Certified Compliance Pharmacist – 340B Focus (CCP-340B)

CCP-340B (340B-001) Exam Objectives

This exam certifies that the candidate has the advanced regulatory, operational, and financial knowledge to successfully manage a compliant 340B Drug Pricing Program.

Domain 1: Program Eligibility and Registration (20%)

• Covered Entity Eligibility: Differentiate between the eligibility requirements for various types of covered entities (e.g., DSH, FQHC, Ryan White).
• Registration and Recertification: Describe the process for registering a new covered entity and its outpatient child sites in the OPAIS database, and the requirements for annual recertification.
• Patient and Provider Eligibility: Define a 340B-eligible patient and an eligible provider according to HRSA guidelines.

Domain 2: Drug Procurement and Inventory Management (35%)

• 340B Pricing: Explain how the 340B ceiling price is calculated and how to verify pricing.
• Inventory Management: Differentiate between a physical inventory and a virtual inventory model for mixed-use settings (e.g., hospital inpatient/outpatient).
• Contract Pharmacy: Describe the operational and compliance requirements for managing 340B contract pharmacy arrangements.
• Group Purchasing Organization (GPO) Prohibition: Explain the GPO prohibition for DSH, children's, and free-standing cancer hospitals.

Domain 3: Compliance and Program Integrity (35%)

• Prevention of Diversion: Implement policies, procedures, and internal audits to ensure 340B drugs are not diverted to ineligible patients (e.g., inpatients).
• Prevention of Duplicate Discounts: Implement strategies to prevent a duplicate discount, where a 340B discount and a Medicaid rebate are both taken on the same drug.
• Orphan Drug Exclusion: Explain the orphan drug exclusion and its application to specific types of covered entities.
• Recordkeeping: Describe the recordkeeping requirements for maintaining auditable records for all 340B-related activities.

Domain 4: Auditing and Program Optimization (10%)

• HRSA Audit Preparedness: Develop a state of continuous audit readiness, including conducting regular internal self-audits.
• Financial Impact: Analyze purchasing data to quantify the financial savings of the 340B program and identify opportunities for optimization.

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 CCP-340B Professionals

The CCP-340B certification is essential for pharmacists and compliance professionals who oversee the 340B program for a health system, FQHC, or other covered entity. It is also highly valuable for consultants and vendors in the 340B space.

Target Candidates

• Pharmacists and pharmacy technicians working for 340B covered entities.
• Pharmacy business managers and finance directors.
• Compliance officers and internal auditors.
• Consultants and software vendors serving the 340B community.

Primary Job Roles:

• 340B Program Manager / Coordinator / Analyst
• Pharmacy Compliance Officer
• Pharmacy Business Manager
• Director of Pharmacy Finance
• 340B Consultant

Career Advancement:

A CCP-340B professional is positioned for senior leadership roles in pharmacy administration and healthcare finance. They can advance to become a Director of Pharmacy Business Services, a health-system executive in finance or compliance, or a senior partner in a 340B consulting firm.

Study Resources

Prepare for your CCP-340B exam with resources focused on this highly complex federal program.