Governance
How ibogaine is regulated, and what it means for your record-keeping
Ibogaine's legal status varies widely by country and, in federal systems, by state or province. Statuses also change. Rather than a country list that goes stale, the practical framing is the four regulatory shapes clinics operate under, because each one implies a different documentation burden.
Regulatory status changes and differs by jurisdiction, and this page is general information rather than legal or regulatory advice. Confirm the current position with your own regulator, medicines authority and legal counsel before treating anyone.
The four shapes
| Shape | What it means in practice | What the record must carry |
|---|---|---|
| Prescription medicine | Legally available on prescription by an authorised prescriber, usually with supply and compounding conditions. New Zealand is the long-standing example. | Named prescriber, indication, documented screening, informed consent, monitoring record, adverse event reporting to the medicines authority |
| Controlled substance | Scheduled with no ordinary therapeutic route, so lawful use is limited to research or special-access pathways. Common across much of Europe and North America. | Approval or exemption documentation, protocol adherence, chain-of-custody, ethics or institutional oversight records |
| Unscheduled or unregulated | Not specifically scheduled, so treatment occurs without a purpose-built framework. General health-practitioner, consumer-protection and duty-of-care law still applies. | Practitioner scope evidence, rigorous consent, screening and monitoring records, and the programme's own written protocol |
| Research or special access | Permitted within an approved trial, expanded access or named-patient scheme. | Ethics approval, protocol version, deviations, structured outcome data, mandated safety reporting |
What holds across every shape
Whatever the local status, the record a clinic is asked for after an incident looks largely the same, which means the documentation standard can be set once and applied internationally.
- Evidence that cardiac and medication contraindications were screened before the dose, and by whom.
- Informed consent that names the cardiac risk specifically, not a generic treatment consent.
- A monitoring record with timed, attributed observations against a named protocol.
- Documented escalation criteria and the local emergency pathway, plus evidence staff knew them.
- An adverse event register linked to the session that produced the event, with actions taken.
- Health information privacy compliance for the jurisdiction: the Privacy Act and the Health Information Privacy Code in New Zealand, the GDPR across the EU and UK, HIPAA where US-covered entities are involved.
- Data residency and retention decisions made deliberately rather than inherited from a vendor default.
Operating across jurisdictions
Clinics and provider networks working in more than one country hit the same friction: units, dates, currency, emergency numbers and regulatory wording all differ, while the clinical core does not. Rebuilding a record system per country is the wrong answer; treating those differences as configuration is the right one.
Treatment Companion App is built that way. Country, timezone, locale, currency, measurement units and the regulatory wording shown to patients and staff are configuration, and the screening structures, protocols, alert thresholds and audit trail are identical everywhere. A provider network licence covers multiple organisations and regions under one platform.
Documenting the draft US FDA trial safeguards
Draft US FDA guidance for ibogaine research describes a starting dose capped at 10 mg/kg, cardiac monitoring for up to 36 hours after a dose, and 12 months of cognitive follow-up. These are draft requirements; investigators should confirm the final guidance, their approved study protocol and ethics or IRB conditions.
Treatment Companion App supports the documentation side only. Clinics can approve a protocol version based on the included FDA draft trial template: a pre-dose checklist recording that the prescribed dose was confirmed against the protocol ceiling, a 36-hour schedule for staff to enter ECG/QTc and vital-sign values taken on the clinic's own equipment, shift handovers, and follow-up milestones at 1, 3, 6 and 12 months. The app does not calculate or set doses, acquire measurements or monitor patients.
The Network 18-month fixed-term licence suits a typical study timeline: protocol setup and ethics review, dosing, and the 12-month follow-up period, with no automatic renewal.
Run this in one clinical record
Treatment Companion App organises clinician-entered screening findings and measurements, assessments, adverse events and follow-up records for clinics and prescribers in any jurisdiction. 21-day trial, no card required.