Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The compounded semaglutide and tirzepatide products displayed on your website identify “Ready Med” or “Ready Med Medical Weight Loss Center” on the pictured label, suggesting Ready Med is the compounder of those drugs when in fact it is not.
Passage 2The following claims concerning compounded semaglutide and tirzepatide products appear on your website: - “The same active ingredient in Mounjaro® and Zepbound™” - “The same active ingredient in Ozempic® and Rybelsus®” Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.1(h)(2)
- 21 CFR 201.1(a)