Navigating USP Chapters 795 and 797 Revisions to Maintain Compliance
Navigating USP Chapters 795 and 797 Revisions to Maintain Compliance
This course provides a review of the revised USP general Chapters 795 and 797, the USP chapters dedicated to the standards for compounding nonsterile and sterile preparations, respectively. The content focuses on the essential changes to the current official chapters and does not contain all content or requirements from the revised chapters. Take this course to learn about the new training and evaluation requirements, establishing beyond-use dates (BUDs), and other updates that will affect your compounding practice.
Upon successful completion of this knowledge-based CPE course, pharmacists should be able to:
1. Review the history and purpose of the USP (United States Pharmacopeia) and General Chapter <795> and <797> revisions.
2. Define the role and requirements of the designated person(s) responsible for nonsterile compounding.
3. Identify the <USP 795> revision training and evaluation requirements.
4. Explain how to develop beyond-use dating according to the USP <795> revision.
5. Discuss the scope of the USP <797> revision.
6. Recognize the requirements of Categories 1, 2, and 3 compounded sterile preparations (CSPs).
7. Define the role and requirements of the designated person(s) for sterile compounding.
8. Identify the USP <797> revision training and evaluation requirements.
9. Describe the requirements for certification of all ISO rated environments and microbial air and surface sampling.
10. Summarize the cleaning and disinfectant requirements for sterile compounding.
Jean Rhodes, RPh
Compliance Officer
Iowa Board of Pharmacy
Brittney Origer, PharmD
Compliance Officer
Iowa Board of Pharmacy
Jean Rhodes and Brittney Origer have no relevant financial relationships with ineligible companies to disclose.
Course fee includes course, course materials, and CPE credit submission to CPE Monitor.
Course is non-refundable.
Initial Release Date: August 1, 2023
Planned Expiration Date: August 1, 2026
Copyright 2023, CEimpact. All Rights Reserved. Any reproduction of this course without express permission is strictly forbidden.
RV1-5.24
CEImpact is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Obtain CPE credit by completing the course, followed by the exam and evaluation (if applicable). Once successfully completed, your course will appear in your Completed Courses tab. Access your CPE statement of credit at www.MyCPEMonitor.net.
¹CEImpact provides you with two (2) opportunities to complete the exam. The learner will not receive CPE credit after two failed attempts.
Additional information
| Duration | 1h 0m |
|---|---|
| Topic Designator | Compliance & Regulatory |
| ACPE | Yes |
| ACPE Topic | 07 Compounding |
| Role | Pharmacist |
| Media-Type | On-Demand |
| Release Date | 8/1/23 |
| CEUs | 0.1 |
| Rating | 4 |
| ACPE Number | 0107-0000-23-265-H07-P |
