Certified Pharmacy Regulatory Specialist (CPRS)

CPRS (PRS-001) Exam Objectives

This exam certifies that the candidate has the expert-level knowledge to lead and manage a comprehensive pharmacy compliance program, ensuring adherence to all applicable laws, regulations, and accreditation standards.

Domain 1: Controlled Substances Compliance (35%)

• DEA Regulations: Apply federal laws and regulations for the procurement, storage, security, dispensing, and recordkeeping of controlled substances.
• Diversion Prevention: Develop and manage a controlled substance diversion prevention program, including surveillance and internal auditing.
• Prescription Drug Monitoring Programs (PDMPs): Understand the role and use of state PDMPs.
• State-Specific Regulations: Differentiate between federal requirements and stricter state-specific laws for controlled substances.

Domain 2: Accreditation and Quality Standards (30%)

• The Joint Commission (TJC): Apply the Medication Management (MM) and National Patient Safety Goal (NPSG) standards in a health-system setting.
• Other Accreditation Bodies: Describe the standards for specialty pharmacy (URAC) and home care (ACHC).
• Survey Preparedness: Lead a state of continuous survey readiness and manage the survey process.
• Quality Improvement: Implement and monitor continuous quality improvement (CQI) programs related to regulatory and accreditation standards.

Domain 3: Federal and State Practice Regulations (25%)

• FDA Regulations: Apply federal regulations related to drug labeling, recalls, and compounding (e.g., FD&C Act).
• State Boards of Pharmacy: Interpret and apply state-level regulations governing pharmacy practice, including technician supervision and scope of practice.
• Compounding Standards: Ensure organizational compliance with all applicable USP General Chapters for compounding.
• HIPAA: Manage compliance with the HIPAA Privacy and Security Rules.

Domain 4: Medication Safety and Risk Management (10%)

• Medication Error Reporting: Manage a medication event reporting and analysis program to identify and mitigate risks.
• High-Alert Medications: Develop and implement specific policies and safeguards for high-alert medications.

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 CPRS Professionals

The CPRS certification is for pharmacists in leadership, administrative, or safety-focused roles who are responsible for ensuring their organization operates within the complex framework of pharmacy law. This is a critical credential for risk management and senior leadership positions.

Target Candidates

• Pharmacists in management roles (e.g., Pharmacy Manager, Director of Pharmacy).
• Medication Safety Officers or Pharmacy Compliance Specialists.
• Pharmacists with experience in preparing for accreditation surveys (e.g., TJC).
• Consultant pharmacists specializing in regulatory affairs.

Primary Job Roles:

• Pharmacy Compliance Manager / Officer
• Medication Safety Officer
• Director of Pharmacy
• Consultant Pharmacist (Regulatory)
• State Board of Pharmacy Inspector / Executive

Career Advancement:

A CPRS is positioned for high-level administrative and executive roles. They can advance to become a Chief Compliance Officer for a health system, a Vice President of Quality and Regulatory Affairs, or a senior consultant specializing in accreditation and regulatory readiness.

Study Resources

Prepare for your CPRS exam with resources focused on the vast landscape of pharmacy law, regulation, and accreditation.