Compounded GLP-1 processing in a post-shortage regulatory landscape.
Telehealth clinics and 503A pharmacy retailers compounding semaglutide and tirzepatide need processors that track FDA policy, not just card-brand rules.
The compounded GLP-1 landscape changed materially in 2025-2026. FDA resolved the tirzepatide shortage in December 2024 and the semaglutide shortage in February 2025, removing both from the FDA shortage list. On April 30, 2026, FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, finding no clinical need for outsourcing facility compounding from bulk substances absent a shortage. The 503A pharmacy framework remains intact: 503A facilities can compound with active ingredients found in FDA-approved drug products, subject to various requirements. We process for telehealth clinics and 503A pharmacies that operate within those rules.
503A pharmacies remain permitted to compound semaglutide and tirzepatide using active ingredients found in FDA-approved drug products, subject to standard 503A requirements (patient-specific prescriptions, USP standards, state board oversight). 503B outsourcing facilities lost bulk-substance authorization for these molecules under FDA's April 30, 2026 proposal because the shortages resolved. The proposal was open for public comment through June 29, 2026. Your compliance posture depends on which framework your supply runs through.
Medical-adjacent disputes are won with strong intake-form documentation, clear consent language, prescriber records, and shipment proof. We build evidence packages around what the customer agreed to at signup, which is the strongest defense against efficacy or side-effect chargebacks. Education industry chargeback rates run 1.02% on average; medical-adjacent runs lower with proper documentation.
Telehealth practice rules vary widely by state. Your clinical operations team handles licensure and compounding-pharmacy partnerships; we handle payments. We configure address screening at checkout if specific states have shipping or service restrictions for your products.