Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies Guidance for Industry November 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2013-D-0811
• Issued by: Center for Biologics Evaluation and Research

We, FDA, are informing members of the medical and scientific community and other interested persons of our policy regarding the investigational new drug application (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat Clostridioides difficile (C. difficile) infection not responding to standard therapies.   At this time, FDA intends to exercise enforcement discretion with respect to such requirements under limited circumstances as described in section II of this guidance.  This policy does not apply to FMT that is obtained from a stool bank.

A stool bank is defined, for the purpose of this guidance, 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.

In development of this policy FDA has considered input from stakeholders, including physicians, scientists, and patients concerned about sufficient access to FMT for patients with C. difficile infection not responding to standard therapies.  FDA has developed this policy to help facilitate access for such patients, while addressing and controlling the risks that centralized manufacturing in stool banks presents to individuals receiving such products.

This guidance finalizes the draft guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies” dated March 2016, and supersedes the guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies” dated July 2013 (July 2013 guidance).

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