Why Compounded Semaglutide and Tirzepatide Were Allowed—And Why That’s Changing

If you’ve been hearing about compounded versions of medications like semaglutide (the active ingredient in Ozempic and Wegovy) or tirzepatide (found in Mounjaro and Zepbound), you’re not alone. These medications have become increasingly popular for managing type 2 diabetes and, more recently, for weight loss.

But recently, many patients have noticed a shift—compounded versions are becoming harder to find, and some pharmacies have stopped offering them altogether. Let’s break down what happened, why compounding was allowed in the first place, and what’s changing now.

🧪 What Is a Compounded Medication?

Compounding is when a pharmacy creates a customized version of a medication—sometimes to adjust the dosage, avoid certain ingredients (like dyes or allergens), or offer it in a different form (like a liquid instead of a pill). These are made by compounding pharmacies, often when a commercial product is unavailable or doesn’t meet a specific patient’s needs.

✅ Why Compounded Semaglutide and Tirzepatide Were Allowed

Normally, the FDA doesn’t allow compounding copies of drugs that are already commercially available. But there’s an exception: if a medication is on the FDA’s drug shortage list, compounding pharmacies are temporarily allowed to produce it to help meet demand.

In 2023 and early 2024, both semaglutide and tirzepatide were placed on the FDA shortage list due to overwhelming demand and limited supply from the manufacturers. This created a temporary window during which compounding pharmacies could legally prepare versions of these medications for patients—especially those who couldn’t access or afford the name-brand options.

🚫 Why Compounding Is Being Phased Out Now

Now in 2025, things are changing. The supply of commercially manufactured Ozempic, Wegovy, Mounjaro, and Zepbound has begun to stabilize. As a result, the FDA has removed these medications from the official drug shortage list or narrowed the scope of the shortage.

Once that happens, compounded versions are no longer permitted under federal law—unless there’s a very specific medical reason a patient cannot take the FDA-approved product and a physician documents that need. But for most patients, access to compounded semaglutide and tirzepatide will end.

⚠️ Why This Matters

It’s important to understand that compounded medications are not FDA-approved. While they can be safe and effective when made by reputable pharmacies, the quality, purity, and strength may vary. As the FDA-regulated supply returns, the goal is to ensure all patients receive consistent, high-quality medications.

💡 What You Can Do

If you’ve been taking a compounded version of semaglutide or tirzepatide, talk to your healthcare provider as soon as possible to create a transition plan. This is especially important because:

• Weight regain is common when treatment is interrupted. This is not a failure of willpower or lifestyle—it’s a reflection of the chronic nature of metabolic dysfunction and the body’s natural metabolic adaptation to weight loss.

• Maintaining treatment continuity helps support long-term success and protects against the health risks of weight cycling.

At Rainier Medical, we can help:

• Transition you to an FDA-approved product

• Explore insurance or manufacturer savings programs

• Determine if you’re eligible for a patient assistance program

• Complete prior authorization based on diagnoses, medical data, to advocate for coverage on your behalf.

Good news: The cost of brand-name medications is becoming more manageable for many people:

• Wegovy is available with a manufacturer coupon for $499/month (link to coupon site)

• Zepbound is now available directly from the manufacturer in vials for $324–$499/month for up to 10 mg doses (link to official site)

These prices are often comparable to or even lower than compounded versions—and come with the reassurance of FDA approval, standardized dosing, and manufacturer support.

🩺 Final Thoughts

The use of compounded semaglutide and tirzepatide was a necessary bridge during a time of limited supply. Now that access to the original medications is improving, the focus is returning to FDA-approved options to ensure the safest, most effective care possible.

If you're concerned about your access to treatment, don’t wait—reach out to your healthcare provider. You deserve ongoing support for your health, and it’s important to understand that any challenges with weight or metabolic health are not personal failures—they’re part of a complex medical condition that often requires long-term treatment, just like any chronic disease.

Take Back Your Treatment,

Valerie Hope-Slocum Sutherland, MD

Diplomate, American Board of Internal Medicine

Diplomate, American Board of Obesity Medicine