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In companion (non-food-producing) animals, you can prescribe an approved human drug for an extra-label use even if an approved animal drug is available. You have found, in the context of a valid veterinarian-client-patient relationship, that the approved drug is clinically ineffective when used as labeled.

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There is an animal drug approved for the intended use, but the approved drug is not in the required concentration (for example, you need 5 mg, but the approved drug is only available at 50 mg) or.

There is an animal drug approved for the intended use, but the approved drug is not in the required dosage form (for example, you need a liquid dosage form, but the approved drug is only available as a tablet dosage form) or.

There is an animal drug approved for the intended use, but the approved drug does not contain the active ingredient you need to use or.

There is no animal drug approved for the intended use or.

In addition, one of the following general conditions must be met before you can legally prescribe an approved human or animal drug for an extra-label use: The purpose of FDA’s requirements for extra-label drug use in animals is to limit this use to situations where an animal’s health is threatened or where the animal may suffer or die without treatment. This means you have recently examined the animal or animals, made “medically appropriate and timely visits” to the premises (usually the case for food-producing animals), or done both.īack to the top General Conditions for Extra-Label Drug Use Such a relationship can exist only when you have recently seen and are personally acquainted with the keeping and care of the animal or animals.

You are readily available for follow-up in case of adverse drug reactions or treatment failure.

You have sufficient knowledge of the animal, or animals, to develop a general or preliminary diagnosis of the medical condition and.

In turn, the client (the owner or other animal caretaker) has agreed to follow your instructions

You have assumed responsibility for making medical judgments about the health of an animal, or animals, and the need for medical treatment.

A valid veterinarian-client-patient relationship has three parts: The AMDUCA provisions of the FD&C Act allow extra-label drug use only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship. Valid Veterinarian-Client-Patient Relationship We’ll look at each point separately as well as touch on how FDA’s judicious use recommendations affect extra-label use of antimicrobials in food-producing animals. Drugs Prohibited from Extra-Label Uses in Animals.Conditions for Extra-Label Drug Use in Food-Producing Animals.General Conditions for Extra-Label Drug Use.Valid Veterinarian-Client-Patient Relationship.The AMDUCA provisions amended the FD&C Act to allow veterinarians to prescribe approved human and animal drugs for extra-label uses in animals under specified conditions. Extra-Label Drug Use in Animalsīefore Congress passed the Animal Medicinal Drug Use Clarification Act (AMDUCA) in 1994, federal law did not permit extra-label drug use in animals. You should also educate your clients, particularly food animal producers, on these requirements and on FDA’s recommendations for the judicious use of antimicrobials. To prescribe drugs in an extra-label manner, you need to follow FDA’s requirements for extra-label drug use, as stated in the FD&C Act and FDA regulations. Extra-label drug use is sometimes called off-label because the use is “off the label.” This means, in some cases, you can use an approved drug in a way that isn’t listed on the drug’s labeling. In 1994, Congress added provisions to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that give veterinarians the legal ability - with certain restrictions - to use approved human and animal drugs in an extra-label manner. What does that mean? What gives you the legal ability to do so? What conditions must you meet? By explaining FDA’s requirements for extra-label drug use in animals, this article answers these questions and more. As a practicing veterinarian, you’ve likely prescribed a drug for an extra-label use.