PTCB Regulatory Compliance Certificate Exam — Information & Free Practice
US · Examination information
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PTCB Regulatory Compliance Certificate Exam
- Provider
- Pearson
- Format
- Computer-based multiple-choice examination; online with live proctor or in person at a Pearson test center.
- Exam questions
- Total questions: 70.
- Time limit
- 80-minute examination within a 90-minute appointment including a 5-minute tutorial and a 5-minute post-exam survey.
- Passing score
- 300 on a 0–400 scaled-score range.
- Exam fee
- USD 89 application/examination fee.
Examination outline
Laws, Regulations, and Guidelines (37%)
- Roles of various regulatory bodies
- Use of USP Standards pertaining to Regulatory Compliance
- Federal requirements for pharmacy
- EPA hazardous waste management in the pharmacy
- Federal Controlled Substances Act
- Federal Food, Drug, and Cosmetic Act (FDCA)
- Drug Quality and Security Act (DQSA) — CQA and DSCSA
- Accreditation Standards
Legal Requirements and Practice Standards (37%)
- Regulatory and accreditation-related terminology
- Foundational principles of pharmacy laws and pharmacy ethics
- Federal requirements for controlled substances
- Federal requirements for handling and disposal of substances and waste
- Federal requirements for restricted drug programs and medication processing
- Compliance and auditing laws and regulations
- Federal requirements pertaining to the medication dispensing process
- Federal requirements pertaining to personnel competency
- Federal requirements pertaining to compounding sterile preparations (CSP)
- Federal requirements pertaining to non-sterile compounding
- Licensing and reporting requirements for personnel and facility
Patient Safety and Quality Assurance Strategies (26%)
- Elements of compliance programs
- Methods or techniques to systematically improve accuracy
- Cause and impact of medication dispensing errors
- Cause and impact of other types of quality-related events
- Medication storage requirements
- Rules, policies and regulations related to disposal of pharmaceutical drugs
- Reporting of medication errors and quality-related events
- Institute for Safe Medication Practices (ISMP) best practices
Examination sources
- PTCB Regulatory Compliance Certificate
Prepare for Your Exam — Exam Content Outline adoption statement
- PTCB Regulatory Compliance program guidebook
Exam Content Outline — adoption statement
- PTCB Regulatory Compliance Certificate
Exam Content Outline — Laws, Regulations, and Guidelines, table rows 1–9
- PTCB Regulatory Compliance Certificate
Exam Content Outline — Legal Requirements and Practice Standards, table rows 10–21
- PTCB Regulatory Compliance Certificate
Exam Content Outline — Patient Safety and Quality Assurance Strategies, table rows 22–30
- PTCB Regulatory Compliance Certificate
Eligibility Requirements — recognized training and outline distinction
- PTCB Regulatory Compliance Certificate
About the Exam
- PTCB Regulatory Compliance Certificate
Scoring
- PTCB Regulatory Compliance program guidebook
Exam Passing Score
- PTCB Regulatory Compliance Certificate
Eligibility Requirements
- PTCB Regulatory Compliance Certificate
How to Apply and Schedule
- PTCB Regulatory Compliance Certificate
Exam Fee
- PTCB Authorization to Schedule Exam
Authorization period and expiration
- PTCB Authorization to Schedule Exam
Authorization extensions
- PTCB Scheduling an Exam Appointment
Scheduling an Exam Appointment — opening paragraph
- PTCB Regulatory Compliance Certificate
Exam Day Requirements; Testing Accommodations
Related license preparation
This examination may be required or accepted as an alternative, depending on the license and application pathway.