The End of the Shortage Loophole Reshaped the Compounded GLP-1 Market
Compounded semaglutide and tirzepatide were lawful only while the reference products sat on the FDA shortage list. Once resolved, that pathway closed, and enforcement shifted to telehealth marketers.
Section 503A permits compounding of a drug that is on the FDA shortage list. When semaglutide and tirzepatide shortages were formally resolved, the statutory basis for compounding copies disappeared, with limited wind-down periods.
Some sellers pivoted to 'peptide blends' or salt forms — semaglutide sodium, for example — which the FDA has stated are not the same active ingredient as the approved drug and are therefore not lawfully compoundable substitutes.
The result is a market where legitimate access runs through prescriptions for approved products, and the remaining supply channels carry both legal and product-quality risk.