What Does USP 797 Require for Compounding Room Cleaning?

What USP chapter 797 covers, and who enforces it

USP general chapter 797, Pharmaceutical Compounding, Sterile Preparations, sets standards for preparing compounded sterile preparations in pharmacies, hospitals, clinics and other settings. The current revision became official on November 1, 2023. It sorts preparations into Categories 1, 2 and 3 by how long they may be used, and the category affects some cleaning and monitoring intervals.

USP does not inspect anyone. State boards of pharmacy and accrediting bodies enforce the chapter. In California, the Board of Pharmacy's sterile compounding regulations in Title 16 of the California Code of Regulations, sections 1736 through 1736.21, took effect on October 1, 2025, replacing the former sections 1751 through 1751.10 and adding state requirements to the USP baseline.

USP 797 cleaning frequency, area by area

The chapter's frequency table covers classified rooms and the perimeter of a segregated compounding area. Each minimum also applies whenever surface contamination is known or suspected, such as after a spill, and after any event that could have compromised the room.

USP 797 cleaning requirements for agents, supplies and technique

Three distinct steps run through the chapter: cleaning to remove residue and soil, disinfecting to kill microorganisms, and applying a sporicide to kill spores. Cleaning, disinfecting and sporicidal agents used inside the hood must be sterile, and concentrated agents diluted for use there must be diluted with sterile water. Agents are used according to the manufacturer's directions, including the wet contact time.

Wipers, pads and mop heads should be low-lint, and many pharmacies dedicate tools to the classified rooms so they never leave except for disposal. Cleaning moves from the cleanest area to the dirtiest: the buffer room before the ante-room, and high surfaces before floors. Wiping the hood work surface with sterile 70 percent isopropyl alcohol during compounding is a compounder's task, not part of a janitorial scope.

Training and garbing for staff who only clean

The 2023 chapter closes a gap that older versions left open. The pharmacy's designated person must make sure that personnel who restock or clean and disinfect, not only compounders, are trained and qualified before performing those duties independently, and that the training is documented. The pharmacy's SOPs define what each role must learn and how often training is repeated.

In practice, an environmental services worker or contract cleaner learns hand hygiene and garbing for the rooms they enter, the pharmacy's agents and contact times, the cleaning sequence, and how to complete the cleaning log. Staff with rashes, sunburn, weeping sores or respiratory infections report them before entering, as the chapter requires of everyone working in compounding areas.

Hazardous drug rooms: what USP 800 adds

Where hazardous drugs such as many chemotherapy agents are compounded, USP chapter 800 adds requirements. Surfaces go through deactivation, decontamination, cleaning and, in sterile areas, disinfection, because a disinfectant alone does not remove drug residue. Staff doing that work wear protective gowns and two pairs of chemotherapy gloves, and the ante-room serving a negative-pressure hazardous drug buffer room must be ISO 7. Cleaning waste from these rooms follows the pharmacy's hazardous waste procedures, and anyone who cleans there needs hazardous drug training as well.

How EBS supports compounding pharmacy cleaning

EBS cleanroom programs use full gowning, strict entry and exit procedures and non-shedding tools, and every visit is documented in cleaning logs and service reports for inspection readiness. The walkthrough covers your room classifications, frequency table and agents, and settles which tasks stay with pharmacy staff, such as hood interiors, so the scope matches your SOPs.