Drug-use Guidance...

Animal Drugs for Minor Uses and Minor Species

Given the paucity of drugs available for aquatic species (as well as other minor species that include all animals other than cattle, horses, swine, chickens, turkeys, dogs, and cats), and the apparent lack of applicability of the normal New Animal Drug Application (NADA) process to minor species, the FDA's Center for Veterinary Medicine was instrumental in the passage of the "The Minor Use and Minor Species Animal Health Act of 2004" or what is more commonly referred to as the MUMS Act.

In essence, the MUMS Act provides two new ways to legally obtain drugs for use on minor species, as well as several incentives (e.g., tax incentives, research grants and increased marketing exclusivity). The first new type of approval is called a "conditional approval." It is identical to a standard approval obtained via the NADA process, with one exception. In the case of the conditional approval (CA), all data requirements are the same, but the drug sponsor has 5 years from the time the CA was granted until the effectiveness data are due.

The second new type of "approval" is not actually an approval. Instead it is a new way of legally marketing unapproved drugs for minor species. The basis for this process called "Indexing" is a review package submitted to CVM from an outside expert panel that documents and argues that the drug is safe and effective.

For more general information on the MUMS Act, click here.

Since the MUMS Act was passed in 2004, the required regulations have been passed for several of the major components of the Act, i.e., conditional approvals, indexing and MUMS "designation." To access these regulations refer to CVM's general information link or the links below.

MUMS Designation

Indexing