Hello,
We are preparing for a Joint Commission visit and working on USP <797> compliance in ORs/procedural areas. We are hoping you would be willing to share information about your sterile product practices in these areas and any recent experience with TJC surveyors on this topic.
- Do you consider preparing sterile products in ORs/procedural areas (Examples: drawing up a dose from a vial, drawing propofol into a syringe, etc.) to be immediate-use compounding or per approved labeling?
- If you consider these preparations to be per approved product labeling, how do you ensure compliance with all the required components per USP <797> such as the product labeling including information on diluent, final strength, container closure device, and storage time?
- What BUD do you assign these prepared sterile products?
- If you have been surveyed by TJC on this topic recently, what has your experience been and do you have any recommendations based on the survey?

Thank you in advance for your feedback,
Leana