Establishing a system-wide assessment of risk process for investigational drugs

To describe the development and implementation of a standardized, pharmacy-led assessment of risk (AOR) process for investigational products (IPs) in compliance with United States Pharmacopeia (USP) chapter <800> across a large academic health network.

USP <800> mandates institutions to maintain a hazardous drug list but offers limited guidance for investigational agents. The US National Institute for Occupational Safety and Health (NIOSH) has a published list of hazardous drugs that institutions should reference. However, the list only includes agents approved through December 2015, leaving a large gap in hazardous drug standardization for marketed products, providing less precedent for those working with investigational agents. In response, a multidisciplinary workgroup led by pharmacy services developed a system-wide IP AOR process. Two distinct tools incorporating toxicological and biosafety criteria were created to assess small-molecule and biopharmaceutical agents. A centralized database and oversight committee were established to ensure consistency, transparency, and regulatory compliance. As of July 2025, 255 IPs were assessed: 8 high-risk hazardous, 126 low-risk hazardous, and 121 nonhazardous agents. The process has enabled appropriate labeling, safe handling, and efficient review workflows across research pharmacies.

The IP AOR process demonstrates the essential role of pharmacists in operationalizing USP <800> requirements for investigational drugs. This model supports occupational safety, regulatory compliance, and scalable implementation across health systems engaged in clinical research. The process outlined in this manuscript is applicable to both investigational agents and any newly marketed drugs being brought into an institution that haven't been reviewed by NIOSH for inclusion on their list.