Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
SECTION 6: PROVISION OF CARE AND RECORD MANAGEMENT TCRX6-C Frequency of the citation: 41% Overview of the requirement: Policies and procedures are written to support safe storage, labeling, handling, and disposal of pharmaceutical components and preparations. Comment on deficiencies: Compliance is assessed through direct observation, interviews, and review of policies and temperature/ cleaning logs. Most deficiencies noted improper handling of cleaning/sanitizing agents and insufficient monitoring of the temperature of storage areas.
This standard represents the implementation of an ongoing QC process designed to assess finished preparations. Requirements for CNSPs differ from CSPs, but policies and procedures must contain these core elements regardless: ■ When to test preparations and what tests should be performed. ■ Appropriate methods and equipment. ■ How to interpret the test and limits of the test. ■ Specific actions required when a preparation does not meet the test. ■ How QC information is used to improve the performance of personnel and incorporated into the PI Program. ■ Each role involved in delivering care to an individual understands the full scope of that client/patient’s goals for care. ■ If care is not documented, there is no evidence that it occurred. Ensure policies and procedures governing QC address: ■ Compliance with USP <1163>. ■ A program of weight variation assessment. ■ Various bases used, and testing of high and low concentrations of added ingredients. ■ Potency testing is conducted according to your policies and procedures: ٝ At required intervals. ٝ For non-sterile to sterile preparations. ■ Accuracy of dosing. ■ Systematic processes to address test results that fall out of required specifications. ■ Frequency of quality control testing is performed at a minimum every 12 months on all compounded products, or at a shorter interval according to your organization’s policies. ■ Conduct master formulation record and compounding record audits. ■ Observe the various compounding processes to ensure QC activities are being conducted according to the facility’s policies and procedures and USP <1163>. ■ Interview staff on the QC activities. For example, ask how they record the results for pH meter, weight variation, and/or bubble point integrity testing. ■ Perform QC testing every six months on all compounded products, and incorporate this interval into organizational policies.
Nerd Newbies (understand the requirement)
Examples of ACHC Surveyor findings: ■ Cleaning practices:
Nerd Apprentices (audit for excellence)
ٝ The agent used for cleaning is not listed on the log. ٝ Cleaning is performed using 70% Isopropyl Alcohol (IPA). IPA is a disinfecting agent, not a cleaning agent. Use a cleaning agent, followed by IPA, or an EPA-registered one-step cleaning- disinfecting agent. ٝ The pharmacy does not clean and disinfect reusable storage containers and spray bottles prior to refilling for reuse. ٝ There was a week when cleaning was not documented. It was unclear if the weekly cleaning took place and documentation was overlooked, or if the week was skipped accidentally. ٝ Chemicals are transferred from larger containers, and the label on the smaller container is missing the date of transfer and the ingredient name. ■ Temperature and humidity: ٝ Temperature sensing devices were not calibrated to National Institute of Standards and Technology (NIST) or manufacturer standards. ٝ Room temperature storage areas are not monitored for appropriate temperature and humidity conditions as described in USP <659>. ٝ The freezer where ice bricks were stored was not monitored continuously with a calibrated device. ٝ Drug storage is monitored only on weekdays. The pharmacy is not open on weekends or holidays; staff cannot effectively determine if an excursion has occurred when the pharmacy is closed.
Nerd Trailblazers (prepare the path for others)
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