Notice regarding Tirzepatide and the end of the shortage

Hey there everyone,

Yesterday evening it was brought to our attention that the FDA has officially ended the shortage for Eli Lilly’s branded variants of Tirzepatide (Mounjaro®, Zep Bound®). This was expected, as Eli Lilly has announced multiple times over the past few months that they have worked diligently to resolve the shortage.

However, it is very apparent to us that the shortage is not really over. Despite the FDA’s hasty removal of the most popular branded GLP-1 medications from shortage, it seems that a ton of patients are still having trouble fulfilling their prescriptions and we anticipate that this ‘end’ to the ongoing shortage will end as abruptly as it started. 

So what does this mean for compounded weight loss programs and telehealth companies? Well, as some of you have already pointed out, many telehealth companies have suspended refills and removed any mention of Tirzepatide from their websites and social media. This is because without the overarching shortage and FDA oversight, there is virtually no legal protection from Eli Lilly enforcing their patent and pursuing legal action against anyone offering the compounded variant of their drug. We’re a small company of seven healthcare professionals and an even smaller support team, and we’re certainly not equipped to deal with any legal battle that could befall us in the future. If and when that does happen, we will cease offering Tirzepatide programs immediately and both cancel and refund any pending orders, subscriptions, and refills. But until then, as long as there are still providers willing to fulfill prescriptions we will NOT be pausing/removing Tirzepatide from our programs. Note that while 503a pharmacies have no protection moving forward, 503b pharmacies do have a 60 day grace period in which they can continue to produce Tirzepatide.

We are closely monitoring the situation, and will update any current and new patients as we learn more. We are confident that the future of compounded GLP-1 isn’t as dim as it appears right now, and we urge everyone in this space to stay diligent and await more news soon.

Best,

The TRYM Health Team