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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 regulations 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 categories, 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 at the following intervals:

Every six months
• Visual observation of hand hygiene and garbing. 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) clarify 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
• Training in appropriate sterile compounding principles and practices.
• Return demonstration of competency.

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

 

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), which 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

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.

More on BUDs:
A Category 1 Facility (PEC/C-PEC located in an SCA or C-SCA)beyond use date (BUD) is:
• 12 hours or less at controlled room temperature
• 24 hours or less when refrigerated

A Category 2 Facility (located in a Buffer Room with an Anteroom) beyond use date can be:
• Greater than 12 hours at controlled room temperature
• Greater than 24 hours when refrigerated

Keep in mind the chemical stability of the drugs being compounded. Please note that the chemical stability of some drugs may be shorter than the chapter default BUDs.

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