As a practicing aquatic veterinarian, you’ve likely utilized a drug in an extra-label manner. But you might be wondering, “What kind of use is actually considered “extra-label?” “What gives me the legal ability to use and prescribe extralabel drugs?” or “What conditions must be met so that I don’t run afoul of the rules?”
These are all great questions. By explaining the FDA’s requirements for extra-label drug use in animals, this article helps provide some answers.
In 1994, Congress added provisions to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that give veterinarians the legal ability to use approved human and animal drugs in an extra-label manner. This means you can use an approved drug in a way that isn’t listed on the drug’s labeling when a patient’s health is threatened. Extra-label drug use is sometimes mistakenly called “off-label.” But, to the contrary, extra-label drug use is an FDA-regulated activity specific to veterinarians.
To prescribe drugs in an extra-label manner, you need to follow FDA’s extra-label drug use requirements, as stated in the FDA regulations. You should also educate your clients, particularly food animal producers, on these requirements and on FDA’s recommendations for the judicious use of antimicrobial drugs.
The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians, a new FDA web-based resource, provides additional information and links to important documentation on:
- Extra-Label Drug Use in Animals
- Valid Veterinarian-Client-Patient Relationship
- General Conditions for Extra-Label Drug Use
- Conditions for Extra-Label Drug Use in Food-Producing Animals
- Drugs Prohibited from Extra-Label Uses in Animals
- Judicious Use of Medically Important Antimicrobial Drugs and Extra-Label Drug Use in Food-Producing Animals
Additional useful FDA information on drugs used in aquatic animals
- Aquaculture and Aquaculture Drugs Basics
- FDA Q&A about Fish Drugs
- A Quick Reference Guide to Approved Drugs for Use in Aquaculture
- A single source for FDA/CVM Updates, Press Releases, Guidance Documents, and Policy & Procedures Manuals concerning aquatic veterinary drugs
For more information, please call FDA’s Center for Veterinary Medicine at (240) 276-9300, or send an email to AskCVM@fda.hhs.gov.