Which of the following is a typical Trading Partner role under the DSCSA?

• A. To be a consumer
• B. To own products exclusively and never transfer
• C. To be the entity from whom direct ownership is transferred or to whom it is transferred
• D. To set pricing

Answer: (C)

Under DSCSA, a Trading Partner is any entity that participates in the wholesale distribution of prescription drugs or in the transfer of ownership of those drugs. The typical role is the entity from whom direct ownership is transferred or to whom it is transferred, because the tracing system is built around these ownership transfer events. Each time ownership changes hands, transaction information and history accompany the transfer, allowing the next link in the chain to verify origin and movement of the product. Consumers aren’t part of this trading partner network, and an entity that never transfers ownership wouldn’t align with the DSCSA’s goal of traceability. Setting prices isn’t a role defined by DSCSA; the focus is on ownership transfers and accompanying traceability data.