Comment from Bailey Elizabeth

I am writing to support FDA’s proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. Patient safety should remain the highest priority when evaluating medications that affect millions of Americans. I appreciate FDA’s determination that there is no clinical need for outsourcing facilities to compound these GLP-1 medications from bulk substances. Patients deserve medications that meet rigorous standards for safety, quality, consistency, and transparency. FDA-approved GLP-1 therapies undergo review and oversight so patients and healthcare providers can have confidence in the products they use. Communities that already face healthcare inequities should not be disproportionately exposed to products that may lack the same level of regulatory review, manufacturing oversight, and quality assurance as FDA-approved medications. I encourage FDA to finalize this proposal and continue prioritizing patient safety, transparency, and accountability in the GLP-1 marketplace. Thank you for considering my comment.