What are Unapproved Animal Drugs?

Quoted from FDA found at https://www.fda.gov/animal-veterinary/compliance-enforcement/unapproved-animal-drugs

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What are Unapproved Animal Drugs?

FDA considers an “unapproved animal drug” to be a drug that:

• Is intended for use in animals; and
• Meets the definition of “new animal drug” in the Federal Food, Drug, and Cosmetic (FD&C) Act; but
• Does not have legal marketing status, meaning FDA has not approved, conditionally approved, or indexed the drug.

To better understand this, a couple of definitions are in order.

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First, what’s a drug? The FD&C Act defines “drug” to include, among other things, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”1

The intended use of a product determines if it’s a drug. Here are a few examples to illustrate this concept:

• When a company sells bottled water for people to drink as a beverage, the water is not a drug. But if the company sells those same bottles of water as a cure for cancer in dogs, then the water is a drug under the FD&C Act because the intended use is to cure a disease (cancer) in dogs.
• When a company sells formaldehyde for a car manufacturer to use to make automotive parts, it’s not a drug. But when a company sells formalin—a solution of formaldehyde—for a fish biologist to use to kill external parasites on finfish, it’s a drug under the FD&C Act because the intended use is to treat a disease (parasitism) in fish.
• When a company sells a product claiming it makes cows ovulate at the same time, the product is a drug. Although it’s not treating or preventing a disease in the cows, the product’s intended use is to change how their bodies function, which makes it a drug under the FD&C Act.

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Second,what's a new animal drug? The FD&C Act defines “new animal drug” as a drug intended for use in animals that is not Generally Recognized As Safe and Effective (GRASE) by qualified experts for the uses listed on the label.2 Taken in the reverse, if a drug is GRASE, then it’s not a new animal drug under the FD&C Act. For an animal drug to be GRASE, the experts must generally agree that, based on published studies, the drug is safe and effective for its intended uses.

There is a very narrow exception to the definition of a new animal drug and that is grandfathered drugs. For an animal drug to be grandfathered, it must have been approved under the 1906 Food and Drug Act and before June 25, 1938 (the date President Franklin Roosevelt signed the FD&C Act into law), and its label and composition have not changed since that time. If a drug is grandfathered, then it’s a not a new animal drug under the FD&C Act.

FDA thinks it’s very unlikely that any currently marketed animal drug would be considered GRASE or would qualify for the “grandfather” exception. And so, if a drug is intended for use in animals, it’s almost certain to be a new animal drug.

The entire term “new animal drug” is defined by law and applies to any product which fits that definition. The adjective “new” doesn’t mean the drug just went on the market; some “new animal drugs” have been marketed for years. For example, the drug ivermectin has existed for decades and even though FDA originally approved it to prevent heartworm disease in dogs in March 1987,3 ivermectin is still a “new animal drug” under the FD&C Act.

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FDA Pre-Market Review & Legal Marketing Status

As required by the FD&C Act, new animal drugs must be reviewed by FDA for safety and effectiveness and obtain legal marketing status before they can be marketed. The pre-market review is integral to FDA’s ability to protect animal and public health. During the review, the agency evaluates information submitted by the drug company to make sure the drug is safe and effective for its intended use and that the drug is properly manufactured and properly labeled.

The FDA pre-market review is also necessary for the drug to obtain legal marketing status through an approval, conditional approval, or indexed listing.4 After the drug company gets a new animal drug approved, conditionally approved, or indexed by FDA, the company can legally market it for the uses listed on the label.