Here are a few questions we received and wanted to provide the answers that were found on the Animal & Veterinary section of the FDA website that focuses on FDA’s Center for Veterinary Medicine. Protecting human and animal health.

What is the definition of MUMS?

“Minor use” drugs are for intended uses in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) for diseases that occur infrequently or in limited geographic areas and in only a small number of animals annually.

“Minor species” are all animals other than humans that are not one of the major species. They include animals such as zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include sheep, goats, catfish, game birds, and honeybees among others.

Can a drug for people be legally used in animals?

Yes. Veterinarians can legally prescribe an approved human drug in animals in certain circumstances. This is called an extra-label use.
What does extra–label use mean?

Extra-label use means using an approved human or animal drug in a way that isn’t listed on the drug’s label. It’s sometimes called off-label because the use is “off the label.” In 1994, Congress passed a law that allows veterinarians to prescribe approved human and animal drugs for extra-label uses in animals under specified conditions.

What Databases can be used to find drug information on products used in animals?

You can also find drug information by searching for the label in one of two online databases: Animal Drugs @ FDA or DailyMed, a website run by the National Library of Medicine. You can search both databases in several ways, such as by the drug’s proprietary name or active ingredient. You can also find any recent safety-related label changes at Animal Drug Safety-Related Labeling Changes.

Look up the drug in the Index

The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species contains information about every indexed animal drug.

Why can’t I find information about a drug in Animal Drugs @ FDA?

There are several reasons why a drug might not be found in Animal Drugs @ FDA:

• The drug’s proprietary name or active ingredient is misspelled. Be sure to carefully check the spelling.
• It’s a drug for people, not animals. Check Drugs @ FDA for information about approved human drugs.
• The drug isn’t approved in the United States by the FDA Center for Veterinary Medicine.
• The drug is an indexed animal drug. Check the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species for information about indexed animal drugs.

What are the differences between an over-the-counter animal drug, a prescription animal drug, and a veterinary feed directive animal drug?

One difference between these three categories of animal drugs is whether FDA has determined that veterinary oversight is required for the safe and effective use of the drug. If the agency determines that adequate “directions for use” can be written on the drug’s label in such a way that a non-veterinarian can use the drug safely and effectively, then the drug company can market the animal drug as over the counter (OTC). If not, then the drug company must market the animal drug as either prescription (Rx) or veterinary feed directive (VFD).

Both Rx and VFD drugs require veterinary oversight to be used safely and effectively. The main difference between these two categories of animal drugs is whether the drug is used in or on animal feed. When the drug is for use in or on animal feed (a medicated feed), FDA approves it as a VFD drug. When the drug is not for use in or on animal feed, FDA approves it as a prescription drug. Federal law makes it clear that VFD drugs are not prescription drugs. A VFD drug requires veterinary oversight without invoking state pharmacy laws for a prescription drug that are unworkable for medicated feed.

An animal prescription drug can be dispensed only by or on the lawful written order of a licensed veterinarian and must have the following statement on the label: Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
A VFD is a written order issued by a licensed veterinarian in the course of the veterinarian’s professional practice that authorizes the client (the owner or other animal caretaker) to obtain and use a VFD drug in or on animal feed. A VFD animal drug must have the following statement on the label: Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.