Pharmacy Products


USP 797 Compliance:
Pharmaceutical Compounding Regulations


The purpose of USP 797 is to protect the health of patients by reducing the potential for microbial contamination caused by an unclean environment, excessive bacterial endotoxins, large errors in the strength of ingredients and the use of incorrect ingredients. The chapter was developed for use in healthcare institutions, pharmacies, and physician practice facilities. It also applies to other facilities in which compounded sterile preparations (CSPs) are prepared, stored and dispensed, such as pharmacy intravenous rooms, chemotherapy clinics, hospital nursing stations and in operating rooms by anesthesiologists.

It is critical to understand the environment and potential sources of contamination and put appropriate controls in place. Complying with USP 797 requires the design and use of cleanroom facilities as well as the development of policies and procedures for cleaning, sterility testing and personnel and environmental monitoring.

Aseptic manipulations using only sterile ingredients and components entirely within ISO Class 5 or better conditions are considered low risk. Examples would be to use a sterile needle and syringe to transfer sterile drugs from the manufacturer’s original packaging or to manually measure and mix no more than three sterile products to compound drug admixtures and nutritional solutions. An increase in complexity or duration of the compounding process increases the risk level.

Compounding or pooling multiple doses of sterile products for administration to multiple patients or single patient on multiple occasions is considered medium risk. An example of medium risk is the transfer of multiple ampules or vials into a single final sterile container or product. If a sterility test is not performed, the usable shelf life is 3 days at room temperature, 7 days at refrigerated temperature, and 45 days frozen at -20°C or colder.

High-risk conditions include the use of non-sterile ingredients or components or the exposure of sterile ingredients or components to conditions less than ISO Class 5. An example of a high-risk condition is measuring and mixing sterile ingredients in non-sterile devices before terminal sterilization. If a sterility test is not performed on high-risk preparations, the usable shelf life is 24 hours at controlled room temperature, 3 days at refrigerated temperature, and 45 days frozen at -20°C or colder.

It is critical to understand the environment and potential sources of contamination and put appropriate controls in place. Complying with USP 797 requires the design and use of cleanroom facilities as well as the development of policies and procedures for cleaning, sterility testing and personnel and environmental monitoring.


 

 

 

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