Compounded semaglutide and tirzepatide – alternatives to brand-name medications like Ozempic, Wegovy, Mounjaro, and Zepbound – are still accessible despite increased regulation. While these custom-made drugs can be cheaper, they carry significant risks due to a lack of FDA oversight.
Why Compounding Exists (and Why It Matters)
Compounding pharmacies create custom medications when FDA-approved options don’t meet a patient’s needs: allergies to inactive ingredients, non-standard dosages, or temporary shortages. These services are legal and fill a vital role in healthcare. However, mass production and marketing of compounded drugs raise concerns about safety and legality.
The Risks of Unregulated Formulations
Compounded drugs don’t undergo the same rigorous testing as FDA-approved medications. Quality, consistency, and safety can vary widely. Some research suggests higher risks of adverse effects like diarrhea, gallbladder inflammation, and even suicidal ideation.
Clinicians are divided on prescribing compounded GLP-1s. Experts warn that limited oversight may expose patients to unnecessary dangers. “I’m very clear in telling my patients to not get compounded versions,” says Dr. Juliana Simonetti of the University of Utah. “I feel their pain and desperation, but I’m telling them not to do it because these are dangerous practices.”
Dosing Errors and Unknown Ingredients
FDA-approved medications have standardized amounts and clear labeling. Compounded versions may vary in concentration or be mixed with other ingredients without proper disclosure. Dosage miscalculations are common, especially since patients often draw medication from vials with syringes, increasing the risk of underdosing, overdosing, or inconsistent treatment.
Some compounding operations use unapproved “salt forms” of semaglutide, such as semaglutide sodium or acetate. The FDA states that these contain different active ingredients and have no lawful basis for use in compounding.
Counterfeit Drugs and Illegal Markets
An illegal market for experimental weight loss drugs, like retatrutide and cagrilintide, is growing. These drugs are still in clinical trials and not FDA-approved. Their safety profiles, effective dosages, and long-term effects remain unknown.
Fraudulent online suppliers sell counterfeit medications, some containing inaccurate concentrations or even toxic contaminants. One study found that some websites demanded more money after taking orders without delivering any product.
Mitigating Risks: What Can You Do?
If you choose to use compounded GLP-1 drugs, consider these steps:
- Check the FDA’s list of registered compounding pharmacies.
- Use pharmacies recommended by your doctor.
- Inquire about quality programs and sterility certificates.
- Ask for the exact milligrams of active ingredients per dose.
The Bottom Line
Compounded GLP-1 drugs offer a cheaper alternative to brand-name medications, but lack strict FDA oversight. Risks include dosing errors, contamination, and the potential for fraudulent products. Consult your healthcare provider and use only licensed compounding pharmacies to minimize these dangers.
