July 25, 2022

The U.S. Food and Drug Administration has withdrawn guidance for industry (GFI) #210, “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species,” in order to revise it in accordance with a statutory change to the wording of required label statements and because the guidance no longer represents the agency’s current thinking. The FDA plans to issue a revised draft guidance as expeditiously as possible.

The FDA published final GFI #210 in April 2018, which included guidance on a statutory requirement at the time to label products on the Index with the statement “Not Approved by FDA.” With the recent statutory change, this statement has been modified for products that are part of the Index. 

Additionally, the FDA received feedback regarding guidance #210 in response to a Request for Information in June 2021 asking for stakeholder feedback on expanding eligibility for Indexing for certain groups of animals from food-producing species when there is reasonable certainty that those animals would not enter the food supply.

The vast majority of comments received in response support the contention that there is a “reasonable certainty” that certain subsets of minor species generally considered to be food-producing animals will not be used as food for humans or food-producing animals, including laboratory rabbits and broodstock fish.  As we consider these comments, we encourage potential requestors for Indexing to consult GFI #201, “Small Entities Compliance Guide for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species,” and consult with the agency’s Office of Minor Use & Minor Species (OMUMS). OMUMS will determine the eligibility of a drug for Indexing on a case-by-case basis.