Regulatory & compounding

Approved products, compounding, and quality control

Semaglutide is FDA-approved only as specific prescription products for specific indications; it is not an over-the-counter peptide. During the 2022 to 2025 shortage, compounded versions proliferated, and the FDA has flagged real quality and dosing concerns with them. That shortage was declared resolved in February 2025, and the permission to compound copies wound down over the following months.

This unit walks the approved-versus-compounded distinction and checks a common claim: that a compounded version is simply a cheaper copy of the approved product. Framing everything as clinician-supervised prescription use is the responsible stance.