For prescribing physicians

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 practise 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 pharmacist-in-charge at Altima Care, the US-licensed specialty wholesaler currently in our US supply chain (while Reserve Meds advances its own wholesale distributor license), is the counterparty you will interact with on any question that touches dispensing, stability, handling, or dose verification. Every prescription we receive is reviewed by that pharmacist-in-charge before it is released for fulfilment, 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 minimised. Common examples are a named-patient authorisation form for the ministry of health, an unregistered-product declaration, and, in paediatric 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 programme and, where relevant, to the manufacturer and destination-country regulator.

The AI Clinical Review Agent, plainly described

Our editorial and operational workflow is supported by two AI reviewer archetypes. The AI Clinical Review Agent checks the coherence of the intake against the current FDA label, flags dose or indication mismatches before the pharmacist-in-charge sees the file, and surfaces relevant product-level updates such as label changes, REMS program amendments, or manufacturer shortage notices. The AI Regulatory Review 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 the pharmacist-in-charge's 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.

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.