CPS Launches Comprehensive Compliance & Regulatory Affairs Portfolio

Behind every safe medication dispensed, every successful clinical program, and every trusted pharmacy service, there is an intricate and often invisible scaffolding of laws, regulations, and standards. This is the world of the pharmacy compliance and regulatory professional. They are the navigators of an increasingly complex sea of federal and state rules, the guardians of institutional integrity, and the architects of the systems that ensure patient safety on a macro scale. Their work requires them to be fluent in the languages of the DEA, Boards of Pharmacy, The Joint Commission, CMS, HRSA, USP, and the FDA—a landscape where a single misstep can lead to multi-million-dollar fines, loss of accreditation, or catastrophic patient harm.

In this high-stakes environment, expertise is not an option; it is an absolute necessity. Yet, until now, there has been no comprehensive, national standard to validate the highly specialized knowledge and skills of these essential professionals.

Today, that changes. Drawing on the most extensive research of its kind ever conducted, the Council on Pharmacy Standards (CPS) is proud to introduce the Comprehensive Compliance & Regulatory Affairs Portfolio. This is a groundbreaking suite of six highly specialized certification programs designed to be the definitive standard of excellence for the guardians of our profession.

This portfolio includes:

• Certified Pharmacy Compliance Officer (CPCO)

• Certified DEA Compliance Pharmacist (CDCP)

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

• Certified USP 800 Compliance Officer (CUCO)

• Certified Pharmacy Law & Ethics Specialist (CPLES)

• Certified Regulatory Affairs Specialist (CRAS)

Forged by Data: The Genesis of the Portfolio

This portfolio was not created in a boardroom; it was forged from the collective expertise of the profession itself. As we announced in September of 2022, we embarked on a National Job Task Analysis (JTA) dedicated exclusively to the practice of pharmacy compliance and regulatory affairs. We extend our deepest gratitude to the thousands of compliance officers, medication safety leaders, 340B coordinators, and regulatory specialists who participated in this landmark study. Your input provided an unprecedented, data-rich view into the realities of your practice.

The JTA findings were unequivocal. They revealed a profession that has evolved into a series of deep and distinct sub-specialties, each requiring a unique and sophisticated body of knowledge. The data confirmed that the financial, legal, and patient safety risks associated with non-compliance are higher than ever, and that there is a clear and urgent demand from health systems and employers for a reliable, evidence-based way to identify and verify true expertise in these critical domains. This portfolio is the direct, data-driven product of that national mandate. Each certification is built upon the blueprint you helped create.

An In-Depth Examination of the Compliance & Regulatory Affairs Portfolio

Each of the six certifications in this portfolio has been designed to validate a specific and critical area of expertise. They are intended for experienced professionals seeking to demonstrate an advanced level of mastery in their respective fields.

Certified Pharmacy Compliance Officer (CPCO)

The Professional Imperative: The modern pharmacy enterprise operates under a complex umbrella of healthcare law and regulation. The CPCO is the strategic leader responsible for overseeing this entire framework, ensuring the organization not only follows the law but also fosters a pervasive culture of integrity and ethical conduct. The Scope of Practice: This certification is for the senior leader of a pharmacy compliance program. Their role is broad and strategic, encompassing the development and implementation of the annual compliance work plan, chairing the pharmacy compliance committee, conducting internal investigations into potential non-compliance, and serving as the primary liaison and strategist during major external audits. The CPCO must be fluent in the major tenets of healthcare compliance law, including the Anti-Kickback Statute, the Stark Law, and the False Claims Act, as they apply to pharmacy operations. They are responsible for ensuring effective training and education for all staff, maintaining open lines of communication for reporting concerns (e.g., hotlines), and taking decisive corrective action when deficiencies are found. Who Should Certify: This certification is designed for Directors of Pharmacy, dedicated Pharmacy Compliance Officers or Managers, and other senior leaders who hold ultimate responsibility for the department’s compliance program. Validated Competencies: The CPCO credential validates the competencies essential for executive-level compliance leadership. It assesses an individual’s ability to design and implement an effective compliance program based on the OIG’s seven fundamental elements. It validates expertise in conducting risk assessments, developing auditing and monitoring plans, leading internal investigations, and preparing comprehensive reports for executive leadership and the Board. Earning the CPCO signifies that a professional possesses the strategic vision and operational knowledge to protect their organization from the significant legal, financial, and reputational risks of non-compliance.

Certified DEA Compliance Pharmacist (CDCP)

The Professional Imperative: The management of controlled substances is arguably the single most high-risk function within a pharmacy. The regulations set forth by the Drug Enforcement Administration are extensive and exacting, and the consequences of failure—including diversion, patient harm, and severe legal penalties—are profound. The Scope of Practice: The CDCP is the designated institutional expert on all aspects of controlled substance management, mastering the Code of Federal Regulations (CFR) Title 21. Their expertise covers the entire lifecycle of controlled substances: secure procurement through CSOS, stringent physical security and storage requirements, meticulous record-keeping for inventories and dispensing, the implementation and management of robust drug diversion prevention programs using analytics software, and the compliant handling of waste and disposal. Who Should Certify: This certification is essential for pharmacists directly responsible for controlled substance oversight, including pharmacy operations managers, diversion specialists, and compliance analysts in both hospital and community settings. Validated Competencies: The CDCP credential validates an expert-level mastery of DEA regulations and best practices. It assesses a candidate’s ability to design and manage a perpetual inventory system, conduct biennial inventories, utilize diversion detection technology effectively, manage automated dispensing cabinet security, and lead the response to a DEA audit or inspection. A CDCP-certified pharmacist is a recognized expert in building a closed-loop system of control that protects patients, staff, and the community from the dangers of controlled substance diversion.

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

The Professional Imperative: The 340B Drug Pricing Program provides immense financial benefits that allow covered entities to stretch scarce resources, but it is also one of the most audited and complex programs in all of healthcare. Maintaining program integrity is a full-time, high-stakes responsibility. The Scope of Practice: The CCP-340B is the definitive expert in navigating the notoriously complex world of the 340B program. Their role requires a deep, functional understanding of all Health Resources and Services Administration (HRSA) regulations, audit trends, and policy interpretations. Their work involves the daily oversight of the program, including maintaining an accurate and auditable database, ensuring the “patient definition” is met for every prescription, preventing GPO violations for inpatient drugs, and scrupulously avoiding duplicate discounts with state Medicaid programs. They must also manage the immense complexities of split-billing software, replenishment models, and contract pharmacy arrangements. Who Should Certify: This certification is designed for 340B Program coordinators, managers, and analysts, as well as pharmacy leaders at covered entities who hold primary responsibility for program compliance. Validated Competencies: The CCP-340B credential validates an individual’s ability to maintain a continuously audit-ready 340B program. It assesses expertise in conducting rigorous internal self-audits, preparing for and managing an official HRSA audit, optimizing inventory management models to ensure compliance, and developing comprehensive policies and procedures that govern all aspects of the program. Earning the CCP-340B signifies that a professional has the specialized skills to safeguard this vital program, ensuring its benefits can be maximized while its significant compliance risks are minimized.

Certified USP 800 Compliance Officer (CUCO)

The Professional Imperative: The implementation of USP General Chapter <800> established a new, comprehensive standard for the safe handling of hazardous drugs. Ensuring compliance is not just a regulatory requirement; it is a fundamental obligation to protect the health and safety of every healthcare worker who handles these medications. The Scope of Practice: The CUCO is the designated organizational expert responsible for the implementation and oversight of all aspects of the hazardous drug safety program. Their mastery spans the entire chapter, from facility design requirements (e.g., containment strategies for receiving, storage, and compounding areas) to the proper use of engineering controls (C-PECs and C-SECs) and personal protective equipment (PPE). Their responsibilities include developing the official Assessment of Risk for lower-risk drugs, managing staff training and competency assessment programs, and overseeing the complex processes of deactivation, decontamination, cleaning, and disinfection. Who Should Certify: This certification is critical for Medication Safety Officers, Compounding Supervisors, and any pharmacy leader who has been formally designated as responsible for USP <800> compliance. Validated Competencies: The CUCO credential validates an expert’s ability to build and manage a compliant hazardous drug handling program. It assesses expertise in interpreting and applying the standards of USP <800>, managing an environmental monitoring program (including wipe sampling), developing a comprehensive medical surveillance program for exposed staff, and maintaining all required documentation to demonstrate ongoing compliance. A CUCO-certified professional is a leader in creating a culture of safety and protecting their colleagues from the occupational risks of hazardous drug exposure.

Certified Pharmacy Law & Ethics Specialist (CPLES)

The Professional Imperative: Beyond the black-and-white text of regulations lies a complex gray area where law, ethics, and professional judgment intersect. The CPLES is an expert in navigating this nuanced space, serving as an internal consultant who can guide the organization through its most challenging dilemmas. The Scope of Practice: This certification covers a broader domain than a single set of regulations. It focuses on the deep interplay between federal and state pharmacy law, established codes of professional ethics, and the principles of risk management. The CPLES provides guidance on issues of professional liability and malpractice, the legal parameters of the pharmacist-patient relationship, and the application of formal ethical decision-making frameworks to complex clinical and business scenarios. Who Should Certify: This certification is ideal for pharmacists with a passion for law and ethics, including pharmacy leaders, compliance officers, and academics who teach in this area. Validated Competencies: The CPLES credential validates a professional’s ability to interpret complex statutes, regulations, and case law and apply them to real-world pharmacy practice. It assesses expertise in developing policies and procedures that proactively mitigate legal risk, serving as a resource during litigation, and leading discussions on difficult ethical issues, such as conflicts of interest or resource allocation. The CPLES is a recognized expert on the professional responsibilities that form the bedrock of trustworthy patient care.

Certified Regulatory Affairs Specialist (CRAS)

The Professional Imperative: While many pharmacists practice within healthcare systems, a significant and growing number practice at the intersection of pharmacy, the pharmaceutical industry, and the Food and Drug Administration (FDA). This domain of regulatory affairs requires a unique skill set focused on the drug development and approval lifecycle. The Scope of Practice: The CRAS is a specialist in the regulatory pathways that govern pharmaceuticals. While primarily designed for pharmacists in the pharmaceutical industry, their knowledge is highly relevant to health-system leaders managing clinical trials and REMS programs. The scope includes a deep understanding of the drug approval process (INDs, NDAs), FDA regulations on drug labeling, advertising, and promotion (including the PhRMA code), post-marketing surveillance and pharmacovigilance requirements, and the operational management of complex Risk Evaluation and Mitigation Strategies (REMS) programs. Who Should Certify: This certification is designed for pharmacists working in regulatory affairs, medical affairs, and clinical development within the pharmaceutical and biotech industries, as well as for leaders in academic medical centers who manage large investigational drug services. Validated Competencies: The CRAS credential validates expertise in interpreting FDA guidance documents, contributing to regulatory submissions, managing the operational components of clinical trials within an institution, and ensuring organizational compliance with industry-led programs like REMS. The CRAS is a crucial bridge between the worlds of drug development and patient care.

An Interconnected System of Risk Mitigation

We are launching these six certifications as a cohesive portfolio because compliance is not a silo. It is an interconnected system of risk management. A potential DEA compliance issue (CDCP) is also a profound legal and ethical issue (CPLES) that reflects on the overall effectiveness of the compliance program (CPCO). A challenge in the 340B program (CCP-340B) will inevitably trigger the need for a rigorous internal audit (CPAS).

“No compliance issue exists in a vacuum,” said a Chief Compliance Officer from a major health system who served as the SME Chair for this JTA. “This portfolio brilliantly recognizes both the profound need for deep specialization in areas like 340B or USP, and the reality that all of these domains are interconnected. It provides a comprehensive toolkit for building a truly resilient, multi-faceted compliance program.”

For the Guardians of the Profession: Eligibility and Details

These are advanced certifications designed to recognize highly experienced professionals. Eligibility requires a minimum of five (5) years of pharmacy practice experience, with a significant and documentable focus in the specific compliance or regulatory domain for which you are applying.

Detailed eligibility pathways and application requirements are available in the official Candidate Handbooks, now downloadable from our website. Registration for the inaugural examination window for all six certifications opens on March 1, 2023. Examinations will be available via both Live Remote Proctoring and at our network of in-person test centers beginning June 1, 2023.

In a world of increasing complexity and risk, validated expertise is the ultimate safeguard. It is time to recognize the leaders who provide that protection.

Validate your expertise. Protect your patients. Lead your organization with confidence. Explore the Compliance & Regulatory Affairs Portfolio.

The Leadership Team, Council on Pharmacy Standards (CPS)