FDA Logo links to FDA home page HHS Logo links to Department of Health and Human Services website U.S. Food and Drug Administration Center for Veterinary Medicine link to the Minor Uses and Minor Species page link to the Antimicrobial Resistance page link to the Biotechnology page link to the Aquaculture page link to the Food Safety page link to the BSE page link to the Guidance Documents page link to the Green Book page link to the Freedom of Information page
Center for Veterinary Medicine
Spacer Spacer


Powered by Google

" "

Table of Contents

Spacer Spacer
Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) allows veterinarians to prescribe extralabel uses of certain approved animal drugs and approved human drugs for animals under certain conditions. Extralabel (or extra-label) use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. The key constraints of AMDUCA are that any extralabel use must be by or on the order of a veterinarian within the context of a veterinarian-client-patient relationship, must not result in violative residues in food-producing animals, and the use must be in conformance with the implementing regulations published at 21 CFR Part 530. A list of drugs specifically prohibited from extra-label use (530_41.txt and 530_41.pdf) appears in the Code of Federal Regulations.

The following list of documents pertains to the Animal Medicinal Drug Use Clarification Act of 1994 and its implementation by CVM.

CVM Updates

Federal Law/U.S. Code of Federal Regulations

  • Animal Medicinal Drug Use Clarification Act of 1994, Public Law 103-396

Federal Register Notices

AMDUCA Satellite Teleconference, February 12, 1997

  • Videotapes of the AMDUCA Satellite Teleconference are available from:

    AVMA, Scientific Activities
    1931 North Meacham Road, Suite 100
    Schaumburg, IL 60173-4360

    The cost is $10.00 per tape; please include a check made payable to AVMA with your order.

Web Page Updated by hd - August 15, 2008, 1:39 PM ET

horizonal rule