Training and Competency for USP <800> Compliance

June 2021 - Vol.18 No. 6 - Page #10
Category: USP Training Programs

On February 1st, 2016, the United States Pharmacopeia (USP) first published USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, establishing a framework for safe hazardous drug (HD) handling practices. After the public comment period, the chapter became official on December 1st, 2019, as informational only and not compendially applicable.1 Despite this classification, most organizations have chosen to pursue widespread adoption of the standards in order to promote staff, patient, and environmental safety.

One of the key requirements set forth in USP <800> is personnel training. Per the chapter, employees handling HDs must receive job-specific training. Many aspects must be considered when developing a training program, including:

  • Identifying all staff that handle HDs
  • Establishing role-appropriate training content
  • Developing documentation processes once training is complete

It is important to acknowledge that there is not one specific, correct way to train staff; rather, each organization must assess the tools available and then develop training programs that reflect their practices. The discussion herein details the experiences encountered as we worked across our health system, Froedtert & the Medical College of Wisconsin Health Network, to develop education pathways for USP <800> training.

Froedtert & the Medical College of Wisconsin Health Network is a Milwaukee, Wisconsin-based integrated health care system. The flagship location, Froedtert Hospital, is a nationally recognized, 689-bed academic medical center that operates the region’s only adult Level I trauma center. Pharmacy services are integrated across the system and include acute care, ambulatory, outpatient, and supply chain operations. The development of USP <800> training resources required a partnership among pharmacy, nursing, occupational health, safety, risk, compliance, and various other departments.

Identifying Staff Roles

Considering the broad scope of USP <800>, an initial challenge faced by our team was trying to clearly delineate which staff members handle HDs. To address this, an online training module for USP <800> was developed and assigned to all staff in the system.

Each staff member receives a brief introduction to USP <800> and then answers a series of questions related to their role and job duties. Based on these answers, the training module then prompts a pathway for each staff member based on involvement in patient care, preparation and/or administration of HDs, and spill response responsibilities (see FIGURE). A multidisciplinary team collaborated to develop the series of questions prompting the pathways, as well as the training materials contained in each pathway.

Crafting the series of questions used to prompt the various pathways was a complex endeavor, as question design was critical to ensuring that staff members receive the proper training. Staff were separated into three general domains: provider, patient care, or non-patient care (FIGURE). Staff members that fell under the provider and patient care domains were asked if they handle or administer medications, while the non-patient care domain was further separated by work locations. This process was time consuming and required engagement across disciplines, including the organizational learning team, nursing, and compliance. Moving forward, the ideal state would be to identify staff members who handle HDs by job descriptions, which will theoretically facilitate a targeted assignment of training. In turn, each department will update job descriptions as needed to include handling of hazardous medications as a potential component of the work environment.

Designing Role-Based Training

The content for each pathway is structured to meet USP <800> requirements and the corresponding organizational policy. For example, the Patient Care with Administration of HDs pathway includes an introduction that comprises information and concepts covered in USP <800>. The pathway then becomes more specific and addresses concepts from the organization’s Hazardous Drugs – Handling and Administration policy and procedure.

Each pathway offers the opportunity to educate staff on changes in practice required as a result of USP <800>. For example, adjustments in the required personal protective equipment (PPE) for each category of HD are included. In addition, available organizational resources also appear in the online training module, such as a listing of hazardous drug policies and procedures, the organization’s hazardous drug list, and PPE tables.

Documentation of Training

Documentation of organization-wide training is monitored through the assignment and completion of the modules in the online system. Included in the system is the HD Acknowledgement of Risk form. To comply with USP <800>, each staff member utilizing the system also signs this form. Additional pharmacy-specific training is recorded in a separate online IV management tool.

Looking to the Future

Moving forward, the multidisciplinary team will ensure USP <800> compliance with the creation of two separate online training modules. The initial online training module created for implementation of USP <800> will be utilized for all new staff members, given the greater depth of the materials. The second online training module will be more succinct, focus on key changes, and serve to meet the ongoing annual training requirement.


  1. United States Pharmacopeia (USP). USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. Accessed October 27, 2020.

Matthew Wolf, PharmD, MS, BCSCP, is the pharmacy director of Acute Care Operations at Wake Forest Baptist Hospital. Matt received his pharmacy degree from the University of Michigan and completed a 2-year administrative residency at the University of Wisconsin.

Taylor Mancuso, PharmD, is a medication safety pharmacist at Froedtert & the Medical College of Wisconsin Health Network. Taylor received her pharmacy degree from Midwestern University. She completed her PGY1 training at Wheaton Franciscan St. Joseph Hospital and PGY2 training in Medication Safety at Froedtert & the Medical College of Wisconsin Health Network. Her interests include smart pump analytics, Second Victim support, and quality data metric evaluation.


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USP Training Programs
For a full list of vendors offering USP Training Programs, go to:
Key USP Training Programs Suppliers
CAPS (A B. Braun Company)
CriticalPoint, LLC
Fagron, Inc
Kastango Consulting Group
LDT Health Solutions, Inc
TRC Healthcare, Inc
Technical Safety Services, LLC
Visante Inc
Wolters Kluwer Health

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