(a) Compounding facility. - (i) All pharmacies engaging in sterile compounding shall have a Quality Assurance Program that is in written format with documentation that illustrates that the Program is being followed. Documentation of compliance with the Quality Assurance Program will be available for evaluation by Inspectors of the Wyoming Board of Pharmacy and other pertinent regulatory agencies. The Quality Assurance Program shall include, though not be limited to:
- (A) Adequacy of training and evaluation of personnel;
- (B) Verification, monitoring, and review of the adequacy of the compounding process;
- (C) Maintenance of an appropriate environment for compounding sterile preparations;
- (D) Review of the final product for accuracy of preparation, quality, and purity and, where appropriate, sterility and bacterial endotoxin content;
- (E) Monitoring for adverse or negative patient outcomes due to utilization of a compounded sterile preparation or other quality related issue, and that identified issues are included in the facility's overall Quality Assurance Program.
- (F) Addressing problems or issues identified by the Quality Assurance Program, including follow-up and assurance of correction.
(b) Personnel. - (i) All personnel engaged in preparation of sterile products will be adequately trained before they begin compounding.
- (ii) Training shall include didactic learning and experiential components with results validated by testing of aseptic skills and knowledge including, but not limited to:
- (A) Gowning and garbing assessment;
- (B) Media-Fill Testing that is representative of compounding performed;
- (C) Gloved fingertip testing done three (3) times prior to initial compounding and annually thereafter;
- (D) Knowledge of sterile compounding processes; facility policies, procedures and quality programs; and legal requirements of state, federal, and pertinent regulating agencies.
- (iii) All documentation of results will be available for review by pertinent individuals or agencies.
(c) Compounding Risk Levels. - (i) The Quality Assurance Program will correspond to the level of compounding risk that is undertaken at the individual facility. The facility's Quality Assurance Program shall include the following for each level:
- (A) Low-Risk Level Compounding.
- (I) Routine disinfection and air quality testing conducted to minimize microbial surface contamination and maintenance of ISO Class 5 conditions;
- (II) Visual confirmation of personnel practices and garbing;
- (III) Review of all orders and materials to ensure that the correct identity and quantity of ingredients were compounded;
- (IV) Visual inspection of the sterile product to ensure the absence of particulate matter in the solution; appropriateness of color, clarity, and volume; the adequacy and competence of the container; and appropriateness of labeling. Visual inspection of Low-Risk Level radiopharmaceutical CSPs will be limited, in accordance with radiation safety practices.
- (V) Annual basic Media-Fill Testing that is conducted in conditions of equal stress to the actual compounding process.
- (B) Medium-Risk Level Compounding.
- (I) All elements of the Low-Risk Level compounding quality requirements plus a more challenging Media-Fill Test performed at least annually.
- (C) High-Risk Level Compounding.
- (I) All elements of the Low-Risk Level compounding quality requirements plus a Media-Fill Test that represents High-Risk Level compounding completed semiannually by all compounding personnel.
(d) Verification of accuracy and sterility in High-Risk Level compounding. - (i) The compounding facility will have policies and procedures detailing standard practices that assure compounded sterile products are accurately produced and that the quality procedures in place achieve and maintain sterility.
- (ii) High-Risk Level compounding shall have additional procedures and quality assurance to ensure accurate and sterile products.
- (iii) Sterility and depyrogenation shall be achieved when necessary by the appropriate application of dry-heat, steam-heat, or filtration. Appropriate resources shall be used to determine the appropriate method for sterilization while maintaining strength, purity, quality, and package integrity.
- (iv) Sterility and Bacterial Endotoxin testing shall be done when there are batches of more than twenty-five (25) identical individual single-dose packages; when in multiple-dose vials for administration to multiple patients; or when exposed longer than twelve (12) hours at two-to-eight degrees Centigrade (2°C to 8°C), or longer than six (6) hours at above eight degrees Centigrade (8°C).
- (v) If dispensed before results are obtained, daily monitoring of the testing will occur and, if positive results come back, the product will be immediately recalled and notification of results will be forwarded to the end patient and physician.
(e) Environmental quality and control. - (i) The facility producing compounded sterile preparations will have policies and procedures sufficient to ensure preparation of products that are sterile and of accurate strength, purity, quality, and package integrity. A Quality Assurance Program will be present that illustrates the adequacy of the processes used. The Quality Assurance Program will include, but not be limited to:
- (A) Viable and nonviable environmental air sampling performed:
- (I) As part of commissioning and certification of facilities or equipment;
- (II) Following servicing of facilities or equipment;
- (III) As part of re-certification (every six (6) months);
- (IV) In response to identified problems with end products, staff technique or work practices, or patient-related infections that could be due to the compounded sterile preparation.
- (B) Primary Engineering Controls and equipment will be monitored as part of the comprehensive Quality Assurance Program that assures maintenance of appropriate air quality and the ability to produce sterile and stable compounded products.
(f) Patient monitoring. - (i) The compounding facility will have policies and procedures detailing its Quality Assurance Program that monitor for adverse effects, negative outcomes, and medication errors.
- (ii) The compounding facility will have a process that allows patients and other recipients to address their questions and to report any concerns they may have with the compounded sterile preparation or administrative device.
- (iii) Reports of adverse events will be reviewed promptly and thoroughly by compounding supervisors to correct and prevent future occurrences.
- (iv) Compounding personnel are encouraged to participate in the adverse event reporting and product defects programs of the FDA and USP.
059-17 Wyo. Code R. § 17-10