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AI Summary: This regulation updates the Maryland Board of Pharmacy's standards for sterile pharmaceutical compounding. The regulation revises and expands requirements for pharmacies engaged in sterile compounding, including updates to definitions, facility requirements, equipment standards, training protocols, and quality assurance processes. Key changes include more detailed standards for cleanroom environments, comprehensive training requirements for staff, enhanced documentation and record-keeping protocols, and specific guidelines for handling hazardous drugs. The regulation incorporates updated United States Pharmacopeia (USP) Standards for sterile compounding, specifically USP Chapters 797 (Sterile Preparations), 800 (Hazardous Drugs), and 825 (Radiopharmaceuticals). The updates aim to improve the safety, quality, and consistency of sterile pharmaceutical compounding practices in Maryland pharmacies, with a focus on preventing contamination, protecting staff, and ensuring the integrity of compounded medications.