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Frequently asked questions

Answers to the most common questions from patients, families, physicians, and institutions. For anything not covered here, start a short intake at reservemeds.com/request and our clinical team will reach out as our first cohort opens.

About Reserve Meds

Is Reserve Meds a pharmacy?

Reserve Meds operates in partnership with a US-licensed specialty wholesaler. Our US-licensed wholesaler partner reviews and approves every order, under applicable state pharmacy supervision, before dispensing. Reserve Meds is the patient-facing and physician-facing service; our wholesale pharmacy partner is the licensed dispenser of record.

Why does this exist?

A patient in Dubai or Riyadh is prescribed an FDA-approved oncology, rare-disease, or gene therapy. The drug is not registered locally, is registered but not stocked, or is available but not reimbursed. Conventional channels work when the drug is local. When it is not, there is a gap, and the gap is the patient's. Reserve Meds exists to close that gap compliantly, through the destination country's named-patient or personal-import pathway, with the US-side sourcing and cold chain handled. See When conventional access fails.

Who operates Reserve Meds?

Reserve Meds is operated by a US-licensed specialty-pharmacy team with AI-augmented pharmacist and regulatory-counsel review. See About and Trust & Compliance.

What is the difference between Reserve Meds and a compassionate-use program?

Compassionate use is a regulatory mechanism that permits access to an investigational (pre-approval) medicine. Reserve Meds coordinates cross-border access to FDA-approved medicines through the destination country's named-patient or personal-import pathway. The two are complementary; where a compassionate-use program is the correct answer for a given patient, we will signpost it.

Are you affiliated with a manufacturer?

No. Reserve Meds is independent of any pharmaceutical manufacturer. Where a therapy's supply runs through a manufacturer's limited-distribution network, we engage that network on a named-patient basis under the program's terms.

Is there a difference between Reserve Meds and a medical-tourism agency?

Yes, a significant one. We are not a travel-booking service and we do not coordinate a patient travelling to the United States for care. We coordinate a US-approved medicine travelling to the patient's treating physician, under a compliant destination-country pathway.

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Eligibility & process

Who can use Reserve Meds?

Three groups. Patients and families who have been told locally that a therapy is unavailable. Treating physicians who want to prescribe a specific FDA-approved therapy for a specific patient and need a compliant way to source it. Hospitals and family offices that coordinate complex cases across borders. In all three cases, a valid prescription from a licensed physician in the destination country is required before dispensing.

What does the process look like?

Step one: short intake with drug, destination country, and indication. Step two: feasibility response within one business day. Step three: if the case is appropriate and the pathway is open, a formal quote is issued. Step four: with a signed prescription and clinical justification, we source the therapy, coordinate cold-chain delivery, and ship to the treating physician or hospital pharmacy. Step five: after dispensing, follow-up on receipt, adverse events, and next-cycle planning where relevant.

How long does it take?

Feasibility within one business day. End-to-end timelines run two to eight weeks, with most cases closing in three to five weeks. UAE MoHAP approval lands in roughly 5 to 15 business days from a clean submission. KSA SFDA runs 7 to 15 business days. India CDSCO (Rule 36) runs 14 to 30 days, since the import-permit step adds time. Variation beyond that is driven by drug availability in US specialty inventory and whether the destination-country physician documentation is in hand when the case opens. Complex cases (rare drug, novel mechanism, REMS enrolment) extend; we say so on day one rather than at the end.

Do I need a prescription?

Yes. A valid prescription from a licensed physician in the destination country is required. We do not substitute for physician judgment, and we do not dispense without a prescription even where a pathway technically permits it.

My doctor has not heard of this pathway. Can you speak with them?

Yes. We are glad to speak with a treating physician who is new to named-patient access. A short physician-to-pharmacist call often saves a great deal of paperwork. Contact [email protected].

Can I engage Reserve Meds before I have a prescription in hand?

You can submit a preliminary intake so we can assess feasibility, but we will not begin procurement or quote firm pricing until the prescription and medical-rationale documentation are in hand. The feasibility step is free.

Will Reserve Meds give me a second medical opinion on my diagnosis or treatment plan?

No. We do not practice medicine. Our role is to coordinate access to a therapy chosen by a treating physician, not to assess or recommend therapy. Where a patient is seeking a second opinion, we will point to established international second-opinion services run by US academic medical centres (for example, Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering). We do not receive referral fees from any of them.

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Safety, sourcing & quality

Where does the medicine come from?

From DSCSA-compliant US specialty wholesalers, McKesson Specialty, AmerisourceBergen (Cencora) Specialty, and Cardinal Health Specialty, supplemented by a set of smaller licensed distributors for specific products and limited-distribution networks. Every unit carries serial-level traceability from manufacturer to patient. We do not source from parallel-import channels or internet pharmacies.

Is the medicine authentic?

Yes. Supply is restricted to DSCSA-compliant US wholesalers. If a serial number on a package we have received cannot be verified against manufacturer records, that unit never moves.

Is cold chain maintained?

Yes. Refrigerated and controlled-room-temperature therapies ship in validated thermal packaging with embedded temperature logging. Any shipment that exceeds the approved excursion profile is quarantined on arrival and replaced at our cost.

What if the shipment is damaged or outside temperature tolerance on arrival?

Place the shipment on quarantine and notify us within 24 hours. A replacement shipment mobilises at our cost. We conduct a follow-up root-cause review jointly with the receiving site.

Is there a written quality agreement?

For institutional engagements we execute a written receiving and handover protocol as part of the enterprise-account framework. For individual-patient engagements the receiving checklist is included in the delivery pack.

Who performs pharmacist review?

Orders are dispensed by our US-licensed wholesaler partner under applicable state pharmacy supervision; our clinical team coordinates the case and reviews each request against the product label, the medical-rationale documentation, and the applicable regulatory frame before release.

Do you perform manufacturer verification?

Where a product is supplied under a manufacturer's limited-distribution network or carries a REMS program, we confirm the shipment against the manufacturer's program records before it leaves the US facility.

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Logistics & delivery

Where do you ship to?

To the treating physician's clinic or a hospital pharmacy. We do not ship to private residences.

How long does shipping take?

Door-to-door transit time is typically three to seven business days from release, depending on destination country and receiving-site customs procedures. Validated cold-chain packouts are qualified for at least that duration with margin.

Do you handle customs clearance?

We pre-file the relevant authorisation with customs on the destination side, prepare the commercial invoice and export documents on the US side, and either work with the institution's preferred customs broker or bring our own nominated agent.

What if customs holds my shipment?

Our regulatory team engages destination-country customs the same business day the hold is logged, in coordination with the nominated customs broker and the importer of record. Most documentation holds clear within 24 to 72 hours once the requested paper is filed. The treating physician, the receiving site, and the family receive a written update at the start of the hold, on resolution, and at any 48-hour mark in between.

Can I track my shipment?

Yes. Every shipment carries a tracking reference that is provided to the prescribing physician and, where the family is the primary client, to the family coordinator.

Do you ship in the patient's name?

No. Shipments are addressed to the named receiving pharmacist, technician, or clinician at the clinic or hospital pharmacy. The patient is identified in the regulatory documentation that accompanies the shipment, not on the airway bill.

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Pricing & payment

What does it cost?

The total is the drug acquisition cost plus a tiered coordination fee. Drug cost is the US Wholesale Acquisition Cost (WAC) at the time of order plus the specialty-wholesaler handling margin, which puts us at the lowest legitimate ex-US price for most specialty therapies outside US patient-assistance programs. The coordination fee runs 15 to 25 percent of drug cost for routine cases and scales with complexity (REMS enrolment, cold-chain frozen, multi-leg routing). Every quote breaks out drug cost, international shipping, regulatory documentation, and the coordination fee as separate line items. Nothing is bundled. See our ethics page.

Why is pricing not published?

Specialty-pharmacy pricing is patient-specific. The same drug, same strength, can vary 10 to 20 percent across an order depending on quantity (single vial vs. four-week supply vs. cycle), REMS or LDN posture, and frozen vs. refrigerated shipping. A published list would be wrong for most cases the moment a patient read it. We share an indicative range when you join the waitlist and a firm itemised quote before documents change hands.

Do you offer financial assistance?

We are not a charity and we do not administer patient-assistance programs. For rare-disease therapies there are often manufacturer-sponsored international access programs, and for some therapies there are patient-advocacy foundations with travel or sourcing grants. We signpost these where they exist and will decline to quote if a case is more appropriately served by an existing free program.

When do I pay?

We operate a prepay model. Payment is required before sourcing begins. See cancellation and refund standards.

How is my prepayment held before sourcing?

Your prepayment sits in a segregated, purpose-restricted Reserve Meds operating account at our US bank (Chase Business). It is not an escrow account, and we say so plainly. Funds are released against named line items: drug acquisition, regulatory documentation, international shipping, and the coordination fee. The release schedule and the cancellation-refund standards are in writing before any payment is taken. Full detail on our trust page.

What happens if the case cannot proceed after I have paid?

If a case cannot proceed for reasons outside the patient's control (a closed pathway, a regulatory denial, a supply constraint that emerges after the engagement opens), we refund the prepayment less any non-refundable third-party expenses already incurred on the patient's behalf, and we document the reasons in writing. The refund framework is in our cancellation and refund standards.

What payment methods do you accept?

Wire transfer and institutional or personal credit card. We do not accept cryptocurrency. We do not accept payment from any jurisdiction on the OFAC comprehensive-sanctions list, which currently covers Cuba, Iran, North Korea, Syria, and the Crimea, Donetsk, and Luhansk regions of Ukraine.

Can I submit your invoice to my insurer or employer benefit for reimbursement?

Yes. We do not bill payers on your behalf, but our invoice and dispensing documentation are structured to support a patient-submitted claim. We cannot guarantee a specific payer will reimburse a cross-border specialty-pharmacy expense; that is a decision that sits with the payer.

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Countries & regulation

Which countries do you serve?

Our active depth at launch is in the UAE (MoHAP Personal Importation), Saudi Arabia (SFDA Personal Importation), India (CDSCO Rule 36), Egypt (EDA personal-use), and Pakistan (DRAP named-patient). Where a named-patient or personal-import pathway is open in a destination country and a treating physician is willing to file, we will assess. We assess every new jurisdiction case by case rather than claim a country count. See our country pages.

Is this legal?

Yes, when the destination-country pathway is open for the indication in question and when US export requirements are met. Every case is screened against both destination-country regulatory feasibility and US export-control requirements before quoting. If a case cannot be coordinated compliantly we decline and explain why.

What about controlled substances?

We do not source DEA-scheduled controlled substances. This is a deliberate policy and we will not make exceptions.

Do you operate under a FDA export licence?

Our US-side operations are conducted under the licensing posture required for a licensed US specialty wholesaler, including state pharmacy-wholesaler licences in the relevant jurisdictions and compliance with Section 801(d) and associated FDA export requirements. Reserve Meds is advancing its own wholesale distributor licence in parallel with operations through our wholesale pharmacy partner; see Trust & Compliance for the current state.

Can I take the medicine through my own airline travel?

Personal-import by patient carriage is a distinct pathway and is not how we operate. Reserve Meds ships to a clinic or pharmacy under commercial cold-chain protocol. We are happy to discuss the pros and cons of personal-carriage versus coordinated shipping in a feasibility call.

Is my case subject to US export controls?

Every case is screened against US export controls, OFAC sanctions, and end-use restrictions before we engage. Where a restriction applies, we decline and explain.

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Privacy & data

How is my information protected?

Patient health information is handled under HIPAA, GDPR, and destination-country privacy frameworks where applicable. See our HIPAA Notice and Privacy Notice. We do not share patient information with third parties without written consent, with the standard legal exceptions for regulatory inquiry and manufacturer pharmacovigilance.

Who sees my case file inside Reserve Meds?

Only our dispensing partner's pharmacy team (as needed for release), the regulatory lead, the coordinator assigned to the case, and, where applicable, the treating physician or receiving pharmacy. Access is on a need-to-know basis and is logged.

Do you use patient data for research or marketing?

No. We do not use identifiable patient data for research, marketing, or any purpose other than the engagement for which it was provided, with the standard exceptions for regulatory and pharmacovigilance reporting.

How long do you retain my file?

Records are retained under a defined retention schedule that meets the longer of the US dispensing-record retention requirement, the destination-country requirement where applicable, and any institutional requirement agreed under a written data-processing agreement.

Can I request deletion?

Subject to the legal retention requirements above, yes. Contact [email protected]. Where a retention requirement applies, we will confirm the relevant legal basis and the earliest date on which deletion can be effected.

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For physicians

Do you work directly with physicians?

Yes. Many of our cases are physician-initiated. Physicians can submit an intake on behalf of a patient and we coordinate directly.

Can I remain the prescriber of record if I am not licensed in the destination country?

That depends on the destination country. Some jurisdictions require a locally licensed prescriber of record for the receiving-side authorisation, in which case we coordinate between you (as the treating physician of continuity) and a locally licensed colleague. See our physician page.

Do you pay referral fees?

No. We do not pay referral fees to physicians or to any party.

How do I submit a case?

Short intake at reservemeds.com/request, or by direct email to [email protected].

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For hospitals

Can you dispense to a hospital pharmacy?

Yes. Hospital-pharmacy dispensing is our preferred route for most institutional engagements. Receipt protocols, chain-of-custody documentation, and cold-chain logs are delivered with the shipment.

Will you sign our vendor MSA or BAA?

Yes, subject to review and targeted amendment where required. See our hospital page.

Do you offer enterprise pricing?

For institutions expecting repeat named-patient activity 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.

Can the P&T committee speak directly with your dispensing partner's pharmacy?

Yes. The enterprise briefing includes a session between our dispensing partner's pharmacy (under state supervision), our regulatory lead, and the pharmacy-and-therapeutics committee. Ad-hoc questions are welcome at any time.

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After delivery

What happens after the shipment is received?

The treating physician and the receiving pharmacy take custody. We close our role at pharmacy acceptance and retain the engagement file under the applicable retention schedule.

How do I report an adverse event?

Email [email protected]. We take responsibility for onward reporting to the FDA MedWatch program and, where relevant, to the manufacturer and the destination-country regulator.

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