Insights
Field notes from a Texas life sciences insurance practice.
503B Hospital Purchase Contract Insurance: The 2026 Field Guide
Hospital purchase contracts and GPO supplier agreements with 503B outsourcing facilities have converged on a specific insurance schedule structure - products liability tower, named additional insured wording, primary/non-contributory, waiver of subrogation, 30-day notice, FDA recall extension. Here's what each clause means, how the major GPO schedules differ, the five most common gaps that lock 503Bs out of credentialing, and how to read a schedule before signing.
USP 797 / USP 800 Compliance and Compounding Pharmacy Insurance: A 2026 Guide
How USP 797 and USP 800 compliance affects compounding pharmacy underwriting, what the 2023 USP 797 revision changed, and an inspection-readiness checklist.
The 2026 GLP-1 Compounding Insurance Crisis: What FDA Enforcement Did to Coverage and How to Re-Paper
March 2026 FDA enforcement against large-scale GLP-1 compounders ended the shortage-list safe harbor and triggered carrier exclusions across the specialty pharmacy market. Here's the coverage landscape and what to do.
Pharmaceutical and Medical Device Recall Insurance: Coverage Architecture, Cost, and What Sponsors Actually Require
The difference between recall expense extensions, contamination coverage, and standalone product recall policies. With benchmarks for limit selection and a summary of what carriers will write in 2025.
Products Liability Insurance for Pharmaceutical and Medical Device Contract Manufacturers: A Buyer's Guide
How premium is calculated, how limits should be selected, what carriers actually underwrite this segment in 2025, and the four endorsements that matter most for a CDMO.
The Pharma MSA Insurance Requirements Guide: Translating Sponsor Contract Language into a Compliant Program
A clause-by-clause translation of the insurance section in a typical pharmaceutical sponsor MSA, with negotiability commentary and a compliance scorecard CDMOs can use before signing.