Certified Non-Sterile Compounding Pharmacist (CNSCP)

CNSCP (NSCP-001) Exam Objectives

This exam certifies that the candidate has the knowledge and skills to safely and compliantly prepare customized non-sterile drug preparations according to USP standards.

Domain 1: USP Standards and Regulatory Compliance (35%)

• USP <795> Pharmaceutical Compounding – Nonsterile Preparations: Apply the standards for facilities, equipment, personnel, ingredient sourcing, and documentation.
• USP <800> Hazardous Drugs – Handling in Healthcare Settings: Apply the standards for handling both sterile and non-sterile hazardous drugs, including facility requirements and personnel protective equipment (PPE).
• Beyond-Use Dating (BUD): Assign appropriate BUDs for aqueous and non-aqueous formulations based on USP <795> guidelines.
• Federal and State Regulations: Describe the regulatory framework for traditional pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act.

Domain 2: Formulation, Calculations, and Compounding Procedures (45%)

• Pharmaceutical Calculations: Perform all calculations required for non-sterile compounding, including percentage strength, ratio strength, and alligation.
• Formulation Science: Select appropriate bases, excipients, and equipment for preparing various dosage forms (e.g., solutions, suspensions, emulsions, creams, ointments, suppositories).
• Compounding Techniques: Demonstrate proper techniques for weighing, measuring, mixing, and packaging non-sterile preparations.
• Recordkeeping: Maintain compliant compounding records, including the master formulation record and the compounding record.

Domain 3: Quality Assurance and Patient Safety (20%)

• Quality Assurance (QA): Develop and implement a QA program, including standard operating procedures (SOPs), staff training, and product verification.
• Patient Counseling: Counsel patients on the proper use, storage, and disposal of compounded non-sterile preparations.
• Error Prevention: Identify and implement strategies to prevent common compounding errors.

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 CNSCP Professionals

The CNSCP certification is for pharmacists who are dedicated to the practice of compounding. It is a key credential for professionals working in community pharmacies with compounding services, dedicated compounding pharmacies, and in academic settings.

Target Candidates

• Community pharmacists who perform non-sterile compounding.
• Pharmacists working in dedicated 503A compounding pharmacies.
• Hospital pharmacists who compound non-sterile preparations.
• Academics who teach pharmaceutical compounding.

Primary Job Roles:

• Compounding Pharmacist
• Compounding Lab Manager / Supervisor
• Formulation Specialist
• Pharmacy Owner (Compounding Focus)
• Quality Assurance Officer (Compounding)

Career Advancement:

A CNSCP is positioned to become a leader in the compounding field. They can advance to become a Director of Compounding for a large organization, an owner of a PCAB-accredited pharmacy, a consultant for other pharmacies, or an instructor for compounding training programs.

Study Resources

Prepare for your CNSCP exam with resources designed to master the art and science of non-sterile compounding.