GLP-1 Compounding Carrier Exclusion
What this clause says
Notwithstanding any other provision, this policy does not respond to any claim arising out of the compounding, dispensing, or distribution of any drug that is not approved by the FDA for the specific use, formulation, or route of administration in question, including without limitation compounded versions of FDA-approved branded products.
What this means in plain English
Following March 2026 FDA enforcement against large-scale GLP-1 compounding, several specialty carriers added exclusions for claims arising from compounded versions of FDA-approved branded drugs (semaglutide, tirzepatide).
What it means for a CDMO program
A pharmacy compounding GLP-1s under a policy with this exclusion has uninsured products liability for that revenue line. Re-papering with a carrier without the exclusion (or a manuscripted carve-back) is the only path to coverage — and underwriters are increasingly nervous. Read endorsement schedules carefully at every renewal.
Carrier notes
Markets willing to write GLP-1 compounding without exclusion are limited and pricing is moving fast. Expect quote validity windows of 7-14 days.
How this evaluates
The Decoder applies these rules in order; the first match wins.
- glp1 › compounded is set → Borderline: GLP-1 compounding active — verify the policy does not exclude non-FDA-approved drug claims.
See this in your MSA
Pre-loaded with this clause selected.
Run the Decoder