CSCP Exam Content Outline

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Certified Sterile Compounding Pharmacist (CSCP)

Official Examination Content Outline

This document provides the official content outline for the Certified Sterile Compounding Pharmacist (CSCP) examination. This gold-standard blueprint certifies that a pharmacist possesses the advanced, performance-based competencies required to oversee all aspects of a sterile compounding operation, ensuring that all Compounded Sterile Preparations (CSPs) are prepared, stored, and dispensed in compliance with USP standards to guarantee patient safety.

Examination Specifications

Name of Credential Certified Sterile Compounding Pharmacist (CSCP)
Certification-Issuing Body The Council on Pharmacy Standards (CPS)
Designation Awarded CSCP
Target Population Pharmacists, designated persons, and operational leaders responsible for sterile compounding in settings such as hospitals, infusion centers, and 503A/B compounding facilities.
Examination Length 120 multiple-choice items
Administration Time 3.0 hours

Examination Content Outline

The CSCP examination is weighted according to the five domains listed below. This structure reflects a comprehensive, risk-based approach to sterile compounding, aligning with USP General Chapter <797> and other relevant standards. The domains cover foundational knowledge, facility control, personnel competency, preparation integrity, and quality management systems.

Domain 1: Foundations, Standards, and Regulations 15%
Domain 2: The Sterile Compounding Environment 25%
Domain 3: Personnel Training, Competency, and Aseptic Technique 30%
Domain 4: Formulation, Preparation, and Release of CSPs 20%
Domain 5: Quality Management Systems and Documentation 10%

Domain 1: Foundations, Standards, and Regulations (15%)

Task 1: Apply the principles of USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.
  • Define the scope of USP <797> and its applicability to different practice settings.
  • Differentiate between CSP Categories 1, 2, and 3 based on compounding conditions and BUD limits.
  • Identify the roles and responsibilities of the designated person(s) overseeing the compounding program.
  • Explain the importance of a risk-based approach to sterile compounding policies and procedures.
  • Interpret the relationship between USP <797>, <795>, and <800>.
Task 2: Apply principles of pharmaceutical microbiology to prevent contamination.
  • Identify common sources of microbial contamination in the cleanroom environment (e.g., personnel, air, surfaces).
  • Describe the characteristics of microorganisms relevant to sterile compounding (e.g., bacteria, fungi, endotoxins).
  • Explain the mechanisms of action and appropriate uses of various disinfecting and sterilizing agents.
  • Apply first-air principles during aseptic manipulations to prevent contamination.
  • Analyze microbial growth kinetics and its implications for beyond-use dating.
Task 3: Interpret and apply other relevant standards and regulations.
  • Apply principles from USP <71> Sterility Tests and USP <85> Bacterial Endotoxins Test.
  • Recognize the applicability of FDA cGMP (21 CFR Parts 210/211) for 503B outsourcing facilities.
  • Incorporate principles from USP <1163> Quality Assurance in Pharmaceutical Compounding into the QMS.
  • Adhere to applicable state board of pharmacy, FDA, and DEA regulations for sterile compounding.
  • Incorporate guidance from organizations like ASHP and ISMP into sterile compounding practices.
Task 4: Manage medication safety principles within the sterile compounding process.
  • Develop procedures to prevent common medication errors in compounding (e.g., wrong drug, wrong concentration).
  • Implement strategies to mitigate risks associated with high-alert medications.
  • Analyze look-alike/sound-alike (LASA) risks within the compounding pharmacy.
  • Utilize failure mode and effects analysis (FMEA) to proactively identify process risks.
  • Establish a non-punitive reporting system for compounding errors and near misses.

Domain 2: The Sterile Compounding Environment (25%)

Task 1: Evaluate the design and classification of the sterile compounding facility.
  • Differentiate between the ante-room, buffer room, and primary engineering control (PEC) areas.
  • Verify that cleanroom suites meet the required ISO classifications (e.g., ISO 7 buffer room, ISO 5 PEC).
  • Assess the placement of equipment and fixtures to ensure proper airflow and cleanability.
  • Ensure proper pressure differentials and airflow between adjacent classified areas.
  • Evaluate the design of segregated compounding areas (SCAs) and their limitations.
Task 2: Manage Primary and Secondary Engineering Controls (PECs and SECs).
  • Differentiate between various PECs (e.g., laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators).
  • Ensure all PECs and SECs are certified according to CETA standards at least every 6 months and when moved.
  • Review and maintain certification reports for all engineering controls.
  • Develop procedures for the proper daily use and cleaning of PECs.
  • Manage the response to any out-of-specification results from engineering control certification.
Task 3: Develop and oversee a cleaning and disinfection program.
  • Develop evidence-based standard operating procedures (SOPs) for cleaning and disinfecting all classified areas.
  • Select appropriate agents for cleaning, disinfection, and sporicidal treatment based on their properties and dwell times.
  • Establish and verify the frequency of cleaning for all surfaces (daily, monthly).
  • Ensure proper cleaning techniques, materials (e.g., low-lint wipes), and solution application.
  • Train and validate the competency of all personnel responsible for cleaning.
Task 4: Oversee the environmental monitoring program.
  • Develop a comprehensive environmental monitoring plan based on risk assessment.
  • Manage the collection of viable air and surface samples according to the required frequency.
  • Establish alert and action levels for microbial contamination.
  • Investigate any out-of-specification results, identify the root cause, and implement corrective actions.
  • Analyze environmental monitoring data over time to identify trends and proactively address potential issues.

Domain 3: Personnel Training, Competency, and Aseptic Technique (30%)

Task 1: Design and manage a comprehensive personnel training program.
  • Develop a didactic training curriculum covering all aspects of sterile compounding theory and practice.
  • Ensure training includes principles of microbiology, aseptic technique, and cleanroom conduct.
  • Provide education on medication safety, calculations, and proper documentation.
  • Incorporate training on the proper use of all equipment used in the compounding process.
  • Maintain complete documentation of all initial and ongoing training activities for each employee.
Task 2: Manage hand hygiene and garbing procedures.
  • Develop and enforce strict SOPs for hand hygiene and garbing based on USP <797> requirements.
  • Ensure proper sequence for donning and doffing all personal protective equipment (PPE).
  • Select appropriate garb (e.g., sterile gloves, gowns) based on the compounding activity.
  • Train personnel on the importance of garbing as a critical contamination control measure.
  • Regularly observe and provide feedback on garbing practices.
Task 3: Validate personnel competency in garbing and hand hygiene.
  • Conduct initial and recurring competency validation for hand hygiene and garbing.
  • Perform gloved fingertip and thumb sampling (GFTS) after garbing to assess aseptic technique.
  • Establish passing criteria for GFTS based on USP <797> action levels.
  • Investigate and remediate any GFTS failures through retraining and re-evaluation.
  • Document all competency validation activities for regulatory review.
Task 4: Validate personnel competency in aseptic manipulation (Media-Fill Testing).
  • Design media-fill tests that simulate the most complex and challenging compounding procedures performed.
  • Oversee the aseptic conduct of media-fill tests for all compounding personnel.
  • Ensure proper incubation and examination of completed media-fill units for any signs of microbial growth.
  • Investigate the root cause of any media-fill test failure and implement corrective actions.
  • Conduct and document successful media-fill testing initially and at required intervals for all staff.

Domain 4: Formulation, Preparation, and Release of CSPs (20%)

Task 1: Review and verify orders for Compounded Sterile Preparations (CSPs).
  • Assess the clinical appropriateness of the prescribed formulation for the patient.
  • Verify the accuracy and completeness of the medication order.
  • Perform all necessary pharmaceutical calculations (e.g., dose, volume, infusion rate).
  • Consult Master Formulation Records and Compounding Records for preparation instructions.
  • Ensure all required information is documented before compounding begins.
Task 2: Determine appropriate Beyond-Use Dates (BUDs) for CSPs.
  • Assign BUDs based on the CSP Category and storage conditions as defined in USP <797>.
  • Utilize peer-reviewed literature and stability data to assign BUDs that ensure chemical and physical stability.
  • Differentiate between sterility-based BUDs and stability-based BUDs.
  • Develop policies for assigning BUDs to different types of preparations (e.g., single-dose, multi-dose).
  • Understand the requirements and testing needed to extend BUDs beyond default limits.
Task 3: Oversee the aseptic preparation and final verification of CSPs.
  • Ensure proper aseptic technique is used throughout the entire compounding process.
  • Manage the introduction and disinfection of components into the PEC.
  • Implement and manage technologies to enhance safety (e.g., IV workflow systems, barcode scanning, gravimetrics, image capture, robotics).
  • Develop procedures for visual inspection of CSPs against a lighted background for particulate matter and defects.
  • Oversee the final verification of the CSP, including checking ingredients, volumes, and final product integrity.
Task 4: Manage the proper labeling, storage, and transport of CSPs.
  • Ensure all CSP labels contain the required information in a clear and standardized format.
  • Verify that storage conditions (e.g., refrigeration, protection from light) are met after compounding.
  • Develop procedures to maintain the integrity and sterility of CSPs during transport.
  • Use temperature-controlled packaging and monitoring when necessary.
  • Provide clear instructions for patients or caregivers on proper handling and storage at home.

Domain 5: Quality Management Systems and Documentation (10%)

Task 1: Establish and maintain a formal Quality Management System (QMS).
  • Develop a written quality assurance and quality control plan for the compounding facility.
  • Ensure all policies and procedures (SOPs) are well-documented, approved, and reviewed regularly.
  • Utilize data analytics and dashboards to monitor quality trends (e.g., environmental monitoring, deviations, personnel competency).
  • Manage a change control program to evaluate and approve any changes to processes or facilities.
  • Conduct routine audits of the QMS to ensure ongoing compliance and effectiveness.
Task 2: Manage deviations, complaints, and adverse events.
  • Develop a system for documenting, investigating, and resolving any deviations from SOPs.
  • Perform a thorough root cause analysis (RCA) for any significant event or out-of-specification result.
  • Implement a formal process for handling product complaints and reports of adverse drug events.
  • Establish and test a recall procedure for any potentially non-sterile or defective CSPs.
  • Analyze event data to identify trends and implement preventative actions.
Task 3: Oversee the component and release testing program.
  • Establish procedures for qualifying vendors and verifying the quality of all components and supplies.
  • Manage the process for sterility and endotoxin testing for CSPs requiring it.
  • Interpret the results of release testing and take appropriate action.
  • Ensure that no CSP requiring release testing is dispensed before satisfactory results are received.
  • Maintain complete documentation of all component verification and release testing activities.
Task 4: Maintain comprehensive documentation and records.
  • Ensure Master Formulation Records and Compounding Records are accurate, complete, and properly maintained.
  • Maintain all records related to personnel training, competency, and qualifications.
  • Keep organized records of facility certification, environmental monitoring, and equipment maintenance.
  • Ensure all documentation is readily retrievable for review by regulatory and accrediting bodies.
  • Adhere to all record-keeping requirements for controlled substances used in compounding.

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