Trust & Compliance

Starting a case: what an inquiry means

We accept inquiries from patients, families, and physicians. Sending an inquiry is not an order and does not create a commercial commitment. When we take on your case, full eligibility and compliance review begins, and you get a written custom quote and a written timeline estimate before you commit. Timelines and availability statements across this site are general information and should not be read as guarantees. If your clinical situation is time-sensitive, please tell us and we will prioritise accordingly. We never publish patient case details without written consent.

Sourcing: where your medicine comes from

Every therapy we coordinate is acquired through licensed US specialty wholesalers operating under the Drug Supply Chain Security Act (DSCSA). We do not purchase from parallel-import channels, unlicensed brokers, or internet pharmacies. Medicines are supplied through a US-licensed pharmaceutical wholesale partner that buys from licensed US distribution channels. Every unit our wholesale partner supplies carries a transaction history (TH), a transaction information (TI) record, and a transaction statement (TS) traceable from manufacturer to patient under DSCSA serialization.

Licensing: who is responsible for what

Reserve Meds is a digital health company. We are not a pharmacy and we do not dispense. Medicines are supplied through a US-licensed pharmaceutical wholesale partner, which keeps the supply-chain records. In your country, the medicine is received and given out by a locally licensed hospital or pharmacy under your doctor's prescription. Ask us and we will share the wholesale partner's license details for your case.

How we review content, and where AI fits

Pages are reviewed by the Reserve Meds clinical operations team. We use AI tools to help with this work. They are not a replacement for a human professional and they do not make medical or supply decisions. They do three things: they keep our content consistent with the current FDA label, they flag regulatory and privacy risk before content is published, and they watch the change log for every therapy so updates propagate quickly.

Medical decisions always stay with your own treating doctor. Regulatory information on this site is general information, not legal advice. AI tools help us check our work; they are not a legal or medical substitute.

DSCSA, drug supply chain security

DSCSA is the US federal statute (21 U.S.C. § 360eee et seq.) that requires product-level serialization, transaction tracking, and suspect / illegitimate-product investigation across the pharmaceutical supply chain. Our wholesale partner keeps the DSCSA records for every unit it supplies. In practice this means that if a serial number on a package cannot be verified against manufacturer records, that unit never moves. Our full DSCSA policy is available on request to licensed clinicians and to regulators.

HIPAA and international privacy

We handle protected health information (PHI) under the US Health Insurance Portability and Accountability Act (HIPAA) for all US-facing clinical data, under the EU General Data Protection Regulation (GDPR) for patients with an EU nexus, and under destination-country privacy frameworks (UAE DHA, India DPDP 2023, KSA PDPL) where applicable. See our Protecting health information and Privacy Notice.

Quality, cold chain and chain of custody

Specialty therapies that require refrigerated or controlled-room-temperature handling ship in validated thermal packaging with embedded temperature logging. Cold-chain deviations are flagged on receipt by the treating physician or hospital pharmacy, and any unit that exceeded the approved temperature excursion profile is quarantined and replaced at our cost.

Adverse-event reporting and pharmacovigilance

If you or your patient experience an adverse event with a therapy we coordinated, we ask that you report it to us at pv@reservemeds.com. Serious adverse events are reported to the FDA MedWatch program and, where relevant, to the manufacturer and the destination-country regulator. Our pharmacovigilance policy is available on request.

What we will not do

We do not source controlled substances (DEA-scheduled drugs). We do not operate direct-to-patient without physician oversight. We do not sell in jurisdictions where the named-patient or personal-import pathway is closed for the indication in question. We do not accept payment in crypto or untraceable instruments. We do not forward patient information to third parties without written consent, with the standard legal exceptions for regulatory inquiry and manufacturer pharmacovigilance.

Complaints and escalation

If something has gone wrong, or if you believe our sourcing or privacy practices fall short, please write to quality@reservemeds.com. We reply within one business day and aim to resolve complaints within five business days. Serious complaints are escalated to our wholesale partner and, where appropriate, to the relevant regulator.

Reviewed 2026-10-13 by the Reserve Meds clinical operations team. Next scheduled review: 2027-01-13.