As we enter the new year various states around the United States have new laws going into effect. The pharmacy industry is no different.
Over the past few years we have seen a new enforceable chapter from USP (United States Pharmacopeia) taking shape, USP Chapter 800. As USP 797 deals with the processing of Sterile items in the pharmacy/ doctor’s office, USP 800 specifically deals with Hazardous items being compounded, bot Sterile and Non-Sterile.
The chapter affects any pharmacy that is working with hazardous items. When we spoke of hazardous in the past it used to be just Chemotherapy Drugs, now it could be that or hormone replacement compounds. The list of items you may be working with considered hazardous under USP 800 is maintained and updated by NIOSH.
How will this affect you?
Here is what we probably know for sure:
- Chemo/ Biological Safety Cabinets and CACIs will need to be vented to the outside
- These hoods as well as Powder Hoods will need to be in a negative pressure room vented to the outside with monitoring
- Powder hoods used to compound hazardous items will need to be vented to the outside or specially designed
- Hazardous hoods and non-hazardous hoods will need to be in separate rooms
Based on enforcement in the past you should have 2 years to make these changes and comply with USP 800. That being said it should go into effect in February 2018, but you should start thinking about the best options for your pharmacy soon.
Any questions or need assistance with compliance contact us at firstname.lastname@example.org or 877-254-7890.