Extralabel Drug Use in Animals

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), amended the FD&C Act to allow licensed veterinarians to prescribe extralabel uses in animals of approved drugs. Under AMDUCA, FDA may establish by regulation or order a safe residue level for an extralabel use and may require development of an analytical method for residue detection if it finds there is a reasonable probability of a risk to public health. Respondents to the collection, therefore, are private drug sponsors, veterinarian associations, veterinarians, or individuals submitting an analytical method for the quantification of residues for consideration by the agency.

The latest form for Extralabel Drug Use in Animals expires 2021-03-31 and can be found here.