AVMA Develops Extra-label Drug Use FAQs

August 11, 2010 — 

The Animal Medicinal Drug Use Clarification Act (AMDUCA) passed by Congress in 1994 made extra-label drug use (ELDU) an FDA-regulated veterinary medical activity and provided veterinarians with a degree of flexibility when prescribing extra-label uses of approved animal and human drugs to animals. Given the relatively few numbers of animal-label drugs available for veterinary use, the enactment of AMDUCA provided veterinarians with an important tool they could use to relieve animal pain and suffering.

But, as they say, the devil is in the details. The ELDU rules are complex and can be difficult to understand. At the same time, food safety and drug residue concerns have been increasing among Congress and the general public. To help veterinarians ensure they are following FDA's ELDU regulations under AMDUCA, the AVMA has developed a new resource that provides answers to some of the most frequently asked clinical questions regarding ELDU. You can find it here. Used along with the AVMA's algorithm (PDF), veterinarians can now more easily determine when it is appropriate to administer or prescribe drugs in an extra-label manner.

Keep in mind that extra-label use is limited to those circumstances in which the health of an animal is threatened or suffering/death may result from failure to treat. Bottom line - extra-label use to enhance production is prohibited. But by following these overarching rules for appropriate use of extra-label drugs, along with the more specific components of ELDU rules, veterinarians can help ensure that illegal drug residues are avoided, that antimicrobial resistance is mitigated and that America's food continues to be among the safest in the world.

Source:
AVMA
By Jessica Green, Scientific Activities Division extern