Phar 15.12(18)(18)Copy of the label to dispense final product.
Phar 15.12(19)(19)Documentation of any adverse reactions or preparation problems reported by the patient or caregiver.
Phar 15.12 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Phar 15.13Phar 15.13Quality control.
Phar 15.13(1)(1)One or more pharmacists shall complete a verification of all the following before dispensing:
Phar 15.13(1)(a)(a) Written procedures were followed in the compounding process.
Phar 15.13(1)(b)(b) Preparation instructions were followed.
Phar 15.13(1)(c)(c) Finished preparation appears as expected.
Phar 15.13(1)(d)(d) Label includes all required elements.
Phar 15.13(1)(e)(e) Quality control procedures were completed.
Phar 15.13(1)(f)(f) Compounding records are complete.
Phar 15.13(2)(2)A pharmacist shall investigate any discrepancies found during any of verifications and take appropriate corrective action before dispensing.
Phar 15.13 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Phar 15.14Phar 15.14Training, Policies, and Procedures.
Phar 15.14(1)(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.
Phar 15.14(2)(2)Policies and procedures. The pharmacy and managing pharmacist shall establish written policies and procedures governing all of the following:
Phar 15.14(2)(a)(a) Personnel qualifications and training, responsibilities, and competencies.
Phar 15.14(2)(b)(b) Personal hygiene, garb, garbing, and personal protective gear.
Phar 15.14(2)(c)(c) Use and maintenance of compounding facilities and equipment, including applicable certifications.
Phar 15.14(2)(d)(d) Environmental monitoring.
Phar 15.14(2)(e)(e) Cleaning and disinfection of compounding area.
Phar 15.14(2)(f)(f) Component selection.
Phar 15.14(2)(g)(g) Sterilization and depyrogenation, if pharmacy does sterilization and depyrogenation.
Phar 15.14(2)(h)(h) Documentation requirements.
Phar 15.14(2)(i)(i) Establishing BUD.
Phar 15.14(2)(j)(j) Reporting of adverse drug events.
Phar 15.14(2)(k)(k) A risk management program, including documentation of incidents, adverse drug reactions and product contamination.
Phar 15.14(2)(L)(L) A quality assurance program.
Phar 15.14(2)(m)(m) Maintaining the integrity of any classified work areas.