The semaglutide shortage ended in 2025, and compounded copies are generally no longer permitted. Here is the history, what went wrong during the shortage era, and what to do if you are still being offered compounded semaglutide.
By Dr. Teja V. Surapaneni, MD, MS • Board-Certified Internal Medicine • May 2026
Compounded semaglutide was a shortage-era workaround. The shortage is over. This article explains the history, why compounded copies are now generally not permitted, the safety problems FDA documented, and how to move to brand-name treatment.
Between 2022 and early 2025, semaglutide (Ozempic and Wegovy) was on the FDA drug shortage list. During a declared shortage, federal law lets licensed compounding pharmacies prepare copies of the shortage drug. That created a temporary legal pathway for compounded semaglutide.
That pathway has closed. FDA determined the semaglutide shortage was resolved, and its enforcement discretion ended on April 22, 2025 for 503A pharmacies and on May 22, 2025 for 503B outsourcing facilities. (The tirzepatide shortage also ended in 2025.) Compounded copies of semaglutide are now generally not permitted except for a documented, patient-specific clinical need — for example, a documented allergy to an inactive ingredient in the brand product. Lower price alone is not such a need.
503B facilities are FDA-registered, subject to FDA inspection, and held to Current Good Manufacturing Practice (cGMP) standards. During the shortage they could produce semaglutide in batches; that ended May 22, 2025.
503A pharmacies compound per individual patient prescription under state pharmacy board oversight. They serve an important role for patients who need a customized preparation, but they may not make copies of a commercially available drug like semaglutide except in narrow, documented patient-specific circumstances.
FDA received adverse event reports linked to compounded semaglutide, including dosing errors — some involving concentration confusion and up to 10-fold overdoses — hospitalizations for severe nausea and vomiting, and products labeled with salt forms such as “semaglutide acetate” that differ from the approved drug. Brand-name products avoid these problems: they are made under FDA-approved manufacturing, in fixed-dose pens or tablets, with the formulation studied in clinical trials.
Do not simply stop or switch on your own — doses of compounded products do not always map neatly onto brand-name doses. Talk with a physician about moving to an FDA-approved medication at an appropriate starting dose. Brand-name GLP-1s for weight management are Wegovy® (semaglutide injection), the Wegovy® pill (oral semaglutide), Zepbound® (tirzepatide), and Foundayo™ (orforglipron). Ozempic® and Mounjaro® are FDA-approved for type 2 diabetes, not weight loss.
YourMD does not prescribe compounded semaglutide, compounded tirzepatide, or any compounded GLP-1 — never flex-dose or micro-dosed versions. We prescribe brand-name, FDA-approved medications only, through NovoCare® (Novo Nordisk) or LillyDirect™ (Lilly), which bill you for the medication directly (or through your insurance). The YourMD GLP-1 Essential plan is $79/month and GLP-1 Concierge is $149/month (adds prior-authorization support, labs coordination, and priority scheduling). YourMD does not ship GLP-1s or include injection supplies or shipping.
Our prescribing physicians are board-certified MDs. Every prescription is reviewed by a physician, not generated algorithmically.
Compounded semaglutide was a shortage-era workaround. The shortage is over, compounded copies are generally no longer permitted except for a documented, patient-specific clinical need, and a compounded copy is never an FDA-approved drug. YourMD prescribes only FDA-approved brand-name products.
This article is for informational purposes only and does not constitute medical advice. Always consult with a licensed physician before starting any medication.
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