For the past few years, compounded semaglutide has been a key option for medspas looking to meet patient demand during the Wegovy® and Ozempic® shortages. But now, the FDA has declared the shortage over, and with that comes new regulations that will phase out compounded versions.
This change will impact medspas offering compounded semaglutide, so now’s the time to prepare—from updating patient communication to ensuring compliance. Here’s what you need to know and how to get ahead of the transition.
Here’s What’s Changing:
💉 The FDA has officially ended the semaglutide shortage, which started in 2022.
💉 Compounded semaglutide will be phased out—503A compounding pharmacies must stop by April 22, 2025, and 503B outsourcing facilities by May 22, 2025.
💉This will impact medspas offering compounded versions, so now’s the time to get ahead of patient conversations and compliance updates.
What Happened & Why It Matters
Since the FDA declared semaglutide shortages in March 2022 (Wegovy) and August 2022 (Ozempic), compounding pharmacies have stepped in to fill the gap in semaglutide availability. But now that supply is stable, the FDA is reinstating its usual regulations—which means compounded versions won’t be an option for most patients.
Deadlines for Compounded Semaglutide
📌 April 22, 2025 – 503A compounding pharmacies must stop making and selling semaglutide.
📌 May 22, 2025 – 503B outsourcing facilities must comply with FDA rules and phase out production.
Could these dates change? Possibly. As we have seen with tirzepatide, legal challenges may affect deadlines, but for now, these are the deadlines to plan around.
What Medspa Providers Need to Do Now
✅ Check your supply chain – If you offer compounded semaglutide, now’s the time to prepare for a possible transition.
✅ Educate your team – Patients will have questions about what’s happening, their options, and costs. Make sure your staff is ready with clear answers.
✅ Get ahead of patient communication – No one likes surprises. A proactive, transparent approach will help keep trust intact. If your medspa is supported by Moxie, we’ll be providing templates to make outreach easy.
✅ Stay compliant with state laws – Federal guidelines apply, but some states may have additional rules. Review your practice’s compliance plan and make any needed adjustments.
✅ Keep an eye on updates – We’re monitoring this closely and will share any changes as they happen.
Your FAQs, Answered
Can we still offer compounded semaglutide?
You should follow all FDA guidelines. If you’re considering it, consult legal counsel to understand your options.
What happens if we keep selling compounded semaglutide after the deadline?
This could put your practice at risk of FDA enforcement, legal action, and potential manufacturer lawsuits.
How do we talk to patients about this?
Be upfront. Let them know:
- Why compounded semaglutide is being phased out
- What alternatives are available
- What this means for pricing and access
(If your practice is supported by Moxie, we’ll provide patient-friendly messaging to help make these conversations easier.)
Will alternative medications be available?
Yes—FDA-approved semaglutide (like Wegovy® and Ozempic®) mayl still be an option for eligible patients.
Where can we get more compliance guidance?
📌Section 503A of the FD&C Act
📌 If you partner with Moxie, reach out to your Practice Success Manager
Moxie’s Here to Help
We know changes like this can feel overwhelming, but you’re not navigating this alone. We’ll help by sharing:
✅ Regulatory updates as new details emerge
✅ Patient communication templates to help you keep patients informed
✅ Guidance on next steps and alternative treatments
👉 We’ve got your back—stay tuned for more updates.
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