Field Alert Report
FAR
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A Field Alert Report is a rapid post-marketing notification a drug applicant must submit to FDA about specific quality problems with a distributed product — including information that a distributed batch may be mislabeled or may not meet its specifications, and reports of bacteriological contamination or significant chemical/physical/other change or deterioration. The first alert is due within a short, defined timeframe of becoming aware of the information, and serves as an early-warning trigger for potential recalls and investigations. It is a quality-signal duty distinct from adverse-event (safety) reporting.
The FAR system is intentionally fast and low-threshold: it captures the possibility of a distributed-product quality defect early, before the full investigation is complete, so the agency and firm can act if a recall proves necessary. Follow-up reports update the initial alert as the investigation matures.
Practitioners must not confuse FARs (product-quality defects on marketed drugs) with medical product safety reporting or with the biological product deviation report used for licensed biologics.
- —Early-warning report of a possible distributed-drug quality defect
- —Covers mislabeling, out-of-spec batches, contamination, deterioration
- —First report due within a short defined window of awareness
- —Distinct from adverse-event reporting and from BPDRs
US Field Alert Report requirement, 21 CFR 314.81(b)(1).
Frequently asked questions
What does Field Alert Report stand for?
Field Alert Report stands for FAR.
What is Field Alert Report?
A Field Alert Report is a rapid post-marketing notification a drug applicant must submit to FDA about specific quality problems with a distributed product — including information that a distributed batch may be mislabeled or may not meet its specifications, and reports of bacteriological contamination or significant chemical/physical/other change or deterioration. The first alert is due within a short, defined timeframe of becoming aware of the information, and serves as an early-warning trigger for potential recalls and investigations. It is a quality-signal duty distinct from adverse-event (safety) reporting.
Which regulations cover Field Alert Report?
US Field Alert Report requirement, 21 CFR 314.81(b)(1).