What is USP Chapter 797

As a standard established by the United States Pharmacopeia Convention (USP), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply. These standards are also applied and followed by many other governing bodies and state boards of pharmacy to keep themselves updated with USP standards, USP has no role in enforcement. USP 797 also outlines the required procedures for compounding sterile drug preparations. It applies to all pharmacies that produce compounded sterile preparations (CSPs), including those in hospitals, retail settings, radio/nuclear pharmacies, ambulatory care centers, long-term care facilities, and other environments, such as chemotherapy units, hospital nursing stations, and operating rooms.

First implemented on January 1, 2004, and published in the United States Pharmacopeia and National Formulary (USP-NF), USP 797 establishes a standard of practice. It provides the foundation under which regulatory agencies, particularly the state-level Department of Public Health and Board of Pharmacy, can pursue pharmacies for unsafe compounding practices. Specifically, the chapter is designed to "prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs." The Joint Commission actively enforces USP Chapter 797 compliance as required by many state boards of pharmacy. A nationwide meningitis outbreak in 2012 due to improper sterile compounding led many state-level pharmacy laws and regulations to be updated to require USP 797 compliance in all pharmacy settings, requiring added diligence in meeting the intent of the chapter.

How to maintain USP 797 compliance

Designed to protect both patients and pharmacists, USP 797 requires attention to three main areas to ensure compliance: staff training and ongoing guidance, determination of categories, and development and implementation of appropriate policies and procedures. A task management system is recommended to ensure each requirement is addressed as outlined in policy and procedure.

Regular staff training for USP 797

USP 797 applies to everyone involved in sterile compounding: pharmacists, nurses, physicians, and pharmacy technicians. Staff USP 797 training should cover best practices and core competencies for each type of employee, ideally in a hands-on, situation-based learning format with both practical and written exams.

Techniques should be reviewed at the following intervals

Every six months

Observe hand hygiene and garbing of staff. Garbing order is no longer specified in the chapter and must be defined in the organization’s standard operating procedures.
Gloved fingertip and thumb sampling (GFS) clarifies that GFS is done after “separate and complete hand hygiene and full garbing.” It also indicates that fingers and thumb are to be rolled over the surface. Multiple options for devices to use for the sampling process are provided. Also, incubation parameters are longer and require two temperatures.
Media fill testing. This procedure must simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean–casein digest media.

Every twelve months

Train staff in appropriate sterile compounding principles and practices.
Return demonstration of competency.
Annually for low and medium-risk preparations
Semi-annually for high-risk compounding

Topics to cover include

Antiseptic hand washing and disinfection of nonsterile compounding surfaces
Use of appropriate protective garb, such as gloves, gowns, and masks
How to maintain CSPs in an ISO Class 5 environment
Protection of staff and environments from contamination by radioactive, cytotoxic, and chemotoxic agents
Measurement and identification of ingredients
Proper aseptic handling of products, sterilization of high-risk CSPs
Proper labeling and packaging

USP category determination

In 2008, USP designated three levels of risk as it related to compounded pharmaceuticals, classifying those three levels as low, medium, and high. But now the chapter focuses on where the compounded preparation is being made, making the lines completely clear and eliminating frustration when trying to achieve compliance.

Category 1 would be any primary engineering control (PEC) located in a segregated compounding area (SCA), that is not ISO classified. This would be your typical satellite or oncology unit that doesn’t have HEPA-filtered air or an anteroom.

Category 2 becomes everything else. This would be any PEC located in an ISO-classified buffer room, which is supplied by HEPA-filtered air, and it is supported by an ante-room. The facility category determines the Beyond Use Date (BUD) of the compounded sterile preparation (CSP). See below for more information on BUDs.

Policies and procedures for USP 797 compliance

To comply with USP 797, pharmacies need policies and procedures that cover specific situations that arise during compounding. Templates and reference resources make the development of these policies and procedures easier and help ensure that staff knows what to do and how to document their actions. Areas that should be addressed in the policy include verification of accuracy and sterilization, environmental quality and control, verification of automated compounding devices for parenteral nutrition compounding, final checks prior to CSP release, storage, and beyond-use dating (BUD), proper processing in the specific compounding environment, product quality control and patient monitoring and adverse effects reporting.