FDA Announces Initiative to Address Unapproved Animal Drugs

December 20, 2010

The Food and Drug Administration (FDA) announced today an initiative to address unapproved animal drugs. To start off the initiative, FDA published a notice in the Federal Register and launched a new Web page.

In the Federal Register notice, FDA requests comments from the public on ways to increase the availability of legally marketed animal drugs. FDA expects drug companies to legally market animal drugs, in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. However, FDA is open to using both the agency’s existing authority and new approaches to make more drugs legally available to veterinarians, animal

When FDA exercises enforcement discretion, the agency decides to not strictly enforce the requirements of the Federal Food, Drug, and Cosmetic Act.

producers, and pet owners. Also, under limited circumstances, FDA may exercise enforcement discretion to maintain access to essential unapproved animal drugs while drug companies work to get these drugs on the market legally. 

The Unapproved Animal Drugs Web page explains what illegally marketed unapproved animal drugs are and why FDA is concerned about these drugs. The Web page also explains the difference between an animal drug and an animal device, and the risks of a company marketing an unapproved animal drug as an animal device.
 

Additional Information on the Federal Register Notice: To read the Federal Register notice, please visit the following website: http://edocket.access.gpo.gov/2010/pdf/2010-31889.pdf. Public comments will be accepted for 60 days after the date of publication. To submit comments, go to http://www.regulations.gov. For more information, contact: Tracey H. Forfa Center for Veterinary Medicine (HFV-1) Food and Drug Administration 7500 Standish Pl Rockville, MD 20855 240-276-9000 tracey.forfa@fda.hhs.gov