Adverse Event Reporting for Compounded Drugs (US)
- Canine Cushing's Alliance
- 3 days ago
- 2 min read
Adverse events associated with compounded drugs, such as trilostane compounded, can be reported to the U.S. Food and Drug Administration (FDA). More information about this process can be found below.
What types of problems can be reported?
According to FDA, adverse events include:
Side effects in animals, such as vomiting, diarrhea, seizures, and other symptoms.
Side effects in people exposed to animal drugs or devices, such as rashes, headaches, or nausea secondary to product contact.
Product defects, such as broken product seals, leaking bottles, and other problems.
Medication errors, such as giving the wrong drug or dose, giving a drug too frequently, or other scenarios.
Lack of effectiveness, such as a product not working or a product that stops working.
How to submit a report to FDA
Adverse events can be reported to FDA by submitting Form FDA 1932a. You can use this form to report adverse events for any animal drug (FDA-approved or unapproved) or device. Unapproved animal drugs include compounded drug products.
NOTE: You must download and save (as described below) the blank form to your computer BEFORE filling out the form.
Save the blank Form FDA 1932a to your computer. PDF Forms must be opened using a Windows or Mac desktop or laptop computer. NO smartphones or tablets are supported.
Open the file and complete the fillable form.
Save the completed form to your computer.
Email the completed form to CVM1932a@fda.hhs.gov.
Additional Information
When you submit your report by email, FDA will send you an automatic acknowledgement message. Reports are reviewed by FDA staff, and they will contact you if additional information is needed. For questions about ADE reporting or to request a hard copy of the form, contact AskCVM@fda.hhs.gov or 1-888-FDA-VETS (1-888-332-8387). You can also contact FDA by mail:
Food and Drug Administration
Center for Veterinary Medicine
5001 Campus Drive
College Park MD 20740
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