This course aims to improve your knowledge in the implementation of USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.
The course describes the scope of USP <797>, outlines the responsibilities of compounders, defines the criteria for component selection and describes the facility requirements for sterile compounding.

Subject area:
Healthcare Quality & Safety

Objectives (If applicable):
Describe the scope of USP <797>, including the definition of sterile compounding, categories of compounded sterile preparations (CSPs), personnel and settings affected, the role of the designated person(s) and the practices both in scope and out-of-scope for USP <797>.
Identify USP <797> Standards for personnel training and evaluation, including the requirements for personal hygiene and garbing in sterile compounding environments.
Distinguish the USP <797> requirements for facility design, engineering controls, and certifications that help minimize the risk of contamination to CSPs.
Summarize the USP <797> Standards for environmental monitoring of air and surfaces in sterile compounding environments, including the requirements for placement of water sources, and cleaning and sterilization procedures.
Define the USP <797> requirements for equipment, supplies, and various components used to prepare CSPs.
Analyze the USP <797> requirements for documentation pertaining to all aspects of sterile compounding including Standard Operating Procedures (SOPs), Master Formulation Records and Compounding Records.
Articulate the USP <797> quality assurance (QA) and quality control (QC) program requirements, release testing, recall notifications, and complaint and adverse event reporting procedures for CSPs.
List the required elements for labeling CSPs and handling of finished CSPs, including storage and transportation.

Target Audience (If applicable):
Practitioners including pharmacists, pharmacy technicians, nurses, physicians, veterinarians, and persons involved in compounding sterile preparations