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What is USP 797 and How to Stay Compliant

USP Chapter <797>, Pharmaceutical Compounding: Sterile Preparations, delineates the standards for compounding sterile preparations in all pharmacy settings. 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, 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 and long-term care facilities as well as 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 and provides the foundation under which regulatory agencies, particularly 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 regualtions to be updated to require USP 797 compliance in all pharmacy settings, requiring added diligence with 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 risk levels, and development and implementation of  appropriate policies and procedures. A task management system is recommended to assure each requirement is addressed as outlined in policy and procedure.

Staff Training

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 annually for low and medium-risk preparations and 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 a 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

Risk Determination

Chapter 797 defines three levels of microbial contamination risk. Low level compounded sterile preparations include simple sterile “one to one” compounding within an ISO 5 environment such as reconstitution of lyophilized powder for transfer to a infusion bag. Medium-risk level CSPs involves more complex “one to many/many to one” sterile compounding in an ISO 5 environment where multiple additives may be aggregated into an infusion device, batch compounding, and/or pooled admixtures. High-risk compounds are preparations that may take place outside an ISO 5 environment or are derived from non-sterile ingredients.

Policies and Procedures

To comply with USP 797, pharmacies need policies and procedures that cover specific situations that arise during compounding. Templates and reference resources make development of these policies and procedures easier and help ensure that staff know what to do and how to document their actions. Areas that should be addressed in 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.

What are you doing to stay up to speed on USP 797 compliance? Leave your comments below and let’s discuss.


Understanding USP 71-Sterility Testing and Extending Beyond-Use Dating. Watch the webinar.

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