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PTCB Regulatory Compliance Certificate — Requirements & Free Practice

US · License preparation

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PTCB Regulatory Compliance Certificate

PTCB specialty certificate demonstrating pharmacy technicians' knowledge of pharmacy laws, regulations, legal requirements, and practice standards.

Licensing authority: Pharmacy Technician Certification Board · Application information

Initial by examination
PTCB Regulatory Compliance Certificate Exam
Assessment
Pass the Regulatory Compliance Certificate Exam; this is the single identified exam for the certificate, not a new PTCE sitting.
Eligibility
{"allOf":["Hold an active PTCB CPhT Certification","Complete a PTCB-Recognized Regulatory Compliance Education/Training Program"]}
Evidence Claim Ids
["rc-route-structure","rc-route-requires-exam","rc-registration"]
Exam Day
Check in 30 minutes before the appointment and bring an approved ID matching the PTCB Account name; request required testing accommodations during application.
Experience Boundary
The three-year work-experience condition and four-certificates OR three-certificates-plus-CSPT alternatives concern CPhT-Adv only; this route retains the active-CPhT and recognized-training conditions without importing CPhT-Adv's separate eligibility combination.
Scheduling
Apply through the PTCB Account; approval precedes emailed authorization. The ordinary authorization lasts 90 days, sponsored periods may differ, and up to two additional 90-day extensions must each be requested within the authorization period. An expired authorization forfeits fees and requires reapplication. Authorized candidates schedule through the account or Pearson; testing is online with a live proctor or at a Pearson test center.

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