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USP Chapter 800 Out for Comment

The United States Pharmacopeia has released a new chapter 800 dealing with the handling and preparation of Hazardous Sterile and Non-Sterile items.

The chapter is currently out for comments and should take affect in 2015.

The main points of the chapter are the requirement of biological safety cabinets (BSC) to be vented to the outside. This includes powder hoods used for hazardous non-sterile weighing and measuring.

All hazardous drugs (refrigerated and non) need to be stored in a negative pressure room with monitoring and at least 12 air changes per hour (ACPH).

Many of these points and other that are part of USP Chapter 800 come from the NIOSH Alert Letter released in 2004.

Comments can be sent to with the Line # of the proposed chapter.

More updated to come as we learn more.

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