FDA has declared the shortage has ended and should outlaw compounded versions, they insist
of ConsumerAffairsA 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, theObesity Action Coalition (OAC)andThe Obesity Society (TOS) along with major organizations including theAlliance for Womens Health & Prevention, theAssociation of Black Cardiologists, and theNational Hispanic Medical Association urged the FDA to stop compounding pharmacies and outsourcing facilities from continuing to produce unapproved versions of GLP-1 medications such astirzepatide (Zepbound)andsemaglutide (Wegovy/Ozempic).
GLP-1 medications have made a transformative impact in the obesity care space, saidJoseph 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 thatEli Lillys tirzepatideandNovo Nordisks semaglutideare 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, saidAnthony 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 posesserious safety risksto patients. They called on the FDA to:
- Enforce existing regulationsand end unauthorized compounding.
- Monitor complianceduring and after the transition period.
- Educate providers and patientsabout the importance of using FDA-approved drugs.
- Combat misinformationfrom 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 aboutunregulated compounding practices, which can lead to inconsistencies in dosage, contamination risks, and misleading marketing. The coalition emphasized that regulatory clarity is essential toprotect patientsand upholdtrust in the healthcare systemas GLP-1 medications become more widely used for chronic disease management.
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Posted: 2025-03-21 21:03:50
