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    Welcome to HotPause Health!

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    *Content reviewed by HotPause Health medical advisor and Obesity and Family Medicine physician, Dr. Sejal Desai.

    The End of Compounded GLP-1s? What You Need to Know

    What Is a Compounded GLP-1?

    A compounded GLP-1 medication is a version of a drug like semaglutide (Ozempic/Wegovy) or tirzepatide (Mounjaro/Zepbound) that has been custom-mixed by a pharmacy rather than manufactured by the original pharmaceutical company. Compounded drugs are not FDA-approved and do not undergo the same safety, quality, and efficacy testing as the brand-name versions.

    Compounding pharmacies are legally allowed to make customized medications for patients who need a different formulation—such as an alternative dose or removing an allergen—or when a drug is in short supply. This is why compounded semaglutide and tirzepatide became widely available in the last few years: They were permitted during a national shortage of the FDA-approved versions.

    However, now that the shortage has ended, compounded versions of these medications must be discontinued—leading to major changes in how patients can access GLP-1 treatments moving forward.

    Why Are Some Compounded GLP-1s Being Phased Out?

    Until recently, compounded versions of GLP-1 medications were available because of a drug shortage. Under U.S. law, compounding pharmacies can legally make versions of FDA-approved medications only when there is a shortage or when a patient requires a customized formulation not commercially available.

    However, the FDA has now removed both tirzepatide and semaglutide from its drug shortage list:

    • Tirzepatide was removed in December 2024
    • Semaglutide was removed in February 2025

    With these changes, compounding pharmacies must stop producing standard compounded versions of these drugs on the following timelines:

    • Tirzepatide: No longer legally available as of March 19, 2025
    • Semaglutide: Will no longer be available from 503A pharmacies after April 22, 2025, and from 503B outsourcing facilities after May 22, 2025

    What Does This Mean for Patients Who Take Compounded GLP-1

    If you have been receiving compounded GLP-1 medications through a pharmacy, telehealth provider, or clinic, you may soon experience interrupted access to your prescription. Some providers have already begun discontinuing compounded GLP-1 prescriptions, while others are notifying patients about upcoming changes.

    If you are affected by this, it’s important to speak with your healthcare provider as soon as possible to discuss next steps.

    Why Is the FDA Restricting Some Compounded GLP-1s?

    The FDA and leading medical organizations have raised safety concerns about compounded and counterfeit GLP-1 medications. Unlike FDA-approved drugs, compounded medications do not go through the same rigorous testing for safety, effectiveness, or quality control.

    Some risks associated with non-FDA-approved versions of these medications include:

    • Variability in drug purity and potency
    • Differences in formulation (e.g., added ingredients that may alter effectiveness or safety)
    • Potential for contamination or improper dosing

    Multiple professional organizations, including The Obesity Society, the Obesity Action Coalition, and the Obesity Medicine Association, have issued statements urging caution around compounded versions of these medications.

    Can Compounded GLP-1s Still Be Prescribed?

    Some compounding pharmacies and telehealth providers have suggested they may continue offering “customized” formulations of these drugs, such as compounded semaglutide with added B12. However, FDA regulations require that any compounded drug must provide a clinically necessary difference from commercially available versions. It is unclear how the agency will handle these cases moving forward.

    What Are My Options If I’ve Been Taking Compounded GLP-1s?

    If you’ve been relying on compounded versions of semaglutide or tirzepatide, here’s what you can do:

    1. Talk to Your Prescriber: Your healthcare provider can discuss FDA-approved alternatives and help determine the best path forward for your weight management or diabetes treatment.
    2. Check Insurance Coverage: Some insurers are expanding coverage for FDA-approved weight loss medications, especially in light of their growing use for cardiovascular and metabolic health benefits.
    3. Explore Manufacturer Discount Programs: Both Novo Nordisk (Wegovy, Ozempic) and Eli Lilly (Zepbound, Mounjaro) have direct-pay programs that may reduce the monthly cost of these medications.
    4. Consider Other Weight Management Options: For those who cannot access or afford FDA-approved GLP-1s, other medically approved options—including older weight-loss medications, metabolic treatments, and lifestyle interventions—may be available.

    Bottom Line

    The era of compounded GLP-1s may be coming to an end, and if you’ve been taking one of these medications, now is the time to plan your next steps. While access to brand-name versions remains a challenge for some, there are legal, safe, and medically backed alternatives that can help support your health goals.

    As always, speak with your healthcare provider before making any changes to your medication or treatment plan.

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