How to Fill Out FDA Form 1932A (w/Examples) + FAQs

FDA Form 1932a is the official document used to voluntarily report veterinary adverse drug reactions, lack of effectiveness, or product defects to the Food and Drug Administration’s Center for Veterinary Medicine. Under 21 U.S.C. 352 (a) and (f), pet owners, veterinarians, and animal caretakers can submit this form when animals experience negative reactions to drugs, devices, or other veterinary products—yet the FDA cannot investigate problems it does not know exist.

According to FDA data, the Center for Veterinary Medicine has collected over 865,000 adverse event reports since 1987, with many coming from voluntary submissions like Form 1932a. These reports have led to safety warnings, label changes, and product recalls that protect millions of animals each year.

In this article, you will learn:

📋 The exact purpose of FDA Form 1932a and who must use it versus who should use it

✍️ Step-by-step instructions for completing each section of the 7-page form with real examples

⚠️ Common mistakes that delay processing and how to avoid them

📊 How Form 1932a differs from Form 1932 (mandatory reporting) and when each applies

📬 The three ways to submit your completed form and what happens after FDA receives it

What Is FDA Form 1932A and Why Does It Matter?

FDA Form 1932a serves as the primary tool for voluntary adverse event reporting to the Center for Veterinary Medicine (CVM). The form captures critical safety information about drugs and devices used in animals that may cause harm, fail to work, or contain defects.

The FDA uses these reports as a post-market surveillance tool to monitor animal drug safety after products reach the market. Pre-approval clinical trials test products on limited animal populations under controlled conditions. Widespread use often reveals problems that were not identified during testing.

Types of Problems You Can Report

Form 1932a accepts reports for three categories of issues:

You can report problems with FDA-approved animal drugs, indexed drugs for minor species, unapproved drugs (including compounded products), and medical devices used in animals. Unapproved drugs include human drugs used in animals, compounded medications, and animal supplements.

What You Cannot Report on Form 1932a

The FDA does not regulate all products used in animals. Veterinary vaccines and biological products fall under the USDA’s Center for Veterinary Biologics—not the FDA. If your animal has a reaction to a vaccine, contact the USDA APHIS at 800-752-6255.

Some flea and tick products carry an EPA registration number instead of FDA approval. Look for “EPA Reg. No.” on the label. Report problems with EPA-registered pesticides to the National Pesticide Information Center at 800-858-7378.

Who Should Use Form 1932A vs. Form 1932

The FDA maintains two adverse event reporting forms for veterinary products. Understanding which form applies to your situation prevents wasted effort and ensures your report reaches the correct destination.

Form 1932 is required for manufacturers of FDA-approved animal drugs. Under 21 CFR 514.80, applicants must report serious adverse events within 15 working days and product defects that could cause serious harm within 3 working days.

Form 1932a allows anyone to report. Compounders are not required to report adverse events for drugs compounded from bulk substances. This makes voluntary reports from veterinarians and pet owners especially important for compounded medications.

Scenario: When to Use Each Form

Maria’s dog takes an FDA-approved heartworm medication and develops liver problems. Maria has two options. She can call the manufacturer (recommended for approved products) because manufacturers must report events to FDA. She can also file Form 1932a directly with FDA if she prefers.

Dr. Chen compounds a pain medication for a cat from bulk drug substances. The cat experiences kidney failure. Because compounders face no reporting requirement, Dr. Chen should file Form 1932a directly with FDA to alert the agency.

Downloading and Preparing Form 1932a

Form 1932a exists as a fillable PDF document. The FDA provides specific instructions for downloading the form that you must follow to avoid technical errors.

Critical: Do not open the form directly in your browser. The form will not function properly. Follow these steps:

1. Right-click the 1932a electronic form link on the FDA website
2. Select “Save Link As” (or “Save Target As” depending on your browser)
3. Save the blank form to your computer
4. Open the saved file using Adobe Reader
5. Complete the form
6. Save the completed version
7. Email to [email protected]

The form works only on Windows or Mac desktop/laptop computers. Smartphones and tablets are not supported. You may need to upgrade your Adobe Reader version if the form does not display properly.

Section-by-Section Guide to Completing Form 1932A

The form contains seven pages with multiple sections. The FDA estimates completion takes approximately one hour per response. Gather all relevant information before starting.

Header Information

Individual Case Safety Report Number: Leave blank. The FDA assigns this number after receiving your report.

Submission Type: Choose “Initial” for a first-time report about this event. Choose “Follow-up” if you are providing additional information about a report you already submitted.

Report Type: Select all categories that apply:

• “Adverse Event” — for reactions in animals or humans, including lack of effectiveness
• “Product Problem” — for packaging defects, discoloration, or other product issues
• “Both” — when an adverse event and product problem occurred together

Date of this Report: Enter today’s date in mm/dd/yyyy format.

Section 1: Sender Information

This section identifies who is filling out the form.

Sender Category: Check the box that describes you:

• Veterinarian
• Animal Owner
• Physician (for human exposures)
• Patient (human affected)
• Other Health Care Professional
• Other
• Unknown

Previously Reported to Manufacturer: Check “Yes” if you already called the drug company. Include the Manufacturer’s Case Number if they provided one.

No Identity Disclosure: Check this box if you do not want FDA to share your identity with the manufacturer. The FDA will never disclose your identity in response to public Freedom of Information Act requests.

Section 2: Healthcare Professional Information

Complete this section only if different from the sender. Enter the veterinarian’s name, address, and contact information if:

• You are a pet owner reporting about your vet’s patient
• A staff member is filing on behalf of the veterinarian
• Follow-up questions should go to someone other than the sender

Section 3: Owner Information

Complete this section only if the animal’s owner is different from both the sender and healthcare professional.

Section 4: Suspected Product Information

This section captures details about the drug or device you believe caused the problem.

Name of Suspected Product: Enter the brand name exactly as shown on the label. Include the spelling, capitalization, and any trademark symbols if visible.

Is this a Compounded Product? Check “Yes,” “No,” or “Uncertain.” For products compounded from bulk drug substances, this information helps FDA track safety patterns.

Diagnosis and/or Reason for Use: Explain why the product was prescribed or used. Example: “Prevention and control of flea and tick infestations.”

Dosage Form: Enter the physical form of the product:

• Chewable tablet
• Liquid/oral solution
• Topical spot-on
• Injectable
• Tablet
• Capsule
• Paste

Strength of Active Ingredient(s): List each active ingredient and its concentration. Example: “Fluralaner 250 mg.”

Date of First Exposure / Date of Last Exposure: Enter when the animal first received the product and when it last received it in mm/dd/yyyy format. If the product was used for less than one day, enter the same date in both fields.

Duration of Product Use: If exact dates are unknown, describe the time period. Example: “Approximately 2 weeks during October 2025.”

Dose Administered: How much was given per dose. Example: “1 chewable tablet (250 mg).”

Interval of Administration (Frequency): How often was the product given. Example: “Once every 12 weeks.”

Route of Administration: How was the product given. Examples: oral, subcutaneous injection, topical application.

Product Administered By: Check who gave the medication:

• Veterinarian/Veterinary Staff
• Owner
• Other (describe in narrative section)

Lot Number and Expiration Date: Find these on the product packaging. This information helps FDA identify specific batches for investigation.

Name of Manufacturer or Compounding Pharmacy: Enter the company name shown on the label. For compounded products, provide the pharmacy name.

Section 5: Adverse Event Information

This section describes what happened to the animal.

Veterinarian’s Level of Suspicion: Rate how strongly you believe the product caused the adverse event:

• High — strong evidence linking product to reaction
• Medium — possible connection
• Low — unlikely but reporting for documentation
• Unknown — cannot assess

Treatment of Adverse Event: Describe any treatments given. Example: “IV fluids, anti-seizure medication (diazepam), activated charcoal.”

Did Adverse Event Abate After Stopping the Product? Check “Yes” if symptoms improved after discontinuing use. Check “Not Applicable” if the product was not stopped.

Did Adverse Event Reappear After Reintroduction? If the product was given again and symptoms returned, check “Yes.” This information strongly supports causation.

Outcome: Select the final result:

• Recovered
• Died
• Other (describe in narrative)

For “Other,” provide details. Example: “Dog survived but has permanent liver enzyme elevation.”

Section 6: Species and Related Information

Species: Check the appropriate box (Dog, Cat, Horse, etc.). If “Other,” identify the species in the narrative section.

Breed: Enter the specific breed. Examples: “Golden Retriever,” “Mixed Breed,” “Domestic Shorthair.”

Gender: Male, Female, Male Neutered, or Female Neutered.

Age: Provide age at time of event with time descriptor. Example: “4 years, 6 months.”

Weight: Enter in pounds. Estimate if exact weight is unknown.

Overall Health Status When Product Given: Rate the animal’s health before receiving the product:

• Excellent
• Good
• Fair
• Poor
• Critical

Number of Animals Treated: If multiple animals received the same product simultaneously, enter the total.

Number of Animals Affected: If more than one animal had an adverse event, enter that number. Submit separate reports for animals with different reactions.

Section 7: Adverse Event Occurrence

Date of Onset: When did symptoms first appear?

Length of Time Between First Exposure and Onset: How long after starting the product did symptoms begin? Example: “3 days.”

Length of Time Between Last Dose and Onset: How long after the most recent dose? Example: “4 hours.”

When Event Occurred, Treatment with Product:

• Had already been completed
• Was discontinued
• Was discontinued and replaced with another product
• Was discontinued and reintroduced later
• Was continued at an altered dose
• Other

Section 8: Concurrent Information

Attached Documents: List any files you are including (medical records, lab results, photos). Provide filename and description.

Concurrent Clinical Problems: List any health conditions the animal had before or during product use. Example: “Chronic allergic dermatitis, hypothyroidism.”

Concurrent Products: List all other medications, supplements, vitamins, and over-the-counter products the animal was receiving. Do not include treatments given to address the adverse event.

Section 9: Long Narrative

Use this final section to describe the event in your own words. Include:

• Complete timeline of events
• All symptoms observed
• How symptoms progressed or resolved
• Any contributing factors
• Available test results
• Outcome details

Example narrative: “My 6-year-old spayed female Golden Retriever, Bella, received her first dose of Product X on 11/15/2025 at approximately 4 PM for flea prevention. By 11 PM, she began tremoring and appeared uncoordinated. The next morning, she had a grand mal seizure lasting approximately 2 minutes. I brought her to ABC Emergency Vet Clinic where she received IV fluids and diazepam. She had two more seizures over the next 24 hours despite treatment. Blood work showed no abnormalities. Bella had no prior seizure history. She recovered after 3 days of hospitalization but now takes daily phenobarbital for seizure prevention. Product X was never administered again.”

Three Ways to Submit Your Report

You can submit Form 1932a through three channels:

The FDA encourages email submission. You receive an automatic acknowledgment confirming receipt. FDA staff review reports but only contact you if they need additional information.

For paper submissions, triple-fold the form, seal with tape, and mail using the pre-printed address. No postage is required if mailed within the United States.

Common Mistakes to Avoid

Filing an incomplete or incorrect report delays FDA review and may prevent proper investigation.

Scenarios Illustrating Common Problems

Dr. Martinez files a report about a dog’s reaction to a pain reliever. She forgets to list that the dog was also taking a corticosteroid. FDA cannot assess whether the adverse event resulted from a drug interaction.

Tom reports his cat’s reaction to a compounded medication. He provides only “bad reaction” in the narrative without symptoms, timeline, or outcome. FDA cannot determine whether this report indicates a safety concern.

Do’s and Don’ts for Effective Reporting

Do’s

✅ Report promptly — File while details remain fresh in your memory

✅ Gather documentation first — Collect veterinary records, lab results, and product packaging before starting the form

✅ Be specific — Include exact dates, doses, and symptoms rather than general descriptions

✅ Include concurrent products — List vitamins, supplements, and over-the-counter medications even if they seem unrelated

✅ Provide contact information — Allow FDA to follow up if they need clarification

Don’ts

❌ Do not wait for confirmation of causation — Report suspected connections even without proof

❌ Do not assume someone else reported — The manufacturer may not have received the same information

❌ Do not omit embarrassing details — Incorrect administration matters for accurate assessment

❌ Do not combine reports — Submit separate forms for different animals with different reactions

❌ Do not skip the narrative — The long-form description often contains the most valuable information

What Happens After You Submit

The FDA processes voluntary reports through its Adverse Event Reporting (AER) system. Staff review submissions and enter data into the database maintained by CVM.

The FDA does not confirm causation for individual reports. The information in the database reflects what reporters submitted—not FDA’s determination that the product caused the event.

When multiple reports suggest a pattern, FDA conducts signal detection analysis. This process identifies potential safety issues requiring further investigation. Confirmed safety signals may result in:

• Updated package labeling
• Dear Veterinarian letters
• Public safety alerts
• Required manufacturer studies
• Product recalls

The FDA publishes adverse event data on openFDA.gov for researchers and the public. This database is updated quarterly and includes reports dating back to 1987.

Pros and Cons of Voluntary Reporting

Pros

✅ No requirement to prove causation — You can report suspected connections based on clinical judgment

✅ Protects future animals — Your report may prevent harm to other pets receiving the same product

✅ Confidentiality protected — FDA will not disclose your identity to the public

✅ No cost or fee — Submission is free through all channels

✅ Contributes to safety database — Even single reports can contribute to pattern detection over time

Cons

⚠️ No individual feedback — FDA does not provide case-by-case analysis

⚠️ Time investment — Completing the form takes approximately one hour

⚠️ No compensation — Reporting does not result in reimbursement for veterinary costs

⚠️ Limited technical support — Form requires specific software and computer access

⚠️ Underreporting remains common — Many adverse events are never reported to FDA or manufacturers

Real-World Reporting Scenarios

Scenario 1: Flea Medication and Seizures

Sarah’s Border Collie, Max, receives an isoxazoline flea treatment. Two days later, Max experiences his first seizure with no prior history.

Sarah’s report contributes to the FDA’s ongoing monitoring of neurologic events associated with isoxazoline products.

Scenario 2: Compounded Medication Failure

Dr. Patel prescribes a compounded thyroid medication for a cat. After three months, blood tests show the cat remains hypothyroid despite consistent medication administration.

Because compounders have no reporting obligation, Dr. Patel’s voluntary report is critical for FDA surveillance.

Scenario 3: Product Defect Discovery

A veterinary clinic receives a shipment of injectable antibiotics. Upon inspection, staff notice several vials contain cloudy solution that should be clear.

FAQs

Can I report an adverse event anonymously?
No, but you can request no identity disclosure. The FDA needs contact information for follow-up questions, but checking the “No Identity Disclosure” box prevents FDA from sharing your identity with the manufacturer.

Do I need veterinary records to file a report?
No, records are not required. However, including medical documentation strengthens your report and helps FDA evaluate the event more accurately.

How long does FDA review take?
No specific timeline exists for individual reports. Reports enter the database for signal detection analysis. FDA contacts reporters only when additional information is needed.

Can I report human exposure to animal drugs?
Yes, Form 1932a accepts reports of adverse events in humans exposed to veterinary products. Check “Human” in the species section and provide details in the narrative.

Should I report if I already called the manufacturer?
Yes, filing directly with FDA ensures your report reaches the agency. Manufacturers must submit their reports, but your direct submission provides independent documentation.

What if I do not know the lot number?
Yes, you should still report. Include all information you do have. Missing lot numbers reduce investigative capability but do not prevent filing.

Can veterinary technicians file reports?
Yes, anyone can submit Form 1932a. The sender section includes “Other Health Care Professional” as a category option.

Do I report vaccine reactions on this form?
No, veterinary vaccines are regulated by USDA, not FDA. Report vaccine adverse events to the USDA APHIS Center for Veterinary Biologics at 800-752-6255.

What qualifies as a “serious” adverse event?
Yes, any event causing death, hospitalization, disability, or life-threatening conditions qualifies. However, you should report all suspected adverse events regardless of severity.

Can I file on behalf of another pet owner?
Yes, anyone can file a report. Include the animal owner’s information in the Owner section and your own information in the Sender section.