list that can number in the hundreds.”
The shortage list maintained by the American Society of Health System Pharmacists, considered to be a much more real-time indicator of drug shortages, continues to list tirzepatide injection in shortage.
We encourage pharmacies to report difficulty obtaining Mounjaro and Zepbound pens from their wholesalers here: https://cdernextgenportal.fda.gov/publicportal/s/dsm-submission
The Alliance for Pharmacy Compounding is the voice for pharmacy compounding, representing more than 500 compounding small businesses – including compounding pharmacists and technicians in both 503A and 503B settings – as well as prescribers, educators, researchers, and suppliers. To learn more, go to a4pc.org.
