Extra Label Drug Use ...
Certain drugs approved by FDA's Center for Veterinary Medicine (CVM) for other animals or other conditions of use (i.e., treatment claims) may, under very specific circumstances, be legally used on aquatic species for which the drugs are not approved. Any such use is referred to as "extra-label" or "off-label" drug use.
All of the following general conditions must be true before extra-label drug use (ELDU) is permissible.
- ELDU may only be prescribed by a licensed veterinarian.
- The prescribing veterinarian must have established a valid veterinarian - client - patient relationship as it relates to the specific situation under which the ELDU is being prescribed.
- Under most circumstances, ELDU does not apply to medicated feed.
- The drug being extra-labeled must be an FDA-approved drug
- There can be no FDA-approved drug for the particular species and condition of use for which the ELDU is being prescribed. However, there is one exception. If there is an approved drug for the species and condition of use, but that particular drug is ineffective for that species/condition, then another drug may be extra-labelled.
- ELDU is only applicable to therapeutic claims; i.e., a production drug such as a spawning hormone could not be extra-labeled.
- ELDU does not apply to apply to Veterinary Feed Directive (VFD) drugs (see CVM Update on VFD Final Regulations.
A pivotal law was passed in 1994, the Animal Medicinal Drug Use Clarification Act, which essentially legalized extra-label drug use. The following information has been excerpted from another page on AADAP's website, and provides valuable links to information about ELDU.
The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA): FDA's Center for Veterinary Medicine states that “...[AMDUCA] allows veterinarians to prescribe extra-label 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.”
The table below summarizes several key sources of information, from CVM and the American Veterinary Medical Association (AVMA)documents, that provide extensive information about AMDUCA and should be consulted for details. In essence, AMDUCA converts (or codifies) what was once a case of regulatory discretion (i.e., it was illegal, but something that CVM would normally choose not to take regulatory action against) into a law, which now means that extra-labeling by veterinarians is legal if conducted per the conditions of the Act. Click on document number to view actual document.
Document
Number |
Title |
| Webpage for the Animal Medicinal Drug Use Clarification Act of 1994 | |
| Code of Federal Regulations covering Extralabel Drug Use in Animals | |
Extra-label
Use of Medicated Feeds for Minor Species |
|
| Extralabel Use of Approved Drugs in Aquaculture | |
| An Informational Outline of the Animal Medicinal Drug Use Clarification Act (AMDUCA) |