GLP-1 Access, Safety, and the Road Ahead: What Advocates Need to Know

Sponsored by Eli Lilly and Company

At Lilly, we know healthcare providers are looking to us to deliver real medicine—medicine that has been rigorously trialed and tested and that has been manufactured in accordance with the highest standards for safety and quality.

Last year, the FDA declared that FDA-approved tirzepatide medicines were fully available to meet patient needs. A federal court upheld FDA’s decision and made clear that compounders “must cease production” of compounded tirzepatide knockoffs. However, some compounders continue to mass advertise, manufacture and sell compounded tirzepatide and semaglutide. This poses serious risks to patient safety.

Compounded products are never FDA-approved, which is why FDA cautions that compounded products “pose a higher risk” than FDA-approved medicines because they “do not undergo FDA review for safety, effectiveness or quality before they are marketed.” These risks are real. For example, late last year, FDA warned the public not to use tirzepatide products from a compounder that “used non-sterile ingredients” and “took no steps to sterilize them.”

In March 2025, FDA warned a tirzepatide mass compounder for violating federal law by producing drugs in unsanitary conditions and using active ingredients from an unregistered entity. And in April 2025, FDA warned another mass compounder for “[r]epeated failures,” and “serious deficiencies in [its] practices for producing drug products intended or expected to be sterile, which put patients at risk.” A month later, that same entity recalled over 8,000 vials of injectable compounded products due to concerns about their sterility. These problems underscore the significant risks that continued mass compounding poses to patient safety and the broader healthcare system and should alarm patients, physicians and regulators alike.

Critically, none of this should be happening. While we understand that some people turned to compounded products when FDA-approved tirzepatide medicines were in short supply, the shortage is over. We call upon healthcare providers to educate patients about the risks of compounded knockoffs—including those currently being marketed as “custom” or “personalized.” As the Obesity Action Coalition put it, “using a compounded medication is like playing a guessing game with your health. You don’t know what you’re getting, and if something goes wrong, it’s hard to know why.”

We also applaud OMA for its continued advocacy in helping expand access to FDA-approved medicines. Lilly remains committed to working with all stakeholders to help improve access to real, proven treatments.