Wisconsin Administrative Code
Pharmacy Examining Board
Chapter Phar 15 - Compounding Pharmaceuticals
Subchapter I - General
Section Phar 15.14 - Training, Policies, and Procedures

Universal Citation: WI Admin Code ยง Phar 15.14

Current through August 26, 2024

(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.

(f) Component selection.

(g) Sterilization and depyrogenation, if pharmacy does sterilization and depyrogenation.

(h) Documentation requirements.

(i) Establishing BUD.

(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.

Disclaimer: These regulations may not be the most recent version. Wisconsin may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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