Fecal Microbiota Transplantation
Summary
Fecal microbiota transplantation using a conventional compounded product may be considered medically necessary for the treatment of individuals with recurrent Clostridioides difficile infection who have had at least 2 recurrences that are refractory to standard antibiotic treatment. Fecal microbiota transplantation is considered investigational in all other situations. A conventional compounded product is an FMT product not involving a stool bank, where the FDA exercises enforcement discretion regarding applicable investigational new drug requirements.
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