Certified USP 800 Compliance Officer (CUCO)

CUCO (UCO-001) Exam Objectives

This exam certifies that the candidate has the comprehensive, operational knowledge to serve as the designated person responsible for the development and implementation of all procedures related to the safe handling of hazardous drugs.

Domain 1: Program Management and Oversight (30%)

• Role of the Designated Person: Describe the responsibilities of the designated person as outlined in USP <800>.
• Hazardous Drug (HD) List: Develop and annually review an entity’s list of HDs, including an Assessment of Risk (AoR) for dosage forms that may not require full containment.
• Standard Operating Procedures (SOPs): Develop, implement, and maintain all SOPs required by the chapter for the entire lifecycle of an HD.
• Personnel Management: Oversee the training, competency assessment, and medical surveillance program for all personnel who handle HDs.

Domain 2: Facility and Engineering Controls (30%)

• Containment and Storage: Ensure designated areas for HD receipt, storage, and compounding meet all chapter requirements, including proper ventilation.
• Engineering Controls: Verify the proper selection, installation, and performance of Containment Primary and Secondary Engineering Controls (C-PECs and C-SECs).
• Environmental Monitoring: Develop and oversee a program for environmental wipe sampling to detect and manage HD surface contamination.

Domain 3: Safe Handling Procedures (30%)

• Personal Protective Equipment (PPE): Ensure the selection and proper use of appropriate PPE for every activity involving HDs.
• Receiving, Dispensing, and Transport: Implement compliant procedures for unpacking, storing, transporting, and dispensing HDs.
• Administration: Describe the required safe handling precautions for administering HDs to patients.
• Deactivation, Decontamination, Cleaning, and Disinfection: Develop and implement procedures for the routine and terminal cleaning of all areas and equipment.
• Spill Control: Manage a comprehensive spill control program, including training and documentation.

Domain 4: Quality and Compliance Assurance (10%)

• Documentation and Recordkeeping: Ensure all required documentation (e.g., training records, SOPs, AoRs) is maintained and accessible.
• Continuous Readiness: Implement a quality assurance program that ensures the organization is in a constant state of compliance and readiness for any regulatory inspection.

Eligibility Requirements

To be eligible to sit for a CPS certification exam, candidates must meet the criteria outlined in one of the two pathways below.

Pathway 1: For U.S. Licensed Pharmacists

This pathway is for pharmacists licensed to practice within the United States, regardless of country of graduation.

• Hold an active and unrestricted pharmacist license in any state or territory of the United States.
• Meet educational requirements by being a graduate of an ACPE-accredited school of pharmacy or holding a Foreign Pharmacy Graduate Examination Committee® (FPGEC) Certificate.
• Fulfill the specialty experience requirement as outlined below.

Pathway 2: For International Pharmacists (Non-U.S. Licensed)

This pathway is for pharmacists who practice outside of the United States.

• Hold an active and unrestricted license to practice pharmacy in their country of practice. A certified English translation of the license must be provided if the original is not in English.
• Hold a professional degree in pharmacy equivalent to a U.S. pharmacy degree, such as a Bachelor’s degree (BPharm), Master’s degree in Pharmacy Practice (MPharm), or Doctor of Pharmacy degree (PharmD).
• Fulfill the specialty experience requirement as outlined below.

Specialty Experience Requirement (for all pathways)

To ensure candidates have foundational knowledge in the specialty, one of the following criteria must be met:

• Standard Pathway:
  Completion of at least one year of professional experience in a practice setting directly related to the certification area.
• Certificate Pathway:
  The one-year specialty experience requirement is waived for candidates who hold an active certificate of completion from a nationally recognized provider in a related subject matter. This includes, but is not limited to, the completion of a relevant PGY residency, fellowship, certificate/training program, or a relevant graduate degree (e.g., a Master's degree in the specialty field). Recognized providers of certificate programs include, but are not limited to:
  • American Society of Health-System Pharmacists (ASHP)
  • American Pharmacists Association (APhA)
  • American College of Clinical Pharmacy (ACCP)
  • American Society of Consultant Pharmacists (ASCP)

Career Path for CUCO Professionals

The CUCO certification is for the designated leader of a hazardous drug handling program. This credential is vital for pharmacists in roles focused on medication safety, compounding supervision, and regulatory compliance in any setting that handles hazardous drugs.

Target Candidates

• Pharmacists serving as the "designated person" for USP <800>.
• Compounding pharmacy managers or supervisors.
• Medication safety or pharmacy compliance officers.
• Directors of pharmacy in facilities handling hazardous drugs.

Primary Job Roles:

• USP 800 Designated Person / Compliance Officer
• Medication Safety Officer
• Pharmacy Compliance Manager
• Compounding Supervisor or Manager
• Director of Pharmacy

Career Advancement:

A CUCO is positioned as the ultimate subject matter expert on hazardous drug safety for their organization. This expertise is critical for advancement into senior leadership roles such as Director of Medication Safety, Chief Compliance Officer, or an independent consultant specializing in USP <800> implementation and remediation.

Study Resources

Prepare for your CUCO exam with resources designed to master the operational implementation of USP <800>.