For prescribing physicians
A coordination partner for the narrow but consequential moment when the therapy you have chosen is approved in the United States and not yet available where your patient is being treated.
Coordination by specialty
If you want the pattern described for your specialty, the subpages below extend this one:
Oncology · Rare disease · Pediatrics · Rheumatology & immunology · Ophthalmology · Hepatology · Neurology & psychiatry · View all
Reserve Meds exists to remove a particular kind of friction from the treating physician's day. You have identified the therapy, you have established eligibility, you have had the conversation with the family, and the remaining obstacle is procurement. The medicine is approved by the FDA, it is sitting in US distribution, and the path from that shelf to your patient's chair crosses two regulatory regimes, a customs broker, a cold-chain carrier, and a specialty pharmacy invoice. We run that crossing, under your clinical direction, so that you can keep your attention where it belongs.
Our posture is to extend your plan, not to replace it
We coordinate a named-patient import. We do not practice medicine. The treating physician remains the prescriber of record, the clinical decision-maker, the monitoring clinician, and the party with whom the patient has a therapeutic relationship. Our licensed US specialty pharmacy partners are the counterparties you will interact with on any question that touches dispensing, stability, handling, or dose verification. Every order we receive is reviewed, under applicable state pharmacy supervision at our dispensing partner, before it is released for fulfillment, and any clinical clarification is handled physician-to-pharmacist, in writing, with a documented trail.
What we need from you
A clean named-patient engagement typically begins with three documents. The first is a valid prescription on your letterhead, written for the named patient and the specific therapy, with dose, frequency, and quantity expressed in terms consistent with the FDA label. The second is a short chart letter or medical-rationale memorandum setting out the diagnosis, the relevant eligibility findings, the therapies tried or considered and why this agent is the choice, and any monitoring plan that is relevant to sourcing decisions such as cycle timing. The third is written confirmation of the receiving site, which is almost always your clinic or an affiliated hospital pharmacy and never a private residence.
Where the destination country or the indication requires additional documentation, our regulatory team prepares drafts for your signature, so that the marginal administrative burden on your practice is minimized. Common examples are a named-patient authorisation form for the ministry of health, an unregistered-product declaration, and, in pediatric cases, a parental consent form countersigned by the treating physician.
Where the medicine actually comes from
Every therapy we coordinate is acquired through licensed US specialty wholesalers operating under the Drug Supply Chain Security Act. Our primary channels are McKesson Specialty, AmerisourceBergen / Cencora Specialty, and Cardinal Health Specialty, supplemented by a set of smaller licensed distributors for specific orphan products and limited-distribution networks. Every unit carries a DSCSA transaction history, transaction information, and transaction statement traceable from manufacturer to patient. We do not purchase from parallel-import channels, unlicensed brokers, or internet pharmacies. If a serial number on a package we have received cannot be verified against manufacturer records, that unit never moves.
Cold-chain handling and the physical delivery
Specialty therapies that require refrigerated or frozen handling ship in validated thermal packaging with embedded temperature logging. Packouts are qualified against the label storage requirements for the specific product, with a defined excursion tolerance and a monitored duty cycle. On receipt, the clinical site inspects the logger, confirms the seal, and either signs for acceptance or quarantines the shipment. Any unit that exceeded its approved excursion profile is replaced at our cost. For biologics and cell-therapy logistics that require hand-carry, chartered cold-chain, or direct hospital-pharmacy delivery, we arrange that in advance of shipment and share the routing with your team.
How we share outcomes back to you
For each cycle we coordinate, you receive a delivery pack that includes the dispensing documentation, the cold-chain log, the lot and serial trace, and the regulatory paperwork filed on the import side. Where the indication warrants, we request a short follow-up note from your office for our pharmacovigilance file; this is a soft request, typically one to two minutes of your nurse coordinator's time, and it materially improves the quality of our ongoing program oversight for the therapy. Any adverse event you wish to report can be sent directly to [email protected] and we take responsibility for onward reporting to the FDA MedWatch program and, where relevant, to the manufacturer and destination-country regulator.
The Reserve Meds AI clinical reviewer, plainly described
Our editorial and operational workflow is supported by two AI reviewer archetypes. The Reserve Meds AI clinical reviewer checks the coherence of the intake against the current FDA label, flags dose or indication mismatches before our dispensing partner's pharmacy team sees the file, and surfaces relevant product-level updates such as label changes, REMS program amendments, or manufacturer shortage notices. The Reserve Meds AI access agent performs the equivalent function on the import and privacy side. Neither agent makes dispensing decisions, writes prescriptions, or counsels patients. They are a decision-support layer that raises the floor of our work; your clinical judgement and our dispensing partner's pharmacy-level legal responsibility remain the ceiling.
Credentialing and how we verify you
Before we act on a prescription, we verify the prescriber. This typically means a copy of the current medical licence or registration, a statement from the institution if you are practising at a hospital, and a short call or email exchange to confirm the request. For hospital-based prescribers we work through the pharmacy director or the named clinical lead for the indication. For international prescribers we additionally confirm any local registration required for the receiving site to take delivery. The credentialing is done once per prescriber; subsequent engagements move more quickly.
What we will not do
We do not source controlled substances, we do not supply without physician oversight, and we do not operate in jurisdictions where the named-patient pathway is closed for the indication in question. We do not share patient information with any party other than the treating physician, the receiving site, and the regulator, with the standard legal exceptions for pharmacovigilance reporting. We will tell you when a request falls outside our scope, and where we can, we will point you to a more appropriate counterpart.
The workflow, stage by stage
The chart below sets out the path a named-patient engagement travels from the moment a treating physician submits an intake through to dispensing and post-delivery follow-up. The chart is descriptive rather than prescriptive; the actual sequence of any given case is shaped by the indication, the destination country, the manufacturer's program if any, and the clinical window within which the therapy must land.
- 1 Intake (Day 0). Physician or patient submits drug, destination country, indication, and a short clinical summary through reservemeds.com/request or a direct email to [email protected]. An engagement reference number is issued on submission.
- 2 Feasibility (Day 1). Our clinical team confirms indication-against-label coherence, destination-country pathway status, and US supply availability. A feasibility response is returned within one business day.
- 3 Prescriber credentialing (Days 1-3). We verify medical licence, institutional affiliation where applicable, and any destination-country registration required for the receiving site. Credentialing is a one-time step per prescriber.
- 4 Regulatory preparation (Days 2-10). Our regulatory team drafts the destination-country named-patient authorisation, unregistered-product declaration, and parental consent (pediatric cases) for prescriber signature. English and local-language versions are prepared where required.
- 5 Quotation & engagement (Day 3-7). A formal written quotation is issued covering drug acquisition, coordination fee, logistics, and estimated duty. Engagement letter signed; prepayment received into escrow-structured operating account.
- 6 Procurement (Day 7-14). Order placed through a licensed US specialty wholesaler. DSCSA transaction documents received and archived. Serial-level records confirmed against manufacturer where applicable.
- 7 Pharmacist review & release (Day 14-16). Our licensed US specialty pharmacy partners, under applicable state pharmacy supervision, review the order, medical-rationale letter, and label-coherence check before authorising release. Any clinical clarification is handled physician-to-pharmacist in writing.
- 8 Cold-chain shipment (Day 16-20). Validated thermal packout with embedded temperature logging. Routing, customs broker, and destination receiving party pre-confirmed. Shipment tracked continuously.
- 9 Receipt & acceptance (Day 20-25). Clinic or hospital pharmacy inspects the logger, confirms the seal, and either signs for acceptance or quarantines pending review. Delivery pack (DSCSA trace, cold-chain log, regulatory file) handed over at receipt.
- 10 Post-delivery follow-up (Day 25+). Soft request for a short receipt-and-administration note. Pharmacovigilance channel remains open for the engagement. Next-cycle planning initiated where the therapy is cyclical.
Day references above are indicative of a straightforward case; cell therapies, gene therapies, and first-in-country cases typically run longer and are sequenced individually.
A sample physician letter
The letter below is a template for the medical-rationale memorandum that accompanies a named-patient authorisation. It is a starting point only; the treating physician adapts it to the case in front of them. The object is a document that reads as clinically serious to a ministry reviewer and a hospital P&T committee, and that leaves no ambiguity about the prescriber's reasoning.
[PRESCRIBER LETTERHEAD]
[Date]
To: [Destination-country regulatory authority / hospital P&T committee]
Subject: Named-patient import authorisation, [patient initials / medical record number]
I am the treating [specialty] physician for the above-named patient. I am writing to request authorisation to import, on a named-patient basis, the following US-approved therapy for this individual patient under my clinical supervision.
Product: [International non-proprietary name / US brand name], [dose form, strength, quantity]
Indication: [Clinical indication, ICD-10 or ICD-11 where relevant]
Treatment plan: [Dosing regimen, cycle length, planned duration, monitoring cadence]
Clinical rationale. This patient has [brief diagnostic summary, including the findings that establish eligibility for the requested therapy]. Locally registered therapies have been considered as follows: [list of prior therapies with brief outcome summary, or explanation of why available options are inappropriate]. The requested therapy is FDA-approved for this indication and is, in my clinical judgement, the most appropriate next line for this patient. It is not currently registered in [destination country].
Supply, handling, and pharmacovigilance. Supply will be coordinated by Reserve Meds, dispensed by our licensed US specialty pharmacy partners, with logistics handled by our 3PL providers, under a DSCSA-compliant chain of custody. The product will be delivered in validated cold-chain packaging addressed to [receiving site]. I undertake to oversee administration, monitoring, and any adverse-event reporting arising from this therapy, and to notify the relevant parties of any pharmacovigilance concerns.
I would be grateful for your consideration of this request. I am available by telephone on [number] or by email at [address] for any clarification.
Sincerely,
[Signature]
[Printed name, registration number, institution]
P&T committee dossier, standard contents
For physicians practising in institutions where a pharmacy and therapeutics committee reviews named-patient imports before the pharmacy order is placed, Reserve Meds prepares a standard dossier. The dossier is organized for a 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.
- Product summary, FDA prescribing information, mechanism of action, approved indications, dose-and-administration section, warnings-and-precautions section, REMS status where applicable.
- Regulatory status, US approval history, orphan-drug or breakthrough designation where applicable, and registration status in the destination country and in comparable reference jurisdictions (EMA, MHRA, TGA, PMDA).
- Clinical evidence pack, abbreviated summary of pivotal trials, published efficacy and safety data, and any NCCN/ESMO/specialty-society guideline positioning.
- 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, receiving-site SOP compatibility, 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.
Physician-specific questions, answered
Does the prescription need to be on a specific form?
No. A prescription on your ordinary letterhead or e-prescribing output is sufficient, provided it carries your name, registration number, the patient's identifier, the product, the dose, and the quantity. For named-patient imports into certain jurisdictions, an additional destination-country form is required; we prepare that for your signature.
Can I remain the prescriber of record if the patient is in a country where I am not licensed?
That depends on the destination country. Some jurisdictions require a locally licensed prescriber of record for the receiving-side authorisation, in which case we will coordinate between you (as the treating physician of continuity) and a locally licensed colleague. Others permit a foreign prescriber to remain of record provided the receiving site is an appropriate clinical setting and the patient is under a locally licensed supervising clinician.
What if the therapy I want has a REMS program?
REMS-restricted products add a program-enrolment step for the prescriber and, in some cases, the dispensing pharmacy. We coordinate the enrolment on your behalf, prepare the documentation, and verify that the receiving site meets any program-specific handling requirement.
How do you handle a product in a limited-distribution network?
We engage the manufacturer's program directly, confirm that cross-border named-patient supply is permitted under the program terms, and if so, enrol the case. If the manufacturer's program does not permit cross-border supply, we will tell you plainly and, where possible, point you to a manufacturer-sponsored international access pathway.
Can I order for a cycle before the patient is in country?
Yes, provided the destination-country authorisation is in hand or expected within a known window. We frequently sequence the first shipment so that it lands within the patient's planned initiation window; where the patient is relocating from one country to another on a continuing therapy, we can run the authorisation and procurement in parallel with the clinical handover.
What is the expected end-to-end timeline?
Feasibility within one business day. End-to-end timelines typically run two to eight weeks, with most cases in the three-to-five-week window. The variables are destination-country pathway, drug availability, REMS or limited-distribution status, and whether the destination-country documentation is already in hand when the case opens.
What happens if the destination customs authority holds the shipment?
We pre-file the relevant authorisation with customs where the pathway permits, name an in-country agent on the airway bill, and route shipments through airports and 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 we keep the treating physician informed in writing of the status and the expected release.
Can you supply on a compassionate or pro-bono basis?
We are not a charity. Where a case would be more appropriately served by an existing manufacturer-sponsored compassionate-use program, a patient-advocacy foundation, or a charitable pathway, we will signpost it and, where helpful, support the application. We will decline to quote on a case that fits cleanly inside a free or subsidised pathway that the family or the treating physician was not aware of.
Do you accept insurance?
We operate on a cash-pay basis and do not bill insurance on the destination side. Families or institutions that are eligible for reimbursement from a destination-country payer or employer benefit are able to submit our invoice and dispensing documentation for claim recovery on their own. We do not coordinate the claim.
Can I refer a colleague?
Yes. Physician-to-physician referral is how most of our prescriber relationships begin. We ask only that the referring physician tells us, so we can appropriately credit the referral and credential the new prescriber efficiently. We do not pay referral fees.
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.