Many human drugs are not labeled for animal use but can be prescribed by veterinarians for certain species and indications. It’s also common for a veterinary drug to be approved for only one species but be prescribed for other species as well.
This is thanks to the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), which permits veterinarians to prescribe approved animal and human drugs in an extra-label manner under certain conditions.
So how do you know which drugs can be prescribed—and for which species?
The content found in Plumb’s Veterinary Drugs® is specific for animal use. When you’re viewing a drug monograph to verify a dosage for a particular species, you’ll encounter one of three potential scenarios.
Dosage Details You Should Know About
1. The species is not listed in the dosages section.
This means no established and/or safe dosage has been determined for this drug in that species—and using this drug in that species is not advised.
2. The species is listed and “label dosage; FDA-approved” appears in praentheses beside the indication.
The presence of a label dosage means there is an approved veterinary formulation of the drug, and this is the defined dosage intended for a specific indication in a specific species.
3. The species is listed and “extra-label” appears in parentheses beside the indication.
Extra-label refers to using an FDA-approved drug in a manner that is not in accordance with an approved veterinary label.
The most common types of extra-label dosages include:
- The drug has been approved for humans but is not specifically approved for use in animals.
- An FDA-approved veterinary drug is being used but not in the way that’s described on the veterinary label. For example, the drug is being used:
- In a species not listed on the label
- For indications not listed on the label
- Via a different route of administration or at a different dose or frequency than what is stated on the label
The decision to publish extra-label drug information in Plumb’s™ is made by our expert team once substantial peer-reviewed clinical evidence exists for the safe use of a drug in animals.
It’s important to note that you may find both label and extra-label dosages listed under a single drug depending on the species and indication.
Have questions? Just contact us—we’re always happy to help.