Animal & Veterinary

Unapproved Animal Drugs

What are Unapproved Animal Drugs?

As it is used in the different sections of the website, the term unapproved animal drugs means animal drugs that have not been approved by the Food and Drug Administration. Unlike for FDA-approved or indexed animal drugs, FDA has not reviewed data and other information for unapproved animal drugs to determine whether these products are safe, effective, properly manufactured, and accurately labeled.

In order to be legally marketed, a new animal drug must be the subject of an approved new animal drug application (NADA) or abbreviated new animal drug application (ANADA), a conditional approval, or a listing on the Legally Marketed Unapproved New Animal Drug Index for Minor Species.

A new animal drug is defined by the FD&C Act as a drug intended for use for animals that is:

  • not generally recognized as safe and effective (GRAS/GRAE) by qualified experts for use under the conditions prescribed, recommended, or suggested in the drug’s labeling; or
  • that has not been grandfathered (i.e., before June 25, 1938, was subject to the Food and Drug Act of 1906 and its labeling contains the same representation concerning the drug’s conditions of use).

These two exclusions to the definition of new animal drug are construed narrowly and FDA believes it is very unlikely that any currently marketed animal drug can qualify for one of these exemptions.

Approved by FDA – Pathway to the Marketplace

An approved animal drug has gone through the New Animal Drug Application (NADA) process, or for an approved generic animal drug, the Abbreviated New Animal Drug Application (ANADA) process. If the information in the NADA or ANADA meets the requirements for approval, the animal drug is approved by FDA. FDA’s approval means the drug is safe and effective when it is used according to the label. FDA’s approval also ensures that the drug’s strength, quality, and purity are consistent from batch to batch, and that the drug’s labeling is truthful and complete.

A conditionally approved animal drug has gone through the Conditional New Animal Drug Application (CNADA) process. This process has the same approval requirements as the NADA process except the drug is conditionally approved by FDA before the effectiveness requirement is complete. FDA’s conditional approval means the drug is safe and likely to be effective when it is used according to the label. When the effectiveness requirement is complete, the animal drug goes through the NADA process to become fully approved by FDA. Conditional approval is only available for drugs for minor species or minor uses in a major species.

Minor species are all animals that are not major species. The seven major species are cattle, horses, pigs, chickens, turkeys, dogs, and cats. Ferrets, eagles, fish, and sheep are examples of minor species.

A minor use in a major species is using a drug in a major species for a condition that occurs:

  • Infrequently and in only a small number of animals each year; or
  • In limited geographic areas and in only a small number of animals each year.

For example, using a drug to treat a rare disease in dogs is a minor use in a major species.

Learn more about minor species and minor uses by visiting the following website:

Lions and Tigers and Bears! OMUMS!

Learn more about the drug approval process by visiting the following websites:

Learn more about the conditional drug approval process by visiting the following website:

Indexed by FDA – A Different Pathway to the Marketplace

Some drugs don’t take the pathway to the marketplace described above. Instead, they take a different pathway called indexing. Indexed animal drugs are technically unapproved but still legally marketed for some minor species.

An indexed animal drug is a drug on FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, referred to as “the Index.” A drug listed on the Index can be legally marketed for a specific use in certain minor species. Indexing is allowed for drugs for:

  • Non-food-producing minor species, such as pet birds, hamsters, and ornamental fish. These animals do not produce food for people to eat; and
  • Early life stages of a food-producing minor species, such as oyster spat (immature oysters). Because people do not generally eat oyster spat, a drug to treat a disease in spat can be indexed, but a drug to treat a disease in adult oysters, which people commonly eat, cannot be indexed.

Indexing a drug is a three-step process that includes a review of the drug’s safety and effectiveness by a panel of qualified experts outside FDA. All members of the expert panel must agree that, when used according to the label, the drug’s benefits outweigh the risks to the treated animal. If FDA agrees with the panel, the drug is added to the Index.

Learn more about indexing by visiting the following websites:

 

Page Last Updated: 10/14/2014
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