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# Enforcement Guide on Fecal Microbiota for Transplantation
- URL: https://www.fdaweb.com/enforcement-guide-on-fecal-microbiota-for-transplantation/
- Published: 2022-11-28T12:00:00.000Z
- Updated: 2026-09-14T18:07:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153269

FDA has posted a [final guidance](https://www.fda.gov/media/86440/download?ref=fdaweb.com) entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies.” The document outlines the agency’s intended enforcement discretion with respect to IND requirements under limited circumstances. The policy does not apply to FMT that is obtained from a stool bank, which is defined as an establishment that collects, prepares, and stores FMT product for distribution to other establishments, health care providers, or other entities for use in patient therapy or clinical research. “An establishment that collects or prepares FMT products solely under the direction of licensed health care providers for the purpose of treating their patients (e.g., a hospital laboratory) is not considered to be a stool bank under this guidance,” the agency says.

“Centralized manufacturing in stool banks presents safety concerns related to the number of patients that may be exposed to a particular donor and particular manufacturing practices,” the guidance says. “These safety concerns include transmission of infectious agents.”