Ok - I’m going to try to BRIEFLY (but let's be real, you know I can't be brief) and not stupidly or wrongly explain what is going on with compounded GLP1’s/weight management medications and how big pharma trying to make us all unhealthy, sad, and poor. Jk jk jk, but no really. I gathered this info from speaking to multiple compounding pharmacies, reading a lot, and me trying to understand legal jargon. So, take it as such, and always feel free to do your own research and school me better.
Please read until the end, I might have a solution that can maybe help with at least a little bit of the uncertainty, but I need your input.
Let’s start with TIRZEPATIDE.
As you all are likely aware, on October 2nd, 2024, tirzepatide was removed from the FDA drug shortage list. Following litigation by the Outsourcing Facilities Association (OFA), the FDA reaffirmed on December 19th, 2024 that the shortage was resolved.
The FDA then set the following deadlines for pharmacies to cease compounding tirzepatide:
503A pharmacies (these are patient specific pharmacies that I currently use for clients) - February 18, 2025
503B pharmacies (offering office based prescriptions if I were to have you come get an injection from me weekly) - March 19, 2025
HOWEEVVER, due to continued litigation, the FDA has confirmed it will not take enforcement action against state-licensed pharmacies compounding GLP-1 medications while the ongoing case between the FDA and the Outsourcing Facilities Association (OFA) is being decided.
This means that the pharmacies I work with will continue compounding and supplying Tirzepatide without interruption while this litigation continues.
The long and short of it AS IT STANDS TODAY:
Tirzepatide remains available for compounding and prescribing.
The FDA’s enforcement discretion applies until until the court reaches a decision--the problem here is there currently no guidance as to when this decision could occur, so the timeline is a very big unknown
Now semaglutide.
Most recently, as of Friday, February 21st 2025, the semaglutide shortage was identified as being “Resolved.” The OFA plans to move forward with litigation challenging the resolution of the shortage. Currently, semaglutide can be compounded and dispensed until:
503A pharmacies (the ones we deal with) until April 22nd, 2025
503B pharmacies have until May 22nd, 2025
As I have more information on the status of tirzepatide and semaglutide, I will be sure to provide updates as they become available.
MEGAN’S HOT TAKE.
Both semaglutide and tirzepatide are available as litigation continues. And seeing how tirzepatide has been on the chopping block since October and it has been extended for so long, who knows how much longer it could be around. Same with semaglutide since it is now going through similar tribulations.
Also, I have found that some compounding pharmacies that formulate differently (say adding in vitamin B of some sort) will be able to continue to make their variations even after the shortage is declared and it is pulled. However, the price would likely increase and I will have to do more research to make sure there are no legal implications for me if I continue to offer this, but it’s something I will seriously look into. I have read mixed thoughts on this, so it’s really hard to determine the right course of action at this time.
My recommendation: order a three month supply GLP with your next visit. This at least helps with some uncertainty, but obviously increases the up-front cost.
I understand that these regulatory updates can create uncertainty, but rest assured that I am always on your side closely monitoring the situation and will keep you informed.
My priority is ensuring seamless access to high-quality, compliant GLP1’s for you all and to keep you going on your journey to feeling like the best version of you
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