Technician Compounding; Compliance; Patient Safety Written 8 credit hours

This course provides a comprehensive review of USP <797> requirements and essential practices for maintaining the quality and sterility of compounded sterile preparations. The course examines personnel competency, aseptic technique, facilities and environmental controls, cleaning and monitoring, CSP preparation, beyond-use dating, immediate-use compounding, quality assurance, and documentation. You will strengthen your ability to incorporate USP <797> requirements into sterile compounding practices that promote quality, compliance, and patient safety.

Learning Objectives

Upon successful completion of this application-based CPE course, pharmacists should be able to:
1. Summarize the purpose, scope, and applicability of USP <797> to sterile compounding practice.

2. Differentiate Category 1, Category 2, and Category 3 compounded sterile preparations (CSPs).

3. Describe the responsibilities of the Designated Person in overseeing sterile compounding operations.

4. Explain the role of quality assurance and quality control in maintaining compliance with USP <797>.

5. Outline personnel hygiene and garbing requirements for sterile compounding activities.

6. Sequence appropriate hand hygiene and garbing procedures for entry into sterile compounding areas.

7. Identify initial and ongoing personnel training and competency requirements for sterile compounding.

8. Discuss principles of aseptic technique that protect critical sites and maintain first air during sterile compounding.

9. Illustrate how HEPA filtration and unidirectional airflow support an appropriate sterile compounding environment.

10. Compare primary and secondary engineering controls used in sterile compounding.

11. Recognize practices that support appropriate movement of personnel and materials within sterile compounding environments.

12. Interpret requirements for environmental and microbiological monitoring of sterile compounding areas.

13. Distinguish cleaning, disinfection, sporicidal treatment, and application of sterile 70% isopropyl alcohol within sterile compounding areas.

14. Calculate quantities, concentrations, dilutions, and final volumes required to prepare CSPs accurately.

15. Define appropriate measuring, mixing, and verification practices for CSP preparation.

16. Determine appropriate beyond-use dates based on CSP category, preparation conditions, testing, stability, and storage requirements.

17. Evaluate sterile compounding scenarios to determine whether preparations meet criteria for immediate-use CSPs.

18. Select appropriate sterilization, depyrogenation, and release-testing requirements for a given CSP.

19. Specify labeling, handling, storage, packaging, and transport requirements for CSPs.

20. Characterize documentation requirements for Master Formulation Records, Compounding Records, and other sterile compounding quality records.

Faculty

Nic Mastascusa, PharmD, BCNP

Disclosures:

Nic Mastascusa has no relevant financial relationships with ineligible companies to disclose.  

Course Details