Course Description:
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.
Upon completion of this course, you will be able to:
- 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.
Who should participate:Practitioners including pharmacists, pharmacy technicians, nurses, physicians, veterinarians, and persons involved in compounding sterile preparations.
Earn Continuing Education Credits (Home Study): NABP and the NABP Foundation® are accredited by the Accreditation Council for Pharmacy Education as providers of CPE. ACPE Provider Number: 0205This knowledge-based course has been approved by NABP and the NABP Foundation® for 6.5 hours of continuing pharmacy education (CPE) credit for both pharmacists and pharmacy technicians. Participants must
attend the session its entirety, submit the completion code online, and pass
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