For USDA-approved products, such as animal vaccines, to whom should you report the adverse event first?

• A. FDA
• B. NPIC
• C. Manufacturer
• D. EPA

Answer: (C)

Adverse event reporting for USDA-approved veterinary vaccines starts with the manufacturer. They’re the first point of contact because they oversee post-market safety surveillance, collect the details of what happened, and then relay the information to the appropriate regulatory body with all the necessary data (product name, lot number, date of administration, species and condition of the animal, and contact information). The regulatory bodies you might hear about in humans or pesticides (FDA, NPIC, EPA) aren’t the first recipients for animal vaccines. The manufacturer has the immediate responsibility to document and pass along adverse event information so proper investigations and tracking can occur.