How to Report an Adverse Drug

Veterinarians and animal owners are encouraged to report adverse experiences and product failures to the government Agency that regulates the product in question. Pretesting by the manufacturer and review of the data by the government does not guarantee absolute safety and effectiveness due to the inherent limitation imposed by testing the product on a limited population of animals. CVM encourages you to contact the manufacturer of a suspect product. Reporting information for the following product categories:

1. Animal Drugs, Devices and Foods

Veterinarians and animal owners may report adverse drug experiences to FDA by:

A. Submitting FORM FDA 1932a, "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report". The 1932a is a pre-addressed, prepaid postage form which can be completed and dropped in the mail. This form may be obtained by <clicking> the highlighted title above or by writing to:

ADE Reporting System
Center for Veterinary Medicine
U.S. Food & Drug Administration
7500 Standish Place
Rockville, MD 20855-2773

The Center may occasionally need more detailed information about an incident and the reporter may be called by a CVM staff veterinarian.

B. Telephoning the Center for Veterinary Medicine: 1-888-FDA-VETS

IMPORTANT: The identities all persons and animals is held in strict confidence by FDA and protected to the fullest extent of the law. The reporter's identity may be shared with the manufacturer or distributor unless requested otherwise. However, FDA will not disclose the reporter's identity to a request from the public, pursuant to the Freedom of Information Act.

2. Animal Biologics: Vaccines, Bacterins and Diagnostic Kits

U.S. Department of Agriculture
(800) 752-6255

3. Pesticides: Topically Applied External Parasiticides

U.S. Environmental Protection Agency
(800) 858-PEST

4. USP Veterinary Practitioner's Reporting Network (USP PRN)

Yet another option for reporting is the USP PRN, which is sponsored by the United States Pharmacopeia. The USP PRN is an independent, non-government reporting program. The phone number to reach USP regarding any veterinary product is (800) 4-USPPRN.

5. The following links are provided to the agencies below:

USDA - Animal Immunobiologic Vigilance
EPA - Office of Pesticide Programs
USP - Veterinary Practitioners' Reporting (VPR) Program

Web page updated by mdt, January 9, 2004, 8:38 AM ET