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During the shortage, sections 503A and 503B allowed pharmacies to compound copies of a drug in shortage. That was the legal basis for the entire compounded GLP-1 industry. FDA resolved the semaglutide shortage on 21 February 2025, and tirzepatide in October 2024.
Once a shortage resolves, the exemption goes with it, and the FD and C Act's prohibition on compounding drugs that are "essentially a copy" of an available commercial product applies again. On 30 April 2026 FDA moved to bar semaglutide, tirzepatide and liraglutide from the 503B bulks list entirely.
Operations still selling compounded semaglutide are working against an active and well documented enforcement position. That is a risk to them, but it is also a risk to you: if the supplier is shut down mid-course, your supply stops without notice and you have no recourse.
Patient-specific compounding remains possible where a prescriber documents a genuine clinical need the commercial product cannot meet, such as a documented allergy to an excipient. That is a narrow, individually documented circumstance. It is not a catalog product and it is not a workaround.
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Regulatory status current as of the page date. This area is changing quickly and this page is reviewed monthly. [set review reminder]