This post has been replaced with a new post Understanding the Impact of USP 800 on Pharmacies that addresses the compounding of hazardous drugs as well as the updated USP 797.
USP 797 is a regulation that governs any pharmacy that compounds sterile preparations including centralized and satellite hospital-based pharmacies, outpatient pharmacies, and off-site pharmacies. USP 797 is designed to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. Issued by U.S. Pharmacopeia (USP), USP 797 has been endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) who expects that organization will be in full compliance by January 2008.
PHARMACY CLASSIFICATIONS
If the pharmacy being planned will be compounding sterile preparations, it must be categorized into one of the following classifications in order to determine the facility requirements for compliance with USP 797:
- Low-risk level of compounding includes single transfers of sterile dosage forms from ampoules, bottles, bags, and vials using sterile syringes with sterile needles, other administration devices, and other sterile containers, and manually measuring and mixing no more than three manufactured products to compound drug admixtures.
- Medium-risk level of compounding includes the compounding of total parenteral nutrition fluids using manual or automated devices, filling of reservoirs of injection and infusion devices with multiple sterile drug products or volumes of sterile drug solutions, and transfer of volumes from multiple ampoules or vials into a single final sterile container or product.
- High-risk level of compounding includes dissolving nonsterile bulk drug and nutrient powders to make solutions which will be terminally sterilized, measuring and mixing sterile ingredients in nonsterile devices before sterilization is performed, and where sterile ingredients, components, devices, and mixtures have been exposed to air quality inferior to ISO Class 5 (maximum of 100 particles per cubic foot).
FACILITY REQUIREMENTS
USP 797 requires the creation of two physical zones:
- Buffer room where the sterile compounding is performed
- Anteroom where nonsterile compounding activities occur such as hand washing, storage, and measuring/weighing/mixing of nonsterile substances
The configuration of the buffer room and anteroom is different in low- and medium-risk environments (buffer and anteroom can be in one shared room if separated by a visible line or physical barrier) than in a high-risk environment (buffer and anteroom must be separated by a wall with a door). USP 797 provides specific direction on the cleanliness or purity of the air in the buffer room. Compounding of sterile substances must be done in a laminar airflow workbench or a biological safety cabinet which, in turn, must be located in the buffer room. Detailed guidelines for architectural finishes in the buffer room are also specified and the minimum amount of furniture, equipment, and supplies should be brought into this room. Pharmacy staff must scrub their hands and gown in the anteroom before entering the buffer room.
As an alternative to a clean room, particularly for a smaller facility with minimal compounding, USP 797 specifically allows the use of a mobile isolator chamber (MIC). MICs can take the place of a clean room by providing clean room conditions within a contained workspace. Pharmacy staff access the work area via sealed gloves and do not have to fully gown before they begin work. However, barrier isolators should still be located in an environment that is as clean and sterile as possible. When compared with a clean room, they may be more economical to install and operate, require less space, and are less costly to maintain.
Please see the more recent update to this post.