This complete USP <797> Standard Operating Procedure (SOP) Bundle provides licensed compounding facilities with all the protocols required to meet national sterile compounding standards.

It includes detailed SOPs for training and evaluating compounding staff, aseptic technique, environmental monitoring, documentation, quality control, gowning, cleaning, and emergency response.

Designed to ensure safety, consistency, and regulatory compliance, this bundle is essential for any practice preparing compounded sterile preparations (CSPs). Download now to standardize operations and uphold the highest standards of patient safety and care.

150+ pages

37 documents

What's included:

1. Orientation Program & Job Descriptions
2. Job Description - Compounding Pharmacy Technician
3. Job Description - Designated Person-in-Charge of the IV Preparation Area
4. Personnel Records for Compounding
5. Sterile Personnel Training and Evaluation
6. Designated Person Responsible for Sterile Compounding
7. Staff Testing – Hand Hygiene
8. Staff Testing – Garbing
9. Staff Testing - Disinfecting Sterile Compounding Area
10. Staff Testing - Aseptic Technique Working with an Isolator
11. Staff Testing – Media Fill Challenge
12. Staff Testing – Gloved Fingertip Sampling
13. Calibration of Temperature Sensing Equipment
14. Expired Compounded Preparations
15. Final Inspection of Your Compounded Product
16. Good Documentation Practices
17. How To Disinfect Non-Hazardous Sterile Compounding PEC Work Surfaces
18. Ordering IV Vitamins & Drugs
19. Safety Data Sheets
20. Surface and Viable Air Sampling – Environmental Monitoring
21. The Cleaning Log for Your Sterile Compounding Area
22. The Compounding Record
23. Using the NU-PR797 Containment Aseptic Isolator (CAI)
24. Using Your Emergency Eye Wash
25. What do to for a Drug Recall
26. When there is Equipment and Facility Maintenance
27. Your Performance Improvement Program
28. Complaints and Adverse Events
29. Labeling Immediate Use CPSs
30. Personal Hygiene and Preparation for Compounding Areas
31. Storage and Stability Requirements for Compounded Sterile Preparations
    (CSPs)
32. Establishing a Beyond Use Date for a Compounded Sterile Preparation
33. Use of Conventionally Manufactured Single-dose and Multiple-dose Containers
34. Preparation Per Approved Labeling and Compounding Staff Training
35. Management and Maintenance of Water Sources in Compounding Facilities
36. Personnel Training and Qualification for Compounded Sterile Preparations
    (CSPs)
37. Implementing USP 797 Guidelines