Regulatory Brief

 Index Drugs: Making more drugs legally available for non-food minor species


Formal title: Docket Number [2006N-0067] Index of Legally Marketed Unapproved New Animal Drugs for Minor Species


Brief Description:

The Minor Use and Minor Species Animal Health Act of 2004 amended the Federal Food, Drug, and Cosmetic Act to authorize the U.S. Food and Drug Administration (FDA) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. In the Federal Register of August 22, 2006 (71 FR 48840), the FDA proposed regulations to implement section 572 of the act entitled "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." These regulations propose administrative procedures and criteria for index listing a new animal drug for use in a minor species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species.

The FDA requested comments on these proposed regulations by November 20, 2006.

Background Documents:

View AVMA's request for extending the comment period (PDF)

View AVMA's comments to the proposed drug index regulations (PDF)

View Federal Register document (PDF)

Status:

View the Final FDA MUMS Indexing Rule that becomes effective February 19, 2008 (PDF)