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Compounded GLP‑1s emerged during the 2022-2024 FDA shortage. The FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025, and is enforcing 503A/503B rules more strictly. Compounded supply is contracting.
503A compounding pharmacies make patient-specific formulations for individuals. 503B outsourcing facilities (FDA-registered) make standard formulations in larger volumes. Most telehealth-channel compounded GLP-1s come through 503A or 503B pharmacies operating under shortage exemptions. With shortages resolved, both pathways face increased regulatory pressure.
The FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025. 503A pharmacies can still compound for individual medical necessity (allergy, alternative dosing), but population-scale compounding is no longer protected by shortage exemption. Some telehealth providers are exiting compounded GLP-1 lines; others continue under narrower medical-necessity framings.
Compounded semaglutide and tirzepatide ranged $150-350/mo through telehealth providers during the shortage years. As supply normalizes and regulatory pressure rises, prices are converging toward $250-400/mo and some providers are exiting. The price advantage over LillyDirect ($349-499/mo) and NovoCare ($499/mo) is narrowing.
Editorial summary. Pricing and pipeline reflect public information at the date of last review. Manufacturer cash-pay channels, formulary status, and FDA labels change; confirm before relying on any single source.