The U.S. Food and Drug Administration has issued final guidance for industry, “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” This final guidance includes only minor editorial differences from the draft guidance to improve clarity.
September 14, 2017
The U.S. Food and Drug Administration has issued draft guidance for industry, “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.”
Drugs listed on the Index are unapproved but can be legally marketed for specified use(s) in specified minor species. Indexing is allowed for drugs that are intended for use for:
- Non-food-producing minor species, such as pet birds, hamsters, zoo animals, and ornamental fish. These animals are typically not eaten by people or food-producing animals; and
- An early non-food life stage of a food-producing minor species, such as oyster spat (immature oysters). Because people do not generally eat oyster spat, a drug to treat a disease in spat can be indexed, but a drug to treat a disease in adult oysters, which people commonly eat, cannot be indexed.
Although the Index is available for new animal drugs intended for use in minor species, it is not available for drugs intended for minor use in major species (such as horses, cattle, pigs, turkeys, chickens, dogs, and cats).
This guidance describes the process for adding a new animal drug to the Index, including the use of an alternative review process to confirm the drug’s safety and effectiveness for the intended use. In many cases, minor species drug products are intended for uses that cannot reasonably go through the standard drug approval process, because they are often intended for use in species too rare or varied to be used in traditional safety and effectiveness studies. Index listing is a legal pathway to market these products, an alternative to the existing new animal drug approval process. The intent of this guidance is to aid the animal health industry in complying with the indexing regulations.
The FDA is accepting public comments beginning on September 15, 2017. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2017-D- 2462 in the search box.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2017-D- 2462 on each page of your written comments.
Comments will be accepted at any time, but should be submitted no later than November 14, 2017 to ensure that the FDA takes the information into consideration before making further decisions on this issue.
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
- Notice of Availability of Draft Guidance for Industry; The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- Regulations.gov: please note that the public comment period opens on September 15, 2017
- Guidance for Industry #210 The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- Minor Use/Minor Species
- Lions and Tigers and Bears! OMUMS!
- Unapproved Animal Drugs
For questions, Contact CVM.