Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
■ Storage areas: ٝ There was no designated area for recalled medications. ٝ Several boxes of components are stored on the floor. ٝ There was no evidence of regular inspections for expired pharmaceuticals, components, and compounded preparations.
■ Ensure all electronic/paper cleaning forms/logs list all areas to be cleaned (e.g., non-sterile compounding areas, SCA, SECs, and PECs) and the frequency they are required to be cleaned (e.g., daily, weekly, or monthly). ٝ Review each log monthly to verify: о All required cleaning has taken place. о Cleaning and disinfection agents are listed with appropriate details. ٝ Sign the log to verify completed tasks have been reviewed. ■ Regularly audit inventory with a specific focus in mind, such as: ٝ Confirming labels on repackaged containers reflect all required elements. ٝ Separating expired, recalled, and quarantine items. ■ Routinely check temperature-sensing devices as well as any other equipment used to monitor the environment. ٝ Are they properly calibrated? Are the manufacturers’ guidelines easy to find? ٝ Is third-party certifier’s equipment certified and calibrated? ٝ If using duplicate thermometers, do you use two different models or brands? ٝ Have you calibrated thermometers using, for example, NIST standards? ■ Review policies and procedures to ensure compliance with the most recent USP updates. ■ Select any required log related to this standard and hold an in-service for staff. Discuss common errors using data from your PI Program. Develop checklists for any items that are routinely missed. ■ Educate staff on processes for transferring cleaning agents and chemicals from a larger container to a smaller container. Include these tasks in competency assessments. ■ Develop a clear process for handling recalled, expired, quarantined, or adulterated products. Educate, implement, and include the process in the organization’s policies and procedures.
Nerd Apprentices (audit for excellence)
Compliance tips for:
■ Temperature monitoring applies to all pharmaceuticals, components, and compounded preparation storage areas. ■ Maintaining compliant storage requires attention to: ٝ The manufacturers’ requirements for devices used to assess and maintain the correct temperature. ٝ Whether the storage is refrigerated, frozen, or room temperature. ٝ USP <659> requirements for every scenario. ٝ The alert and reporting capabilities. ■ Storage areas also require established processes for: ٝ Regular inspections to remove and dispose of expired pharmaceuticals, components, and compounded preparations. ٝ Quarantine areas for expired, recalled, and quarantined products waiting for test results or DSCSA resolution. ٝ Contingency plans when storage conditions fall outside of established ranges. ٝ Hazardous vs non-hazardous drugs. ٝ Labeling. ٝ Cleaning and disinfection.
Nerd Newbies (understand the requirement)
Nerd Trailblazers (prepare the path for others)
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