FMT's clinical evidence outpaced its legal framework; here we trace why oversight became essential and how its rules took shape across four eras.
FMT is at once a drug, a tissue, and a procedure; this chapter explains why a living microbial ecosystem resists every existing legal box.
Rules differ from country to country; we map how the FDA, Health Canada, and Europe's member states handle FMT, from the strictest regimes to the most permissive.
The SOHO regulation is the first European law to bring the medical use of human stool under one framework; we look at what it means for patients and stool banks.
Sound FMT regulation balances three goals — patient safety, access, and research — and this chapter shows exactly where no compromise is acceptable.
Commercial products, synthetic consortia, and global harmonization: we sketch the directions regulation will push FMT over the coming decade.