Sterile compounding pharmacies have become one of the most regulated areas in a health care facility. The regulations set forth by USP (United States Pharmacopeia) and local boards of pharmacy have been changing significantly, leaving even recently constructed pharmacies out of compliance. Many owners are trying to understand how the regulations will affect the built environment and how pharmacy staff will work within it. This presentation will address how to be in full compliance and the action steps for a successful outcome.
Outline the proposed standards for USP Chapter < 797> Pharmaceutical Compounding–Sterile Preparations Standards, and < 800> Hazardous Drug-Handling in Healthcare Settings and their dates of expected compliance.
Explain the importance of forming an integrated design team, which includes pharmacy staff, facilities, infection control, architects, engineers, and other key stakeholders.
Identify how local pharmacy boards are enforcing the USP standards.
Describe how to translate pharmacy operational processes into effective space planning that keeps staff and patients safe.