Section Phar 15.14 - Training, Policies, and Procedures(1) TRAINING. All personnel involved in the compounding, evaluation, packaging, and dispensing of compounded preparations shall be properly trained and competency is assessed for the type of compounding conducted. It is the responsibility of the managing pharmacist to ensure personnel training and competency assessments are completed and documented.(2) POLICIES AND PROCEDURES. The pharmacy and managing pharmacist shall establish written policies and procedures governing all of the following: (a) Personnel qualifications and training, responsibilities, and competencies.(b) Personal hygiene, garb, garbing, and personal protective gear.(c) Use and maintenance of compounding facilities and equipment, including applicable certifications.(d) Environmental monitoring.(e) Cleaning and disinfection of compounding area.(g) Sterilization and depyrogenation, if pharmacy does sterilization and depyrogenation.(h) Documentation requirements.(j) Reporting of adverse drug events.(k) A risk management program, including documentation of incidents, adverse drug reactions and product contamination. (L) A quality assurance program.(m) Maintaining the integrity of any classified work areas.(n) Handling small and large spills of antineoplastic agents and other hazardous substances.(o) Notification to patients or practitioners of a preparation which is recalled when there is potential for patient harm.(3) REVIEW OF POLICIES AND PROCEDURES. The policy and procedures shall be reviewed at least once every 36 months and shall be updated, on a continuous basis, to reflect current practice. Documentation of the review shall be made available to the board upon request.Wis. Admin. Code Pharmacy Examining Board Phar 15.14
Adopted by, CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; correction in (2) (o) made under s. 35.17, Stats., Register April 2018 No. 748, eff. 11/1/2018