AMDUCA, do I have to exhaust all other options prior to extra label usage

A great question in our Leap session today…

Do I need to exhaust all other approved drugs in order to exercise AMDUCA for off label use in companion animals? No.

From the AMDUCA statute and the FDA guidebook-


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. This is not the case for food-producing animals. For these animals, FDA’s requirements for extra-label drug use prohibit you from prescribing an approved human drug if there’s a drug approved for food-producing animals that you can prescribe instead. For example, if a drug approved for chickens is available, you must first use that drug to treat a sick cow before reaching for a drug approved for people.

https://www.fda.gov/animal-veterinary/resources-you/ins-and-outs-extra-label-drug-use-animals-resource-veterinarians


After careful reading, it is still the case that particularly for companion animals, you do not have to exhaust FDA approved animal drugs, with a few minor exceptions.


From the guidebook linked above:
“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.”

In food animal cases this is not the same –
“This is not the case for food-producing animals. For these animals, FDA’s requirements for extra-label drug use prohibit you from prescribing an approved human drug if there’s a drug approved for food-producing animals that you can prescribe instead. For example, if a drug approved for chickens is available, you must first use that drug to treat a sick cow before reaching for a drug approved for people.”


However, even in this case, you need to fulfil only ONE (not all) of the following conditions-

 “…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:

  • There is no animal drug approved for the intended use; 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 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 is not in the required concentration (for example, you need 5 mg, but the approved drug is only available at 50 mg); or
  • You have found, in the context of a valid veterinarian-client-patient relationship, that the approved drug is clinically ineffective when used as labeled.“

Note the general companion animal exception of the FDA Guidebook still also applies.

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