Ozempic injection pen. Credit: Wild Awake/Adobe Stock
The American Diabetes Association has issued a guidance statement that cautions against using compounded versions of popular GLP-1 diabetes and weight-loss drugs such as Wegovy and Zepbound. Compounders have added extra ingredients such as vitamins B12 and B6, or have used salt forms of the active prescribing ingredients, leading to dosing errors and adverse events, according to the organization.
“We urge health care professionals to consider this guidance statement due to concerns around the safety, quality and effectiveness of compounded versions of these products,” said Joshua Neumiller, president-elect of the association and coauthor of the statement, according to BioPharma Dive.
Recommended For You
GLP-1 drugs have been shown to be effective at controlling weight, and further testing has shown other notable health benefits, such as reducing heart risk for Wegovy and helping control sleep apnea for Zepbound. Demand has soared as a result, leading to periodic short supply over the past two years as manufacturers have struggled to make enough doses.
To help alleviate shortages of brand-name GLP-1s, the FDA temporarily authorized compounding pharmacies to produce low-cost versions of the medications. Although 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.
"Compounded products are not FDA-approved and do not undergo FDA review for safety, quality or effectiveness standards,” the statement said. “As a result, these products may present elevated risks to individuals.”
If a medication is unavailable, the association 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 after it becomes available again.
“Although compounded medications play a critical role in the health care system, there are numerous concerns regarding the availability and use of non-FDA-approved versions of these products,” the statement concluded. “Regulatory authorities should continue prioritizing safety and enforcement of compounding standards to ensure safe and reliable options during critical drug shortages.”
© 2025 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
Alan Goforth
Alan Goforth is a freelance writer in suburban Kansas City. In addition to freelancing for several publications, he has written a dozen books about sports and other topics.
