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USP 797 and USP 795: Creating and Managing a State of Control

Posted on 04/07/16


Both USP Chapter 795 and Chapter 797 address the need of compounding pharmacies to maintain a state of control. Chapter 795 focuses on applying good compounding practices to the process of preparing nonsterile compounded formulations, while Chapter 797 provides procedures and requirements for compounding sterile preparations.

Chapter 795

Chapter 795 addresses the extemporaneous compounding of non-sterile pharmaceuticals by explaining what constitutes good compounding practice and establishing guidelines that minimize the likelihood of error or cross-contamination.

Compounders must take steps to ensure that their preparations are the specified strength and have the quality and purity expected of a medicinal or nutritional product. Packaging and labeling must comply with federal regulations and the requirements of the relevant state board of pharmacy.

To meet these standards, Chapter 795 requires that compounding personnel be qualified and demonstrably capable of discharging their duties. Documentation of training and testing should be maintained. Only authorized individuals may be in the immediate vicinity of the drug compounding area.

Ingredients used in compounding must be acquired from reliable sources, stored according to manufacturer’s specifications, have appropriate labeling, and meet the requirements for quality and purity. Both the equipment used in compounding and the surrounding area must be kept clean and well maintained. The type and sizes of equipment required depend on the dosage forms, ingredients used, and quantities compounded.

Steps to reduce the risk of errors and of cross-contamination, particularly of hazardous drugs and those known to be allergens, must be implemented. The compounding area must haveadequate space to properly store ingredients and prevent confusion between ingredients, preparations or containers so as to reduce the risk of errors or cross-contamination. The compounding environment must be suitable for the process as specified in the chapter, and the compounder must provide assurance that compounding processes take place as intended or specified and can be consistently reproduced. Potable water must be available for the hand and equipment washing and appropriate hand washing facilities should be readily accessible.

Documentation must be maintained on all aspects of compounding. Records should also demonstrate that procedures for investigating and correcting failures or problems in compounding, testing or preparations have been followed.1

Chapter 797

Chapter 797 delineates the procedures and requirements for compounding sterile preparations. It focuses on ensuring that compounding pharmacies provide the conditions and institute practices to prevent harm to patients from microbial, chemical or physical contamination; excessive bacterial endotoxins; variations in product strength; or poor quality ingredients.

Meeting USP 797 standards requires specific training and testing for all personnel involved in sterile compounding. Individuals involved in compounding must perform regular media fill tests using conditions that replicate actual compounding as closely as possible. The prepared product (a soybean-casein digest medium) is then incubated at the specified temperature range for a specific period of time. If microbial growth occurs, the test failed and both the compounder and the process should be reevaluated to identify opportunities for improvement. The chapter also details how compounding personnel should garb and what they must wear to prevent potential contamination.

The concern for sterility affects both the laboratory design and engineering control placement, and drives the practices for maintaining, verifying and documenting aseptic laboratory conditions. Both air and surfaces in the compounding area must be tested for viable and nonviable particulates at least once every six months. Electronic air samplers can be used to test for non-viable particles, while the presence of viable particles is tested by sampling a volume of air and checking for growth of bacteria on TSA or fungi on MEA. Surfaces should be swabbed where compounded sterile products (CSPs) are actually prepared as well as in the buffer area and the ante-area. The results should be compared to the Action Limit tables in the chapter and determine whether remediation is necessary. Test results, corrective actions, and retesting results should be documented until all areas are in compliance.

Proper handling of CSPs depend on their risk classification. USP 797 divides sterile compounds into low-risk, medium-risk and high-risk categories. Low-risk preparations are single doses that are compounded in designated compounding areas using sterile materials. Medium-risk preparations are similar except that they require a longer manipulation time or are combined into a larger preparation used either for multiple patients or for one patient over an extended period of time. High-risk CSPs include those made with non-sterile ingredients or those exposed to non-sterile environments during preparation. These preparations must be sterilized after compounding.

Hazardous drugs have special requirements for handling and preparation which are addressed in recently published USP Chapter 800. Other precautions and rules are detailed in the chapter and must be observed in preparation of classifications of compounds.

Does your facility compound non-sterile preparations, sterile preparations, or both?

sterile compounding

  1. Gaunt, MJ. What Does USP <795> Mean to You? Pharmacy Times. April 18, 2013.

Topics: Sterile Compounding

About the Author

Deb Oroszlan is the Marketing Director for Pharmacy OneSource - Wolters Kluwer.