Semaglutide and tirzepatide are probably the two most-searched drug names in the country right now, and also two of the most misunderstood when it comes to compounding. Here's the honest, current picture — not the marketing version.
The Shortage Is Over, and That Changed Everything
For a while, semaglutide and tirzepatide were both on the FDA's official drug shortage list. During a shortage, compounding pharmacies get real latitude to produce a medication to fill the gap. That's the era that made $150–300/month compounded GLP-1s common.
That era is over. The FDA resolved the tirzepatide shortage in late 2024 and the semaglutide shortage in early 2025. Once a shortage ends, the special compounding latitude ends with it — 503A pharmacies and 503B outsourcing facilities both lost that enforcement flexibility in early 2025.
So Is Compounded GLP-1 Therapy Still Legal?
Yes — but the bar is different now, and higher than most people realize. Under Section 503A of the FD&C Act, a licensed pharmacy can still compound a personalized version of semaglutide or tirzepatide for a specific patient, but only when there's a documented clinical reason the FDA-approved brand product won't work for that patient — not simply because compounded is less expensive. Legitimate reasons include things like needing a different strength than what's commercially available, or an ingredient sensitivity to something in the brand formulation.
This is exactly why our process includes a telehealth visit before any compounded medication is approved — that visit is where a provider actually determines whether compounding is clinically appropriate for you, or whether an FDA-approved option is the better fit.
What Just Happened at the FDA (April 2026)
On April 30, 2026, the FDA proposed removing semaglutide, tirzepatide, and liraglutide from the 503B Bulks List — the list that lets large outsourcing facilities compound these drugs at scale from raw ingredients. The FDA's stated reasoning: there's no ongoing clinical need for mass compounding at the outsourcing-facility level now that the shortage has resolved. A public comment period on that proposal closed June 29, 2026, and a final rule hasn't been issued as of this writing.
This mainly targets large-scale 503B operations, not individualized 503A compounding for a specific patient with a documented need — which is the model we operate under. But it's part of a broader tightening across the entire compounded-GLP-1 space, and it's worth knowing about if you're comparing options.
What About Brand-Name Options?
If a compounded formulation isn't the right fit for you, FDA-approved Zepbound and Wegovy remain available through the manufacturer's direct-purchase programs, typically in the $300–550/month range self-pay. There's also a new Medicare GLP-1 Bridge program launching this month that covers Wegovy and Zepbound at a $50/month copay for eligible patients under Part D — worth asking your provider about if you have Medicare coverage.
Our Approach
We don't default to "compounded is cheaper, so that's what we'll give you." Every GLP-1 request goes through a telehealth visit where a provider looks at your labs and your history and tells you honestly whether a personalized compounded formulation is appropriate — or whether you'd be better served by a brand-name option or a different program entirely.
Curious what's right for you?