Regulations Under AMDUCA

The Animal Medicinal Drug Use Clarification Act, passed in 1994, was the result of considerable political effort by the American Veterinary Medical Association. AMDUCA made into law pre-existing FDACVM policy concerning the extra-label use of drugs in animals. FDACVM then passed regulations governing veterinary extra-label pharmaceutical use; the regulations are found in Title 21, Part 530 of the Code of Federal Regulations.

Source: [61 FR 25105-18].

FDA regulations implementing AMDUCA are in Title 21, Part 530 of the Code of Federal Regulations (CFR), which can be found at http://www.access.gpo.gov/nara/cfr/index.html. I downloaded the appropriate sections of the CFR for quicker access.

View the appropriate CFR sections through this link: http://cpharm.vetmed.vt.edu/vm8784/AMDUCA/CFRToc.htm.

The Federal Register notice where the AMDUCA regulations were orginally published, which provides background and interpretive guidance, is at http://cpharm.vetmed.vt.edu/vm8784/AMDUCA/fedreg.html.

The text of the Senate bill that became AMDUCA is at http://cpharm.vetmed.vt.edu/vm8784/AMDUCA/s340.html.