Trust & Compliance
How we source, how we review, how we dispense, and how we protect your information. The short answer: US-licensed pharmacy, DSCSA-compliant supply chain, AI-assisted pharmacist and regulatory counsel review, and a human-licensed pharmacist checking every prescription before it ships.
Pre-launch posture, what "first cohort" means
Reserve Meds is in active pre-launch. We are accepting waitlist requests from patients, families, and physicians but fulfilling only within a limited first cohort while we complete operational rollout. Being added to the waitlist is not an order and does not create a commercial commitment. We will contact you individually when your case is ready to enter intake, at which point full eligibility, pricing, and compliance review begin. Published timelines, fulfilment windows, and availability statements across this site are indicative for the first cohort and should not be read as guarantees. If your clinical situation is time-sensitive, please say so, we triage accordingly.
Sourcing, where your medicine actually 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. Our primary sources are the three major specialty distributors (McKesson, AmerisourceBergen / Cencora, and Cardinal Health Specialty) plus a set of smaller licensed distributors for specific therapies. Every unit that enters our dispensing queue carries a transaction history (TH), a transaction information (TI) record, and a transaction statement (TS) traceable from manufacturer to patient under DSCSA serialization.
Licensure, who is legally responsible for dispensing
Dispensing is performed by our wholesale pharmacy partner, a US-licensed specialty wholesaler, under applicable state pharmacy supervision at our licensed dispensing partner. Our US-licensed wholesaler partner reviews and approves every order, under applicable state pharmacy supervision, before it is dispatched. Reserve Meds operates in partnership with a US-licensed specialty wholesaler and does not dispense independently.
The AI-review model, what it is and what it is not
Our editorial and operational workflow is reviewed by two AI reviewer archetypes: an AI Clinical Review Agent and an AI Regulatory Review Agent. These are not replacements for a human professional and they do not make dispensing 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.
A human US-licensed pharmacist is the legal prescriber-facing counterparty on every dispense. A human regulatory attorney is retained for case-specific legal questions and for any enforcement correspondence. AI review is a quality floor, not a legal 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. We are compliant with DSCSA obligations applicable to a dispenser. In practice this means that if a serial number on a package we received 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 HIPAA Notice 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 [email protected]. 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, dispensing, or privacy posture falls short, please write to [email protected]. Complaints are logged, investigated, and responded to within five business days. Material complaints are escalated to our dispensing partner's pharmacy leadership and, where appropriate, to retained outside counsel.
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: 2026-07-22.