Compounded Semaglutide: What You Need to Know in 2025

Quick Takeaway

Compounded semaglutide offered a cheaper alternative ($150-300/month vs $1,000+) during the drug shortage. With the shortage resolved, the legal landscape has shifted dramatically. Options now include brand-name at reduced prices through partnerships (like Ro's $499/month), or waiting to see how ongoing lawsuits play out. The days of $199 compounded semaglutide appear to be ending.

What Is Compounded Semaglutide?

Let's start with the basics. Compounded semaglutide is the same active ingredient found in Ozempic and Wegovy, but it's mixed by a compounding pharmacy rather than manufactured by Novo Nordisk (the pharmaceutical company that makes the brand-name versions).

Think of it like this: Novo Nordisk makes the "Coca-Cola" version. Compounding pharmacies were making the "generic cola"—same basic ingredient, but not the official product.

Why Did Compounded Versions Exist?

Under normal circumstances, compounding pharmacies can't just copy FDA-approved drugs. But there's an exception: when there's a drug shortage, compounders can step in to meet patient demand.

And that's exactly what happened. The explosive demand for GLP-1 medications (thanks to their effectiveness for weight loss) created a massive shortage. Novo Nordisk couldn't make enough Ozempic and Wegovy to meet demand. Enter compounding pharmacies, which filled the gap with their own versions.

The February 2025 FDA Announcement: What Changed

On February 21, 2025, the FDA officially declared the semaglutide shortage "resolved." This wasn't just a status update—it fundamentally changed what compounders can legally do.

Key Dates & Deadlines

Feb 21, 2025:FDA declares semaglutide shortage resolved

Apr 22, 2025:Deadline for state-licensed pharmacies to stop compounding semaglutide (may be extended by court rulings)

May 22, 2025:Final deadline for 503B outsourcing facilities

What This Means Practically

For most people: Compounded semaglutide will become unavailable or already has. Telehealth companies that built their business on compounded versions are scrambling to pivot.

The exceptions: Compounding is still allowed if your doctor can demonstrate a specific medical reason why FDA-approved versions don't work for you—like an allergy to a dye in the brand-name product, or needing a different delivery method. This is a narrow exception, not a loophole for everyone.

Legal Battles: It's Not Settled Yet

The compounding industry isn't going quietly. On February 24, 2025, the Outsourcing Facilities Association filed a lawsuit challenging the FDA's determination that the shortage is actually resolved. Their argument: just because Novo Nordisk says they can meet demand doesn't mean patients can actually afford or access the medication.

This lawsuit could extend the timeline. Federal Judge Mark Pittman is hearing the case, and a preliminary injunction could delay enforcement. But betting your treatment plan on legal proceedings is risky.

Compounded vs. Brand-Name: What's the Actual Difference?

Factor	Brand-Name (Ozempic/Wegovy)	Compounded Semaglutide
FDA Approved	✓ Yes	✗ No
Cost (cash-pay)	$1,000-1,800/month	$150-300/month
Quality Control	Standardized, rigorous	Varies by pharmacy
Dosing Consistency	Exact, batch-to-batch	May vary slightly
Clinical Trial Data	Extensive	Limited (same ingredient)
Legal Status (2025)	Fully legal	Restricted/phasing out

The Semaglutide Salt Controversy

Here's something the FDA has specifically warned about: some compounders use semaglutide salts (like semaglutide sodium or semaglutide acetate) instead of the base form of semaglutide used in approved products.

The FDA says these salt forms are not the same as the approved medication, and their safety and effectiveness haven't been evaluated. If you've been using compounded semaglutide, it's worth asking your provider whether they use the base form or a salt version.

Was Compounded Semaglutide Actually Safe?

This is the million-dollar question. The honest answer: probably, for most people, from reputable sources—but with important caveats.

What We Know

Hims published data on 10,000+ patients using their compounded semaglutide, showing similar safety and effectiveness to brand-name versions. Patients lost an average of 9.3 pounds in the first month with tolerable side effects.
The active ingredient is the same—semaglutide is semaglutide. The concerns are about purity, dosing accuracy, and sterility, not the molecule itself.
Reputable compounding pharmacies follow standards—they're licensed, inspected, and have quality control processes. They're not sketchy overseas operations.

The Concerns

Less oversight—compounded drugs don't go through FDA approval, meaning no independent verification of safety data.
Quality varies—not all compounding pharmacies are equal. Some have had contamination issues in the past (with other drugs).
Dosing precision—brand-name manufacturers have extremely tight tolerances. Compounders may have more batch-to-batch variation.

Your Options Going Forward

If you've been on compounded semaglutide (or were considering it), here's what you can actually do now:

Option 1: Brand-Name Through Insurance

If you have commercial insurance, Wegovy or Zepbound may be covered—especially if you have obesity with a comorbidity (diabetes, hypertension, etc.). Copays with coverage can be $25-200/month.

Downside: Many insurers still don't cover weight loss medications, and prior authorizations can be a hassle.

Option 2: Brand-Name via Telehealth Partnerships

Ro has partnered with Novo Nordisk to offer brand-name medications at reduced prices. Their Body program offers Wegovy/Zepbound starting at $499/month—still expensive, but nearly half the retail price.

Best for: People who want FDA-approved medication without fighting insurance.

Option 3: Tirzepatide (While Supplies Last)

As of late 2024, tirzepatide (Mounjaro/Zepbound) was still in shortage, meaning compounded versions remained available. However, this situation is also evolving. Check current shortage status before assuming availability.

Note: The FDA has also been scrutinizing tirzepatide compounding.

Option 4: Manufacturer Savings Programs

Novo Nordisk (for Wegovy) and Eli Lilly (for Zepbound) offer savings programs for eligible patients. These can significantly reduce costs if you don't have insurance coverage.

Check: NovoCare.com and Lilly.com for current programs.

Option 5: Wait and See

The lawsuit challenging the FDA's shortage determination could change things. If you're not in a rush, monitoring the legal situation over the next few months might reveal new options.

Risk: No guarantee of any change, and you'll be without medication in the meantime.

What Are Telehealth Companies Doing?

The major players who built businesses on compounded semaglutide are pivoting in different ways:

Company	Current Approach	Starting Price
Hims/Hers	Transitioning to brand-name; check current availability	~$199/mo (was compounded)
Ro Body	Brand-name via Novo Nordisk partnership	$499/mo
Calibrate	Brand-name only (always was)	$199/mo + insurance for meds
Noom Med	Check current offerings	Varies
Found	Transitioning; multiple medication options	$99-399/mo

Key insight: The GLP-1 telehealth landscape is in flux. Prices and availability change frequently. Before signing up with any provider, confirm exactly what medication they're currently offering and at what price.

The Bottom Line

Compounded semaglutide served an important role during the shortage—it made effective weight loss medication accessible to people who couldn't afford $1,500/month. But the regulatory window is closing.

If you're currently on compounded semaglutide: Talk to your provider now about transition plans. Don't wait until you run out of medication.

If you were considering starting: Your realistic options are now brand-name (through insurance, savings programs, or telehealth partnerships) or waiting to see how the legal situation evolves.

The silver lining: the intense demand has pushed manufacturers and telehealth companies to find ways to reduce costs. Brand-name options at $499/month—while still expensive—represent a significant drop from the $1,500+ retail price. Competition and innovation may continue to improve access.