FDA Allows Compounding of Tirzepatide

FDA Update: Continued Access to Compounded Tirzepatide Injections

In this video, Christopher Durham announces significant news for patients requiring compounded tirzepatide injections. The FDA has confirmed that both 503A and 503B pharmacies can continue compounding these injections, providing an alternative to Eli Lilly’s Zepbound, Mounjaro during this critical period. This decision follows a request for clarification from the Alliance for Pharmacy Compounding (APC) after the FDA's recent decision was challenged by the Outsourcing Facilities Association (OFA) and Pharma Keo Pharmacy. The temporary allowance ensures that thousands of patients are not left without essential medications while the FDA reconsiders its earlier resolution. The video also emphasizes the importance of consulting with state boards and healthcare professionals regarding compounded medications.



00:00 Introduction and FDA Confirmation
00:17 Clarification Request and FDA Decision
00:39 Understanding 503A and 503B Pharmacies
01:10 Legal Challenge and Temporary Allowance
01:44 Impact and Caution for Pharmacies
02:46 Conclusion and Final Thoughts

[MindyMikami]

🎉🎉🎉🎉 Happy for my compounding friends!

[heatheru]

Thanks for keeping on top of this! This should at least get all of us on compounds until the end of the year.

[sallysmack]

I feel as though I've received another stay.

[nydia]

Just to confirm, am I understanding this correctly? Until November 21st, all compounding pharmacies are allowed to resume their Tirz production, and this will remain in effect until the FDA makes its decision. Is that correct?

[caddygirlever]

CD thanks for breaking this amazing news! Whew, a reprieve for a bit.

[justme]

What type of shelf life do compounds have on them? I use Mounjaro so no experience with compounds.