Legal, safety, and practical considerations of compounded injectable semaglutide

Abstract

The use of long-acting incretin-based therapies, such as semaglutide, has increased in recent years due to their benefits for glycemic control in diabetes, cardiovascular risk reduction, and weight management. Ongoing drug shortages have led clinicians and patients to seek alternative routes for accessing these therapies, including the use of non-United States Food and Drug Administration (FDA)-approved compounded incretin-based therapy. This review paper describes the legal, safety, and practical considerations of compounded injectable semaglutide for diabetes and weight management. While this paper is specific to injectable semaglutide, the concepts described apply to all compounded injectable incretin-based therapies. While there is a general recommendation against the use of non–FDA-approved compounded incretin analogs, if clinicians elect to use compounded incretin-based therapy, the potential harms and benefits for each patient must be considered, and patients must be properly educated on the correct administration of the product they receive.