The "Personalization Loophole": How Companies Keep Compounding GLP-1s

You've probably noticed something strange.

The FDA officially declared semaglutide and tirzepatide shortages "resolved" in early 2025. The grace periods for compounding ended. By May 22, 2025, compounders were supposed to stop making "essentially copies" of these drugs.

And yet... you can still find compounded GLP-1s everywhere. Hims offers them. Noom offers them. Mochi Health, Ro, and dozens of other telehealth companies continue selling compounded semaglutide and tirzepatide as if nothing changed.

What's going on?

Welcome to the "personalization loophole"—a regulatory gray area that's keeping the compounded GLP-1 market alive. It's fascinating, it's legally precarious, and if you're using compounded GLP-1s, you need to understand it.

The Background: Why Compounding Was Allowed

First, let's understand why compounding pharmacies could make GLP-1s in the first place.

Under FDA regulations, compounders generally cannot make drugs that are "essentially copies" of FDA-approved products. The whole point of FDA approval is that the manufacturer went through rigorous testing. Letting anyone copy the drug would undermine the system.

But there's an exception: When an FDA-approved drug is in shortage, compounding pharmacies can step in to help meet patient demand. The logic is simple—if patients can't get the medicine they need, compounders can fill the gap.

From 2022-2024, both semaglutide and tirzepatide were on the FDA's drug shortage list due to unprecedented demand. Compounders legally produced millions of doses, often at a fraction of the brand-name price.

Then the shortages ended:

• Tirzepatide: Removed from shortage list December 19, 2024
• Semaglutide: Removed from shortage list February 21, 2025

The FDA gave compounders grace periods—60 days for 503A pharmacies, 90 days for 503B outsourcing facilities—to wind down production. After that, making "essentially copies" would violate federal law.

The Loophole: "Not Essentially a Copy"

Here's where it gets interesting.

The FDA's guidance says compounders can't make drugs that are "essentially a copy" of approved products. But the FDA also says a compounded product is NOT essentially a copy if it has a "clinical difference" that makes it appropriate for an individual patient's needs.

What counts as a "clinical difference"? According to FDA guidance:

• Different dosage strength (beyond ±10% of approved doses)
• Different dosage form
• Added ingredients that serve a clinical purpose
• Modified delivery method

Crucially, the FDA has stated it "will not second-guess the prescriber" regarding whether a clinical difference determination is appropriate—as long as the rationale is documented and specific to the patient.

This is the opening compounders are using.

How Companies Are Using the Loophole

Strategy 1: Adding Vitamins (B6, B12, Niacinamide)

The most common approach: add a vitamin or supplement to the compounded GLP-1.

You'll see formulations like:

• Semaglutide + B12 (cyanocobalamin)
• Tirzepatide + B6 (pyridoxine)
• Semaglutide + niacinamide
• Tirzepatide + L-carnitine

The clinical rationale varies. B6 and B12 may help with GLP-1-related nausea. B12 is commonly deficient in weight loss patients. Niacinamide has anti-inflammatory properties.

But let's be honest: the primary purpose of these additions is regulatory, not clinical. By adding an ingredient that isn't in the FDA-approved product, the compounded version becomes a "different" product—not essentially a copy.

Is this legit? It depends. If a prescriber genuinely believes the added ingredient benefits the patient and documents that rationale, it may be defensible. If it's purely a workaround with no real clinical basis, FDA could challenge it.

Strategy 2: "Personalized" Dosing

Another approach: offer doses that don't match FDA-approved strengths.

For example, brand Wegovy comes in 0.25mg, 0.5mg, 1mg, 1.7mg, and 2.4mg doses. A compounder might offer:

• 0.3mg (between standard doses)
• 0.75mg (for slower titration)
• 1.25mg (between 1mg and 1.7mg)
• 2.0mg (slightly below maintenance)

The argument: some patients need doses between standard increments due to side effect sensitivity or individual response. Since these exact doses aren't commercially available, compounding fills a legitimate clinical need.

Is this legit? Potentially more defensible than vitamin additions, if the prescriber documents why a specific patient needs a non-standard dose. The FDA's ±10% rule means 0.75mg might be considered "essentially the same" as 0.5mg or 1mg—there's ambiguity.

Strategy 3: Different Delivery Forms

Some compounders offer semaglutide in forms not available from manufacturers:

• Sublingual drops (under-the-tongue)
• Troches (dissolving lozenges)
• Multi-dose vials (vs. pre-filled pens)

The clinical argument: some patients can't or won't use injections, or need the dosing flexibility of multi-dose vials.

Is this legit? Complicated. Multi-dose vials are essentially the same drug in a different container—probably not enough to escape "essentially a copy." Sublingual and troches are genuinely different delivery methods, but they also have questionable bioavailability. The FDA hasn't explicitly blessed or banned these approaches.

What the FDA Has Actually Said

Here's the frustrating reality: the FDA hasn't clearly ruled on these "personalization" strategies.

In FDA guidance documents and the declaratory orders ending the shortages, the agency:

• Confirmed that making "essentially a copy" of non-shortage drugs violates federal law
• Acknowledged that compounding for individual patient needs remains legal if there's a genuine clinical difference
• Stated it won't second-guess prescriber determinations if properly documented
• Warned that vague rationale like "medically necessary" or "patient prefers compounded" is insufficient
• Did NOT specifically address vitamin additions or non-standard dosing

The September 2025 FDA warning letters targeted companies making prohibited claims—like calling compounded semaglutide "as effective as Ozempic"—but not the practice of compounding with added ingredients.

As one legal analyst put it: "We have not seen evidence publicly that the FDA is taking action specifically against the practice of compounding GLP-1 products that are no longer in shortage as products that are 'essentially a copy.'"

Who's Still Compounding (And How)

Several major telehealth companies continue offering compounded GLP-1s post-shortage. Here's what they're doing:

Hims & Hers: Offers "personalized" compounded semaglutide with added B12. Emphasizes customization for individual patients. Received FDA warning letter in September 2025 for marketing claims, but continues compounding.

Noom: Partnered with compounding pharmacies for GLP-1 offerings with modified formulations. Positions as "personalized" weight loss treatment.

Mochi Health: Continues compounded tirzepatide with niacinamide additions. Active in the space despite regulatory uncertainty.

Ro: Offers both brand-name (through LillyDirect/Wegovy pill) and compounded options, giving patients choice.

Meanwhile, some smaller telehealth companies shut down their compounded GLP-1 programs entirely after the shortage ended, deciding the legal risk wasn't worth it.

The Legal Risks

Let's be clear about what could happen:

For Compounders:

• FDA warning letters and enforcement actions
• State pharmacy board investigations
• Lawsuits from Novo Nordisk and Eli Lilly (already happening)
• Loss of licensure

For Patients:

• Potential supply disruption if your provider is shut down
• No legal liability for using a legal prescription
• Quality uncertainty (compounded drugs aren't FDA-tested)
• No clear recourse if something goes wrong

The lawsuits are real. Novo Nordisk sued 12 compounding pharmacies in August 2025. Eli Lilly has filed multiple cases against compounders, including a major suit against Empower Pharmacy. These aren't just threats—they're active litigation.

What Should You Do?

If you're currently using compounded GLP-1s, here's the practical advice:

1. Understand Your Risk Tolerance
Compounded GLP-1s work for many people. But you're operating in a legal gray zone. The product could become unavailable with little notice if your provider faces enforcement.

2. Have a Backup Plan
Know what you'd do if compounded GLP-1s become unavailable. With Wegovy pill at $149-299/month and LillyDirect vials at $299-449/month, brand-name options are more affordable than ever.

3. Ask About the Formulation
Is your compounded GLP-1 "pure" semaglutide/tirzepatide, or does it have added ingredients? If it's pure and at a standard dose, it's potentially more vulnerable to "essentially a copy" arguments.

4. Document Your Medical Need
If you genuinely benefit from a non-standard dose or added ingredient, make sure your prescriber documents that rationale. "Patient prefers cheaper option" isn't a valid clinical reason.

5. Stay Informed
The regulatory landscape is changing fast. FDA enforcement priorities could shift. Court decisions in pending lawsuits could clarify the rules.

The Bottom Line

The "personalization loophole" is real, and it's keeping the compounded GLP-1 market alive post-shortage. Companies are adding vitamins, offering non-standard doses, and arguing their products aren't "essentially copies" of FDA-approved drugs.

Is it legal? Probably, for now—if done correctly with genuine clinical rationale. The FDA hasn't specifically cracked down on vitamin-added formulations or non-standard dosing.

Will it last? Unknown. The FDA could change its enforcement priorities. Manufacturer lawsuits could succeed. State pharmacy boards could intervene.

The safest prediction: brand-name GLP-1s will continue getting cheaper (Wegovy pill, LillyDirect, retail programs), gradually eroding the value proposition of compounded alternatives. The loophole may close not through enforcement, but through market economics.

Until then, compounded GLP-1s remain available—but anyone using them should do so with eyes open about the regulatory uncertainty involved.