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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Issues Final Regulations on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

December 6, 2007

The Food and Drug Administration (FDA) is issuing final regulations today to implement Section 572 of the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The MUMS Act amended the Federal Food, Drug, and Cosmetic Act to establish new regulatory procedures to increase the availability of animal drugs for the treatment of minor animal species and uncommon diseases in major animal species. Today's final regulations, entitled "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species" ("the Index") describe administrative procedures and criteria for Index listing of a new animal drug for use in a minor species.

Minor species are all animals other than the major species (cattle, horses, swine, chickens, turkeys, dogs, and cats), for example, sheep, goats, honey bees, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. However, the "Index" is limited to nonfood-producing minor species with a limited exception for certain early life stages of food animals, such as some fish eggs.

The "Index" is intended to allow companies to legally market veterinary drugs for minor species for which there are no human food safety concerns without having to go through the long and expensive process of a new animal drug approval. Inclusion in the "Index" will largely be based on the evaluation of the target animal safety and effectiveness of each specific product by a panel of qualified experts.

The final regulations describe the process FDA will use to determine whether a new animal drug can be added to the Index. The process includes sponsor submission of a request for eligibility, selection of a qualified expert panel to consider the target animal safety and effectiveness of the new animal drug, and submission of the findings of the expert panel to the agency for consideration in support of a request to add a drug to the "Index".

The regulations become effective on February 19, 2008 and submissions for indexing cannot be accepted prior to this date.

Additional information on the final rule is included in the December 6, 2007 Federal Register. Questions may be directed to Dr. Bernadette Dunham, Center for Veterinary Medicine (HFV-50), 7519 Standish Place, Rockville, MD 20855, 240-276-9090, Bernadette.Dunham@fda.hhs.gov.

For additional information on animal drugs for minor uses and minor species, please see http://www.fda.gov/cvm/minortoc.htm.


In early 2008, the Office of Minor Use and Minor Species (OMUMS) will be adding to the growth of the Center for Veterinary Medicine's newest office. Dr. Joan Gotthardt will be joining OMUMS in February 2008 to direct the implementation of the Indexing provisions of the MUMS Animal Health Act of 2004.

Dr. Gotthardt received her bachelor's degree in Animal Science from the University of Maryland and her Doctorate of Veterinary Medicine from the Virginia Maryland Regional College of Veterinary Medicine. She has been with CVM since 1995, and has served as Director of the Division of Therapeutic Drugs for Food Animals in the Office of New Animal Drug Evaluation for the past 5 years. Her extensive experience with minor species issues and stakeholders will be invaluable in her new role.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855