Final answer:
USP 800 mandates that hazardous drugs and HD-APIs be opened in a negative or neutral pressure area to minimize exposure and contamination. Negative pressure rooms pull air in, while neutral pressure rooms maintain equal air pressure with the environment.
Step-by-step explanation:
When receiving Hazardous Drugs (HDs), USP 800 requires that all hazardous drugs and active pharmaceutical ingredients (HD-APIs) be removed from shipping containers in an area that is negative or neutral pressure relative to the surrounding areas. The primary goal of this regulation is to minimize the exposure of staff and the environment to potentially harmful drug particles. In a negative pressure room, air is pulled into the room, preventing HD particles from escaping outside. In a neutral pressure room, the air pressure is equal to the surrounding areas, which does not facilitate the movement of contaminants into or out of the room.
It is critical for facilities handling HDs to comply with these guidelines to ensure worker safety and maintain a controlled and uncontaminated environment. Failure to comply with USP 800 can lead to significant health risks for employees and could result in regulatory action.