Comment from Baynes Annette
AnonymousSupportIndividual
Summary: Ms. Annette Baynes supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. She argues that compounding these GLP-1 drugs from bulk substances poses significant patient safety risks and lacks the safety requirements of FDA-approved medicines.
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act,
I am writing in support of the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list.
The compounding of GLP-1 drugs from bulk substances is not a patient safety solution — it is a patient safety risk. Studies have found higher rates of adverse events, including hospitalizations, associated with compounded GLP-1s compared to FDA-approved versions. Recalls have affected tens of thousands of units. And unlike FDA-approved medicines, compounded products carry no requirement to demonstrate safety or effectiveness through clinical trials.
I support this proposed finding because patients should not be exposed to preventable harm. I urge the FDA to finalize the rule and protect patients who are simply trying to manage their health.
Sincerely,
Ms. Annette Baynes