Credentialing Guidelines and Requirements

Scope

PTCB Supply Chain and Inventory Management certificate holders have demonstrated an expert knowledge of regulatory compliance, including understanding pharmacy laws, regulations, legal requirements, and practice standards. 

Eligibility Requirements 

A candidate must hold an active PTCB CPhT Certification and complete a PTCB-Recognized Supply Chain and Inventory Management Education/Training Program.

Exam

Candidates are required to pass the Supply Chain and Inventory Management Exam to earn the PTCB Supply Chain and Inventory Management Certificate. The Supply Chain and Inventory Management Exam is a computer-based exam with 75 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 Supply Chain and Inventory Management Exam covers several knowledge areas organized into three domains, as shown in the following table.

Laws, Regulations, and Guidelines (37%)

Role and jurisdiction of FDA in ensuring safety, efficacy, and security of drugs

FDA registration requirements and trading partner reporting requirements

Role and jurisdiction of DEA in ensuring safety, efficacy, and security of drugs

DEA registration requirements and registrant reporting requirements

Role of State Boards of Pharmacy in ensuring safety, efficacy, and security of drugs (e.g., licensure of supply chain entities)

Products subject to the DSCSA and exceptions

DSCSA Track and Trace requirements (i.e., serialization)

Types and purpose of transaction data (i.e., T3) and methods of transmission (e.g., EDI)

Requirements for receiving medications under the DSCSA and signs and characteristics of suspect products (e.g., counterfeits, diverted drugs, grey market products, misbranded products, and products of poor integrity)

Inventory Management, Documentation, and Recordkeeping (35%)

Documentation and file maintenance requirements (e.g., invoices, recalls, wastage, inventory records, hazardous drugs)

Controlled substance records and reporting (e.g. theft/loss, inventories, wastage, reverse distributed)

Types of inventory management (e.g., want book, par levels, just-in-time, perpetual, formulary and non-formulary, seasonal and emergency forecasting, automation)

Considerations for determining inventory days’ supply/inventory “turns”

Drug shortage mitigation and implications (e.g., significant pricing increases)

Characteristics of contract types and compliance requirements (e.g., market share and tiers, individual contracts vs GPO, 340B, formularies, buying groups, consignment, and state vaccine programs)

Understand other sources of products for administration to patients such as 503A pharmacy compounded products and white/brown/clear “bagging”

Types of Suppliers and Supply Chain Entities (28%)

Purpose and scope of suppliers and supply chain entities, including what they do, when and why to use them, and what they are not allowed to do. ● Manufacturers Rx and OTC ● Repackagers and relabelers ● Primary Wholesale Distributors ● Secondary and Specialty Wholesale Distributors ● OTC-only Distributors ● Virtual Manufacturers and Virtual Wholesalers ● Third-Party Logistics (3PLs)

503B Outsourcing Facilities

Foreign sourcing

Types of and requirements for drug transfers* between pharmacies

*Note: “transfer” means the physical transfer of the prescription drug, not the transfer of a patient prescription from one pharmacy to another.

Exam Passing Score

A panel of subject-matter experts established a passing score for the Supply Chain and Inventory Management 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 Supply Chain and Inventory Management Exam is 300. The range of possible scores is 0 to 400.

Advanced Certified Pharmacy Technician Credential

Earning your Supply Chain and Inventory Management 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.