White Paper
Facility and Engineering Control Design Under USP 800
In light of the recently published versions of USP chapters <795>, <797>, and <800>, with the intention of creating cohesive alignment between nonsterile and sterile compounding, it is essential to consider engineering controls for Hazardous Drug (HD) handling within these two categories of compounding. Issues such as compounding volume, production downtime during renovations, air filtration, make up air units, and exhaust methods all factor into the design considerations for creating a compliant HD compounding operation.
