Certified Sterile Compounding Pharmacist (CSCP)

CSCP (SCP-001) Exam Objectives

This exam certifies that the candidate has the comprehensive knowledge and skills to develop, implement, and manage a compliant sterile compounding program based on USP <797> and related standards.

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

• USP <797> Principles: Apply the definitions, scope, and risk-based principles of USP <797> across all compounding activities.
• Microbiology: Apply principles of pharmaceutical microbiology to prevent microbial contamination of CSPs.
• Regulatory Landscape: Adhere to standards from USP <71>, <85>, state boards of pharmacy, and the FDA.
• Medication Safety: Implement medication safety strategies to prevent errors in the compounding process.

Domain 2: The Sterile Compounding Environment (25%)

• Facility Design: Evaluate the design and classification of cleanroom suites, including buffer rooms, ante-rooms, and SCAs.
• Engineering Controls: Manage the certification, operation, and maintenance of PECs (e.g., LAFWs, BSCs) and SECs.
• Cleaning and Disinfection: Oversee the selection of agents and procedures for cleaning and disinfecting classified areas.
• Environmental Monitoring: Manage the environmental monitoring program, including air and surface sampling, and respond to out-of-spec results.

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

• Training Programs: Design and manage a comprehensive training program for all compounding personnel.
• Garbing and Hand Hygiene: Enforce and validate proper hand hygiene and garbing procedures.
• Competency Validation: Manage competency validation through written exams, gloved fingertip sampling, and direct observation.
• Aseptic Technique and Media-Fill Testing: Oversee media-fill testing to qualify personnel in aseptic manipulation.

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

• Order Review and Calculations: Verify the clinical appropriateness and accuracy of CSP orders, performing all necessary calculations.
• Beyond-Use Dating (BUD): Assign appropriate BUDs based on the CSP Category, storage conditions, and available stability data.
• Aseptic Processing: Oversee the aseptic preparation and final verification of CSPs, including the use of compounding technology.
• Labeling, Storage, and Transport: Ensure proper labeling, storage, and transport of finished CSPs to maintain quality and sterility.

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

• Quality Program: Establish and maintain a formal Quality Management System (QMS) for the compounding facility.
• Event Management: Manage deviations, complaints, adverse events, and product recalls through root cause analysis and corrective actions.
• Release Testing: Oversee component verification and release testing (e.g., sterility, endotoxin) for required CSPs.
• Documentation: Maintain all required documentation, including formulation records, compounding records, and personnel files.

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 CSCP Professionals

The CSCP certification is designed for pharmacy professionals who are leaders in sterile compounding operations. This credential opens doors to advanced roles in any setting that requires sterile preparations, from large academic medical centers to specialized 503B outsourcing facilities.

Target Candidates

• Pharmacists or designated persons managing sterile compounding facilities.
• Medication safety officers and pharmacy compliance managers focused on sterile products.
• Pharmacy leaders responsible for quality assurance and regulatory compliance in compounding.
• Pharmacists seeking to advance into supervisory roles within hospital IV rooms, infusion centers, or 503A/B facilities.

Primary Job Roles:

• Compounding Supervisor or Manager
• Cleanroom Manager
• Director of Compounding Operations
• Quality Assurance Pharmacist
• USP 797 Designated Person

Career Advancement:

A CSCP is positioned for significant leadership roles. They can advance to become a system-level Director of Pharmacy, a Vice President of Quality/Regulatory Affairs in a 503B facility, or an independent consultant specializing in cleanroom design, remediation, and USP compliance.

Study Resources

Prepare for your CSCP exam with resources designed to master the comprehensive requirements of USP <797> and sterile compounding best practices.