On February 21, 2025, the Food and Drug Administration (“FDA”) announced that semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy, is no longer on its drug shortage list. This decision signals the FDA’s assessment of an improvement in the national supply of the widely used diabetes and weight loss medication and comes amid increased demand over the past year.
In its latest update, the FDA clarified its policies regarding compounding practices now that the shortage of semaglutide has been deemed resolved. With the removal of semaglutide from the shortage list, at this moment, compounding pharmacies will no longer be permitted to produce and distribute compounded versions of the medication. unless they meet strict legal exemptions.
The FDA does not intend to take action against state-licensed pharmacies or physician compounding under section 503A of the FD&C Act within 60 calendar days from the FDA’s announcement until April 22, 2025. For outsourcing facilities under section 503B of the FD&C Act, the timeframe is until May 22, 2025.
Implications for Health Care Providers
- Return to FDA-Approved Medications: Providers who have relied on compounded semaglutide should prepare for a transition to prescribing FDA-approved Ozempic and Wegovy.
- Regulatory Compliance: With the shortage designation resolved, compounded versions of semaglutide will now be subject to increased scrutiny. Health care providers and pharmacies must ensure compliance with FDA regulations regarding compounded medications, including potentially updating patient consents.
- Patient Education: Patients who have been using compounded semaglutide should be informed about this change and the importance of accessing FDA-approved medications moving forward.
Background
Semaglutide, like tirzepatide (the active ingredient in Eli Lilly’s Mounjaro and Zepbound), faced significant supply constraints due to surging demand for its off-label use in weight loss treatments. During this period, many pharmacies turned to compounding as an alternative solution.
The FDA’s announcement follows a similar ruling regarding tirzepatide, which was removed from the shortage list in late 2023. Our previous articles, “Alert: Tirzepatide No Longer on FDA’s Drug Shortage List” and “Alert: Tirzepatide and Semaglutide Still on the Drug Shortage List”, provide additional context regarding these regulatory shifts.
The Future of Compounded Semaglutide
With this announcement by the FDA, health care providers should anticipate changes in the availability of compounded versions and adjust their prescribing practices accordingly. The FDA’s enforcement of its compounding policies will likely result in increased reliance on FDA-approved medications for treating diabetes and obesity.
Providers should continue monitoring regulatory updates and educating patients on the importance of obtaining semaglutide through approved pharmaceutical channels.
The removal of semaglutide from the FDA’s drug shortage list represents a significant shift in the regulatory landscape for compounded GLP-1 medications. Health care providers should ensure they remain compliant with FDA regulations and guide their patients through this transition. Clinics and pharmacies must be prepared for increased scrutiny surrounding compounded semaglutide and should counsel patients accordingly.
Contact ByrdAdatto for Medical Weight Loss Compliance
If you provide medical weight loss services at your practice it is important to stay informed about the evolving FDA guidance to maintain compliance and ensure patient safety. Contact ByrdAdatto to help understand how these changes may impact your practice.
