Time to crack down on compounded GLP-1 drugs, health groups say

A coalition of over 20 leading health organizations is calling on the U.S. Food & Drug Administration (FDA) to enforce federal regulations on compounded weight-loss and diabetes medications now that the nationwide shortage of GLP-1 drugs has officially ended.

In a joint letter sent today, the Obesity Action Coalition (OAC) and The Obesity Society (TOS) — along with major organizations including the Alliance for Women’s Health & Prevention, the Association of Black Cardiologists, and the National Hispanic Medical Association — urged the FDA to stop compounding pharmacies and outsourcing facilities from continuing to produce unapproved versions of GLP-1 medications such as tirzepatide (Zepbound) and semaglutide (Wegovy/Ozempic).

“GLP-1 medications have made a transformative impact in the obesity care space,” said Joseph Nadglowski, President and CEO of the OAC. “As these medicines continue to grow in popularity, regulatory action and enforcement is critically needed to ensure patients have access to safe, FDA-approved treatments.”

The letter follows recent announcements from the FDA confirming that Eli Lilly’s tirzepatide and Novo Nordisk’s semaglutide are no longer in shortage. As a result, compounders must now cease production of these medications under federal law — which only allows compounding in limited circumstances, such as during drug shortages or when a specific patient need cannot be met by an FDA-approved drug.

Deadlines set

The FDA has set firm deadlines for winding down compounding operations:

• March 19: Outsourcing facilities must stop making versions of tirzepatide.
• April 22: Pharmacies must stop compounding semaglutide.
• May 22: Larger outsourcing facilities must stop semaglutide compounding, or earlier if a federal court ruling is issued.

“Now that the GLP-1 shortage is resolved, FDA faces a critical juncture in upholding its commitment to patient safety,” said Anthony Comuzzie, PhD, FTOS, CEO of TOS. “Our message is simple — FDA, the time is now to take decisive action.”

While acknowledging that compounding has a role under limited conditions, the signatories warn that ongoing mass production of these medications outside FDA oversight poses serious safety risks to patients. They called on the FDA to:

• Enforce existing regulations and end unauthorized compounding.
• Monitor compliance during and after the transition period.
• Educate providers and patients about the importance of using FDA-approved drugs.
• Combat misinformation from companies promoting unregulated compounded drugs.

The letter was co-signed by a wide range of organizations representing patients, healthcare providers, minority health advocates, and chronic disease groups.

This action comes amid growing concern about unregulated compounding practices, which can lead to inconsistencies in dosage, contamination risks, and misleading marketing. The coalition emphasized that regulatory clarity is essential to protect patients and uphold trust in the healthcare system as GLP-1 medications become more widely used for chronic disease management.