Certified Pharmacy Compliance Officer (CPCO)

CPCO (PCO-001) Exam Objectives

This exam certifies that the candidate has the strategic and operational knowledge to develop, implement, and manage an effective pharmacy compliance program based on federal guidelines.

Domain 1: Healthcare Compliance Program Elements (30%)

• OIG's Seven Elements: Apply the seven fundamental elements of an effective compliance program as outlined by the Office of Inspector General (OIG).
• Governance and Oversight: Describe the roles and responsibilities of the Compliance Officer and the Compliance Committee.
• Policies and Procedures: Develop a code of conduct and other essential compliance policies.
• Training and Education: Design and implement effective compliance training for all employees.

Domain 2: Federal and State Pharmacy Regulations (35%)

• Fraud, Waste, and Abuse (FWA): Apply knowledge of the False Claims Act, the Anti-Kickback Statute, and the Stark Law to pharmacy operations.
• Payer and PBM Compliance: Ensure compliance with Medicare, Medicaid, and commercial payer regulations and contract requirements.
• DEA and Controlled Substances: Oversee compliance with all federal and state regulations for controlled substances.
• HIPAA and Privacy: Manage a program to ensure the privacy and security of protected health information (PHI).

Domain 3: Auditing, Monitoring, and Investigations (25%)

• Risk Assessment: Conduct an annual compliance risk assessment to identify areas of vulnerability.
• Auditing and Monitoring: Develop and execute a compliance audit plan to monitor adherence to policies and regulations.
• Internal Investigations: Manage the process for investigating compliance-related reports, including whistleblower protections.

Domain 4: Ethics and Professional Conduct (10%)

• Ethical Decision-Making: Apply ethical frameworks to resolve complex compliance dilemmas.
• Professional Responsibility: Understand the compliance officer's role in fostering an ethical culture within the organization.

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 CPCO Professionals

The CPCO certification is for senior pharmacy leaders responsible for risk management and corporate integrity. This is a high-level credential for professionals in health systems, PBMs, specialty pharmacies, and other large healthcare organizations.

Target Candidates

• Pharmacists in management or director-level roles.
• Professionals currently in a compliance, regulatory affairs, or medication safety role.
• Experienced pharmacists seeking to advance into a corporate leadership position.
• Consultants specializing in pharmacy operations and risk management.

Primary Job Roles:

• Pharmacy Compliance Officer / Manager
• Director of Pharmacy (with compliance oversight)
• Medication Safety Officer
• Consultant (Pharmacy Compliance)

Career Advancement:

A CPCO is on a direct path to executive leadership. They can advance to become a corporate Chief Compliance Officer, a Vice President of Risk Management for a health system, or a senior partner in a healthcare compliance consulting firm.

Study Resources

Prepare for your CPCO exam with resources designed to master the strategic management of a pharmacy compliance program.