The Compounding Chronicles: USP <800> Isn’t Just for Pharmacies—Here’s Who’s Still at Risk

January 12, 2026

By Adam West, Course and Curriculum Manager at CriticalPoint

Over the recent holidays, our family’s beloved dog Arla passed away from cancer. Her decline was rapid, and within two months of diagnosis, she was gone. During her veterinary visits, we explored several treatment options, including a consultation with oncology. While the experience was emotionally difficult, I found myself professionally curious about what a modern veterinary oncology clinic looks like.

As a certifier, I’ve visited veterinary chemotherapy suites before (around 2016), and what I observed then was a wide spectrum of compliance with USP <800>. Some facilities were clearly behind the standards, while others had made meaningful efforts to meet containment and design requirements. Seeing these environments again, years later, prompted reflection on how far the industry has—or hasn’t—come.

In this month’s Compounding Chronicles, we turn our attention to hazardous drug (HD) compounding and administration outside the traditional 503A pharmacy setting. Specifically, we explore veterinary practices that compound, prepare, or administer hazardous drugs while caring for our “fur family.” It’s an area potentially overlooked in broader pharmacy compliance discussions.

Who regulates veterinary compounding?

When we think of patient safety, animals may not always be top of mind (something I readily admit). However, when it comes to nonsterile and sterile compounding, including hazardous drugs, USP <795>, <797>, and <800> standards are intended to apply wherever compounding occurs when applicable. That said, enforcement authority in veterinary settings is not always straightforward.

In my state, primary oversight comes from the Veterinary Medical Licensing Board. Veterinary clinics may also be subject to inspection by the state Board of Pharmacy (BOP). However, my state’s BOP’s Veterinary Inspection Guide states only that, “If engaged in hazardous drug compounding, a veterinary clinic may be subject to an additional inspection by a Board Specialist (i.e., pharmacist).” This language leaves room for interpretation and, potentially, inconsistency in enforcement.

In 2023, my state’s Veterinary Medical Licensing Board newsletter further complicates the picture. It announced a compounding rule revision stating that the Board was enforcing USP <797> (2008) and USP <795> (2014), with newer standards not expected to be enforced until at least Spring 2025. Since that notice, little information has emerged regarding how or whether those newer standards will be enforced or if they included USP <800>.

The result appears to be a regulatory gray area: an uncertainty around who inspects veterinary clinics handling hazardous drugs, what standards are actively enforced, and how compliance is evaluated.

What’s the big deal?

Hazardous drug safety is not optional. The risk lies in what people don’t know they don’t know. Facilities that fall behind on USP <800> requirements, whether due to oversight or lack of awareness, may unknowingly expose staff, animals, and even pet owners to hazardous drug residue.

During our recent visit to the veterinary hospital, I observed hazardous drug signage and biological safety cabinets (BSCs) located in a busy corridor between exam and treatment areas. The cabinets were not housed in a designated area away from heavy traffic or containment segregated compounding area (C-SCA), and there was no evidence of negative pressure or containment controls. To be clear, I was not there in an inspection or certification capacity, nor did I inquire into their operations. It simply wasn’t my role in that moment. Fortunately, no active compounding was occurring at the time.

Still, it was unsettling. In 2025, seeing a preparation area so misaligned with basic containment design principles raises serious questions not only about facility design, but about training, policies, and operational controls that may (or may not) be in place.

The takeaway is hazardous drugs do not become less hazardous simply because they’re handled outside a traditional pharmacy. Awareness, training, and containment matter regardless of the setting.

Understanding the Bigger Picture

Yes, hazardous drug labels and handling precautions are intended to inform caregivers and patients; but labeling alone is insufficient when it comes to managing hazardous drug residue, decontamination, disposal, and exposure risks associated with animal bodily fluids and waste. In veterinary settings, these downstream risks are often underestimated or overlooked entirely.

Chemotherapeutic agents commonly used in veterinary medicine, such as chlorambucil and cyclophosphamide, require chemotherapy-rated gloves even when administered in oral dosage forms. This raises important questions beyond compounding and dispensing. What happens after administration? How are animal housing areas cleaned? Are staff trained on proper cleaning, disinfection, and decontamination protocols for surfaces, cages, bedding, and waste? And most important, are teams aware of the risks associated with post-treatment exposure?

These concerns are not hypothetical. Survey data and published studies continue to highlight significant gaps in hazardous drug safety awareness within veterinary practice. In one survey of 201 veterinary nurses and technicians, only 49% reported being informed of hazardous drug exposure risks at the time of hire. Alarmingly, 25% reported mild to severe health effects; 10% reported infertility, miscarriages, or birth defects; and nearly 4% reported a cancer diagnosis. These findings underscore the reality that exposure risks extend well beyond the point of drug preparation.

Moving Toward Solutions

The first and most critical step is awareness. Recognizing that occupational exposure to hazardous drugs exists in veterinary and nontraditional health-care settings just as it does in human health care. Safety must be viewed through a preventative lens supported by consistent adherence to applicable standards, including USP <800>.
Clearer and more consistent enforcement (regardless of regulatory authority) is needed to ensure hazardous drug safety expectations are understood and applied across veterinary settings. However, enforcement alone is not enough.
Training and education remain the cornerstone of effective hazardous drug control. Any staff member who may come into contact with hazardous medications, whether through compounding, administration, cleaning, waste handling, or transport, must be properly trained and equipped to manage risk.

USP <800> extends far beyond engineering controls and negative-pressure room design. The chapter outlines critical operational expectations, including:

defined policies for hazardous drug risk assessment and material use
comprehensive staff training on handling, transport, cleaning, and decontamination
containment design and operational strategies
controls to prevent hazardous drug migration into adjacent spaces and environments

Without these elements working together, facilities remain vulnerable to unintended exposure even when compounding activities appear limited or infrequent.

Summary

Hazardous drugs do not become less hazardous when handled outside traditional pharmacy environments. Veterinary clinics, oncology suites, outpatient clinics, and transport services all represent points of potential exposure that deserve the same level of safety consideration as a cleanroom.

Reconnect the disconnect between hazardous drug standards and real-world practice in veterinary settings, where regulatory oversight can be fragmented and awareness inconsistent. While many clinics are doing their best to provide advanced care for animals, gaps in training, containment, and environmental control place staff, patients, and pet owners at unnecessary risk.

Ultimately, hazardous drug safety is not just a regulatory obligation, it is a responsibility to protect people and animals alike. By prioritizing education, implementing USP <800> principles holistically, and recognizing exposure risks beyond compounding, veterinary practices can move toward safer, more sustainable care environments.