FAPA Resource-Sensitive Guideline on Handling Sterile Hazardous Drugs in Healthcare Settings (Draft)
Introduction
Sterile and hazardous drug handling critically integrates the protection of patients and workers. Failure to achieve this standard of protection will lead to severe harm. Currently, the most referenced documents on the compounding of sterile or hazardous drugs are USP 797 & 800. Due to the long experience in developing sterile and hazardous handling guidelines in Taiwan, there is room for ways of practice in compounding and maintaining effectiveness and safety. The range of the richness in resources among Asian countries is drastic, and the approaches set by USP 797 & 800 may not be feasible when they are implemented universally. This guideline attempted to outline the key aspects of compounding sterile hazardous products per USP 797 & 800 and provide different levels of practices according to the availability of resources. In this way, even those countries with limited resources could still implement this compounding practice and achieve the safety standard for patients and workers.
Sterile hazardous drug compounding in healthcare settings is a critical process grounded in a single, non-negotiable standard: ensuring the safety of both patients and healthcare personnel by maintaining sterility – defined as the minimal presence of viable microorganisms in compounded preparations at levels that do not cause harm to humans – and by minimizing exposure to hazardous substances. In this context, it is important to distinguish between standards and approaches. While the standard – protecting patients and healthcare workers from contamination and hazardous exposure – must be upheld universally, the approaches used to meet it may vary based on institutional resources and national infrastructures.
USP Chapters <797> and <800> are widely regarded as comprehensive references for sterile hazardous drug compounding. However, applying them uniformly across countries with vastly different healthcare systems can be impractical without local adaptation. In recognition of this challenge, the Federation of Asian Pharmaceutical Associations (FAPA) has developed a flexible framework to support countries and institutions in achieving the same safety standards through resource-sensitive approaches.
Sterile and hazardous drug handling critically integrates the protection of patients and workers. Failure to achieve this standard of protection will lead to severe harm. Currently, the most referenced documents on the compounding of sterile or hazardous drugs are USP 797 & 800. Due to the long experience in developing sterile and hazardous handling guidelines in Taiwan, there is room for ways of practice in compounding and maintaining effectiveness and safety. The range of the richness in resources among Asian countries is drastic, and the approaches set by USP 797 & 800 may not be feasible when they are implemented universally. This guideline attempted to outline the key aspects of compounding sterile hazardous products per USP 797 & 800 and provide different levels of practices according to the availability of resources. In this way, even those countries with limited resources could still implement this compounding practice and achieve the safety standard for patients and workers.
Sterile hazardous drug compounding in healthcare settings is a critical process grounded in a single, non-negotiable standard: ensuring the safety of both patients and healthcare personnel by maintaining sterility – defined as the minimal presence of viable microorganisms in compounded preparations at levels that do not cause harm to humans – and by minimizing exposure to hazardous substances. In this context, it is important to distinguish between standards and approaches. While the standard – protecting patients and healthcare workers from contamination and hazardous exposure – must be upheld universally, the approaches used to meet it may vary based on institutional resources and national infrastructures.
USP Chapters <797> and <800> are widely regarded as comprehensive references for sterile hazardous drug compounding. However, applying them uniformly across countries with vastly different healthcare systems can be impractical without local adaptation. In recognition of this challenge, the Federation of Asian Pharmaceutical Associations (FAPA) has developed a flexible framework to support countries and institutions in achieving the same safety standards through resource-sensitive approaches.
| FAPA guideline 202509 |