FDA Letter regarding Retatrutide

The FDA has issued a letter to the Federation of State Medical Boards regarding compounded drug products containing retatrutide, which are being promoted for the treatment of chronic weight management, diabetes, and related conditions. The FDA clarifies that compounded retatrutide products do not currently meet the requirements for exemptions under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These exemptions would allow compounded drugs to bypass certain FDA requirements, such as premarket approval and labeling with adequate directions for use.  

The FDA emphasizes that retatrutide is not the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, is not a component of an FDA-approved drug product, and does not appear on the 503A Bulks List or the 503B Bulks List, nor does it appear on FDA's drug shortage list.  

Additionally, the FDA has warned against unapproved products containing retatrutide that are being sold directly to consumers, often with false labeling and dosing instructions, and advises healthcare providers to discuss the potential harm of these products with their patients.

The FDA recommends that consumers not purchase unapproved products containing retatrutide and they encourage health care providers to discuss the risks of unapproved compounded products with their patients.