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Development & Approval Process

Animal Drugs and Animal Food Additives

Animal Drugs

As required by the Federal Food, Drug, and Cosmetic Act, an animal drug must be approved by FDA before a drug sponsor can legally sell the drug. During this pre-market review, the agency evaluates information submitted by the sponsor to make sure the drug is safe and effective for its intended use and that the drug is properly manufactured and adequately labeled and packaged. (A drug sponsor is the person, company, university, or other entity working to get a drug approved. Typically, drug sponsors are pharmaceutical companies.)

Major Species, Major Uses, Minor Species, and Minor Uses

FDA approves animal drugs for major species, major uses, minor species, and minor uses. The agency classifies horses, dogs, cats, cattle, pigs, chickens, and turkeys as the seven major species. All other animals, such as fish, ferrets, and goats, are minor species. 

A major use in a major species is the use of a drug in one of the seven major species for a disease or condition that isn’t rare or limited to a particular part of the U.S. In contrast, a minor use in a major species is the use of a drug in one of the seven major species for a disease or condition that occurs in a small number of animals each year, either because the disease or condition is rare or because it only occurs in a limited part of the country. For example, the use of a drug to treat bovine respiratory disease (BRD) in cattle is a major use in a major species because BRD occurs commonly in cattle throughout the U.S. The use of a drug to control pain in dogs with bone cancer is a minor use in a major species because relatively few dogs get bone cancer each year.

Generic Animal Drugs

In 1988, the Generic Animal Drug and Patent Term Restoration Act amended the Federal Food, Drug, and Cosmetic Act to allow the approval of generic copies of approved brand name animal drugs. After an approved brand name animal drug has been on the market for a specific number of years, another drug sponsor can start the approval process for a generic copy. (The approved brand name animal drug is also called the “reference-listed new animal drug product” or the “pioneer” animal drug.) Just like the brand name animal drug, a generic animal drug must be reviewed and approved by FDA before a drug sponsor can legally sell it.

Innovative Animal Drugs

FDA encourages the development and research of innovative animal drugs, such as intentional genomic alterations (IGAs) in animals and animal cells, tissues, and cell- or tissue-based products (ACTPs). By intentionally altering an animal’s genomic DNA, desirable traits can be introduced into its genetic make-up. This process includes, but is not necessarily limited to, genome editing technologies and genetic engineering. ACTPs are products that contain cellular material—such as living cells, serum, or other products derived from cells or tissues—for use in animals with the hope of repairing diseased or damaged tissues or organs. 

In general, animals with IGAs are considered animal drugs because the intentional alteration meets the legal definition of a drug. Most ACTPs also meet the legal definition of a drug. Therefore, the same laws and regulations that apply to other animal drugs apply to IGAs and ACTPs. These products must be reviewed and approved by FDA before a sponsor can legally sell them. As part of FDA’s Veterinary Innovation Program, the agency supports an efficient pathway to approval for IGAs and ACTPs in animals. 

Medicated Feed and Veterinary Feed Directive Drugs

FDA reviews and approves drugs for use in or on animal feed (this is called a medicated feed). Manufacturers of medicated feed can mix a drug into feed only for the specific uses and at the specific levels allowed by FDA’s approval. When the drug is for use in or on a medicated feed, FDA approves it as a veterinary feed directive (VFD) drug. 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.

Animal Food Additives 

FDA must review and approve a food additive before a company can legally use it in animal food. In most situations, a food additive is any substance that directly or indirectly becomes a component of a food or that affects a food’s characteristics. An animal food additive is generally intended to supply nutrients, add aroma or flavor, help with the food’s stability, or alter a food’s characteristics. A company submits a food additive petition to FDA to prove that the additive is safe for its intended use and works as expected. 

Resources for You

Approval of New Animal Drugs

  • New Animal Drug Applications – Information about the approval of brand name and generic animal drugs as well as the conditional approval of animal drugs. (A conditionally approved animal drug has gone through the approval process except the drug has not yet met the effectiveness standard for full approval.)
  • Environmental Impact Considerations – This page explains how FDA fulfills the requirements of the National Environmental Policy Act which mandates that FDA must consider how the environment will be affected if the agency approves an animal drug. 
  • Veterinary Master Files (VMFs) – These files contain confidential detailed information about the facilities, processes, or articles used to make, process, package, and store animal drugs and animal drug substances. The information in a VMF is considered proprietary and may be used to support the approval of an animal drug. 
  • Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs – These files contain publicly available studies or other non-proprietary information intended to support drug approvals.  
  • Animal Drugs @ FDA – A searchable online database of most FDA-approved and conditionally approval animal drugs.

Minor Uses & Minor Species

  • Minor Use/Minor Species – News and information about FDA’s efforts to help make more drugs available for minor uses and minor species.
  • Aquaculture – Includes links to information about FDA’s aquaculture program. 

Generic Animal Drugs

  • Abbreviated New Animal Drug Applications – Information about the approval of generic animal drugs.
  • Suitability Petitions – Suitability petitions allow for certain differences between the brand name animal drug and the generic copy. This page explains which differences are allowed and lists the information that a drug sponsor must include in the petition.

Innovative Animal Drugs

  • Veterinary Regenerative Medicine & Animal Cell-Based Products – This page explains how most animal cell-based products are animal drugs, and therefore, require FDA’s pre-market review and approval to be legally marketed.
  • Biotechnology Products at CVM: Animals and Animal Food – Includes links to information about animals with intentional genomic alterations (IGAs) and plants with IGAs intended for use in animal food. In general, FDA regulates animals with IGAs as animal drugs, and therefore, they require FDA’s pre-market review and approval to be legally marketed. FDA regulates animal food made from plants with IGAs in the same way the agency regulates all food. Animal food doesn’t require FDA’s pre-market review and approval to be legally marketed. 

Medicated Feed and Veterinary Feed Directive Drugs

Animal Food Additives 

  • Food Additive Petitions for Animal Food – This page defines food additive, explains the approval process for a food additive petition, and lists the information that a company must include in the petition.