(1) The pharmacy must establish and follow a written program of training and performance evaluation designed to ensure that each person working in the designated area has the knowledge and skills necessary to perform their assigned tasks properly. This program of training and performance evaluation must address at least the following:

(2) Each person engaged in sterile compounding must successfully complete practical skills training in aseptic technique and aseptic area practices using models that are comparable to the most complex manipulations to be performed by the individual. Each pharmacist responsible for, or directly supervising and controlling, aseptic techniques or practices, must demonstrate the skills needed to ensure the sterility of compounded drug preparations. Evaluation must include written testing and a written protocol of periodic routine performance checks involving adherence to aseptic area policies and procedures. Each person's proficiency and continuing training needs must be reassessed at least every 12 months. Results of these assessments must be documented and retained in the pharmacy for three years.