The FDA encourages veterinarians and animal owners to report adverse drug experiences and product defects associated with animal drugs or animal devices (such as thermometers, glucose meters and bandage materials). Adverse drug experiences can include side effects or other problems, such as the drug did not appear to be effective. Examples of product defects include broken product seals or leaking bottles. Report data are used to monitor the safety of products once they have reached the market.
If you have a problem with:
Animal Drugs and Devices - contact the FDA (see instructions below)
Animal Vaccines - contact the USDA APHIS Center for Veterinary Biologics at (800) 752-6255
Flea and Tick Products (not approved by FDA) or Other Pesticides – contact the National Pesticide Information Center at 800-858-7378
- Some flea and tick products are regulated by FDA, and some are regulated by the Environmental Protection Agency (EPA). If you would like to report a problem with a flea or tick product that is FDA approved, you can contact the FDA (see instructions below). The label of the product can help you determine if the product is an FDA-approved or an EPA-registered flea and tick product or other pesticide:
- All 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 drug’s label, although they aren’t required to do so. On the packaging for FDA-approved products you may see the following information: “NADA XXX-XXX Approved by the FDA.”
- For EPA-registered products, look for an EPA registration number on the back panel of the package, usually near the manufacturer’s address: “EPA Reg. No.”
Reporting Information about Animal Drugs and Devices
You can report adverse drug experiences and product defects to FDA in one of the following ways:
- For an FDA-approved product, we recommend calling the drug company to report the adverse drug experience or product defect. The drug company responsible for the approved product(s) is required to submit reports of adverse drug experiences and product defects to FDA. The drug company’s phone number can usually be found on the product’s labeling. When you call the drug company, you can tell them that you wish to report an adverse drug experience or product defect and ask to speak to a technical services veterinarian. The technical services veterinarian will likely ask you a series of questions about the event, will complete an adverse drug experience reporting form, and will forward the report to the FDA’s Center for Veterinary Medicine (CVM). The technical services veterinarian may also contact the veterinarian who treated your pet to obtain more information about the adverse drug experience.
- If you prefer to report directly to the FDA, you can submit FORM FDA 1932a, "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report". You can use this form to report adverse drug experiences for any animal drug (approved or not approved by FDA) or animal device. Unapproved animal drugs include compounded drug products.
- Download the fillable 1932a electronic form and email the completed form to CVM1932a@fda.hhs.gov
- If the PDF form does not open in your browser or you get a “Please Wait…” error message, try downloading it as follows:
1. Right-click the 1932a electronic form link above.
2. Click your browser’s Save option. (On most browsers, this is the Save Link As option, but on other browsers this may be Save Target As or Download Linked File.)
You may also need to upgrade your version of Adobe Reader - http://get.adobe.com/reader/.
PDF Forms must be opened using a Windows or Mac (Apple) desktop or laptop computer. Currently, NO smartphones or tablets are supported.
Reports should preferably include a good medical history; the names and amounts of all drugs, products marketed as supplements, or vitamins the animal has been given; current type and/or brand of pet food and treats; information about any recent surgeries or procedures; and as much medical information as possible. Medical information may include: veterinary examination findings; bloodwork, urinalysis, and fecal exam results; x-ray findings; other relevant information such as blood pressure; and neurologic test results.
In regards to unapproved animal products, you also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product.
If you have a question about ADE reporting or need a hard copy of the form, contact CVM by email at AskCVM@fda.hhs.gov, by phone at 1-888-FDA-VETS (1-888-332-8387), or by writing us at:
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
IMPORTANT: The identities of all persons and animals are held in strict confidence by FDA and are protected to the fullest extent of the law.
This Article was provided by the FDA website, you can find more federal veterinary news and articles here.