CVCS Exam Content Outline

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Certified Veterinary Compounding Specialist (CVCS)

Official Examination Content Outline

This document provides the official content outline for the Certified Veterinary Compounding Specialist (CVCS) examination. The exam certifies that a pharmacist possesses the specialized knowledge and skills in veterinary pharmacology, formulation development, regulatory standards, clinical application, and practice management required to safely and effectively compound medications for animal patients.

Examination Specifications

Name of Credential Certified Veterinary Compounding Specialist (CVCS)
Certification-Issuing Body The Council on Pharmacy Standards (CPS)
Designation Awarded CVCS
Target Population Pharmacists specializing in veterinary pharmacy and compounding.
Examination Length 120 multiple-choice items
Administration Time 3.0 hours

Examination Content Outline

The CVCS examination is weighted according to the six domains listed below, covering the full scope of modern veterinary compounding practice. The domains reflect the knowledge and skills required for competent practice, from foundational science and regulatory compliance to clinical application and practice management.

Domain 1: Foundational Veterinary Pharmacology & Regulatory Compliance 15%
Domain 2: Veterinary Formulation Design & Component Selection 15%
Domain 3: Compounding Procedures & Quality Control 25%
Domain 4: Patient & Caregiver Counseling, Safety, and Pharmacovigilance 20%
Domain 5: Veterinary Clinical Application & Therapeutics 15%
Domain 6: Professionalism, Ethics, & Practice Management 10%

Domain 1: Foundational Veterinary Pharmacology & Regulatory Compliance (15%)

Task 1: Evaluate species-specific pharmacological factors impacting drug therapy.
  • Differentiate the anatomy and physiology of common companion, exotic, and food-producing animal species.
  • Analyze pharmacokinetic and pharmacodynamic variability between species (e.g., absorption, metabolism, receptor sensitivity).
  • Assess species-specific drug toxicities and contraindications to prevent adverse events.
  • Apply principles of allometric scaling for dose calculation and adjustment across species.
  • Evaluate how an animal's age, breed, and concurrent disease states influence drug selection and disposition.
Task 2: Apply federal and state regulations governing veterinary pharmacy.
  • Interpret FDA Compliance Policy Guides (CPGs) and AMDUCA for extra-label drug use.
  • Differentiate legal requirements for compounding from FDA-approved drugs versus bulk drug substances.
  • Assess the validity of a Veterinarian-Client-Patient Relationship (VCPR).
  • Ensure compliance with state-specific board of pharmacy rules for veterinary prescribing.
  • Analyze emerging regulatory issues, including telepharmacy and remote prescribing for animal patients.
Task 3: Manage controlled substances in strict compliance with DEA and state regulations.
  • Implement procedures for ordering, receiving, storing, securing, and dispensing controlled substances.
  • Maintain accurate and perpetual inventories, reconciling records in accordance with federal and state law.
  • Verify the legitimacy of controlled substance prescriptions for animal patients, including all required elements.
  • Develop protocols for the proper disposal and reverse distribution of controlled substances.
  • Ensure all record-keeping for controlled substance compounding is complete and readily retrievable for inspection.
Task 4: Implement USP and other professional standards for veterinary compounding.
  • Apply the principles of USP General Chapters <795>, <797>, and <800> to veterinary-specific scenarios.
  • Develop standard operating procedures (SOPs) that align with current professional guidelines.
  • Establish facility design and engineering controls appropriate for the type of compounding performed.
  • Implement personnel training and competency assessment programs for all compounding staff.
  • Ensure all documentation, including Master Formulation and Compounding Records, meets or exceeds professional standards.
Task 5: Critique veterinary drug information resources to support evidence-based practice.
  • Access and interpret information from primary, secondary, and tertiary veterinary literature (e.g., Plumb’s, journals).
  • Evaluate the quality of evidence for the safety, efficacy, and stability of compounded preparations.
  • Differentiate between established therapeutic uses and anecdotal reports for specific formulations.
  • Serve as a drug information expert for the veterinary healthcare team.
  • Stay current with new drug approvals, guideline changes, and emerging research in veterinary pharmacy.

Domain 2: Veterinary Formulation Design & Component Selection (15%)

Task 1: Select appropriate APIs and excipients based on biopharmaceutical and species-specific principles.
  • Evaluate the physicochemical properties (e.g., solubility, pKa) of APIs to guide formulation development.
  • Interpret Certificates of Analysis (C of A) to ensure the quality and purity of bulk substances.
  • Choose excipients that enhance solubility, stability, or palatability while avoiding species-specific toxicities.
  • Select appropriate preservative systems based on the dosage form and potential for microbial growth.
  • Ensure all selected components are from reputable sources and meet USP-NF or equivalent quality standards.
Task 2: Design non-sterile formulations to optimize palatability and owner adherence.
  • Develop formulations for oral liquids, powders, and capsules tailored to animal size and needs.
  • Design flavored, soft chewable treats considering species-specific taste preferences (e.g., savory for cats, sweet for dogs).
  • Formulate oral pastes and transdermal gels to provide alternative administration routes for difficult-to-medicate animals.
  • Select appropriate suspending and emulsifying agents to ensure content uniformity in liquid preparations.
  • Choose dosage forms that are likely to improve owner adherence to the treatment plan.
Task 3: Formulate sterile and specialized preparations ensuring patient safety and product stability.
  • Design injectable formulations with appropriate pH, tonicity, and sterility for various routes of administration.
  • Develop sterile ophthalmic, otic, and inhalation preparations that are non-irritating and properly preserved.
  • Calculate osmolality and perform necessary adjustments for parenteral and ophthalmic preparations.
  • Select appropriate sterilization methods (e.g., filtration, autoclaving) based on drug and container stability.
  • Evaluate the potential for pyrogens and particulates, implementing procedures to minimize their presence.
Task 4: Design formulations for food-producing animals, ensuring residue avoidance and regulatory compliance.
  • Select APIs and excipients that are approved or have established tolerance levels in food-producing species.
  • Utilize resources like the Food Animal Residue Avoidance Databank (FARAD) to establish appropriate withdrawal intervals (WDIs).
  • Formulate preparations to be stable under farm or field conditions.
  • Avoid components that could interfere with residue testing or are prohibited for extra-label use.
  • Maintain detailed records to ensure traceability and compliance with food safety regulations.

Domain 3: Compounding Procedures & Quality Control (25%)

Task 1: Execute non-sterile compounding procedures using appropriate techniques and equipment.
  • Apply techniques such as comminution, geometric dilution, and levigation to ensure homogenous mixtures.
  • Operate, calibrate, and maintain compounding equipment such as electronic balances, ointment mills, and capsule machines.
  • Utilize appropriate methods for preparing various dosage forms like suspensions, emulsions, and soft chews.
  • Package finished preparations in containers that maintain stability and protect from degradation.
  • Document all steps of the compounding process accurately on the compounding record.
Task 2: Apply aseptic techniques for preparing sterile preparations in compliance with USP <797>.
  • Perform proper hand hygiene, garbing, and aseptic technique within primary engineering controls.
  • Manipulate sterile components and devices without introducing microbial contamination.
  • Conduct media-fill and gloved fingertip sampling tests to validate aseptic proficiency.
  • Implement cleaning and disinfecting procedures for the cleanroom suite and sterile compounding areas.
  • Ensure the proper staging and introduction of materials into the controlled environment.
Task 3: Manage hazardous drugs throughout the compounding lifecycle according to USP <800>.
  • Identify hazardous drugs (HDs) using the NIOSH list and perform an assessment of risk for the veterinary practice.
  • Implement procedures for the safe receipt, storage, compounding, and transport of HDs.
  • Utilize appropriate personal protective equipment (PPE) and closed-system transfer devices (CSTDs).
  • Establish protocols for deactivating, decontaminating, cleaning, and disinfecting HD handling areas.
  • Manage HD spills and waste disposal in accordance with environmental and safety regulations.
Task 4: Implement a comprehensive quality management system, including facility and environmental monitoring.
  • Develop and maintain a written quality assurance (QA) plan that includes SOPs, training, and documentation.
  • Perform final verification of preparations for accuracy, labeling, and physical characteristics.
  • Conduct routine equipment calibration, performance validation, and preventative maintenance.
  • Implement an environmental monitoring program, including air and surface sampling, in compliance with USP standards.
  • Establish a process for investigating, documenting, and resolving compounding errors, deviations, or complaints.
Task 5: Integrate technology to enhance compounding safety, quality, and efficiency.
  • Utilize compounding software for calculations, workflow management, and maintaining digital logs.
  • Implement barcode scanning to verify ingredients and prevent errors during the compounding process.
  • Evaluate and properly use automated compounding devices for mixing, filling, or packaging.
  • Maintain secure and redundant digital records for prescriptions, compounding activities, and quality control data.
  • Leverage technology for inventory management and tracking of chemicals, including lot numbers and expiration dates.

Domain 4: Patient & Caregiver Counseling, Safety, and Pharmacovigilance (20%)

Task 1: Counsel caregivers on the safe and effective administration of compounded medications.
  • Provide clear, step-by-step instructions and demonstrations on how to measure and administer the medication.
  • Educate on proper storage, handling (especially for HDs), and disposal procedures.
  • Discuss potential adverse effects, signs of toxicity, and actions to take if they occur.
  • Address common barriers to adherence, such as palatability or a difficult-to-medicate animal.
  • Verify caregiver understanding through teach-back methods or asking clarifying questions.
Task 2: Manage communication-related risks by documenting informed consent and mitigating liability.
  • Communicate the rationale for using a compounded medication versus an FDA-approved product.
  • Explain the potential risks and benefits associated with the specific compounded formulation.
  • Document conversations with clients regarding risks, benefits, and administration instructions.
  • Develop and utilize consent forms for high-risk preparations or complex cases.
  • Implement strategies to manage professional liability associated with compounded medications.
Task 3: Collaborate with the veterinary healthcare team to optimize therapeutic outcomes and safety.
  • Function as a drug therapy expert, providing formulation recommendations to veterinarians.
  • Communicate effectively to clarify prescription orders and discuss potential therapeutic alternatives.
  • Provide evidence-based information on stability, compatibility, and potential drug interactions.
  • Participate in case discussions to help solve complex therapeutic challenges.
  • Proactively follow up with veterinary clinics to assess patient outcomes and formulation performance.
Task 4: Manage adverse drug events through appropriate pharmacovigilance channels.
  • Recognize and document suspected adverse drug events (ADEs) reported by caregivers or veterinarians.
  • Report ADEs for animal patients to the FDA's Center for Veterinary Medicine (CVM) using Form FDA 1932a.
  • Investigate quality-related complaints that may be linked to an ADE (e.g., suspected sub-potency or contamination).
  • Utilize veterinary pharmacovigilance networks (e.g., VET-LIRN) for surveillance and reporting.
  • Communicate findings and recommendations to the prescribing veterinarian to prevent future occurrences.
Task 5: Generate compliant and informative labeling for dispensed preparations.
  • Create prescription labels that meet all federal and state requirements for veterinary compounds.
  • Clearly state the patient's name and species, owner's name, active ingredients, strength, and quantity.
  • Include the assigned beyond-use date and specific storage instructions.
  • Apply appropriate auxiliary labels (e.g., "Shake Well," "Refrigerate," "Hazardous Drug").
  • Ensure the label explicitly states "Compounded Preparation" or similar required language.

Domain 5: Veterinary Clinical Application & Therapeutics (15%)

Task 1: Develop multimodal pain management and palliative care plans using compounded medications.
  • Compound oral suspensions or transdermal preparations of opioids, NSAIDs, or gabapentinoids.
  • Formulate combination therapies (e.g., creams, gels) to target different pain pathways simultaneously.
  • Design patient-controlled analgesia (PCA) or continuous rate infusion (CRI) solutions for hospitalized patients.
  • Develop palatable formulations to facilitate long-term administration for chronic pain (e.g., arthritis).
  • Formulate medications to manage symptoms in hospice and palliative care, such as appetite stimulants or antiemetics.
Task 2: Design compounded therapies for common chronic conditions in small companion animals.
  • Formulate accurately dosed oral suspensions of cardiac medications for small patients (e.g., pimobendan, benazepril).
  • Develop transdermal preparations for drugs like methimazole for hyperthyroid cats.
  • Compound therapies for managing endocrine disorders like Cushing's disease (trilostane) or diabetes.
  • Formulate anxiolytics and antidepressants (e.g., fluoxetine) into palatable dosage forms for behavioral conditions.
  • Design anticonvulsant therapies (e.g., phenobarbital, potassium bromide) for managing seizure disorders.
Task 3: Formulate specialized treatments for equine, exotic, and oncology patients.
  • Compound large-volume oral pastes or powders for equine patients (e.g., pergolide, omeprazole).
  • Calculate and prepare micro-doses of medications for exotic species (e.g., reptiles, birds, pocket pets).
  • Compound chemotherapeutic agents, ensuring precise dosing and adherence to hazardous drug handling protocols.
  • Develop supportive care medications (e.g., antiemetics, pain medications) for cancer patients.
  • Select appropriate flavoring and dosage forms for species with unique dietary habits and physiological constraints.
Task 4: Assess clinical scenarios to determine the appropriateness of compounding.
  • Evaluate if an FDA-approved, commercially available product could be used instead of a compounded preparation.
  • Analyze a patient case to identify clinical red flags or contraindications for a requested compound.
  • Assess signs of treatment failure and provide recommendations for formulation or dose adjustments.
  • Differentiate between a legitimate therapeutic need and a request for an irrational drug combination.
  • Determine when to decline to compound a prescription due to safety, stability, or regulatory concerns.

Domain 6: Professionalism, Ethics, & Practice Management (10%)

Task 1: Analyze ethical and legal dilemmas in veterinary compounding.
  • Evaluate the ethical principles guiding extra-label drug use and compounding decisions.
  • Manage conflicts of interest that may arise in the pharmacist-veterinarian-client relationship.
  • Assess the legality and ethics of compounding "office use" preparations under current regulations.
  • Determine the professional responsibility to ensure informed consent from the client.
  • Navigate situations where a requested compound may not be in the best interest of the animal patient.
Task 2: Manage practice operations for efficiency and safety.
  • Design a physical pharmacy layout that promotes a safe and efficient workflow.
  • Develop a system for prioritizing prescription orders based on urgency and complexity.
  • Implement effective training, competency assessment, and credentialing programs for all staff.
  • Optimize inventory control systems for APIs, excipients, and supplies to ensure quality and availability.
  • Manage the financial aspects of a compounding service, including pricing, billing, and communicating costs.
Task 3: Foster effective interprofessional collaboration and communication.
  • Build collaborative working relationships with veterinarians, veterinary technicians, and clinic staff.
  • Adapt communication styles to effectively interact with clients from diverse backgrounds.
  • Practice active listening to fully understand the needs of both the prescriber and the caregiver.
  • Provide feedback and receive input in a professional and constructive manner.
  • Communicate effectively with regulatory agencies (e.g., Board of Pharmacy, FDA) during inspections or inquiries.

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