What Are Compounded GLP-1 Medications?
Understand the growing demand for compounded GLP-1 injections in the U.S., their legal status, safety concerns, and how they compare to brand-name weight loss and diabetes drugs.
GLP-1 receptor agonists, such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro), have become highly sought-after in the U.S. for treating type 2 diabetes and obesity. Due to national shortages and rising costs, some patients are turning to compounding pharmacies for more accessible alternatives.
Compounding GLP-1 medication injections refers to the process of custom-formulating injectable versions of these drugs, typically in 503A or 503B pharmacies, to meet patient-specific needs.
Why Are Compounded GLP-1 Injections Gaining Popularity?
High demand and supply shortages of branded Ozempic and Wegovy
Lower cost than commercial products
Flexibility in dosage formulation
Access for patients who cannot afford or obtain FDA-approved versions
Are Compounded GLP-1 Injections Legal?
Yes, under certain conditions. In the U.S., compounding pharmacies are permitted to preparecustom GLP-1 medications only if:
The commercial drug is on the FDA’s shortage list
The pharmacy follows state and federal compounding regulations
The medication is prescribed by a licensed healthcare provider for an individual patient
However, these formulations are not FDA-approved, and patients must weigh the risks of using non-standardized drug sources.
What Are the Risks?
Inconsistent dosing or strength variations
Potential for contamination if not made under sterile conditions
Lack of long-term clinical testing compared to brand-name drugs
Limited regulation compared to commercial pharmaceutical manufacturers
Patients should only use state-licensed, accredited compounding pharmacies and verify proper sterility and sourcing of active ingredients.
How Do Costs Compare?
Branded semaglutide or tirzepatide: $900–$1,300/month (without insurance)
Compounded versions: $250–$500/month on average
Pricing varies by pharmacy, formulation, and location.
What to Ask Before Using Compounded GLP-1 Injections
Is the compounding pharmacy PCAB-accredited?
Do they follow USP 797 sterile compounding standards?
Can they provide batch testing and ingredient sourcing transparency?
Does your healthcare provider support the use of compounded alternatives?