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Compounded preparations are not FDA-approved finished products

Suhrs, H

Common examples include: Ozempic: FDA-approved for type 2 diabetes but sometimes prescribed off-label for weight loss

The distinction between research peptides and pharmaceutical-grade compounds becomes relevant here, as semaglutide has extensive FDA-approved clinical trial data behind it while sermorelin operates primarily in the compounding pharmacy space for adult applications

Lower concentrations would push injection volumes uncomfortably high