Animal & Veterinary
Reporting Veterinary Problems at FDA - Yes! No! Maybe So!
by Ashley Steel, Center for Veterinary Medicine, FDA
With so many different veterinary products and services available, it can be difficult to know how to report a problem when something goes wrong. Each week, the FDA’s Center for Veterinary Medicine (CVM) receives several calls and emails from consumers trying to report a problem with their animal’s medication, vaccine, or flea and tick product. While CVM’s Communications Staff is happy to direct consumers to the appropriate resources, it may be helpful to know that there are other government and non-government organizations that can be contacted when there is a problem with an animal product or service.
If a problem arises when using an FDA-approved animal drug, such as an adverse reaction in a treated animal or a product defect, we request that you report the event directly to the product manufacturer. By law, the product manufacturer is required to send all adverse event reports to FDA within certain time frames, depending on the seriousness of the adverse reaction or product defect. If you choose to report the event directly to FDA and not to the manufacturer, FDA Form 1932a can be used (see link below).
If the drug is not FDA-approved for animals, it is best to submit FDA Form 1932a directly to FDA.
Additional information on reporting an adverse event:
For a list of FDA-approved animal drugs, please visit: Animal Drugs@FDA
Unlike animal drugs, animal devices do not require FDA approval before they can be marketed. Manufacturers and distributors of animal devices are responsible for making sure their devices are safe, effective, and properly labeled. If a device is misbranded, mislabeled, or adulterated, FDA has the authority to take regulatory action.
To report an adverse event associated with an animal device or a defective device, please contact the device manufacturer, and then submit FDA Form 1932a directly to FDA.
Additional information about animal devices:
Animal feed-related problems include, but are not limited to, foul odors coming from the product, a leaking container, product discoloration, and illness believed to be associated with the feed.
Reporting a feed-related problem differs based on the animal species. If a problem occurs with a pet or companion animal food product (this does not include horses), report the incident electronically through the Safety Reporting Portal, or call your state’s FDA Consumer Complaint Coordinator.
To report a problem with a feed for food-producing animals or horses, please call your state’s FDA Consumer Complaint Coordinator. The Safety Reporting Portal does not accept these voluntary feed-related reports at this time.
Please report all feed-related problems to the “Safety Reporting Portal” if:
- You are a registered food facility,
- Are a responsible party that manufactures, processes, packs, or holds food for human or animal consumption in the U.S., or
- You are a public health official and have a reportable food report.
Vaccines for Animal Diseases
Veterinary biologics, including vaccines for animal diseases, are regulated by the U.S. Department of Agriculture (USDA). If your animal experiences an adverse event, such as an illness or reaction, after being vaccinated for an animal disease, first report the problem to the vaccine manufacturer, and then contact USDA’s Center for Veterinary Biologics.
Additional information about vaccine adverse event reporting:
Pharmacists are licensed and registered by their state board of pharmacy and must follow the rules and regulations of that state board. To report a pharmacy practice-related issue, please contact the board of pharmacy for your state.
|Contact information for state boards of pharmacy: National Association of Boards of Pharmacy |
To report a problem regarding a product defect, please see the “Animal Drugs” section above.
Practice of Veterinary Medicine
FDA regulates the devices and drugs veterinarians use. Veterinarians must follow the Federal Food, Drug, and Cosmetic Act when using these products. FDA, however, does not regulate a veterinarian’s medical judgment in the day-to-day practice of veterinary medicine. For example, FDA approves antibiotics to treat bacterial infections, but the Agency does not tell a veterinarian which one to use for a dog with a bacterial skin infection.
Veterinarians are licensed by their state veterinary licensing board and must meet the requirements of the licensing board to practice in that state. If you suspect veterinary malpractice, report the complaint to your state’s veterinary licensing board. You can also report the complaint to your state’s veterinary medical association.
|For more information about veterinary licensing boards and for contact information for each state veterinary medical licensing board, please visit the website of the American Association of Veterinary State Boards (AAVSB). |
The Drug Enforcement Administration’s (DEA) Office of Diversion Control handles controlled substance issues (controlled substances are drugs that have the potential to be addictive or habit forming, such as morphine, hydrocodone, and valium). For more information about controlled substances, please visit DEA’s website.
Flea and Tick Products
The process for reporting a problem with a flea and tick product varies based on the agency you are reporting the problem to. To ensure a speedy response, please check the product’s label to see which agency regulates the product in question.
If a product is regulated by the Environmental Protection Agency (EPA), it will have an EPA Registration Number (sometimes written as “EPA Reg. No.”) on the label. If a product is regulated by FDA, it will typically have the statement “Approved by FDA” followed by a six-digit New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) number on the label.
Regardless of which agency regulates the product, you should first contact the product manufacturer to report a problem. If you are unable or unwilling to contact the manufacturer, and the incident is with an FDA-regulated product, FDA encourages you to fill out FDA Form 1932a, or contact your state’s FDA Consumer Complaint Coordinator.
If the problem is with an EPA-regulated product, you may report the incident to the National Pesticide Information Center (NPIC) at 800-858-7378. EPA encourages veterinarians to report problems with EPA-regulated flea and tick products using the Veterinary Pesticide Incident Reporting portal. This portal, run by NPIC, is for use by veterinarians only.
Additional information about reporting problems with EPA-regulated flea and tick products: