January 3, 2014
New FDA’s “Ins-and-Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians”
As a practicing veterinarian, you’ve likely prescribed a drug for an extra-label use. What does that mean? What gives you the legal ability to do so? What conditions must be met?
By explaining FDA’s requirements for extra-label drug use in animals, this article answers these questions and more. 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. Extra-label drug use is sometimes called off-label because the use is “off the label.”
To prescribe drugs in an extra-label manner, you need to follow FDA’s extra-label drug use requirements, as stated in the FD&C Act and 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.
This new web-based resource (http://tinyurl.com/lkogsv8) provides additional information and links to important documentation on:
• Extra-Label Drug Use in Animals
• Valid Veterinarian-Client-Patient Relationship (VCPR)
• 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 (http://tinyurl.com/lujco64)
• A Quick Reference Guide to Approved Drugs for Use in Aquaculture (http://tinyurl.com/n4nqtnk)
• FDA/CVM Updates, Press Releases, Guidance Documents, and Policy & Procedures Manuals (http://tinyurl.com/n355nh8)
For more information, please call FDA’s Center for Veterinary Medicine at +1 (240) 276-9300, or send an email toAskCVM@fda.hhs.gov.
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