Volume 2024 | No. 2
SURVEYOR
PCAB COMPOUNDING
Examples of surveyor findings:
n The policy governing nonsterile compounding lacks:
Tips for compliance:
n Verify ongoing compliance with the MFR requirements by auditing a certain number of formulas at a certain frequency. n Mark the MFR with a revision date to easily identify that it has been updated and complies with the 2023 chapters of USP <795> and <797>. n List the quality control tests to be performed and the expected results on the MFR. n Ensure that all BUDs referenced on the MFR are accurate, complete, and reflect the new USP <795> and <797> standards. n Train staff when they identify any variances in the compounding process compared to the MFR to report it to a pharmacist to ensure the appropriate revisions are made. n MFRs must include what container/closure system is to be used to package and dispense the compounded medication. n Develop a process, training, and competency assessments for pharmacy technicians who will be allowed to modify MFRs. n All instructions contained on MFRs should be detailed enough to allow someone unfamiliar with the compounding process to produce the compound from start to finish and with the same expected quality each time. n Create a process to ensure MFRs are created and reviewed by at least one other pharmacist prior to finalization and use. n Review and update MFRs to include accurate ingredient weights/quantities and mixing instructions with equipment settings, if appropriate. n Ensure that all BUD reference studies are appropriate. Even small variances in process and materials can invalidate a BUD study conducted with a specific base because there is no standard formulation for bases and they can vary in water content, pH of the aqueous environment, surfactants and emulsifiers used and many other variables that can affect the ultimate physical and chemical stability of the formulation.
Checks and rechecks for each procedure at each stage of the process. Personal hygiene, hand washing, gowning, and gloving for non- hazardous nonsterile compounding. Documentation of deviations that occur during compounding.
n Additional observations:
The compounder was observed not routinely capturing and recording all balance tares, thereby obviating the ability to perform in-process checks for each stage of compounding the preparation. Cross-contamination issues: о A disposable lab coat was not removed and properly discarded after being visibly contaminated on the sleeves with an API. о One compounder was compounding capsules using loose powders on the countertop at the same time as another technician was weighing and mixing loose powder outside the containment ventilated enclosure (CVE) on the same countertop in very close proximity to the other compounder. Neither compounder compounded within the containment ventilated enclosure (CVE). о There was visible residue on the Hobart mixer, powder hoods, electronic balances, and the hot plate/stirrers. Compounders being repeatedly interrupted during critical compounding processes for issues unrelated to the compounded preparation being compounded at the time. The pharmacy did not clean compounding equipment between compounds with different ingredients. Several stock formulations made did not contain the electronic notation of the pharmacist’s initials; to illustrate, a final check of the preparation was performed, and which pharmacist performed it.
n The pharmacy uses an unsanitary cart to transport chemicals. The cart had visible powder residue on each shelf. There was rust present on the cartwheels and castors.
TCRX6-I Overview of the requirement:
Note: This standard applies to nonsterile compounding only. Policies and procedures define techniques for how nonsterile compounding is performed. Compliance is assessed through review of the policies and procedures, direct observation of compounding, and response to interviews. Most deficiencies resulted from errors observed during compounding procedures, particularly those related to cross-contamination and quality control. Cleaning and sanitizing procedures were also cited.
Tips for compliance:
n Ensure policies and procedures address appropriate hygiene, garbing, and gloving. Gloves and the appropriate garb (mask, gown, beard cover) that must be worn when handling compounded preparations. Use compounding garb that adequately prevents the potential for cross- contamination, including, but not limited to, disposable sleeve covers.
Comment on deficiencies:
Frequency of citation:
39%
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