USP 797 & 800 COMPLIANCE: PATHWAYS TO COMPETENCY AND ACCREDITATION ESSENTIALS

Objectives

• At the conclusion of the activity, participants, should be able to: Explain the 2023 USP 797 updates and their application to sterile preparation practices.
• Discuss the competencies for personnel involved in sterile preparations as per USP 797.
• Describe key aspects of cleanroom engineering, design, and environmental controls required by accrediting agencies.
• List the development and implementation steps of environmental, surface, and personnel monitoring programs, including Media-Fill and Finger Tips tests.
• Explain the difference between risk levels and the new categories in USP 797.
• Discuss the process of creating Standard Operating Procedures (SOPs) and Master Formulation documents with examples as required by USP 797.
• Identify Hazardous Drugs (HD), according to USP 800 and NIOSH criteria.
• List potential exposure routes and risks for handling hazardous drugs as per USP 800.
• Describe facility design for receiving, storing, and compounding hazardous drugs.
• Explain the use of personal protective equipment (PPE), and closed system drug transfer devices (CSTDs), following NIOSH and USP 800 guidelines, including the process for deactivation, cleaning, and disinfection after handling HD.

Activity Number

0151-0000-24-021-L04-P/T

CE Hours