| 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 |
