The United States Pharmacopeia (USP) General Chapter 800 addresses the handling of hazardous drugs (HDs) to minimize the risk of exposure to patients, health care workers and the environment. It became compendially applicable in November 2023. USP 800 contains some key elements that specifically apply to employee safety and HD containment. Section 16, for example, discusses managing HD spills and retaining spill kits on site. This article addresses HD spills that occur in a compounding pharmacy; however, it can be adapted for handling of non-HD chemical spills as well.

On November 1, 2023, revisions to USP Chapter 795 and Chapter 797 became official and made USP 800 compendially applicable and potentially enforceable. However, other regulatory agencies — including state boards of pharmacy and the FDA — may impact whether USP 800 is enforceable in your pharmacy.

A modular compounding cleanroom is a great way to meet evolving regulatory requirements and standards. Learn the basics of a modular cleanroom in the first in a series of articles on Modular Compounding Cleanrooms.