CUCO Exam Content Outline

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Certified USP 800 Compliance Officer (CUCO)

Official Examination Content Outline

This document provides the official content outline for the Certified USP 800 Compliance Officer (CUCO) examination. The exam certifies that an individual possesses the leadership skills and expert knowledge required to develop, implement, and manage a comprehensive hazardous drug (HD) safety program that is fully compliant with USP General Chapter <800> and other relevant safety standards.

Examination Specifications

Name of Credential Certified USP 800 Compliance Officer (CUCO)
Certification-Issuing Body The Council on Pharmacy Standards (CPS)
Designation Awarded CUCO
Target Population Pharmacists and other healthcare professionals designated with responsibility for USP <800> compliance.
Examination Length 120 multiple-choice items
Administration Time 3.0 hours

Examination Content Outline

The CUCO examination is weighted according to the six domains listed below. This comprehensive structure covers the full scope of responsibilities for overseeing a compliant hazardous drug handling program, from governance and facility design to waste management, personnel safety, and fostering a culture of compliance.

Domain 1: Program Management and Regulatory Oversight 25%
Domain 2: Facility, Engineering Controls, and Environmental Monitoring 20%
Domain 3: Safe Handling Practices and Personnel Management 20%
Domain 4: Quality Assurance, Auditing, and Emergency Response 15%
Domain 5: Hazardous Drug Waste Management and Environmental Safety 10%
Domain 6: Leadership, Ethics, and Compliance Culture 10%

Domain 1: Program Management and Regulatory Oversight (25%)

Task 1: Fulfill the responsibilities of the designated person for the hazardous drug (HD) safety program.
  • Analyze and apply the responsibilities of the designated person(s) as defined in USP <800>.
  • Oversee the development, implementation, and maintenance of all HD-related standard operating procedures (SOPs).
  • Ensure compliance with all applicable federal and state laws, regulations, and standards (e.g., OSHA, EPA, NIOSH, Boards of Pharmacy).
  • Manage interdisciplinary collaboration between pharmacy, nursing, environmental services, and facilities.
  • Monitor the effectiveness of the overall HD safety program and implement continuous improvements.
Task 2: Manage the entity's HD list and Assessments of Risk (AoR).
  • Implement a systematic process to create, maintain, and review the entity-specific HD list at least every 12 months.
  • Lead a multidisciplinary team to conduct and document compliant Assessments of Risk for eligible NIOSH Table 1 dosage forms.
  • Evaluate and approve alternative containment strategies and work practices identified through the AoR process.
  • Assess the risks of new drugs as they enter the market to determine if they should be added to the HD list.
  • Ensure all AoR documentation is complete, accessible, and reviewed annually.
Task 3: Integrate USP <800> with related compounding and safety standards.
  • Differentiate the specific requirements of USP <795>, <797>, and <825> as they apply to HDs.
  • Design workflows that incorporate the overlapping requirements for non-sterile, sterile, and radiopharmaceutical HDs.
  • Develop integrated training programs that cover all applicable USP chapters for staff handling HDs.
  • Ensure facility design and engineering controls meet the combined requirements of all relevant standards.
  • Create a unified quality assurance program that addresses the unique risks of different HD compounding activities.
Task 4: Manage compliance with state and accrediting body regulations.
  • Interpret and apply state-specific Board of Pharmacy interpretations of USP <800> and related chapters.
  • Coordinate with accrediting bodies (e.g., The Joint Commission, ACHC, URAC) to prepare for and manage USP <800> compliance surveys.
  • Serve as the primary subject matter expert during regulatory inspections of the HD program.
  • Develop and implement formal corrective action plans (CAPAs) in response to any identified deficiencies.
  • Maintain a state of continuous readiness for unannounced inspections or audits.

Domain 2: Facility, Engineering Controls, and Environmental Monitoring (20%)

Task 1: Assess the design and lifecycle management of engineering controls.
  • Evaluate the design of Containment Primary and Secondary Engineering Controls (C-PECs and C-SECs) against USP <800> requirements.
  • Verify proper ventilation, pressure differentials, and air exchange rates for all HD handling and storage areas.
  • Manage the semiannual certification and recertification of all C-PECs and C-SECs.
  • Oversee facility lifecycle events, including the renovation, certification, or decommissioning of HD rooms and C-PECs.
  • Ensure all certification documentation is complete and corrective actions for failures are documented and resolved.
Task 2: Develop and monitor facility cleaning, decontamination, and disinfection SOPs.
  • Select appropriate deactivating, decontaminating, cleaning, and disinfecting agents based on HD characteristics and surface compatibility.
  • Design detailed, step-by-step SOPs for the routine and terminal cleaning of all HD handling areas and equipment.
  • Implement a training and competency program for personnel responsible for cleaning and decontamination.
  • Evaluate the effectiveness of cleaning protocols through visual inspection and environmental sampling data.
  • Maintain comprehensive logs of all cleaning and decontamination activities.
Task 3: Implement and manage an environmental surface sampling program.
  • Design a routine environmental wipe sampling program that defines locations and frequency based on risk.
  • Interpret wipe sampling results against established action levels and lead root cause analysis for any excursions.
  • Develop and implement a formal Corrective and Preventative Action (CAPA) plan in response to out-of-spec results.
  • Use sampling data to evaluate the effectiveness of cleaning procedures, work practices, and containment strategies.
  • Document all sampling activities, results, investigations, and corrective actions in an auditable format.
Task 4: Evaluate the use of technology and automation in HD handling.
  • Assess the role of supplemental engineering controls, such as Closed System Transfer Devices (CSTDs), in minimizing exposure.
  • Evaluate the impact of automation and robotics on the safety and efficiency of HD compounding and dispensing.
  • Ensure that any technology used for HD handling is integrated into the facility's overall safety program.
  • Develop procedures for the cleaning and decontamination of automated compounding devices.
  • Verify that the use of CSTDs does not compromise the sterility of the final preparation.

Domain 3: Safe Handling Practices and Personnel Management (20%)

Task 1: Implement a personnel training and competency assessment program.
  • Design a comprehensive training curriculum for all personnel who handle HDs, covering risks, SOPs, and emergency procedures.
  • Implement a robust competency assessment program, including didactic, observational, and practical components, at least annually.
  • Verify specialized competencies for personnel engaged in sterile versus nonsterile HD compounding.
  • Maintain complete and auditable records of all personnel training and competency assessments.
  • Ensure all personnel of reproductive capability acknowledge in writing that they understand the risks of HD handling.
Task 2: Manage policies for Personal Protective Equipment (PPE) and safe handling across the HD lifecycle.
  • Evaluate and select appropriate PPE that meets the standards specified in USP <800> for each handling activity.
  • Develop and enforce SOPs for all stages of the HD lifecycle: receipt, storage, compounding, administration, and disposal.
  • Ensure proper procedures for donning, doffing, and disposing of PPE to prevent self-contamination.
  • Audit work practices to ensure consistent adherence to safe handling policies.
  • Manage the supply chain for PPE to prevent shortages of critical items.
Task 3: Implement and oversee a medical surveillance program.
  • Establish a comprehensive medical surveillance program in collaboration with occupational health professionals.
  • Ensure that baseline and periodic health assessments are conducted and documented for all at-risk personnel.
  • Analyze aggregate data from the surveillance program for exposure trend analysis to guide preventative actions.
  • Maintain the confidentiality of individual employee health information while using data to improve program safety.
  • Develop policies that support staff who may need to be reassigned to non-HD handling duties for medical reasons.
Task 4: Establish and manage an exposure incident reporting system.
  • Develop a clear and accessible SOP for reporting and managing acute personnel exposure incidents.
  • Lead a confidential investigation into the root cause of any reported exposure event.
  • Ensure affected personnel receive immediate post-exposure care and follow-up in accordance with occupational health protocols.
  • Implement and document corrective actions to prevent the recurrence of similar incidents.
  • Integrate the exposure incident reporting system with the organization's OSHA logs and HR processes.

Domain 4: Quality Assurance, Auditing, and Emergency Response (15%)

Task 1: Manage a comprehensive quality assurance (QA) and continuous improvement program.
  • Establish a written QA program with key quality metrics to track and trend over time.
  • Lead investigations into any quality failures or process deviations using CQI principles.
  • Conduct annual internal audits of the entire HD safety program to identify gaps and vulnerabilities.
  • Develop and track CAPAs to address any findings from internal or external audits.
  • Integrate HD safety audits into the organization's broader patient safety and medication safety programs.
Task 2: Develop and manage the emergency response and business continuity program for HDs.
  • Develop comprehensive SOPs for the management of HD spills and acute personnel exposures.
  • Ensure that appropriately stocked spill kits and emergency equipment are readily accessible.
  • Lead investigations into the root causes of spills and exposures to implement preventative measures.
  • Develop and maintain contingency plans for C-PEC/C-SEC downtime to ensure business continuity.
  • Document all emergency events, responses, and follow-up actions in a detailed and auditable manner.
Task 3: Conduct mock drills and simulation training to validate emergency response readiness.
  • Design and schedule regular mock spill and exposure drills for all personnel who handle HDs.
  • Evaluate staff response during drills against established emergency procedures to identify performance gaps.
  • Conduct debriefing sessions after drills to identify areas for improvement in training and response protocols.
  • Use findings from simulation training to refine emergency SOPs and equipment placement.
  • Document all drill activities, participant performance, and action items for improvement.

Domain 5: Hazardous Drug Waste Management and Environmental Safety (10%)

Task 1: Design and manage a compliant HD waste segregation and disposal program.
  • Establish clear procedures for segregating trace and bulk HD waste at the point of generation.
  • Ensure all waste containers are properly labeled, stored in a secure area, and meet regulatory specifications.
  • Apply federal EPA Resource Conservation and Recovery Act (RCRA) compliance standards to the management of bulk HD waste.
  • Develop protocols for managing different types of HD waste, including sharps, PPE, and expired drug products.
  • Train all personnel on proper waste segregation to minimize cost and ensure compliance.
Task 2: Oversee hazardous waste vendor relationships and ensure regulatory compliance.
  • Evaluate and select a licensed and reputable hazardous waste vendor for the transport and disposal of HD waste.
  • Manage contracts and service level agreements with the waste vendor.
  • Ensure all hazardous waste manifest documentation is accurately completed and maintained according to regulations.
  • Audit the waste vendor's practices to ensure they are compliant with all federal and state regulations.
  • Maintain a complete and auditable file of all waste disposal documentation.
Task 3: Apply sewer disposal restrictions and environmental safety protocols.
  • Implement a strict policy prohibiting the disposal of raw HDs and contaminated body fluids down drains or sewers.
  • Identify specific HDs that are subject to sewer bans under federal or local regulations.
  • Educate clinical staff on proper handling and disposal of patient waste contaminated with HDs.
  • Assess the environmental impact of the facility's HD handling and disposal practices.
  • Develop procedures to minimize the environmental footprint of the HD program.

Domain 6: Leadership, Ethics, and Compliance Culture (10%)

Task 1: Advocate for and cultivate a culture of safety and compliance.
  • Champion the importance of HD safety to executive leadership to secure necessary resources and support.
  • Communicate cost-safety trade-offs and return on investment for USP <800> resource allocation to leadership.
  • Foster a non-punitive reporting environment where staff feel empowered to report near misses and safety concerns.
  • Promote interdisciplinary ownership of the HD safety program across pharmacy, nursing, and environmental services.
  • Serve as a visible role model for safe work practices and ethical behavior.
Task 2: Manage change and overcome resistance to USP <800> implementation.
  • Develop a strategic plan for implementing new policies, procedures, or facilities related to USP <800>.
  • Identify potential barriers to change and develop strategies to address staff concerns.
  • Communicate the rationale for compliance requirements, linking them directly to staff and patient safety.
  • Engage frontline staff in the design and implementation of new workflows to increase buy-in.
  • Celebrate milestones and successes to maintain momentum during long-term implementation projects.
Task 3: Model and communicate ethical obligations related to staff and patient safety.
  • Articulate the ethical imperative to protect healthcare workers from occupational exposure to HDs.
  • Ensure that all staff, including those of reproductive capability, are fully informed of the risks.
  • Model ethical decision-making when balancing staff safety against operational demands or financial constraints.
  • Advocate for patient safety by ensuring that HDs are handled in a manner that prevents contamination of final preparations.
  • Establish a clear process for addressing ethical concerns raised by staff regarding HD handling.

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