APPENDIX L How to Report an Adverse Drug Reaction
1 Phone the drug sponsor to report an Adverse Drug Experience (ADE) if it is an FDA-approved animal drug. Obtain drug sponsor phone numbers from the product label or from the company’s Web site. When phoning the pharmaceutical company, inform them that you wish to speak with a veterinarian on their staff to report an adverse drug experience.
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Contact the FDA and complete Form 1932a. This form may be completed regardless of whether the drug is an animal-approved drug or human-approved drug. The FDA can be contacted from their Web site at www.fda.gov/AnimalVeterinary/SafetyHealth.
The FDA also may be contacted at this address:
Center for Veterinary Medicine
U.S. Food & Drug Administration
Telephone: 1-888-FDA-VETS (888-332-8387)
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