Quality Assurance, Documentation, and Regulatory Standards
Standards and Oversight
Candidates should understand the roles of USP general chapters relevant to compounding, state boards of pharmacy, and federal requirements. Know that beyond-use dates are assigned based on stability, risk level, and storage conditions, and that documentation must support each compounded preparation. Master formulation records, compounding records, and standard operating procedures are key documents.
QA Program Elements
Know the components of a quality assurance and quality control program: environmental monitoring, equipment certification, personnel training and competency, process validation, and complaint/incident review. Understand the purpose of a prescription or medication order review and the need for a second check for high-risk preparations.
Documentation Traps
Questions often ask which record must contain which element. Remember that the master formulation record is the recipe, while the compounding record documents the specific batch. Another trap: assigning beyond-use dates without considering storage temperature or the risk level of the preparation. Also watch for questions that confuse a policy with a procedure.
Worked Example
If a preparation is assigned a beyond-use date, the answer must be justified by stability data and the assigned storage condition, and the date should be the shorter of the stability-based limit and the risk-level limit.