Glossary
A plain-language guide to the regulatory, supply-chain, clinical, and commercial terms that come up in cross-border named-patient access. We have kept the definitions short; where a term carries a great deal of legal or operational weight, we have linked to a fuller explanation.
Regulatory & pathway
Named-patient programme (NPP)
A regulatory pathway that permits a licensed physician to import, for a specifically identified patient, a medicine that is not registered in the destination country. The authorisation is patient-specific and time-limited, and it is distinct from both commercial registration and from an expanded-access or compassionate-use programme. Reserve Meds is built around the NPP pathway.
Personal import
A related regulatory pathway, used in many jurisdictions, under which an individual patient (or a family member acting on their behalf) is permitted to import a limited quantity of a medicine that is not available locally, usually with prescriber involvement and usually subject to a quantity cap per authorisation. The specifics vary by jurisdiction; we describe the posture country-by-country on our country pages.
Compassionate use / expanded access
A mechanism that permits a patient with a serious or life-threatening condition to access an investigational medicine outside a clinical trial. In the United States this is FDA's Expanded Access programme (sometimes called compassionate use); in other jurisdictions analogous mechanisms exist under different names. Reserve Meds does not ordinarily operate in this space because we source FDA-approved products; we will signpost a compassionate-use pathway where it is the correct answer for a given patient.
Section 801(d), FD&C Act
The provision of the US Federal Food, Drug, and Cosmetic Act that governs the export of unapproved or conditionally approved drugs. Reserve Meds exports only FDA-approved products, but Section 801(d) remains the reference frame for the broader regulatory posture of US specialty export.
Unregistered-product declaration
A common destination-country document, filed alongside the named-patient authorisation, in which the treating physician (and sometimes the importing institution) formally acknowledges that the product is not registered in the country and that the import is for the specifically identified patient.
Ministry-of-Health (MoH) authorisation
The umbrella term for the formal sign-off from the destination-country drug regulator that permits the import. In different jurisdictions the sign-off is issued by a ministry, a regulatory authority, or a specialised agency; the substance is the same.
Hospital formulary exception
An institutional pathway, used in some hospital systems, under which a pharmacy and therapeutics committee can authorise the use of an unregistered product on a specific patient without going through a ministry-level authorisation. The availability and scope of formulary-exception pathways vary by institution and jurisdiction.
Ex-US / cross-border
Umbrella terms for the kind of engagement Reserve Meds supports: a US-sourced medicine shipped to a patient or institution outside the United States under a compliant destination-country pathway.
FDA Expanded Access
A specific US pathway permitting access to an investigational medicine outside a clinical trial. Distinct from the named-patient pathway on the destination side; included here because the two are frequently confused.
Early-access programme (EAP)
A manufacturer-run programme that provides pre-approval access to a medicine for a defined patient population, usually in specific countries. EAPs overlap with compassionate-use and named-patient pathways depending on the jurisdiction.
Supply chain & chain of custody
DSCSA (Drug Supply Chain Security Act)
The US federal law that requires serialisation and lot-level traceability for prescription drugs moving through the US supply chain. Every product Reserve Meds sources travels on a DSCSA-compliant chain of custody. See also TI, TH, TS below.
Transaction Information (TI)
Under DSCSA, the data that identifies each transfer of a lot through the supply chain: the product name, the strength, the lot number, the quantity, the date, and the parties to the transfer.
Transaction History (TH)
Under DSCSA, the cumulative record of all transfers of a given lot from the manufacturer through each authorised distributor, up to the current holder.
Transaction Statement (TS)
Under DSCSA, the statement from each transferor affirming that the product has been handled in accordance with the relevant DSCSA requirements. TI, TH, and TS are provided with every shipment.
Serialisation
The assignment of a unique identifier (the GS1 serialised Global Trade Item Number, or SGTIN, and related data) to each saleable unit, so that it can be traced end-to-end through the supply chain. Required under DSCSA and under analogous frameworks in the EU and other jurisdictions.
Chain of custody
The documented record of who held the product, when, and under what conditions, from manufacture to patient. Reserve Meds maintains an unbroken chain-of-custody record for every unit shipped.
Specialty wholesaler
A licensed US distributor specialised in high-complexity, high-value therapies including oncology, rare disease, and cell-and-gene products. Our US-side channels are McKesson Specialty, AmerisourceBergen (Cencora) Specialty, and Cardinal Health Specialty, with supplementary smaller licensed distributors for specific products and limited-distribution networks.
Limited-distribution network (LDN)
A commercial arrangement under which a manufacturer restricts distribution of a product to a defined set of specialty pharmacies and distributors, typically to manage REMS obligations, cold-chain risk, or programme enrolment. Cross-border named-patient supply from an LDN product requires manufacturer engagement.
Parallel import
A distribution channel under which a product is acquired in one market and re-exported to another, outside the manufacturer's authorised distribution network. Reserve Meds does not source from parallel-import channels, as a policy. All product travels on a DSCSA chain from a licensed US specialty wholesaler.
Prescriber of record
The physician legally responsible for the prescription and the clinical decision behind it. In a Reserve Meds engagement, the prescriber of record is the treating physician, not Reserve Meds or our wholesale pharmacy partner.
Receiving site
The physical address and named recipient to which a shipment is delivered. Typically the treating clinician's clinic or a hospital pharmacy; never a private residence.
Clinical & pharmacy
Dispensing oversight (pharmacy-level)
The US-licensed dispensing function at our wholesaler partner operates under applicable state pharmacy supervision; Reserve Meds coordinates the case. Every order is reviewed, under applicable state pharmacy supervision at our dispensing partner, before release.
Pharmacy and therapeutics (P&T) committee
The institutional committee at a hospital or health system that reviews and approves formulary additions, including named-patient imports in many institutions. Reserve Meds provides a standard dossier organised for P&T review.
Medical-rationale letter
A short letter from the treating physician setting out the diagnosis, the relevant eligibility findings, the therapies tried or considered, and the reasoning behind the requested therapy. A standard accompaniment to a named-patient authorisation. See our physician template.
REMS (Risk Evaluation and Mitigation Strategy)
An FDA-mandated programme, applied to a subset of products, that requires specific prescriber, pharmacy, and patient enrolment or monitoring steps. Reserve Meds coordinates REMS enrolment on the prescriber's and receiving site's behalf where applicable.
Orphan drug
A medicine granted orphan-drug designation under the US Orphan Drug Act, recognising that it is intended to treat a rare disease. Many of the therapies we coordinate carry orphan-drug designation.
Breakthrough designation
An FDA designation accelerating the development and review of medicines that offer substantial improvement over existing therapies for serious conditions. Often a leading indicator of the kind of product for which cross-border named-patient access is sought.
Off-label
Use of an approved product for an indication, dose, or patient population outside its labelled use. Reserve Meds does not source medicines for off-label use as a matter of policy. The pathway we operate is named-patient use of a product for its labelled indication.
Pharmacovigilance (PV)
The activities of detecting, assessing, and reporting adverse drug events. Reserve Meds maintains a pharmacovigilance channel for every engagement and takes responsibility for onward reporting to the FDA MedWatch programme and, where relevant, to the manufacturer and destination-country regulator.
Adverse event (AE) / serious adverse event (SAE)
An untoward medical occurrence in a patient administered a medicine, with a serious AE defined by specific criteria (death, life-threatening, hospitalisation, persistent disability, congenital anomaly, or other important medical event). Reserve Meds's PV channel is configured for both.
MedWatch
The FDA's adverse-event reporting programme for health-care products. Reserve Meds files MedWatch reports where required.
Logistics & cold chain
Cold chain
The uninterrupted handling of a temperature-sensitive medicine within its label storage range, from manufacturer through to patient administration. Cold-chain posture is a central part of our engagement for any product that requires refrigerated or frozen handling.
Validated packout
Thermal packaging whose ability to maintain a defined temperature range, for a defined duration, has been established under controlled testing. We use validated packouts qualified against the label storage requirement of each product.
Temperature logger
A small embedded device that records temperature at a defined interval throughout transit. Downloaded at receipt; the log accompanies the delivery pack.
Excursion
A departure of the shipment temperature from the approved profile. An excursion outside the approved tolerance triggers quarantine on receipt and replacement at our cost; a within-tolerance excursion is logged and does not impair the product.
Quarantine
A holding state applied to a shipment at receipt when a check has failed, pending review. A quarantined unit is not dispensed until the review is complete.
Importer of record (IOR)
The party legally responsible for compliance with destination-country import requirements, including duties and regulatory authorisation. The IOR is typically the institution or the patient; Reserve Meds is the exporter of record on the US side.
Customs broker
A licensed agent that processes a shipment through destination-country customs. For institutional engagements we work through the institution's preferred broker where one exists; otherwise we provide one.
Harmonised System (HS) code
The international classification code applied to a product for customs purposes. Medicines are classified under Chapter 30 of the HS. We file the appropriate HS code with each shipment.
Commercial & access programmes
Named-patient case
An individual patient engagement. Reserve Meds operates exclusively on a named-patient basis; we do not hold inventory against anticipated demand.
Cash-pay
A commercial posture in which the patient, family, or institution pays directly for the product and service, rather than a payer. Reserve Meds is cash-pay; we do not bill insurance.
Coordination fee
The Reserve Meds fee for coordination services, separate from the drug acquisition cost. Tiered by patient context and complexity; quoted in the formal engagement letter.
Patient-assistance programme (PAP)
A manufacturer-sponsored programme providing free or subsidised access to a product for eligible patients. Reserve Meds does not administer PAPs and will signpost a PAP where it is the appropriate route for a given patient.
Charitable foundation pathway
A pathway operated by a disease-specific foundation that supports access to specialty therapy for eligible patients. Typically rare-disease-focused. Reserve Meds signposts foundation pathways where a patient meets eligibility.
Prepay
A commercial posture in which payment is collected before sourcing begins. This is standard in cross-border specialty pharmacy and is how we avoid carrying patient-specific inventory risk. Terms are set out in the engagement letter.
Escrow-structured operating account
A banking arrangement under which patient prepayment is held in a segregated, purpose-restricted account and is released to product acquisition and coordination expenses in defined tranches. See our trust page for a fuller description.
Privacy & data
HIPAA
The US Health Insurance Portability and Accountability Act. Reserve Meds handles patient health information under HIPAA-aligned controls and executes Business Associate Agreements with institutional partners.
Business Associate Agreement (BAA)
A contract required under HIPAA between a covered entity (for example, a US-licensed pharmacy) and a business associate that handles protected health information on the covered entity's behalf. Reserve Meds executes BAAs on institutional engagements in the United States.
GDPR
The European Union's General Data Protection Regulation. Where a patient is located in the EU, an EEA country, or a country applying GDPR-equivalent rules, Reserve Meds handles data under GDPR-aligned controls and executes the equivalent data-processing agreement.
Data Processing Agreement (DPA)
A contract required under GDPR and comparable regimes between a data controller and a data processor, setting out the purposes, duration, and safeguards of the processing. Reserve Meds executes DPAs where applicable.
Protected Health Information (PHI)
Under HIPAA, individually identifiable health information. Reserve Meds collects the minimum PHI required for a named-patient engagement and retains it under a defined retention schedule.
De-identification
The process of removing identifiers from data so that a specific individual cannot reasonably be re-identified. Where Reserve Meds uses case material for quality review or publication, it is de-identified and further disguised as a composite.
Reviewed 2026-04-22 by Reserve Meds's AI clinical and regulatory review agents. Human dispensing oversight: provided by our US-licensed wholesaler partner under applicable state pharmacy supervision. Next scheduled review: 2026-10-22.