USP <797>: What It Means for Pharmacy Safety and Compounding Standards

When a pharmacy mixes a custom IV bag, eye drop, or chemotherapy dose, USP <797>, a set of enforceable standards for sterile compounding in pharmacies. Also known as United States Pharmacopeia Chapter <797>, it’s the rulebook that keeps dangerous contamination out of medications you receive. This isn’t optional—it’s the law in every hospital, clinic, and compounding pharmacy in the U.S. And it’s not just about clean rooms or gloves. USP <797> controls everything: how staff wash their hands, how air flows through the room, even how often surfaces are wiped down. A single mistake can lead to infection, organ failure, or death. That’s why it exists.

USP <797> doesn’t just apply to big hospitals. Even small outpatient clinics that mix insulin or pain meds must follow it. The standard breaks down compounding into three risk levels: low, medium, and high. Each level has different rules for air quality, testing, and staff training. For example, a low-risk mix like a simple saline flush needs basic handwashing and a clean surface. But a high-risk mix like a chemotherapy blend? That requires a certified cleanroom, HEPA filters, and daily environmental testing. The sterile compounding, the process of preparing medications without any live microbes has to be flawless. And it’s not just about the final product—pharmaceutical safety, the system of practices that prevent harm from medications depends on every step being tracked and documented. Pharmacies that skip even one check risk failing inspections, losing their license, or worse, hurting patients.

What you won’t see is the quiet work behind the scenes: staff training logs, air particle counts, glove integrity tests, and media fill simulations. These aren’t paperwork—they’re lifelines. USP <797> forces pharmacies to prove they can do it right, every single time. It’s why your IV bag doesn’t come with a warning label about infection risk. And it’s why compounding pharmacies that cut corners get shut down. The standard keeps things simple: if you’re touching a sterile product, you follow the rules. No exceptions. Below, you’ll find real-world examples of how USP <797> impacts everything from antibiotic prep to cancer treatment—and what happens when it’s ignored.