Updates on the Shortage List and Compounding of GLP-1 medications
The Short Version:
The OFA sued the FDA in December for taking tirzepatide off the shortage list. Yesterday, the court ruled in favor of the FDA, so the FDA will likely order compounding pharmacies to stop producing tirzepatide, and this could happen at any time. They have not provided an updated statement since the ruling. Hallandale is still accepting prescriptions as of right now, and for those who want to bulk order we can place this order for you, but we cannot guarantee your order will be filled. If Hallandale is forced to stop production before your prescription can be sent, refunds will of course be provided. Please remember that for any refills, you must have submitted a Follow-Up Form within the past 3 months and provide an updated blood pressure and pulse. Please contact us if you have additional questions: [email protected]
The FDA also removed semaglutide from the shortage list around 2 weeks ago on Feb 21. The OFA has sued the FDA for this as well. As of now the stop date for compounded semaglutide is 4/22/25.
Semaglutide
Update 3/6/25
The FDA removed semaglutide from the shortage list on 2/21/25. Compounding pharmacies can lawfully continue making semaglutide for 60 days, until 4/22/25. The Outsourcing Facilities Association (OFA) immediately filed a lawsuit against the FDA claiming that it should not have been removed from the shortage list. Yesterday, Novo Nordisk joined the FDA’s legal team in their legal battle against the OFA.
Currently, compounders are still legally permitted to make this medication until 4/22/25. It’s possible that the ruling on tirzepatide may influence the court’s decision on semaglutide, leading to an expedient ruling, but these are two different cases with two different sets of facts and arguments. In any case, compounding pharmacies will have at least until 4/22/25 to keep making semaglutide.
Tirzepatide
Update 3/6/25:
Unfortunately, the courts have ruled in favor of the FDA.
Tirzepatide was removed from the shortage list in mid December. Compounding pharmacies were given 60 days, or until 2/19/25, to stop compounding the medication. The OFA filed a lawsuit soon against the FDA soon after it was removed from the shortage list, claiming that the medicine should not have been removed from the shortage list. On 2/19/25 the FDA stated that compounders could continue making the medication until the court ruled on the lawsuit.
Yesterday, the courts upheld the FDA’s decision to remove tirzepatide from the shortage list. This likely means that compounding pharmacies will almost immediately have to discontinue producing the medicine. As of right now, Hallandale Compounding Pharmacy is evaluating its options. They have not informed us they are not accepting prescriptions for this medicine, so we will continue to send prescriptions until they inform us otherwise.
If you have been on the fence about ordering more compounded tirzepatide, we would recommend doing this as soon as possible because the FDA can alert the compounding pharmacies to stop immediately at any moment. We can discuss the maximum amount we can prescribe if you reach out to us. The compounded medicine has a shelf life of around 8 months if refrigerated, last I checked.
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