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

FDA Form 1932 is the mandatory reporting document that pharmaceutical companies, manufacturers, and distributors must complete to report veterinary adverse drug events (ADEs), product defects, and lack of effectiveness to the FDA’s Center for Veterinary Medicine (CVM). Failure to submit this form within required deadlines can result in withdrawal of your drug approval under 21 CFR 514.80(h).

A study published in the Journal of Small Animal Practice found that approximately 90% of suspected adverse drug reactions in veterinary medicine go unreported. This massive underreporting delays the detection of drug safety concerns and prevents regulators from taking timely corrective action.

Here is what you will learn from this article:

• 📋 Step-by-step instructions for completing every section of FDA Form 1932, including field-specific guidance and code lists
• ⏰ Critical deadlines for 3-day, 15-day, and periodic reports—and what happens when you miss them
• 🐾 Real-world examples showing how to document adverse events in dogs, cats, horses, and livestock
• ⚠️ Common mistakes that trigger FDA scrutiny and how to avoid them
• ❓ Frequently asked questions about electronic submission, voluntary vs. mandatory reporting, and confidentiality

Understanding FDA Form 1932 vs. Form 1932a

Before filling out any paperwork, you need to determine which form applies to your situation. The FDA maintains two separate veterinary adverse event forms that serve different populations.

Form FDA 1932 is the mandatory form for applicants (companies holding approved NADAs or ANADAs) and nonapplicants (distributors, packers, or manufacturers whose names appear on product labels). These parties face legal obligations under 21 CFR 514.80 to report adverse events within specific timeframes.

Form FDA 1932a is the voluntary form for veterinarians, animal owners, and healthcare professionals who want to report adverse events directly to the FDA. While not legally required, the AVMA strongly encourages veterinarians to submit these reports as part of professional responsibility.

When You Must File Form FDA 1932

The timing of your report depends on the severity and nature of the adverse event. The FDA’s reporting regulations establish three distinct reporting categories.

Three-Day NADA/ANADA Field Alert Reports

You must submit a 3-day field alert report when you discover product or manufacturing defects that may result in serious adverse drug events. The clock starts the moment you “first become aware that a defect may exist.” This report goes to your local FDA District Office or resident post.

Examples of defects requiring 3-day reports include:

• Contaminated batches
• Incorrect drug concentrations
• Broken seals or leaking containers
• Mislabeled products

You may initially report by telephone, but you must follow up promptly with a completed Form FDA 1932 marked “3-Day NADA/ANADA Field Alert Report.”

Fifteen-Day NADA/ANADA Alert Reports

You must submit a 15-day alert report for each serious, unexpected adverse drug event. Under 21 CFR 514.3, a serious adverse event includes:

• Death
• Life-threatening conditions
• Hospitalization or prolonged hospitalization
• Persistent or significant disability
• Congenital anomaly
• Events requiring medical intervention to prevent permanent damage

An unexpected adverse event is one not listed in current labeling or that differs from labeled events in severity or specificity.

Periodic Drug Experience Reports

For adverse events that are neither serious nor unexpected, you must include them in your periodic drug experience report using Form FDA 2301. These reports are due:

• Every 6 months for the first 2 years after NADA/ANADA approval
• Annually thereafter

Step-by-Step Guide: Completing Form FDA 1932

The FDA updated Form FDA 1932 in August 2023 to align with VICH GL42 international harmonization standards. The form consists of two main parts: Part A (Administrative Information) and Part B (Description of the Adverse Event).

Part A: Administrative and Identification Information

Section A.1 — Regulatory Authority

Enter the FDA’s contact information exactly as follows:

Section A.2 — Marketing Authorization Holder (MAH)

The MAH is the company responsible for the drug—either the NADA/ANADA holder or the nonapplicant distributor. You must provide:

• Business Name: Your company’s legal name
• Street Address, City, State, Zip, Country: Complete business address
• Person Acting on Behalf of MAH: Include name, title, telephone, fax, and email of your pharmacovigilance contact

Section A.3 — Persons Involved in the AER

Primary Reporter (A.3.1): The individual providing the most pertinent information. This could be the veterinarian, animal owner, or your company representative. Select the appropriate Reporter Category from:

• Veterinarian
• Animal Owner
• Physician (use only when a human is affected)
• Patient (use only when a human is affected)
• Other Health Care Professional
• Other
• Unknown

Confidentiality Note: If the reporter requests anonymity, enter “Withheld” in the Last Name field. The FDA protects reporter identities under the Freedom of Information Act.

Other Reporter (A.3.2): If multiple parties provided information (such as both the veterinarian and animal owner), enter the secondary reporter here.

Section A.4 — AER Information

Unique AER Identification Number (A.4.1): Create this number using the format:

[3-character country code]-[8-character MAH identifier]-[unique case number]

Example: USA-GAPINDUS-000001

This number stays with the case forever—use it for all follow-up reports.

Original Receive Date (A.4.2): The date your company first received information about the event. This date triggers your reporting clock and never changes, even for follow-up submissions.

Type of Submission (A.4.4.1): Select from:

• Expedited: 15-day NADA/ANADA alert report
• Three-Day Field Alert: Manufacturing/product defect
• Follow-up: Additional information on a previous report
• Nullification: Withdraw a previously submitted report
• Periodic: Included in periodic drug experience report

Type of Information (A.4.4.3): This describes the nature of the event. Options include:

• Safety Issue
• Lack of Expected Effectiveness (LOEE)
• Both Safety Issue and Lack of Expected Effectiveness
• Manufacturing/Product Defect (Safety)
• Manufacturing/Product Defect with No Adverse Events

Part B: Description of the Adverse Event

Part B captures the clinical details. Accuracy here directly impacts FDA’s ability to evaluate the report.

Section B.1 — Animal Data

Number of Animals Treated (B.1.1): The total animals that received the drug—not just those affected. If a farmer treated 500 cattle and 3 became ill, enter “500.”

Number of Animals Affected (B.1.2): Only the animals experiencing adverse events. This can be greater than animals treated if indirect exposure occurred (such as nursing offspring or commingled animals).

Species (B.1.3): Select from the provided code list. If your species is not listed, choose “Other” and describe in the narrative (B.3.1).

Breed Information (B.1.4):

• For purebred animals, use B.1.4.1 (e.g., “Labrador Retriever”)
• For crossbred animals, use B.1.4.2 with up to three breeds (e.g., “Labrador Retriever; German Shepherd”)
• For mixed breeds of unknown composition, enter “Crossbred Canine/Dog”

Weight and Age (B.1.8-B.1.9): Indicate whether values are Measured, Estimated, or Unknown. Provide minimum and maximum values if a range applies.

Section B.2 — Veterinary Medicinal Product (VMP) Data

Registered or Brand Name (B.2.1): The product’s commercial name exactly as it appears on the label.

Registration Identifier (B.2.1.2): Use the format USA-USFDACVM-N123456 where the number is your NADA or ANADA number.

Route of Exposure (B.2.1.7): Select from options like oral, injection, topical, etc. You can enter multiple routes if applicable.

Dose Per Administration: Include:

• Numeric value (numerator): e.g., “250”
• Units (numerator): e.g., “mg”
• Numeric value (denominator): e.g., “1”
• Units (denominator): e.g., “animal”
• Interval: e.g., “every 12 hours”
• Dates of first and last exposure

Use According to Label (B.2.5): This critical field asks whether the drug was used as directed. If “No,” you must complete the Off-Label Explanation checklist (B.2.5.1), indicating which aspects were off-label:

• Target species
• Route of administration
• Overdosed or underdosed
• Indication
• Storage conditions
• Expired product

Section B.3 — Adverse Event Data

Narrative of AE (B.3.1): This is your most important field. Write a chronological, detailed account including:

• Animal’s medical history before treatment
• Reason for drug administration
• Complete timeline of events
• Clinical signs observed
• Laboratory findings
• Treatment provided for the adverse event
• Outcome

Adverse Clinical Manifestations (B.3.2): Use VeDDRA terminology to code clinical signs. Common terms include:

• DEATH
• VOMITING
• DIARRHOEA
• ATAXIA
• ANOREXIA

Serious AE (B.3.6): Select “Yes” if the event meets 21 CFR 514.3 criteria for seriousness.

Outcome (B.3.8): Enter the number of animals in each category:

• Ongoing
• Recovered/Normal
• Recovered with Sequela
• Died
• Euthanized
• Unknown

These numbers must equal the Number of Animals Affected (B.1.2).

Three Real-World Scenarios

Scenario 1: Serious Adverse Event in a Dog

Situation: A veterinarian administers an FDA-approved antibiotic to a 5-year-old Labrador Retriever. Within 24 hours, the dog develops seizures—a reaction not listed on the product label.

Scenario 2: Manufacturing Defect Discovered

Situation: A quality control check reveals that Lot #ABC123 of an injectable product contains particulate matter due to a filter failure.

Scenario 3: Lack of Expected Effectiveness

Situation: Multiple reports indicate that a flea/tick preventive is not controlling infestations as claimed. No other adverse signs are present.

Mistakes to Avoid

Drug companies frequently make errors that delay FDA processing or trigger additional scrutiny. The following mistakes can result in rejection, requests for additional information, or worse—withdrawal of your approved application.

Mistake 1: Missing Required Fields

The FDA marks required fields with an asterisk (*). Submitting a form with blank required fields causes immediate rejection. At minimum, you must provide:

• An identifiable reporter
• An identifiable animal or human
• An identifiable VMP
• One or more adverse events

Consequence: Report rejection and potential missed deadline.

Mistake 2: Using Wrong Date for “Original Receive Date”

Companies sometimes enter the date they compiled the report instead of the date they first received information. This field triggers your regulatory clock and affects whether you meet the 3-day or 15-day deadline.

Consequence: Potential violation of reporting timeframes under 21 CFR 514.80.

Mistake 3: Incomplete Narrative

A narrative that simply states “Dog vomited after receiving Product X” provides insufficient information. The FDA needs context to evaluate causality.

Consequence: FDA cannot assess the report properly, potentially delaying safety signals.

Mistake 4: Ignoring Foreign Reports

Under 21 CFR 514.80(a)(1), applicants must maintain records of information from domestic as well as foreign sources. If your European subsidiary receives an adverse event report, you must include it in your FDA submissions.

Consequence: FDA may find your records incomplete during inspection.

Mistake 5: Failing to Submit Follow-Up Reports

When you submit a 15-day alert report and later receive significant new information, you must submit a follow-up within 15 working days. If you seek additional information but cannot obtain it within 3 months, you must still submit a follow-up explaining your efforts.

Consequence: Non-compliance with 21 CFR 514.80(b)(2)(ii).

Do’s and Don’ts

Do’s

Don’ts

How to Submit Form FDA 1932a (For Veterinarians and Pet Owners)

If you are a veterinarian or animal owner, you use Form FDA 1932a rather than Form 1932. The submission process differs significantly.

Downloading the Form

You must download the form to your computer before filling it out. Do not open it in your browser.

1. Right-click the 1932a form link
2. Select “Save Link As” (or equivalent)
3. Save the blank form to your computer
4. Open the saved file
5. Complete all applicable sections
6. Save the completed form

Submitting Your Report

Email the completed form to: [email protected]

Alternatively, you can mail the form (no postage required when folded properly) to:

Document Control Unit (HFV-199)
Attention: Division of Pharmacovigilance and Surveillance
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855-9921

Key Sections for Form 1932a

Form 1932a is simpler than Form 1932 but still requires careful attention:

• Sender Information: Your contact details
• Suspected Product Information: Brand name, dosage form, strength, lot number
• Species and Related Information: Select species, enter breed, age, weight
• Adverse Event Information: Describe what happened
• Long Narrative: Provide a detailed chronological account

Pro Tip: Although the FDA instructs you that mailing is an option, email is more reliable for ensuring your report reaches CVM.

Frequently Asked Questions

Can I report an adverse event for a compounded drug?

Yes. Compounded animal drugs are considered unapproved drugs, and adverse events should be reported using Form FDA 1932a. Indicate “Yes” when asked if the product is compounded.

What if I don’t know all the information requested?

Yes, you should still submit. Enter “Unknown” in fields where information is unavailable. The FDA prefers partial reports submitted on time over complete reports submitted late.

Will the FDA contact me after I submit a report?

No, not routinely. You will receive an automatic acknowledgment when submitting by email. FDA staff contact reporters only when additional information is needed.

Can FDA withdraw my drug’s approval for failing to report?

Yes. Under 21 CFR 514.80(h), if FDA finds that an applicant has failed to establish required records, maintain them, or make required reports, FDA may withdraw approval after providing notice and opportunity for hearing.

Is there a deadline for voluntary reports on Form 1932a?

No. Voluntary reporting has no legal deadline. However, sooner is better—delayed reports can impede FDA’s ability to detect safety signals quickly.

What happens to the data I submit?

Yes, the data enters FDA’s adverse event database. CVM scientists use this information to monitor product safety, which may lead to label changes or regulatory action. Reports are also made available on openFDA.gov (with identifiers removed).

Do I report adverse events for vaccines to FDA?

No. Animal vaccines are regulated by USDA APHIS, not FDA. Report vaccine-related events to the Center for Veterinary Biologics at 800-752-6255.

Can I request that my identity remain confidential?

Yes. Check the “No Identity Disclosure” box on Form 1932a if you do not want your identity shared with the manufacturer. The FDA will not disclose reporter identity to the public under FOIA.

What is VICH and why does it matter?

Yes, VICH matters. The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products developed standardized data elements used in Form FDA 1932. Harmonization allows global companies to report consistently across the U.S., EU, and Japan.

How long must companies keep adverse event records?

Yes, there is a requirement. Under 21 CFR 514.80(e), applicants and nonapplicants must maintain records for 5 years after the date of submission.