For the past two years, as the demand for GLP-1 receptor agonists like Semaglutide and tirzepatide exploded, an alternative market quietly flourished. Amid widespread shortages of the brand-name drugs Ozempic, Wegovy, Mounjaro, and Zepbound, compounding pharmacies and telehealth startups stepped in to meet the need. They created their own versions of these medications—often at a fraction of the cost—and distributed them widely to patients desperate for access.
But as of May 2025, that workaround is officially over.
With brand manufacturers having resolved their supply chain issues, the FDA has rescinded its shortage declarations for both Semaglutide and tirzepatide. That means pharmacies and outsourcing facilities can no longer legally compound these drugs under the exemptions provided by federal law. In short, the grace period has ended, and enforcement is back.
This moment marks more than just a regulatory tightening it’s a turning point. It signals the FDA’s reassertion of its core principles: that pharmaceutical quality matters, that safety cannot be compromised, and that there are no shortcuts when it comes to patient care.
Over 500 adverse event reports have been linked to compounded versions of these drugs. Without standardized dosing, validated injection devices, or FDA oversight, patients were vulnerable to mislabeling, formulation errors, and unpredictable side effects. While the intentions behind compounded GLP-1s may have been rooted in access and affordability, the risks became too significant to ignore.
The return to an approved-only supply model is undoubtedly a win for safety—but it also reopens an uncomfortable conversation around cost. During the shortage, compounded versions of Semaglutide were being offered for $300 to $400 a month, compared to over $1,000 for branded drugs. Now that compounded versions are off the market, patients who can’t afford the brand-name price or whose insurance won’t cover it may find themselves without options.
Some companies are already pivoting. A few have moved toward prescribing liraglutide, a related but less effective drug that remains eligible for compounding. Others are exploring lower-dose regimens of Semaglutide that may comply with patent boundaries. But these alternatives often come with trade-offs: more frequent injections, reduced efficacy, and continued legal ambiguity.
For EMMA International and our clients, this is a critical moment to reassess strategy. It’s a call to return to fundamentals of quality systems, validated manufacturing processes, and data-driven labeling. It’s also an opportunity to innovate responsibly. As interest in GLP-1s continues to grow, from metabolic disorders to potential use in addiction or Alzheimer’s, there’s a chance for manufacturers to step up with next-generation formulations that balance efficacy, accessibility, and regulatory rigor.
More broadly, this crackdown reminds us of the delicate balance between innovation and compliance. Access alone cannot justify risk. And regulation, when guided by science and public health priorities, serves as the safeguard not the barrier to progress.
At EMMA International, we support companies navigating this shifting landscape whether through regulatory strategy, manufacturing design, or product development. The FDA’s message is clear: the era of makeshift solutions is over. Now is the time to build what’s next by the book and built to last.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more about how we can support your remediation efforts.
