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        Vaccines, Blood & Biologics

Fecal Microbiota Products Home
          Vaccines, Blood & Biologics
          Fecal Microbiota ProductsVaccines, Blood & Biologics Fecal Microbiota Products
  	
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    PrintThe 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

REBYOTA (fecal microbiota, live - jslm)
	VOWSTSafety Information

Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus
	August 22, 2022
	Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2
	April 9, 2020
	Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation -- Testing of Stool Donors for Enteropathogenic Escherichia coli and Shigatoxin-Producing Escherichia coli
	April 6, 2020
	Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
	March 23, 2020
	Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
	March 13, 2020
	Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
	March 12, 2020
	Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening and Testing of Stool Donors for Multi-drug Resistant Organisms
	June 18, 2019
	Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms
	June 13, 2019Guidance 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

                                                                                  Content current as of:
      04/28/2023Fecal Microbiota Products
 
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