This eLearning course, delivered through an innovative, interactive, online format, 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.
Earn Continuing Pharmacy Education Credits:
(Insert ACPE logo here) NABP and the NABP Foundation® are accredited by the Accreditation Council for Pharmacy Education as providers of CPE. ACPE Provider Number: 0205
This knowledge-based course has been approved for 6.5 hours of continuing pharmacy education (CPE) credit for both pharmacists and pharmacy technicians.
Access Duration:
This USP Education course will only be available to you for 60 days from the day of registration or until you mark it ‘Complete’ in your Training/Transcript page – whichever occurs first. If you intend to request CPE credits, you must complete all requirements within 60 days of registration.
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):
Compounding professionals responsible for or involved in safe compounding of sterile preparations, including
– Pharmacists
– Pharmacy technicians
– Veterinarians
– Physicians
– Nurses