Use this comprehensive compounding pharmacy inspection checklist to assess compliance with USP 795 and USP 800. Review general licensing and practice types, staffing and training, facility layout and security, temperature control, and storage. Evaluate nonsterile and sterile compounding, hazardous drug handling, equipment qualification and certification, component receipt and API quality, master formulation and compounding records, labeling and beyond-use dating, packaging, and QA/QC programs including complaints, adverse events, and recalls. Includes observational checks for hand hygiene, garbing, cleaning and sanitizing, in-process verification, and final release inspection to help maintain safe, compliant pharmacy operations.
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