059-17 Wyo. Code R. §§ 17-3 - Pharmacy Staff Training and Evaluation

(a) Each sterile compounding pharmacy shall develop a written training program that describes the required training, the frequency of training, and the process for evaluating the performance of pharmacy staff involved in preparing CSPs.

(b) Compounding pharmacy staff shall be initially trained and qualified by demonstrating knowledge of principles and proficiency in core competencies for performing sterile manipulations and achieving and maintaining appropriate environmental conditions. A designated person shall oversee the training of pharmacy staff.

(c) Training and evaluation of pharmacy staff shall be documented.

(d) Compounding pharmacy staff shall be able to demonstrate knowledge and competency in the following:

(i) Using proper aseptic technique

(A) All compounding pharmacy staff shall perform a media-fill test to assess aseptic technique. The media-fill test shall simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean-casein digest media.

(B) Gloved fingertip and thumb sampling shall be performed inside the PEC following the media-fill test to evaluate aseptic technique.

(C) If using commercial sterile microbial growth media, a certificate of analysis (COA) shall be obtained from the supplier stating that the lot of the growth media will support the growth of microorganisms.

(D) If preparing sterile microbial growth media in-house for sterile to sterile media fill testing, the growth promotion capability of the media shall be demonstrated for each batch and documented as described in USP.

(E) Failure of the media fill test is indicated by visible turbidity or other visual manifestation of growth in the media in one or more container-closure unit(s) on or before the end of the incubation period.

(F) Results of the evaluation and corrective actions, in the event of failure, shall be documented and include, at a minimum the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results.

(ii) Appropriately and accurately preparing, identifying, purifying, sterilizing, packaging, labeling, storing, dispensing, distributing, documenting and recordkeeping for CSPs.

(iii) Appropriately cleaning and maintaining the compounding area.

(iv) How to recognize potential problems, deviations, failures, or errors related to equipment, facilities, materials, or compounding processes that could potentially result in contamination or other adverse impact on CSP quality.

(v) Hand hygiene and garbing procedures

(A) All compounding pharmacy staff shall be visually observed while performing hand hygiene and garbing procedures.

(B) Before being allowed to independently compound, all compounding pharmacy staff shall successfully complete an initial gloved fingertip and thumb sampling on both hands, no fewer than 3 separate times. Each evaluation shall occur after performing a separate and complete hand hygiene and full garbing procedure.

(C) The initial evaluation shall be performed on donned sterile gloves in a classified area or SCA. Subsequent sampling shall be performed on donned sterile gloves inside of the PEC. If conducting sampling in a compounding aseptic isolator (CAI), compounding aseptic containment isolator (CACI), or a pharmaceutical isolator, samples shall be taken from the sterile gloves placed over the gloves attached to the restricted-access barrier system (RABS).

(D) Successful completion of initial gloved fingertip and thumb sampling is defined as zero colony-forming units (cfu). Successful completion of subsequent gloved fingertip and thumb sampling after media-fill testing is defined as = 3 cfu (total from both hands).

(E) Failure is indicated by visual observation of improper hand hygiene and garbing procedures and/or gloved fingertip and thumb sampling results that exceed action levels.

(F) Results of the evaluation and corrective actions, in the event of failure, must be documented. Documentation must include, at a minimum, the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results.

(e) Competencies shall be reevaluated every twelve (12) months for low and medium risk level compounding, and every six (6) months for high-risk level compounding.

Notes

059-17 Wyo. Code R. §§ 17-3

Amended, Eff. 5/16/2017. Amended, Eff. 12/19/2018. Amended, Eff. 5/13/2021.