INTL · FDA-ALT-001 · Updated 29.06.2026
FMT Access After FDA 2024: International Options Available
Since FDA's 2024 enforcement actions and OpenBiome's discontinuation of operations, many US patients with recurrent C. difficile have lost access to FMT. Transbiom provides donor microbiota to US clinics with an active IND application.
What changed in 2024?
- ·FDA requires IND (Investigational New Drug) application for all FMT procedures since October 31, 2024
- ·OpenBiome discontinued operations due to inability to obtain IND
- ·Many US clinics lost their stool bank supply chain
- ·International import remains legal with proper FDA IND and CDC permits
How it works
Consult your US physician
Your gastroenterologist determines if FMT is indicated for your condition (e.g., recurrent C. difficile).
Physician orders from Transbiom
Your clinic contacts Transbiom with their active IND number and places a B2B supply order.
Material shipped internationally
Donor material ships with cold chain (dry ice, temperature log). Timing and carrier are agreed with the clinic; no fixed universal SLA.
Procedure performed in US clinic
Your physician performs the FMT procedure. The clinic is responsible for clinical application and outcomes.
Cost & Logistics
FAQ
Is it legal to import FMT material to the US?
Yes. FDA allows import of biological material for specific indications when the receiving clinic has an active IND (Investigational New Drug) application. CDC permit (42 CFR Part 71) is required for import of human biological material.
How long does international shipping take?
Transit is agreed with the clinic. Cold chain uses dry ice and temperature logging. Exact timing depends on route and carrier; do not treat a fixed 48h SLA as a universal promise.
Is the material held to the same standards as US manufacturers?
Transbiom follows stool-bank process logic used internationally: multi-stage donor screening, stool pathogen and MDRO checks, lot quarantine, material passport, and B2B supply to licensed clinics. We do not present held GMP/ISO certificates as marketing badges without documents.
Can patients order directly?
No. Transbiom supplies exclusively to licensed healthcare providers. Patients must consult their physician, who can order on their behalf through a B2B supply agreement.
Are you a US clinic with an active IND?
Contact us for B2B supply of donor microbiota material.
Contact TransbiomThis page is for informational purposes only. Transbiom supplies biological material exclusively to licensed healthcare providers with an active FDA IND. Direct sales to patients are not available. Verify compliance with FDA, CDC, and your state regulations before ordering.