Today, December 19, 2024, the FDA made a pretty major call on compounded tirzepatide. In a re-evaluation of their October decision, they have now announced that the shortage of tirzepatide injections—the same GLP-1 ingredient in Mounjaro and Zepbound—is considered resolved. What does this mean if you’ve been relying on compounding pharmacies or are in the process of figuring out where to get your medication? Let’s break it down.
First off, while the FDA says the tirzepatide shortage is “resolved,” they also made an interesting exception for the next couple of months to avoid interfering with ongoing treatment plans. For standard state-licensed pharmacies operating under section 503A, they can still compound, distribute or dispense tirzepatide injections without the usual supply-related enforcement worries until February 18, 2025. For larger outsourcing facilities operating under section 503B, the deadline is March 19, 2025.
Immediate Impacts
Large, well established telehealth providers that had been offering compounded tirzepatide largely ceased doing so in October, as that is when the FDA initially took steps to declare the shortage over. However, because the ruling was challenged, compounding pharmacies could technically continue to provide the medication, just as they are doing now.
However, the large brands such as Hims, Hers, Ro, and Sesame opted to focus on semaglutide, which remains on the shortage list and is still offered with treatment plans, generally at a 30-40% lower cost than tirzepatide injections (when they were available).
Thus, if you are currently on compounded tirzepatide, you will likely be able to continue for a few more months with your current treatment, but then will need to either switch to Zepbound or Mounjaro to stay on tirzepatide or switch to semaglutide if you are seeking lower cost GLP-1 alternatives.
However, in a likely pre-emptive response to the FDAs decision, Ro.co (Ro Review) just announced they’ll be offering single-dose vials of tirzepatide (as Lilly’s branded Zepbound) at pricing basically mirroring Lilly’s own LillyDirect website. This is huge news because Ro’s Zepbound plan helps expand more affordable access—meaning, if you’re trying to get your hands on this medication and don’t want to spend $1,000+ per month, you now have more than one established option with the Ro.com Zepbound program or a major site like Hers’ semaglutide program.
Ro will use the same pricing that Lilly set – $399 for a monthly supply of the 2.5 mg dose and $549 for the 5 mg dose. With Ro matching that, you’ve got a legitimate, third-party provider charging the same rates. This kind of parallel offering could help alleviate some of the runaround people have faced, allowing more flexibility in where and how you fill your orders.
Parting Words
As always, please, please, please stick with established, reputable providers. I’ve seen, firsthand, how frustrating it can be to deal with questionable suppliers, and I never want anyone else to have those experiences. Right now, with tirzepatide’s shortage officially resolved, you’ve got fewer reasons to gamble on random discount suppliers, especially given that Ro’s Zepbound plan is similar in cost to compounded terzepatide plans while coming straight from the Zepbound patent holder instead of a company that had been willing to potentially draw the ire of regulators by continuing to offer and advertise a drug that was no longer deemed in shortage.
To learn more about current providers of online GLP-1 diet plans, visit our GLP-1 weight loss treatment rankings.
