HomeFAQsIs compounded semaglutide still legal?

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Is compounded semaglutide still legal?

Short answer

Personalized compounded semaglutide (different dose or added vitamin) remains legal through licensed 503A pharmacies. Large-scale identical-copy compounding ended when the FDA declared the shortage resolved in 2025.

Compounded semaglutide was widely accessible during the 2022-2025 FDA shortage. Under Section 503A of the FD&C Act, compounding pharmacies could prepare semaglutide for individual patients when the brand drug was on the shortage list.

Once the FDA declared the shortage resolved (May 2025 for semaglutide), federal rules tightened. 503A pharmacies may still compound semaglutide if the formulation differs meaningfully from the FDA-approved drug — e.g., a different concentration, bundled with vitamin B12, or sublingual/oral form — to meet a specific patient's clinical need.

Identical-copy compounding (replicating Wegovy's 2.4 mg/0.75 mL formulation at scale) is no longer permitted. Some compounding pharmacies have ceased GLP-1 work; others continue with personalized formulations. Telehealth providers using compounded semaglutide must disclose the compounder and formulation.

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