Last week, the US Food and Drug Administration announced that tirzepatide is no longer in shortage. It has been a long time coming: The active ingredient in the weight loss drug Zepbound and diabetes medication Mounjaro has experienced runaway popularity, along with other GLP-1 meds like Ozempic. This unprecedented demand sent it into shortage in December 2022. The end of drug shortages are usually a good thing -- but for many people currently taking tirzepatide, this is a moment of fear and uncertainty rather than celebration. For them, this means the meds they are accustomed to taking may be harder to get.
"Absolutely devastating," says Tennessee-based Gianna Green, who has only taken the drug for a short time but who calls its effects "completely life-changing."
Green belongs to a group of likely millions of people who have been taking a "compounded" version of tirzepatide. In the US, when drugs are in shortage, pharmacies can produce custom copies. Unlike generic drugs, which are FDA-approved products brought to market after patents expire, compounded meds are meant to be substitutes offered for specific purposes, like drug shortages. As such, they have not historically been mass-produced, and they are not subject to the same approval processes as standard pharmaceutical drugs. But the sky-high demand for GLP-1 meds has created a booming market for compounded tirzepatide and semaglutide, especially since telehealth companies sell these meds for a fraction of the price of their name-brand counterparts. The telehealth startup Ro, for example, offered an introductory month of tirzepatide for weight loss for $99; name-brand Zepbound, meanwhile, can cost over $1000 without insurance. (Some companies also allow payment via Klarna and other "buy now, pay later" services for their compounded products, lowering financial barriers even further.) Many of the telehealth companies ship the drugs after a quick questionnaire, with no lab work or doctor visit required, which means new patients can get meds within days.
Now, though, compounded tirzepatide patients are in a precarious position. Many are in the dark about whether they can refill their prescriptions, or how long they have until they need to make alternative medication plans, and they fear a future where they cannot access the drug.
"I mean this without any shred of embellishment, tirzepatide gave me my life back," Jim Bertel says. A 40-year-old who says he's lost 72 pounds on the medication, Bertel has used a variety of telehealth providers to get the compounded version of the drug, bouncing around based on cost. He feels "deeply uneasy" about the shortage ending.
There are two types of pharmacies permitted to compound drugs, known as 503a and 503b pharmacies. With the shortage ended, 503a pharmacies need to cease nearly all production of copies immediately; 503b pharmacies, which typically make larger quantities, have a 60-day off-ramp period. Most of the pharmacies compounding these meds are 503a -- which means that the supply is already slowing, and in some cases lurching to an abrupt halt, for a large number of people who have come to rely on this medication. "It would make sense that people would panic over a shortage," says Maria Rising, a compounded tirzepatide patient who also runs a popular Instagram channel about the medication. "But they're actually panicking because the shortage is over."