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  1. Vaccines, Blood & Biologics

Fecal Microbiota Products

The human intestinal tract contains millions of microorganisms, often referred to as the “gut flora," or "gut microbiome." Many of the microorganisms that live in the gut are also found in stool. Fecal microbiota products are prepared from human fecal matter (stool) donated by healthy individuals and are administered to another individual. The administration of fecal microbiota products is thought to facilitate restoration of the gut flora.

Fecal microbiota products that are used to diagnose, prevent, treat, or cure a disease or condition in humans are biological products and the Center for Biologics Evaluation and Research has oversight of the safety and effectiveness of these products.

FDA-Approved Fecal Microbiota Products

Safety Information

Guidance for Industry

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

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