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

When a pharmacy mixes IV fluids, chemotherapy drugs, or injectables, they’re doing something called sterile compounding, the process of preparing customized medications in a contamination-free environment. Also known as compounding sterile preparations, this isn’t just mixing powders with water—it’s a high-stakes medical procedure where one mistake can lead to infection, organ failure, or death. That’s why USP <797>, the official set of standards for sterile compounding in the United States exists. It’s not a suggestion. It’s the law in every hospital, clinic, and compounding pharmacy that handles injectables.

USP <797> covers everything from the air quality in the room where drugs are mixed, to the gloves pharmacists wear, to how often surfaces are cleaned. It defines what a cleanroom, a controlled environment with filtered air and strict entry protocols must look like. It tells you how often air samples must be taken, what kind of clothing counts as proper garb, and even how to properly disinfect IV bags before use. It also forces pharmacies to prove they can consistently produce sterile products—no guesswork allowed. This isn’t about paperwork. It’s about keeping patients alive. In 2012, a fungal meningitis outbreak linked to contaminated steroids killed 64 people and sickened over 750. That disaster happened because a compounding pharmacy ignored basic sterile practices. USP <797> was strengthened after that to make sure it never happens again.

What you’ll find in the posts below are real-world examples of how USP <797> affects daily pharmacy work. From how nurses check IV bags for particulates, to why some pharmacies refuse to compound certain drugs without proper certification, to how new tech like automated compounding devices help meet these standards—you’ll see how this rule isn’t just a checklist. It’s the backbone of safe medication delivery. Whether you’re a pharmacist, nurse, or patient who’s ever received an injection, you’re directly impacted by what’s written in USP <797>. These articles don’t just explain the rules—they show you why they matter.