Step 4: Sourcing and logistics.

When clinical and regulatory reviews both return positive, the case moves into sourcing and logistics. This is the stage where the case stops being paperwork and starts being a physical unit of medicine moving through a documented chain of custody from a US specialty wholesaler to a patient receiving treatment abroad. The work here is operational, and the standard of execution is the same one a US specialty pharmacy would hold itself to for a domestic patient, extended across the international transit.

Placing the order through the DSCSA chain

Our case-coordination team places the order with the US specialty wholesaler best positioned to fill it. Our primary partners are McKesson Specialty, Cencora Specialty (formerly AmerisourceBergen Specialty), and Cardinal Health Specialty, selected case-by-case based on product availability, pack configuration, cold-chain handling, and delivery timing. The transaction is DSCSA-compliant: the wholesaler generates the transaction history, transaction information, and transaction statement records, and those records accompany the unit through the remainder of its journey. If any element of the DSCSA documentation is inconsistent, the unit is held until the inconsistency is resolved.

Staging at Altima Care

The unit is delivered to Altima Care, the US-licensed specialty wholesaler we currently source through, while Reserve Meds advances its own wholesale distributor license and direct manufacturer relationships. At receipt, the pharmacy verifies the serial number against the manufacturer's records, reconciles the transaction documentation against the purchase order, and stages the unit under the environmental conditions the product requires. The clinical reviewer performs the prescription review under US-licensed specialty pharmacy workflow and either approves or returns the prescription for clarification. No unit ships without the clinical reviewer's approval on the specific prescription.

Cold-chain packaging and monitoring

For any temperature-sensitive therapy, the unit is packaged in a validated thermal shipper engineered for the specific temperature class, payload size, and transit duration of the route. An electronic temperature logger is embedded; where the route or the therapy warrants it, dual loggers from different manufacturers are used. The packaging carries a certificate of validation, and the logger is activated and verified as functional before the shipment leaves the pharmacy. For ultra-cold and cryogenic shipments, the protocol is extended with additional checks, including dewar integrity for cryogenic shipments. A full account of the cold-chain protocol is on the cold-chain handling page.

Customs clearance and the licensed broker at destination

Each shipment is matched to a licensed customs broker at the destination country, and the paperwork assembled during regulatory review is pre-filed so that customs clearance is staged before the unit arrives. The broker's documentation package matches the DSCSA transaction records the product ships with; customs has no reason to hold the unit for paperwork clarification. For destinations where the primary airport's cold-chain handling is limited, we route through a regional hub with validated pharma-grade cold-chain facilities and trans-ship under continuous cold custody. We track the unit from departure to receipt in real time and intervene immediately at any transit anomaly.

Freight selection

We use time-definite international freight services that quote a clearance window rather than a best-effort delivery. Freight is selected case-by-case based on the temperature class, the payload size, the destination, and the clinical urgency. For cryogenic shipments, we use freight partners with validated liquid-nitrogen handling capability. For ultra-cold, we use freight partners with validated dry-ice handling and the operational capacity to re-ice at transit nodes. For refrigerated and controlled-room-temperature shipments, we use our standard pharma-grade partners. We do not use general-purpose courier services for temperature-sensitive product.

Documentation that travels with the unit

Every shipment moves with a documentation package that includes the prescription, the medical-necessity letter, the import-authorization documentation where the destination requires one, the manufacturer's product labeling, the cold-chain validation certificate for the shipper, the temperature logger identification, the DSCSA transaction records, and the destination-country broker's filing confirmation. The prescriber and the receiving institution receive the documentation package at the same time as the physical shipment arrives. Where an institutional receiving protocol requires additional documents, we supply those in advance; see the hospital pharmacy receiving protocol.

Communication to the prescriber and family

We communicate at three points during this stage: at order placement, when the case transitions from paperwork to physical unit; at shipment, when the unit has left Altima Care and is in transit; and at receipt at destination, when the receiving institution confirms chain-of-custody and accepts the unit. If anything goes wrong in transit, we communicate immediately rather than wait until we have a resolution. Transparency here is both operationally important and part of the trust posture we hold with families.

Handoff to delivery and follow-up

Once the receiving institution confirms chain-of-custody integrity and the unit enters the local dispensing inventory, the case moves to delivery and follow-up. Clinical and regulatory review documentation remains archived in the case record; sourcing and logistics documentation is archived for the retention period regulatory obligations require.

Reviewed 2026-04-22 by Reserve Meds’s AI clinical and regulatory review agents. Human pharmacist-in-charge: Altima Care. Next scheduled review: 2026-10-22.