What changed in 2025–2026
When semaglutide (Wegovy, Ozempic) and tirzepatide (Mounjaro, Zepbound) were on the FDA shortage list, compounding pharmacies could legally produce non-brand versions to fill the gap. As of late 2024–early 2025, both drugs were removed from the shortage list — meaning 503A and 503B pharmacies can no longer produce them in standard quantities unless prescribed for specific clinical reasons (allergy, dose customization, etc.) that the brand-name drug can't address.
This shift collapsed the consumer-direct GLP-1 market overnight. Many brands that built on the shortage-list compounding path saw their pharmacy partners stop production and their payment processors terminate.
What's still legal
Compounded GLP-1s remain legal under specific circumstances:
- Clinical justification — patient-specific reasons documented by a licensed prescriber
- Telemedicine + prescription on file — the brand operates as a telehealth platform, not a direct-to-consumer drug retailer
- 503A or 503B pharmacy chain of custody — fully documented, with state licensure on file
- FDA-safe marketing — no claims that the compounded drug is equivalent to the FDA-approved version, no comparison-by-name to Ozempic/Wegovy/Mounjaro
What acquirers require
For payment processing on GLP-1 brands, our underwriting requires:
- Telemedicine platform integration with prescription records auditable
- 503A or 503B pharmacy partnership documented in writing
- State pharmacy licensure for the compounding partner, current
- Product copy review for FDA-flagged language (no human-use claims on RUO products, no comparative GLP-1 claims by name)
- Per-batch CoA from an independent lab, displayed on product pages
Without these, no compliant U.S. acquirer will board the merchant.
What PeptideRails will and won't board
We will board telemed-backed GLP-1 brands with proper 503A/503B chain of custody and FDA-safe marketing. We will not board direct-to-consumer GLP-1 sellers without a telemedicine layer, RUO-only sellers making human-use claims, or brands using compound names that obscure the actual compounder.