Clinicians and patients should avoid using compounded GLP-1 products that are not FDA-approved, the American Diabetes Association wrote in a guidance statement published Dec. 2 in Diabetes Care.
The association cited uncertainty over the content of the compounded medications, as well as their safety, quality and effectiveness.
"Compounded products are not FDA-approved and do not undergo FDA review for safety, quality or effectiveness standards. As a result, these products may present elevated risks to individuals," the ADA wrote in its guidance.
If a medication is unavailable, the ADA recommends switching to a different FDA-approved drug to support patients' glucose-lowering, weight management, and cardiovascular or kidney risk reduction goals. Clinicians should reassess the appropriateness of resuming the original FDA-approved medication once it becomes available again.
To help alleviate shortages of brand-name GLP-1s, the FDA temporarily authorized compounding pharmacies to produce low-cost versions of the medications. While some drugs, such as Mounjaro and Zepbound, have been removed from the FDA's shortage list, the agency continues to permit compounded versions as it reevaluates their necessity in light of ongoing litigation with a compounding trade group.
Brand-name drugmakers Novo Nordisk and Eli Lilly have raised concerns about the quality and safety of compounded GLP-1s, arguing that the medications are too complex to safely compound. Compounding pharmacies have stood by the quality of their medications and contend that brand-name supplies remain insufficient to meet patients' demands.
View the full guidance statement here.