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 In this section:

                Unapproved Animal Drugs

Unapproved Animal Drugs

                        FDA’s Concerns about Unapproved Animal Drugs
          Animal Drugs Marketed as Animal Devices
          Generic Animal Drugs:  Approved or Unapproved?
          Information for Veterinarians
          Regulatory Actions


                        Animal Drug Compounding Home
          Animal & Veterinary
          Compliance & Enforcement
          Unapproved Animal Drugs
          Animal Drugs Marketed as Animal DevicesUnapproved Animal Drugs Animal Drugs Marketed as Animal Devices
  
  	
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    Print*As used on this page, the term “unapproved animal drug” refers to a drug intended for use in animals that meets the definition of “new animal drug” in the Federal Food, Drug, and Cosmetic Act but does not have legal marketing status.*

*The information on this page pertains to animal medical devices, not human medical devices. For more information about human medical devices, please visit the website of**FDA’s Center for Devices and Radiological Health (CDRH)**.*

Animal Drug or Animal Device?Pre-Market Review of Approved Animal DrugsPost-Market Monitoring of Approved Animal DrugsRequired Reporting of Problems with Approved Animal DrugsRisks of Animal Drugs Marketed as Animal DevicesAdditional Resources

Animal Drug or Animal Device?

The key difference between an animal drug and an animal device is how the product works. If it relies on a chemical action occurring in or on the animal’s body to achieve its primary intended effects, the product is a drug, not a device. If it needs to be broken down (metabolized) by the animal’s body to work, the product is a drug, not a device.

Antibiotics, anesthetics, and insulin are examples of drugs. Needles, syringes, surgical instruments, X-ray equipment, certain diagnostic test kits, and dental appliances are examples of devices.

FDA is aware that some companies may market animal drugs as animal devices. Unknown risks may be associated with the use of these products because animal devices do not go through the same rigorous pre-market review and post-market monitoring that animal drugs with legal marketing status go through.

To legally market an animal drug, a drug company must get the drug approved, conditionally approved, or indexed by FDA. Each pathway has different requirements, but they all lead to what’s called “legal marketing status” and provide the benefit of FDA's pre-market review.

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Pre-Market Review of Approved Animal Drugs

FDA rigorously evaluates an animal drug before approving it. As part of the approval process the drug company must prove to FDA that:

The drug is safe and effective for a specific use in a specific animal species. If the drug is for use in food-producing animals, the drug company must also prove that food made from animals treated with the drug is safe for people to eat;
	The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity. The drug company must show that the drug can be consistently produced from batch to batch; and
	The labeling is truthful, complete, and not misleading. The drug company must make sure that the labeling contains all necessary information to use the drug safely and effectively and includes the risks associated with the drug.Back to the top

Post-Market Monitoring of Approved Animal Drugs

FDA’s role does not stop after the agency approves an animal drug. As long as the drug company markets the animal drug, FDA continues to monitor:

The drug's safety and effectiveness. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
	The manufacturing process to ensure quality and consistency are maintained from batch to batch;
	The drug's labeling to make sure the information remains truthful, complete, and not misleading; and
	The company’s marketing communications related to the drug to make sure the information is truthful and not misleading.Back to the top

Required Reporting of Problems with Approved Animal Drugs

As part of FDA’s continued monitoring of safety and effectiveness, a drug company that makes and sells an approved animal drug is required to report to FDA all problems that occur with the drug after it's on the market. Problems include adverse drug experiences and product defects. An adverse drug experience is an undesired side effect associated with the drug or a lack of effect (the drug doesn’t do what it’s expected to do). Adverse drug experiences also include unfavorable reactions in people who handle the drug. Product defects are problems such as defective packaging or an abnormal appearance of the drug. The required reporting of adverse drug experiences and product defects allows FDA to more easily identify and correct problems with approved animal drugs.

For more information about reporting adverse drug experiences, please visit the following website:

How to Report Animal Drug and Device Side Effects and Product Problems

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Risks of Animal Drugs Marketed as Animal Devices

An animal device does not go through a rigorous scientific review by FDA before it is marketed. Without FDA's pre-market review of a product, veterinarians, pet owners, and animal producers have no way to know if it's safe and effective or if its manufacturing process is adequate to maintain quality and consistency from batch to batch.

Also, federal law doesn’t require companies to report problems with an animal device, which may lead to a delay between when the product causes harm and when FDA becomes aware of problems with the product.

Companies that market animal drugs under the guise of animal devices are really selling unapproved animal drugs that have not been reviewed by FDA for safety and effectiveness. Companies that engage in this practice unfairly compete against companies that sell approved animal drugs.

There is often a financial advantage for companies to market unapproved animal drugs as animal devices because the companies do not always:

Conduct all appropriate tests on the product before marketing it; or
	Manufacture the product under strict manufacturing standards.Also, companies must pay FDA user fees to review animal drugs but not animal devices.

Companies that market unapproved animal drugs as animal devices are ignoring their obligation to obtain legal marketing status for their products. These companies potentially put the health of animals and people at risk.

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Additional Resources

If you want to market a product for use in animals and have a question about whether it’s a drug or a device, contact FDA’s Center for Veterinary Medicine at 240-402-7002 or AskCVM@fda.hhs.gov.

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                                                                                  Content current as of:
      07/02/2019Unapproved Animal Drugs

          
                        FDA’s Concerns about Unapproved Animal Drugs
          Animal Drugs Marketed as Animal Devices
          Generic Animal Drugs:  Approved or Unapproved?
          Information for Veterinarians
          Regulatory Actions


                        Animal Drug Compounding
 
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