This is a home study program designed to introduce participants to current version of USP Chapter <797>. USP Chapter <797> describes the minimum practices and quality standards to be followed when preparing compounded sterile human and animal preparations (CSPs).
This 20-hour home study is an optional companion to the Comprehensive Sterile Compounding course for technicians and pharmacists. After successful completion of the two courses, the participant will have earned 40.0 hours of Sterile Compounding CE. This course may also be taken independently of the Comprehensive Sterile Compounding Course.
At the completion of this activity, the participant will be able to:
- Identify the requirements and standards described in this chapter
- Distinguish between the two risk categories
- Determine the minimum qualifications for personnel preparing and handling CSPs
- Review the importance of developing a training program for persons performing sterile compounding
- Determine proper facility design based on workflow, area, number of personnel placement of equipment, etc
- Recognize the need for an environmental monitoring program
- Determine a cleaning and disinfecting schedule with the minimum frequency described in USP Chapter <797>
- Recognize sterilization methods and circumstances in which they are employed
- Recognize all the parameters involved in release testing, labeling, and establishing beyond-use dating
- Review the formal Quality Assurance and Quality Control program as outlined in USP Chapter <797>
- Recognize proper handling, storage, packaging, and transportation of compounded sterile preparations
- Recognize the importance of complete and accurate documentation
- Identify radiopharmaceuticals and the risks associated with compounding them
Purchase of the USP Chapter <797>
Home Study is limited to a single user and a single download. Course materials are copyrighted by the American College of Apothecaries and may not be duplicated, reproduced, or disseminated without express written permission. All rights reserved © 2018.
This home study is currently being reviewed and updated.
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