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# Some FDA Fecal Microbiota Enforcement Discretion
- URL: https://www.fdaweb.com/some-fda-fecal-microbiota-enforcement-discretion/
- Published: 2016-03-01T12:00:00.000Z
- Updated: 2026-09-15T02:39:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134920

FDA says it will exercise enforcement discretion under limited conditions for IND requirements for using fecal microbiota transplantation (FMT) to treat *C. difficile* infection not responding to standard therapies. A draft [guidance](http://www.fda.gov.downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM488223.pdf?ref=fdaweb.com), *Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat* Clostridium difficile *Infection Not Responsive to Standard Therapies*, says FDA intends to exercise enforcement discretion provided that: **(1)** the licensed healthcare provider treating the patient obtains adequate consent from the patient or his or her legally authorized representative for use of FMT products; **(2)** the FMT product is not obtained from a stool bank; and **(3)** the stool donor and stool are qualified by screening and testing performed under the direction of the licensed healthcare provider for the purpose of providing the FMT product for treatment of the patient.

The agency says that enforcement discretion will not be extended for IND requirements applicable to stool banks distributing FMT products.

“FDA has developed this policy to assure that patients with *C. difficile* infection not responding to standard therapies may have access to this treatment, while addressing and controlling the risks that centralized manufacturing in stool banks present to subjects,” the guidance says. “FDA intends for this to be an interim policy, while the agency develops a comprehensive approach for the study and use of FMT products under IND.”

The draft replaces a 3/2014 draft guidance and when finalized will supersede a 7/2013 guidance.