Volume 2025 | No. 2
SURVEYOR
PCAB (COMPOUNDING PHARMACY)
Compliance tips for:
TCRX6-H Frequency of the citation: 27%
■ The pharmacy must maintain a CR for every compounded preparation. The CR documents the ingredients, the compounder, and the approval of the pharmacist—but it doesn’t stop there. ■ A complete CR also includes: ٝ Name, strength or activity, and dosage form. ٝ Date and time of preparation. ٝ Assigned internal identification number (e.g., prescription number, order, or lot number). ٝ Method to identify both the individuals involved in the compounding process and those who verify the final compounded preparation. ٝ Total quantity compounded. ٝ Final yield. ٝ Assigned BUD. ٝ Storage requirements. ٝ Results of QC procedures. ٝ MFR reference, when applicable. ٝ Physical description of the final CNSP, when applicable.
Nerd Newbies (understand the requirement)
Overview of the requirement: Written policies and procedures are established and implemented that outline the contents of the compounding record (CR) for each preparation. Comment on deficiencies: Compliance is evaluated through observation, interviews, and review of policies and procedures. Surveyors cited deficiencies related to incomplete CRs due to missing results of quality control (QC) procedures. CRs were often found to be missing the final yield and physical description. Examples of ACHC Surveyor findings: ■ The pharmacist was observed performing QC procedures, but the results were not documented on the compounding record. ■ The results of QC checks were inaccurate or incomplete. For example: ٝ A paste and capsules were noted as "clear and particulate-free." ٝ Formulas for creams did not have an assessment for the results of expected color and lack of grittiness. ٝ Formulas for suspensions do not contain the results of an assessment or suspendability. ■ The compounding records do not contain a physical description of the final compounded preparation. ■ The sterile CRs do not clearly state the yield as the volume per dispensing unit and the number of dispensing units made. The yield was reported as the total volume in mLs compounded. ■ Troche and suppository dosage forms did not have a quality check done to ensure the weights were within an acceptable variance. ■ The CRs were missing: ٝ The source, lot number, and expiration of ingredients.
ٝ Pertinent calculations. ٝ For each component: о Name.
о Vendor, lot number, and expiration date when CSP is prepared for more than one patient or prepared from nonsterile ingredient(s), and for each CNSP. о Weight, volume, or measurement. о Strength or activity.
ٝ Specification of the supplies needed (syringes, needles, empty sterile bags). ٝ Specification of BUD assignment and rationale (e.g., Mfg for 24 hours). ٝ Calculations of amounts to be added to achieve the final volume. ٝ Specification of which hood is used. ٝ The sterilizing filter in the ingredient list. ٝ Documentation of the container closure system.
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