In October 2024 the FDA declared the tirzepatide shortage resolved, and in February 2025 it did the same for semaglutide. Once each drug was off the FDA Drug Shortages list, the statutory exemption that allowed 503A and 503B compounding pharmacies to produce copies of those FDA-approved drugs no longer applied. The result was an enforced wind-down of mass-compounded GLP-1 production through the first half of 2025, after which compounded semaglutide and tirzepatide for general weight management use became largely unavailable through licensed compounding pharmacies in the United States.
The legal mechanism that allowed compounding pharmacies to produce copies of brand-name GLP-1s was the FDA shortage list exemption under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. When the FDA removed semaglutide and tirzepatide from the shortage list in late 2024 and early 2025, that exemption ended. Compounding pharmacies that continued producing copies after the wind-down deadlines were subject to enforcement action.
FDA-approved drugs are produced by their manufacturer (Novo Nordisk for semaglutide, Eli Lilly for tirzepatide) under specific FDA-registered conditions. Compounding pharmacies under sections 503A (patient-specific compounding by traditional pharmacies) and 503B (outsourcing facilities producing larger volumes) are not generally allowed to produce copies of FDA-approved drugs. There is, however, an exception. When a drug is on the FDA Drug Shortages list, compounding pharmacies are permitted to produce essentially-equivalent versions to meet patient demand that the brand manufacturer cannot supply.
Both semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) went on the FDA shortage list in 2022 and 2023 due to demand from the weight management indication far exceeding manufacturing capacity. That listing opened the door for compounding pharmacies to produce semaglutide and tirzepatide injectables, often at much lower prices than the brand products. The compounded versions were sold through telehealth platforms, medical spas, and pharmacies nationwide.
The compounded supply met genuine demand. Brand-name pricing without insurance ran $1000 to $1300 per month. Compounded equivalents typically ran $200 to $500 per month. The supply chain ramped quickly between 2023 and 2024.
| Date | Event |
|---|---|
| March 2022 | FDA adds semaglutide to the Drug Shortages list as Ozempic demand outpaces supply. |
| December 2022 | FDA adds tirzepatide to the Drug Shortages list. |
| 2023-2024 | Mass expansion of telehealth platforms offering compounded semaglutide and tirzepatide. |
| October 2, 2024 | FDA declares the tirzepatide shortage resolved (initial declaration). |
| October 2024 | Outsourcing Facilities Association sues the FDA; the agency agrees to reconsider. |
| December 2024 | FDA reaffirms the tirzepatide shortage as resolved. |
| February 21, 2025 | FDA declares the semaglutide shortage resolved. |
| Spring 2025 | Statutory wind-down periods for 503A (60 days) and 503B (90 days) compounding of these drugs. |
| Summer 2025 onward | Compounded semaglutide and tirzepatide largely off the legal market via traditional 503A and 503B routes. |
The wind-down periods were the legally-mandated transition windows. 503A pharmacies had roughly 60 days from each "shortage resolved" declaration to stop compounding the drug. 503B outsourcing facilities had roughly 90 days. After those periods, continued compounding was treated as production of an unapproved new drug.
The legal change was clean. Before the resolution declarations, a 503A or 503B pharmacy could produce semaglutide or tirzepatide injectables and sell them to patients under the shortage exemption. After the wind-down deadlines, the same activity was an FDA enforcement matter. Several large compounding pharmacies and telehealth platforms announced wind-downs of their compounded GLP-1 product lines during the first half of 2025.
Some platforms pivoted to selling brand-name Wegovy and Zepbound directly via their telehealth channels. Others pivoted to "personalized" compounded GLP-1 formulations that combine semaglutide or tirzepatide with another active ingredient (such as a vitamin or a low-dose adjunct), which under specific conditions can fall under a different regulatory pathway. The FDA has indicated it will continue enforcement against compounded copies that are essentially identical to the brand drug.
A summary of what remained legal as of early 2026:
"Research use only" peptides sold by chemical suppliers are not authorized by the FDA for human administration. They are sold for laboratory work and are labeled as such. Many of the same compounds appear in this market regardless of whether they are FDA-approved, and the regulatory status of research-grade material is distinct from the regulatory status of compounded pharmacy product.
The factual landscape, as of this writing:
The compounded GLP-1 market that grew between 2022 and 2024 existed because semaglutide and tirzepatide were on the FDA Drug Shortages list. When the FDA declared the shortages resolved in late 2024 and early 2025, the statutory exemption for 503A and 503B compounding ended. Wind-down periods ran through the first half of 2025. As of 2026, compounded semaglutide and tirzepatide for general weight management use are largely off the legal compounding market. Brand-name versions, narrow patient-specific compounding, and research-only material remain available through their respective channels. The regulatory landscape is active and continues to change.
For background on dosing once a user has access to a product, see Tirzepatide titration schedule and How long does reconstituted semaglutide last in the fridge.
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