04-20-2017 04:00 PM
Is is possible under USP 797 and 800 rules to compound sterile hazardous and non-hazard medications in the same negative pressure room? I manage 10 low volume cleanrooms at community oncology clinics where there is a high percentage of hazard sterile medication compounding. In efforts to comply with USP 800 regulations I would like to have one biologic safety cabinet designated as a hazardous compounding and another BSC designated for non-hazardous compounding in the same negative pressure room. I do not have the space to add an additional room for segregated compounding at all these sites. I see my other option as treating all medications as hazardous. This would generate a huge extra cost in closed system transfer devices.
Director of Pharmacy
04-20-2017 04:56 PM
Yes, you can In the back of USP Chapter <800>, you will find several different facility layouts that can help inform your question. There is other critical information to help you comply with the chapter. There have been a number of posts on the subject within this forum and elsewhere that can be searched and found by Google. Hope this helps.
06-12-2017 01:50 PM
I looked up the diagrams you mentioned at the end of USP 800 and the layouts focus on 1) NonSterile HD comp, 2) Sterile HD comp, and 3) both Sterile HD and non Sterile HD compounding. Which diagram shows NON- Hazardous and Hazardous in the same negative pressure room?
Thank you again for all the great work you do.
Fernand Betancourt, PharmD, MBA, CPh
06-12-2017 02:44 PM
Thanks for your kind words. According to USP 800, both non-HD and HD cannot be done in the same room unless you treat everything as an HD medication (handling and other precautions). Under Section 5.3.2 Sterile Compounding, you find the following language.
A laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI) must not be used for the compounding of an antineoplastic HD. A BSC or CACI used for the preparation of HDs must not be used for the preparation of a non-HD unless the non-HD preparation is placed into a protective outer wrapper during removal from the C-PEC and is labeled to require PPE handling precautions.
Hope this helps.