This client is a large not-for-profit health system operating its own central compounding pharmacy to serve patients across multiple hospitals and clinics. Facing heightened regulatory scrutiny, they needed to secure FDA 503B outsourcing facility registration and align operations with strict USP 797 and USP 800 standards for sterile and hazardous drug compounding. Without expert guidance, they risked compliance gaps, operational delays, and higher third-party outsourcing costs. Trinity’s regulatory and technical specialists were brought in to navigate the complex registration process and create a clear, achievable action plan.