Comment from The Alliance for Safe Biologic Medicines

The Alliance for Safe Biologic Medicines (ASBM) believes the FDA should exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, particularly given the growing evidence that current compounding practices are extending far beyond the limited role Congress intended. Traditional compounding exists to address rare situations in which a patient has a documented medical need that cannot be met by an FDA-approved drug. Increasingly, however, the GLP-1 compounding market appears driven not by individualized medical necessity, but by exploitation of the commercial demand for these therapies. Recent reports highlighting impurities and quality inconsistencies in certain compounded GLP-1 products illustrate why FDA oversight and manufacturing standards remain essential safeguards for patients.[1] FDA-approved GLP-1 therapies are manufactured under strict federal quality standards with extensive review of safety, efficacy, and production controls. Compounded versions do not undergo that same review process, yet many are now being distributed on a nationwide scale through online prescribing platforms and high-volume dispensing operations. As these products are distributed more broadly through commercial channels, there is a growing risk that patients may incorrectly assume they have undergone the same regulatory review and manufacturing oversight as FDA approved medicines. They have not—yet many compounders actively mislead patients by claiming that their untested products are FDA-approved. See attached file(s)