Report Animal Drug & Device Side Effects

Expires on 10/29/2045

Description

How to Report Animal Drug and Device Side Effects and Product Problems. FDA-approved animal drugs have a six-digit New Animal Drug Application (NADA) number, or for generic animal drugs, an Abbreviated New Animal Drug Application (ANADA) number. Many drug manufacturers list the six-digit NADA or ANADA number and the statement, Approved by FDA, on the drugs label, although they arent required to do so. On the packaging for FDA-approved products you may see the following information: NADA XXX-XXX Approved by the FDA.
Veterinary biologic products, including animal vaccines, and many flea and tick products are not regulated by FDA.
Medical devices include thermometers, glucose meters, and bandage materials.

You can report adverse drug events to FDA in one of the following ways:

1) For an FDA-approved product or an Indexed product, we recommend calling the drug company to report the adverse drug events. The company responsible for the approved or Indexed drug product(s) is required to submit reports of adverse drug events to the FDA. The drug company's phone number can usually be found on the products labeling. When you call, tell them that you wish to report an adverse drug event and ask to speak to a technical services representative. The technical services representative will likely ask you a series of questions about the event and is required to send the information to the FDA's Center for Veterinary Medicine (CVM). If you are an animal owner, the representative may also contact the veterinarian who treated your pet to obtain more information about the adverse drug event. The report will be assigned a unique case number by the company, which you can request.

If you prefer to report directly to the FDA for an approved product, you can submit FORM FDA 1932a, as described below in #2.
2) For unapproved drugs and devices, submit FORM FDA 1932a, "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report". You can use this form to report adverse events for any animal drug (FDA-approved or unapproved) or animal device. Unapproved animal drugs include compounded drug products.

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