For hospital pharmacies and institutional buyers
A coordination partner for pharmacy directors, P&T committees, and institutional buyers arranging a named-patient import for a specific patient under an open regulatory pathway.
Institutional coordination subpages
The subpages below extend this one for three distinct engagement points:
Pharmacy coordination · Institutional access (framework) · Clinical-trial bridging · View all
Named-patient access looks different from the pharmacy director's seat. The patient is already under hospital care, the ordering workflow expects a purchase order, the receiving dock expects a cold-chain-documented delivery addressed to the pharmacy, and the P&T committee expects the file to be clean enough that the import decision survives a look from the quality office and, in due course, from an inspector. Reserve Meds is built for that file. We coordinate the US-side sourcing, documentation, and cold-chain logistics, under the clinical authority of the treating physician and within the import pathway your institution uses for named-patient products.
The institutional engagement, in brief
A hospital engagement begins with a short enquiry from the pharmacy director or a delegated pharmacy buyer, usually in parallel with the clinical team's engagement on the same patient. We open a single file that carries through from intake to delivery, so that the prescribing physician, the pharmacy director, and the receiving technician are all referring to one set of serial numbers, one cold-chain log, and one regulatory bundle. Where your institution has a preferred broker or customs agent on the destination side, we work through them. Where you do not, we bring ours, on a named-account basis that respects your existing procurement posture.
The questions a P&T reviewer typically asks
In our experience, a pharmacy and therapeutics reviewer asks a consistent set of questions the first time a named-patient import is brought forward. The first is the provenance of the product: where it is sourced, whether the US chain of custody is DSCSA-compliant, and whether serialisation records are available for the specific lots that will be dispensed. The answer, in our case, is that every unit is acquired through a licensed US specialty wholesaler (McKesson Specialty, AmerisourceBergen / Cencora Specialty, or Cardinal Health Specialty) with a full DSCSA transaction history, transaction information, and transaction statement on file and available to the reviewer on request.
The second is the regulatory posture on the destination side. A reviewer wants to see the specific pathway that the import is travelling, whether it is a ministry-of-health named-patient authorisation, a hospital-formulary unregistered-product route, or an institutional compassionate-use mechanism. We prepare that file, in English and in the local language where required, and share it with the reviewer ahead of the import decision. The third is the cold-chain integrity plan, which we cover below. The fourth is the pharmacovigilance and adverse-event reporting commitment, which we accept as part of our standard engagement.
The receiving protocol at the dock
Physical delivery is addressed to the hospital pharmacy, under the name of a receiving pharmacist or technician nominated by the pharmacy director. The shipment arrives in validated thermal packaging with an embedded temperature logger; on receipt, the pharmacy inspects the logger, confirms the seal, and signs for acceptance or places the shipment on quarantine pending review. Any unit that exceeded its approved excursion profile is replaced at our cost. Reserve Meds provides a receiving checklist that the pharmacy can adopt into its existing SOP without modification; for institutions with a more bespoke receiving standard, we align our packout to the institution's protocol in advance.
The documentation package the pharmacy receives
Each shipment is accompanied by a dossier that includes the US dispensing record from our licensed US specialty pharmacy partners, the DSCSA transaction history for the lot, the cold-chain log from pickup through delivery, the export and import paperwork filed on both sides, a copy of the treating physician's prescription and medical-rationale letter (with patient identifiers handled per your preferred redaction policy), and the regulatory correspondence for the named-patient authorisation. The pharmacy retains the dossier as part of its dispensing record; we retain a copy under our own record-retention schedule and make it available to the institution on written request.
Invoice, payment, and the cash-pay posture
Reserve Meds operates on a cash-pay basis. We do not bill insurance, and we do not coordinate reimbursement from manufacturers or payers on the destination side. Institutional engagements are invoiced on a named-patient basis against a standard hospital purchase order, with net terms negotiated at account opening. Payment is accepted by wire transfer or institutional credit card; we do not accept cryptocurrency or payment from any jurisdiction subject to comprehensive sanctions. Pricing is quoted for the specific indication and quantity, is valid for a defined period, and is not published on this site. Where a manufacturer patient-assistance program or charitable-foundation pathway is relevant, we will signpost it; we do not evaluate patient creditworthiness or run financing.
Enterprise briefing and a named account
For institutions expecting repeat named-patient activity, we offer a short enterprise briefing, either virtual or on site, in which our dispensing partner (under state pharmacy supervision) and our regulatory lead walk the pharmacy and the P&T committee through the sourcing, documentation, and handover protocol in advance of the first case. Institutions that complete the briefing move to a named account with a single point of contact on our side and a published response-time commitment. We prefer to do the hard work of alignment once, before the first urgent case, rather than during it.
What we will not do
We do not source controlled substances, we do not act outside the receiving country's published named-patient or unregistered-product pathway, and we do not supply without a named prescriber of record. We do not share patient information with any party other than the treating physician, the receiving institution, and the regulator, with the standard legal exceptions for pharmacovigilance reporting. We will tell you plainly when a request falls outside our scope.
The institutional workflow, stage by stage
The sequence below is the institutional variant of the named-patient workflow. It differs from the physician-level workflow in that the patient-level intake runs in parallel with a pharmacy-director engagement, the P&T committee is a first-class step rather than an afterthought, and the receiving protocol is owned by the hospital pharmacy rather than by the clinic.
- 1 Institutional enquiry. Pharmacy director, pharmacy buyer, or named clinical lead contacts Reserve Meds. A named account is opened with a single point of contact on our side and a published response-time commitment.
- 2 Enterprise briefing. Our dispensing partner (under state pharmacy supervision) and regulatory lead walk the pharmacy and, where requested, the P&T committee through the sourcing, documentation, and cold-chain posture in a single session, virtual or on-site. Institutions expecting repeat activity typically complete this briefing before the first urgent case.
- 3 Patient-level intake & feasibility. Clinical team submits patient-level intake. Feasibility response within one business day, as with non-institutional cases. The file is tagged to the institutional account so that the pharmacy director has visibility from the outset.
- 4 P&T dossier delivered. Reserve Meds prepares the pharmacy-and-therapeutics dossier (standard contents described below). The P&T committee reviews on its usual cadence; we make our dispensing partner's pharmacy contact available, via our coordinator, for any clarifying question.
- 5 Authorisation & purchase order. With P&T sign-off, the destination-country named-patient authorisation is filed (prescriber signs; Reserve Meds prepares). Institutional purchase order issued to our licensed US specialty pharmacy partners on the agreed net terms.
- 6 Procurement & release. Order placed through a licensed US specialty wholesaler. DSCSA transaction documents archived to the institutional file. Our dispensing partner, under applicable state pharmacy supervision, releases the order for fulfillment.
- 7 Shipment & dock delivery. Validated cold-chain packout with embedded temperature logging. Airway bill and customs file addressed to the named receiving pharmacist. Routing pre-confirmed with the institution's ordinary broker or with our nominated agent.
- 8 Receipt, inspection & acceptance. Hospital pharmacy inspects the logger, confirms the seal, and either accepts or quarantines the shipment. Delivery pack (DSCSA trace, cold-chain log, regulatory file) handed over at receipt. Receiving checklist below.
- 9 Dispensing, administration & follow-up. Hospital pharmacy dispenses under its ordinary SOP; treating physician administers and monitors. Pharmacovigilance correspondence, if any, flows through Reserve Meds's standing channel. Next-cycle planning initiated where the therapy is cyclical.
The pharmacy receiving checklist
The following checklist is issued with every institutional shipment. It is designed to be adopted into an existing hospital-pharmacy receiving SOP without rewrite, and it aligns with the common inspection-readiness standards that most of our receiving institutions already operate against. Institutions with a more bespoke receiving standard are free to substitute their own; we will align our packout to the institution's protocol in advance.
On arrival at the receiving dock
- Confirm shipment is addressed to the named receiving pharmacist or technician.
- Confirm outer packaging is intact and the tamper-evident seal is unbroken.
- Confirm airway bill and customs release documents match the pre-notified shipment.
- Move shipment immediately to the pharmacy for unpacking; do not break the cold chain at the dock.
In the pharmacy, at unpack
- Download the temperature logger; confirm excursion profile is within the approved limit for the product.
- Verify the product lot and serial numbers match the DSCSA transaction history attached to the shipment.
- Inspect each unit visually for damage, discoloration, or integrity loss.
- If any check fails, place the shipment on quarantine and notify Reserve Meds within 24 hours; a replacement ships at our cost.
On acceptance
- Archive the delivery pack (DSCSA trace, cold-chain log, regulatory file, prescriber letter) to the patient file.
- Move the product to labelled, secure, temperature-controlled storage under the institution's ordinary SOP.
- Notify the treating physician of receipt; confirm the planned dispensing window.
- Return the signed receipt form to Reserve Meds; engagement file is closed on our side.
P&T dossier, standard contents
The dossier is organized for a pharmacy and therapeutics reviewer who may not have encountered the specific product previously, and it is built to be defensible against a quality-office or inspector review at any future date. The contents are consistent across engagements; the specific evidence pack is tailored to the product and indication.
- Executive summary, one-page description of the patient, the product, the pathway, and the committee's decision request.
- Product monograph, FDA prescribing information, mechanism, approved indications, dosing and administration, warnings and precautions, REMS status.
- Regulatory status, US approval history, orphan-drug / breakthrough / accelerated-approval designation where applicable, registration status in the destination country and reference jurisdictions.
- Clinical evidence pack, abbreviated summary of pivotal trials, published efficacy and safety data, specialty-society guideline positioning, and any real-world evidence if available.
- Supply provenance, named US specialty wholesaler, DSCSA transaction-history availability, serial-level traceability statement, manufacturer's limited-distribution network enrolment where applicable.
- Handling & cold-chain plan, label storage conditions, thermal packout specification, excursion tolerance, compatibility with the institution's receiving SOP, and quarantine protocol.
- Destination-country authorisation, pathway identified (ministry named-patient, personal import, hospital formulary exception), draft authorisation language, and expected turnaround.
- Pharmacovigilance plan, adverse-event reporting commitment to FDA MedWatch, destination-country authority, and manufacturer; contact points and cadence.
- Commercial terms, itemised quotation, payment terms, refund and cancellation policy, estimated destination-country duty where applicable.
- Reference engagements, named peer institutions that have completed engagements with us, on request and subject to their consent.
Enterprise account framework
For institutions expecting repeat named-patient activity, Reserve Meds offers a written enterprise-account framework. It is not an MSA in the ordinary commercial sense; our engagements are patient-by-patient, and no institution is under any obligation to bring a case. The framework establishes the shape of the working relationship so that no time is spent re-litigating first principles on each case. It typically includes: a mutual confidentiality undertaking; a named account manager on our side and a named pharmacy lead on the institution's side; standard commercial terms on net-period and invoicing; a pharmacovigilance and adverse-event reporting agreement; a data-privacy addendum aligned with the institution's privacy posture (HIPAA and GDPR where applicable); and a receiving-protocol annex that pre-aligns the packout specification to the institution's existing SOP.
Institutions that prefer to engage case-by-case without an enterprise framework are equally welcome. The framework is optional; it exists to save time for institutions where the case count supports it.
Institution-specific questions, answered
Will you sign our vendor MSA?
Where an institution requires an MSA or a vendor onboarding pack, we will sign or align to it, subject to review by our General Counsel equivalent and our dispensing partner's pharmacy leadership. We are a named-patient coordination service rather than a formulary vendor, and some institutional templates include clauses that do not map cleanly to our model; in those cases we propose targeted amendments rather than executing a template that we cannot stand behind in operation.
Will you complete our BAA (Business Associate Agreement)?
Yes, for institutions subject to HIPAA. We handle patient health information under HIPAA-aligned controls and will execute a Business Associate Agreement on the institution's standard form or our own, whichever the institution prefers. For institutions subject to GDPR or a destination-country privacy framework, we execute the equivalent data-processing agreement.
Can we nominate our own customs broker?
Yes. Where your institution has a preferred broker on the destination side, we work through them and align the airway bill, the commercial invoice, and the authorisation documents to their expected format. Where you do not, we bring ours, on a named-account basis that respects your existing procurement posture.
Do you accept institutional credit accounts?
We invoice institutions on net-30 terms at account opening by default, and we will consider longer terms on a case-by-case basis for institutions with a documented payment history. Payment is accepted by wire transfer or institutional credit card. We do not accept cryptocurrency and we do not accept payment from any jurisdiction subject to comprehensive sanctions.
How do you handle a shipment held by customs?
We pre-file the authorisation with customs where the destination pathway permits, name an in-country agent on the airway bill, and route shipments through brokers with documented experience handling named-patient imports for the destination regulator. Where a shipment is held pending clarification, our regulatory team engages directly with customs to resolve it and keeps the pharmacy director informed in writing of the status and the expected release.
What is the cold-chain excursion replacement policy?
If the temperature logger on arrival indicates an excursion outside the approved profile for the product, the shipment is placed on quarantine and replaced at our cost. We ask the institution to notify us within 24 hours of receipt so that a replacement can be mobilised promptly. A follow-up excursion review is conducted jointly with the pharmacy on the root cause.
Can you deliver directly to an administration site rather than the pharmacy?
Only by prior arrangement and only where the institution's receiving protocol supports it. Our default posture is that the hospital pharmacy is the receiving party; this is the configuration that best protects chain-of-custody and that most institutions prefer for inspection-readiness.
Do you support multi-cycle contract pricing?
Where the therapy is cyclical and the institution expects a predictable cadence over a defined horizon, we will quote on a multi-cycle basis with agreed review windows. Pricing is fixed for the quoted horizon subject to exceptional changes in the US ex-manufacturer price, which are passed through at cost rather than repriced.
Can we request a site visit before engaging?
Yes. Institutions are welcome to request a site visit to our US operations, subject to reasonable scheduling. We will also make our dispensing partner (under state pharmacy supervision) and regulatory lead available for a virtual walkthrough of our sourcing and documentation posture, which is how most pre-engagement review happens in practice.
Reviewed 2026-04-22 by Reserve Meds's clinical and regulatory team. Human dispensing oversight: provided by our licensed US specialty pharmacy partners under applicable state pharmacy supervision. Next scheduled review: 2026-10-22.