Free PTCB Supply Chain Exam Prep

Roles, jurisdiction, and registration/reporting requirements of FDA, DEA, and State Boards of Pharmacy; products subject to the DSCSA and its exceptions; DSCSA track-and-trace serialization; T3 transaction data and transmission methods (e.g., EDI); receiving requirements and signs of suspect products (counterfeit, diverted, grey market, misbranded, poor integrity). Enhanced drug distribution security took legal effect November 27, 2023, with FDA exemptions phasing enforcement through November 27, 2027 for small dispensers.

Documentation and file maintenance (invoices, recalls, wastage, inventory records, hazardous drugs); controlled substance records and reporting (theft/loss, inventories, wastage, reverse distribution); inventory methods (want book, par levels, just-in-time, perpetual, formulary/non-formulary, seasonal and emergency forecasting, automation); days' supply and inventory turns; drug shortage mitigation; contract types (market share and tiers, individual vs GPO, 340B, formularies, buying groups, consignment, state vaccine programs); 503A compounded products and white/brown/clear bagging.

Purpose, scope, and limits of Rx and OTC manufacturers, repackagers and relabelers, primary wholesale distributors, secondary and specialty wholesale distributors, OTC-only distributors, virtual manufacturers and wholesalers, and third-party logistics providers (3PLs); 503B outsourcing facilities; foreign sourcing; and requirements for physical drug transfers between pharmacies.