Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips continued:
TCRX5-G Frequency of the citation: 33%
■ Audit the pharmacy’s PI Program to ensure all components of this standard are included. ■ Create a PI scorecard for data collection and/or meeting minute template. ■ Review data collected quarterly to identify any trends and implement a corrective action plan for items not meeting the goal/threshold. ■ Create a system for gathering and organizing data to convert trends into a quarterly meeting template. ■ Develop and implement a PI meeting template with all the required reporting activities for recording each quarter's meeting minutes. ■ Put your template in a format that allows you to have all necessary information at the end of the fourth quarter. This will greatly help you with trending for the annual PI report.
Nerd Apprentices (audit for excellence)
Overview of the requirement: Written policies and procedures are established and implemented regarding continuous quality control (QC) for finished preparations. This applies to sterile and non-sterile compounding. Comment on deficiencies: Compliance is evaluated through observation, response to interviews, and review of policies and procedures. Surveyors noted that policies and procedures did not incorporate the most recent USP changes related to quality control processes for finished preparations (e.g. monitoring weight, variation, and potency). Examples of ACHC Surveyor findings: ■ Written policies were not found that define the ongoing continuous quality control program for non-sterile compounding. ■ The pharmacy does not conduct USP <1163> testing of preparations in accordance with its policies and procedures. ■ The SOP governing quality programs refers to USP <1075>. This is an obsolete chapter which has been replaced by USP <1163>. ■ Policies and procedures lack specificity about the QC processes to be performed on compounded sterile preparations (CSPs) and compounded non-sterile preparations (CNSPs). Weight variation and potency testing are not addressed and/or specifically defined. ٝ Volumetric dispensing devices (for example, Topi-clicks) are not addressed. ٝ Formulas for capsules, suppositories, and troches are not being assessed for weight variation. ٝ Formulas of creams made as weight/weight (mg/gram) and dosed as weight/volume (mg/ml) are not assessed for accuracy. ٝ Potency testing is not regularly performed on each compound type; only topical creams are tested. ■ Upon interview, staff were unable to describe: ٝ Steps to conduct final preparation testing and why it was being done. ٝ The procedure to follow if/when a test result falls out of specification. ■ The potency testing of finished preparations each compounder produces is not documented in a manner that tracks each individual's performance. ■ Non-sterile to sterile Category 2 preparations had BUDs assigned beyond guidelines, with no sterility testing.
Nerd Trailblazers (prepare the path for others)
achc.org | (855) 937-2242 | 15
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