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In a major move that could send shockwaves through the aesthetics and weight loss industry, Eli Lilly has just filed lawsuits against two major compounding pharmacies—Empower Pharmacy and Strive Pharmacy—for selling unapproved versions of tirzepatide, the active ingredient in its blockbuster weight loss and diabetes drugs, Mounjaro and Zepbound.

Why this matters? Because Empower is one of the most widely used compounding pharmacies in the medspa world. If your practice has been offering compounded tirzepatide or even listing it on your website, it’s time to hit pause—like, yesterday.

What’s Happening

  • Eli Lilly filed lawsuits on March 26 in federal courts (New Jersey and Delaware), alleging that Empower and Strive are producing unauthorized, potentially unsafe versions of tirzepatide.

  • These compounded versions were being sold with added vitamins like B3, B12, and glycine, and marketed using Lilly’s own clinical research—a big no-no in Big Pharma land.

  • Lilly says the claims suggest these unapproved knockoffs are safer or more effective than FDA-approved medications, which could mislead patients and providers alike.

Does Adding Vitamin B to Tirzepatide Formulations Make Them FDA-Compliant?

Legal Crackdown: What Changed?

Previously, compounders could produce drugs like semaglutide and tirzepatide under a special allowance only while there was an official FDA-declared shortage. But…

  • A U.S. federal judge ruled last month that mass compounding of these drugs must cease, putting a full stop to what had become a booming gray-market business.

  • Lilly is now rolling out cease and desist letters to at least 50 compounders and telehealth companies—a massive legal push that signals the company is no longer tolerating off-label production.

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Medspa Owners: What You Should Do NOW

Let’s be blunt: this isn’t just a “wait and see” situation.

If your medspa is offering compounded tirzepatide or semaglutide (yep, Novo Nordisk is on the warpath too), or even mentioning them on your website, here’s your urgent to-do list:

Audit your website today. Remove any mentions of semaglutide or tirzepatide if you’re not offering the FDA-approved versions.

  • Check your vendors. If you’ve been sourcing from Empower or Strive, it’s time to hit the brakes.
  • Update your staff. Make sure everyone is aware of the potential risks and legal implications.
  • Watch your inbox. Cease and desist letters may be flying fast—and yes, they do count as a warning shot.

‼️ Lilly has already sued more than two dozen medical spas, wellness centers and compounding pharmacies for selling products claiming to contain tirzepatide.

This case is likely just the beginning of a larger regulatory sweep. If you’ve been riding the compounded peptide wave, now’s the time to reassess your strategy and tighten up compliance before the FDA or Big Pharma comes knocking.

We will keep you posted on what this means for GLP-1s and weight loss offerings in the medspa space as more details unfold.