If You’re Using a Compounded Version of Semaglutide, Here’s What You Need to Know
Over the past few years, medications like Ozempic and Wegovy—which contain semaglutide—have become popular tools in the fight against obesity and type 2 diabetes. But with demand skyrocketing and brand-name prices often out of reach, many patients turned to compounded alternatives prepared by local pharmacies.
Now, the FDA has updated its guidelines, effectively limiting the compounding of these drugs. If you’ve been using a compounded version of semaglutide, these new rules may directly impact your treatment, access, and costs.
This article breaks down what’s changed, why it matters, and what your options may still be.
Why Were Compounded Weight Loss Medications So Popular?
Compounded medications are custom-made drugs prepared by licensed pharmacies when commercial versions aren’t available or suitable. Amid shortages of FDA-approved semaglutide and tirzepatide, compounding pharmacies stepped in—offering alternatives at a fraction of the cost.
For many uninsured or underinsured patients, compounded versions became the only affordable pathway to life-changing treatment. They helped bridge care gaps while manufacturers caught up with demand. Though not FDA-approved, their use was legally permitted during the national shortage.
What’s Changed: FDA Pulls the Plug on Compounded GLP-1s
In 2024, the FDA announced that shortages of semaglutide and tirzepatide are officially resolved. As a result, compounding pharmacies are no longer authorized to prepare these medications.
Key Dates:
- Semaglutide: Compounding must stop by May 2025, or sooner if removed from the FDA shortage list earlier.
- Tirzepatide: Subject to the same enforcement timeline.
Without an official shortage, compounded semaglutide and tirzepatide are now considered limited new drugs.
Why Did the FDA Make This Decision?
The decision is rooted in patient safety. The FDA received multiple reports of impurities, inconsistent dosages, and the use of non-pharmaceutical grade ingredients, including forms like semaglutide sodium that are not approved for human use (Kuehn, 2023).
To protect patients from substandard treatments, the agency is enforcing its long-standing position: FDA-approved medications should be used whenever available, unless a medical provider documents a specific, individualized need.
What This Means for You as a Patient
If you’ve been paying cash for a compounded version of Ozempic or Wegovy, these changes could make your treatment harder to access or much more expensive. Insurance coverage for brand-name GLP-1s is often limited or highly variable, leaving many patients without affordable options.
But one thing is clear: Do not stop your medication without talking to your doctor. Abrupt discontinuation can lead to serious health consequences, including weight rebound or blood sugar spikes.
What We’re Doing at Hikma Health Clinic
At Hikma Health Clinic, we’re committed to making sure you’re not left behind.
In response to these changes, we’ve:
- Partnered with a pharmacy that offers a modified semaglutide formulation compliant with current regulations.
- Negotiated discounted pricing on branded medications to support patients without insurance coverage.
- Created a transition support team to help you navigate manufacturer programs, find coverage, or explore other safe alternatives.
This is a limited-time option while long-term solutions are developed, and we’re doing everything possible to protect continuity of care.
Final Thoughts: Stay Informed and Supported
The regulatory landscape around weight loss medications is shifting fast. At Hikma, we’re here to guide you through it—one step at a time. Whether you’re concerned about access, affordability, or safety, we’ll help you find the right path forward.
Don’t hesitate to reach out. Your health matters—and we’re here to support you every step of the way.
References
American Society of Health-System Pharmacists. (2024). ASHP Drug Shortages Resource Center. https://www.ashp.org/Drug-Shortages
Centers for Disease Control and Prevention. (2022). Obesity and Overweight. https://www.cdc.gov/obesity/data/adult.html
Kuehn, B. M. (2023). FDA warns about compounded semaglutide. JAMA, 330(1), 11–12. https://doi.org/10.1001/jama.2023.11362
Taylor, N. P. (2024). FDA cracks down on compounded semaglutide and tirzepatide. Fierce Pharma. https://www.fiercepharma.com/regulatory/fda-cracks-down-compounded-semuglutide-tirzepatide
U.S. Food and Drug Administration. (2023). Compounding and the FDA: Questions and Answers. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
U.S. Food and Drug Administration. (2024). FDA Drug Shortages: Current and Resolved Drug Shortages and Discontinuations Reported to FDA. https://www.fda.gov/drugs/drug-shortages
