What is the difference between USP <797> and USP <800>? In simple terms, USP <797> focuses on sterile compounding and patient safety, while USP <800> focuses on hazardous drug handling and protecting workers, patients, and the environment. If a preparation is both sterile and hazardous, both chapters apply.
USP <797> establishes standards for compounded sterile preparations (CSPs) to help reduce risks such as microbial contamination, infection, and dosing errors. It applies to people and facilities that prepare sterile medications for human and animal patients. USP notes that the current revised chapter became official on November 1, 2023.
USP <800>, by contrast, covers the handling of hazardous drugs (HDs) across the full medication lifecycle, including receiving, storage, compounding, dispensing, administration, and disposal. Its purpose is broader than sterility alone: it is intended to reduce exposure risk for healthcare personnel, patients, and the environment. USP states that <800> became compendially applicable alongside the revised compounding chapters on November 1, 2023.
That distinction matters because many facilities mistakenly treat these chapters as interchangeable. They are not. A sterile but nonhazardous preparation falls under USP <797>. A hazardous nonsterile drug still triggers USP <800> handling requirements. A hazardous sterile compound must meet both standards at the same time.
Another important difference is how hazardous drugs are identified. USP <800> relies on the NIOSH hazardous drug list as a foundational reference. NIOSH published an updated list in December 2024, replacing the 2016 version, adding 25 drugs and removing 7, which means facilities should review their inventories, risk assessments, and SOPs against the current list rather than relying on outdated classifications.
For healthcare organizations, the best compliance strategy is not to treat USP <797> and USP <800> as separate paperwork exercises. Start with a clear inventory review, identify which products are sterile, hazardous, or both, and then map workflow requirements accordingly. From there, focus on facility design, engineering controls, garbing, cleaning, training, competency, and documentation. USP and ASHP both emphasize that the revised compounding framework is more explicit about personnel responsibilities, designated oversight, and the need for consistent process control.
The most common mistake is assuming a room that supports sterile compounding is automatically compliant for hazardous drug work, or that hazardous drug protocols alone are enough to protect sterile product quality. In reality, compliance depends on understanding the intent of each chapter and applying both correctly where they overlap. That is what keeps patients safe, protects staff, and reduces regulatory risk.
USP <797> covers the preparation of compounded sterile preparations and is intended to reduce contamination, infection, and dosing-related risk to patients.
USP <800> covers hazardous drug handling, including receiving, storage, compounding, administration, and disposal, to protect workers, patients, and the environment.
Both apply when a drug preparation is sterile and hazardous. USP’s FAQ for <797> specifically notes that compounding sterile hazardous drugs must additionally comply with USP <800>.
Yes. NIOSH published an updated hazardous drug list in December 2024 and issued additional updates in 2025, so facilities should confirm that their internal lists are aligned with the latest release.