21 CFR 514.80: Animal Drug Records and Reports

21 CFR 514.80 is the US regulation governing records and reports concerning experience with approved new animal drugs. It connects information about safety, effectiveness, and product or manufacturing defects to the holder of an approved new animal drug application (NADA) or abbreviated new animal drug application (ANADA), and ultimately to FDA. Its requirements include indexed records, expedited reports, periodic drug experience reports, and retention.

The central distinction is between keeping information and submitting a particular report. Applicants and nonapplicants have recordkeeping responsibilities, but their reporting destinations differ. Applicants report to FDA; nonapplicants provide information to the appropriate applicant, which then reports to FDA as required. Domestic and foreign information are both covered, even though this definition addresses only US law.

Under 21 CFR 514.3, an adverse drug experience is not limited to an injury proven to be caused by the drug. It includes adverse events associated with use, whether or not considered drug-related, lack of expected effectiveness, and adverse events in humans exposed during manufacture, testing, handling, or use. Events involving extralabel use of an approved new animal drug are also included.

An applicant owns, or holds on behalf of the owner, the approval for an NADA or ANADA. A nonapplicant is a different person whose name appears on the product label and who engages in manufacturing, packing, distribution, or labeling. Both parts of the nonapplicant definition matter: the activity and the name on the label.

For nonapplicant adverse drug experience reports, § 514.80(b)(3) requires records of the receipt date, the applicant's name and address, and a copy of the report with its submission date to the applicant. Electing also to report directly to FDA does not replace the stated forwarding duty; direct FDA reporting follows the provision's electronic-format requirements and exceptions.

In practice, give the applicant access to the original narrative and attachments, not merely a rewritten summary. Keep uncertainty visible: an unconfirmed lot, an incomplete outcome, or a disputed relationship to the drug should remain identifiable as such. A handoff should transfer the information and its history, not create a new apparent first-receipt date.

The two expedited FDA reporting routes address different questions. A three-day field alert concerns a product or manufacturing defect that may result in serious adverse drug events. A 15-day alert concerns each serious, unexpected adverse drug event, regardless of the information source. Neither route should be reduced to a generic complaint deadline.

Section 514.3 defines a product defect by reference to a distributed product: deviation from approved-application standards, or significant change or deterioration in the distributed drug product. A manufacturing defect is a product defect caused or aggravated by manufacturing or a related process. The field-alert trigger therefore does not require a confirmed injury or a completed root-cause investigation: the wording concerns a defect that may exist and may result in serious adverse drug events.

For the 15-day route, serious and unexpected are separate assessments. Serious includes fatal or life-threatening events, events requiring professional intervention, abortion, stillbirth, infertility, congenital anomaly, prolonged or permanent disability, and disfigurement. Unexpected means not listed in current labeling and also includes related events that differ from labeled events in greater severity or specificity.

Field-alert information may initially be provided by telephone or other telecommunication means, with prompt written follow-up using Form FDA 1932. The mailing cover must be plainly marked “3-Day NADA/ANADA Field Alert Report.” Initial 15-day alerts are submitted electronically, unless a waiver is obtained or FDA requests an alternate format.

Under § 514.80(b)(2)(ii), the applicant must promptly investigate every adverse drug event that is the subject of a 15-day alert. Significant new information starts a follow-up obligation: submit the follow-up within 15 working days of receiving that information. The follow-up must state the initial report date and provide the additional information. Electronic submission applies, subject to the specified waiver or FDA-requested alternate-format exceptions.

There is also a no-information follow-up requirement. If additional information is sought but not obtained within 3 months of the initial report, a follow-up is required describing the steps taken and why the additional information was not obtained. This is not a replacement for a significant-new-information follow-up, nor is it expressed as a 90-day period.

• Maintain separate timestamps for first receipt, first awareness of a possible defect, transfer to the applicant, and receipt of significant new information.
• Assign an owner to each active report and follow-up task, with a backup for absences.
• Document information requests and unsuccessful attempts so that a no-information follow-up can explain what happened.
• Reassess new information rather than leaving the initial seriousness, expectedness, or defect assessment unexamined.

Section 514.80(b)(4) establishes the ordinary periodic schedule: every 6 months for the first 2 years following NADA or ANADA approval, then yearly. Six-month reports are due within 30 days after the reporting period ends; yearly reports are due within 90 days of the approval anniversary. Reports cover the full period, identify previously submitted information, and are accompanied by completed Form FDA 2301. Annual timing or frequency may change through an FDA-approved petition, and FDA may require different or more frequent reporting.

At a summary level, the content framework covers:

• Distribution data, including domestic and export quantities and product presentations, under the applicable distribution-data provisions.
• Current applicant and distributor labeling, with a dated summary of changes or a statement that there were none.
• Specified nonclinical studies and clinical information not previously reported, including descriptions of completed applicant-conducted or applicant-sponsored trials within the provision's timeframe.
• Product or manufacturing defects and adverse drug experiences not previously reported through the expedited routes.
• Literature adverse drug experience reports and pertinent references, plus previously unreported experiences from postapproval studies.
• A separate narrative summary of increased frequency of serious adverse drug events, expected or unexpected, when such an increase is identified.

Periodic reporting is not permission to replace all individual cases with a narrative total. Paragraphs (b)(4)(iv)(A) and (C) require individual electronic reporting for the specified defects and adverse drug experiences, subject to the stated exceptions. The increased-frequency assessment must occur at least as often as periodic reporting; its narrative addresses comparison periods, methods, relevant report references, and interpretation.

As a working practice, reconcile the periodic package against intake records, expedited submissions, literature records, and the distribution dataset. This helps distinguish “previously reported,” “reportable in this period,” and “still awaiting information” without treating the periodic report as a substitute for an earlier deadline.

The records obligation is broader than a folder of submitted forms. Section 514.80(a)(1) requires indexed and complete files containing full records of pertinent safety or effectiveness information. For applicants, it addresses information not previously submitted as part of the NADA or ANADA; for nonapplicants, it addresses information received or otherwise obtained. Both include domestic and foreign sources.

The two Part 211 provisions have specific three-year, distribution-based rules for qualifying OTC products without expiration dating. In practice, map each linked record set to its applicable retention requirements and preserve shared evidence through the longest applicable period rather than assigning one blanket destruction date.

Under § 514.80(f), applicants and nonapplicants must allow authorized FDA officers or employees, upon request and at reasonable times, access to copy and verify the required records and reports. A practical index should therefore connect the original intake, assessment, correspondence, submissions, follow-up, and related investigation without losing their individual dates.

FICTIONAL EXAMPLE: A label-named distributor receives a complaint about Fictional Product P, an assumed approved ANADA product, on Monday, September 14, 2026. The account describes a separated bottle seal and visible deterioration in distributed lot FIC-2609, plus an animal event requiring professional intervention. These product, lot, and case details are invented.

For this example only, Saturdays and Sundays are non-working days, there are no holidays or other closures during the illustrated counting period, and the receipt or awareness date is Day 0. Subsequent weekdays are counted. Actual deadline counting requires regulatory confirmation.

Under these assumptions, the three-working-day date from September 14 is September 17, and the 15-working-day date is October 5. Both initial reports were submitted earlier. The September 21 follow-up is on the first working day after the significant new information arrived. Investigation can continue, but neither submission resolves causation or determines the disposition of any remaining stock.

Animal drugs are drugs: Parts 210 and 211 are part of the applicable drug CGMP framework, not an unrelated human-drug requirement. Section 210.2 describes the applicable CGMP regulations as supplementing one another unless otherwise specified. Section 514.80(a)(5) expressly places its records and reports in addition to those required under Parts 211, 225, and 226.

The operational connection is especially clear in § 211.198. Written complaint procedures must provide for quality-control-unit review of possible specification failures and a determination about investigation. They must also provide for review of whether a complaint represents a serious and unexpected adverse drug experience reportable under the cited reporting provisions, including § 514.80.

• Regulatory decision: assess reportability, destination, deadline, submission content, and follow-up.
• Quality decision: assess the product concern, investigation, affected stock, and disposition or release through the applicable quality process.
• Shared evidence: connect the complaint to relevant lot records, distribution information, investigations, and any proposed corrective action without merging the decisions.

Keep these as human decisions: regulatory personnel decide the reporting route, and the quality unit decides disposition and release through its quality process. A completed report is not a release criterion, and an open investigation should not be used as a reason to postpone an otherwise triggered reporting task.

For this site's lot-packet guide, see Veterinary Pharma Manufacturing Readiness. Keep proposed manufacturing changes on a separate assessment path; the NADA/ANADA Readiness Guide addresses change routes rather than treating an experience report as a change submission.

This definition addresses US requirements as of October 20, 2026, for experience with approved NADA and ANADA products. It is not a route guide for conditional approvals, indexed products, or compounded preparations; those categories should not be collapsed into the approved-NADA/ANADA workflow described here. Extralabel use of an approved new animal drug is included in the adverse drug experience definition, but prescribing and compounding rules are outside this page's scope.

Section 514.80(a)(4) also applies the section to approved Type A medicated articles. It specifically applies paragraphs (b)(1), (b)(2), (b)(4)(iv), and (b)(4)(v) to approved Type A medicated articles incorporated in animal feeds. Section 514.80(a)(6) excludes designated medical gases, whose certification and animal-use experience records and reports are addressed under Part 230.

For scope navigation, medicated feed/Part 225, Type A medicated articles/Part 226, and USDA-licensed veterinary biologics/9 CFR Part 113—including the separate topic of serials in licensed establishments—are manufacturing boundaries, not protocols explained here. Use product-specific review rather than extending this glossary's drug-reporting workflow to every animal-health product.