Credentialing Guidelines and Requirements

Scope

PTCB Nonsterile Compounding certificate holders have demonstrated an expert knowledge of regulations and required processes for nonsterile compounding; compounding types, equipment, and formulations; and collecting patient information and identifying medication formulations. 

Eligibility Requirements 

A candidate must hold an active PTCB CPhT Certification and complete a PTCB-Recognized Nonsterile Compounding Education/Training Program.                       

Exam

Candidates are required to pass the Nonsterile Compounding Exam to earn the PTCB Nonsterile Compounding Certificate. The Nonsterile Compounding Exam is a computer-based exam with 70 multiple-choice questions. Be prepared to commit 1 hour and 30 minutes for the exam (5-minute tutorial, 1 hour and 20-minute exam, and 5-minute post-exam survey).

Exam Content Outline

The Nonsterile Compounding Exam covers several knowledge areas organized into two domains, as shown in the following table.

Regulations, Standards, and Guidelines (28%)

Terminology and acronyms used in regulations, standards and guidelines related to nonsterile compounding

Roles of various standards setting, regulatory, and accreditation bodies

Roles of pharmacy technicians in nonsterile compounding

References used for nonsterile compounding (e.g., technical, clinical, regulatory)

Nonsterile Compounding Processes (72%)

Drugs and components used in nonsterile compounding including physical and chemical compatibility criteria

Nonsterile compounding dosage forms and routes of administration

Container closure systems and packaging used for nonsterile compounding

Nonsterile compounding equipment calibration, maintenance, cleaning, and use

Appropriate use of disposable supplies

Cleaning, sanitization, and appropriate use of reusable supplies

Weighing, measuring, and mixing techniques

Compounding process for nonsterile dosage forms

Garb and PPE used for nonsterile compounding (HD and non-HD)

Agents, supplies, and techniques used for deactivating, decontaminating, cleaning, and sanitizing for HD and non-HD areas

Calibration, maintenance, and use of equipment for environmental monitoring (e.g., temperature, humidity, and pressure)

Quality assurance and quality control processes including documentation requirements used prior to and throughout the compounding process (e.g., from vendor qualification to documenting and investigating patient complaints)

 

Exam Passing Score

A panel of subject-matter experts established a passing score for the Nonsterile Compounding Exam using industry best practices. The method used by the panel, as directed by a psychometrician, is the modified-Angoff method. This method requires experts (panel members) to evaluate individual test questions and estimate the percentage of qualified pharmacy technicians that would be able to answer each question correctly. These estimates were analyzed for consistency and averaged to produce the passing score. The passing score and candidate results are reported as scaled scores. The passing scaled score for the Nonsterile Compounding Exam is 300. The range of possible scores is 0 to 400.

Advanced Certified Pharmacy Technician Credential

Earning your Nonsterile Compounding Certificate takes you one step closer to becoming a PTCB Advanced Certified Pharmacy Technician (CPhT-Adv). Active PTCB CPhTs who have completed at least four of the certificate programs, or three certificate programs and the Compounded Sterile Preparation Technician (CSPT) Certification, and 3 years of work experience will be eligible to earn a CPhT-Adv credential.