Background In Europe, there are currently no common enforceable standards of practice for sterile compounding in Hospital Pharmacies. Many national and international guidelines have been published, but they usually only offer practice recommendations In 2004, the United States Pharmacopoeia (USP), published its general chapter <797> Pharmaceutical Compounding-Sterile Preparations, which set rigorous and enforceable standards for sterile compounding in the US.
Purpose To evaluate the degree of compliance in a Pharmacy Service with the sterile compounding requirements in USP Chapter <797>.
Materials and methods An online survey created by a US board of experts on sterile compounding practices was completed and submitted for analysis of compliance with USP chapter <797> standards. The survey included 166 yes-no questions about compliance with specific required elements in <797>, grouped in 38 domains. Upon completion, a complete report and an individualised action plan was generated by the survey tool.
Results 143 of the 166 questions were answered (23 deemed to be non-applicable). The overall compliance score was 79%. Various degrees of deviation from the practice recommendations were noted in 13 of the 29 evaluated domains. Low levels of compliance were most notable in the domains of Single and Multiple-Dose Vials handling (33%), Hand Washing and Garbing requirements (33%), Hazardous Drug Compounding (33%) and Gloved Fingertip Sampling (0%). A 0% score was also obtained in the domains of Sterility Testing and Filter Integrity Testing. Higher levels of compliance were noted in the domains of Inventory Storage and Handling and Delivery of compounded sterile products (CSPs) (80%), Training and Competency Measurement (80%) and Aseptic Technique (92%). Compliance with recommendations in the areas of Facility Design, Compounding Facility Management and Quality Management was almost total.
Conclusions Systematically evaluating compliance with USP <797> standards proved useful to pinpoint inappropriate sterile practices within our sterile-compounding facility and to drive corrective actions accordingly.
No conflict of interest.
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