Courtesy of NAA:
A significant step has been achieved to fully implement a provision within the Minor Use, Minor Species Act (MUMS Act) authorizing Indexed drugs. The U.S. Food and Drug Administration (FDA) has withdrawn guidance for industry (GFI) #210, The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.
This breakthrough was triggered by the National Aquaculture Association presenting to the agency an analysis demonstrating: 1) broodstock do not typically enter the food marketing chain and 2) regulations at the federal and state levels reinforce drug label restrictions preventing broodstock consumption as human food.
An incentive established by the 2004 MUMS Act was the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, also commonly referred to as “the Index.” The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of section 572 of the Food, Drug and Cosmetics Act. Indexing represents a pathway for legally marketing unapproved new animal drugs.
As the agency drafts new guidance for industry, they are encouraging potential Indexing applicants 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.
Next up for the National Aquaculture Association is an effort to achieve FDA recognition that early life stages are eligible for Indexing.