As USP <800> standards transform the management of hazardous drugs (HDs) in healthcare, robotic innovations in compounding pharmacies are offering new solutions to handle these substances safely. Automation and robotics minimize human contact with HDs, improving Occupational Environmental Health & Safety (OEHS) outcomes and supporting USP <800>’s mission to protect healthcare workers, patients, and the environment. But to effectively harness these innovations, facilities must carefully assess and address both the benefits and challenges automation brings in the context of HD handling.

USP <800>: The Standard Protecting Workers, Patients, and Environments

USP <800> was developed to safeguard healthcare professionals, patients, and the environment from the dangers posed by HDs. Guided by the National Institute for Occupational Safety and Health (NIOSH) Hazardous Drug Alert, USP <800> outlines the need for careful handling and storage of drugs known to be carcinogenic or toxic. The standard mandates a combination of engineering controls, personal protective equipment (PPE), and surface sampling to monitor contamination risks. Robotics and automation can streamline these controls, offering innovative ways to ensure safe handling for healthcare workers in environments compliant with USP <800>.

Benefits and Challenges of Robotics and Automation

Robotic automation is changing the landscape of compounding pharmacies, introducing a new level of efficiency and precision. With robotic systems, tasks that traditionally required human interaction can be performed in closed systems that maintain sterility and prevent contamination. These systems can meet USP <797> requirements for sterility while addressing USP <800> containment standards, ultimately reducing potential human exposure to HDs.

However, while automation minimizes routine contact, it does not eliminate it. Maintenance, troubleshooting, and refilling tasks still require human intervention, which means facilities must continue to implement protective measures for these high-risk activities. Understanding both the potential advantages and limitations of robotic systems is crucial in creating a robust safety framework within USP <800>-compliant spaces.

Essential Actions for Compounding Pharmacies Using Robotics under USP <800>

As robotics become integral to compounding pharmacies, adopting specific practices helps ensure compliance with USP <800> while maximizing the safety benefits of automation. Here are five essential actions for robotics-enabled facilities to take:

• Implement maintenance protocols with enhanced protection. Robotics require regular maintenance, troubleshooting, and drug replenishment, potentially exposing staff to HDs even in contained systems. Developing protocols that specify controls including PPE and respiratory protective equipment (RPE) during these tasks is critical in preventing incidental HD contact. Until quantitative surface and air sampling data can confirm low or no exposure risk, requiring staff to wear additional PPE and RPE during maintenance will minimize exposure potential. Focused training on these maintenance protocols reinforces safe handling practices and protects staff.
• Validate cleaning protocols regularly for patient safety. Even though robotic systems are designed for containment, HD residues can accumulate within the system over time, especially with repeated or multi-drug compounding. To prevent cross-contamination and maintain a safe environment, compounding pharmacies should implement cleaning validation protocols similar to those used in pharmaceutical manufacturing. Establishing and monitoring Permitted Daily Exposure (PDE) and Maximum Acceptable Carryover (MAC) levels allows facilities to set safe thresholds and confirm that the robotic system is decontaminated effectively between batches. Regular validation not only supports compliance but also prevents costly shutdowns due to contamination issues.
• Develop a comprehensive surface sampling program. Regular surface sampling in robotic environments is crucial to detect any HD residues that may escape containment, particularly around areas where drugs are loaded, unloaded, or dispensed. A thorough surface sampling program for potential occupational exposure risks should focus on high-contact areas, like touchscreens or robotic entry and exit points, where residues are more likely to accumulate. Establishing a baseline and conducting routine sampling helps identify contamination risks early, allowing facilities to take corrective actions quickly. Partnering with a specialized industrial hygiene laboratory for analysis ensures that samples meet USP <800>’s precision requirements, helping facilities verify that containment measures remain effective over time.
• Identify and control exposure pathways. Robotics can significantly reduce but not eliminate HD exposure risks, and each task within a compounding workflow can present different exposure pathways. Inhalation risks, for example, may be highest during drug preparation, while dermal contact is a concern during tasks that involve direct handling, such as maintenance or loading/unloading HDs. Ideally, automated systems should include negative pressure controls and local exhaust ventilation to limit airborne particles, but facilities also need to equip personnel with appropriate PPE to protect against potential dermal exposure. Understanding these pathways helps facilities create targeted control measures for each potential exposure scenario.
• Conduct long-term exposure monitoring to protect health. Low-dose, repeated exposure to HDs can lead to cumulative and often subtle health risks, including gastrointestinal issues, immune suppression, hormonal imbalances, and reproductive health concerns. For robotics-enabled compounding facilities, the following is recommended to help manage these long-term risks:
  • regular monitoring results, with collection of air and surface samples for potential exposure risk compared to established targets
  • airborne occupational exposure limits (OELs) and acceptable surface limits (ASLs) specific to each HD

Facilities should set targets based on industry standards and manufacturer recommendations and maintain routine air and surface sampling to confirm that robotic environments remain below these limits. This proactive approach creates a “no-harm” threshold, providing confidence that staff health is protected over the long term.

How Trinity Can Help

Trinity Consultants’ WorkingBuildings and SafeBridge teams provide specialized consulting services to help healthcare and life sciences organizations manage hazardous drug safety, comply with regulatory standards, and optimize facility operations for both safety and efficiency. With an American Industrial Hygiene Association (AIHA)-accredited analytical laboratory and a team of seasoned consultants including board-certified pharmacists, industrial hygienists, toxicologists, and quality assurance specialists, we are equipped to help compounding pharmacies navigate an increasingly automated world. We offer exposure
evaluations, contamination assessments, and containment verification for robotic systems, combining safety expertise with a deep understanding of robotics’ unique demands.

With our guidance, facilities can achieve USP <800> compliance, minimize risk, and create a culture of safety, protecting their most valuable assets: their staff and patients.