What is USFDA Field Alert Report (FAR) Submission?

FAR stands for Field Alert Report Submission. Submitting a USFDA Field Alert Report (FAR) is a critical process for pharmaceutical companies to notify the FDA about any significant quality, safety, or efficacy issues related to their products.

FAR should be submitted using Form FDA 3331a. Any drug product marketed under an approved NDA or ANDA, whether distributed domestically or abroad, is subject to FAR requirements.

A Field Alert Report (FAR) is a notification that must be submitted by a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) holder when they become aware of certain problems with their drug product, particularly once it has been distributed.

FAR submissions are a part of an early warning system to protect patient health. This is at a time when the industry is looking at faster clearances and view that this guidance could spur efficiency in operations.

To determine whether a chemical, physical, or other change or deterioration in the distributed drug product is significant, the industry should evaluate the potential impact of the change or deterioration on the drug product’s identity, strength, purity, stability, and efficacy. It should also be ascertained that how a deterioration could impact an individual using the product. These assessments should be based on factors specific the distributed product. These factors could include intended use, route of administration, dosage, length of treatment, and patient population.

When is a FAR Submission Required?

Per 21 CFR 314.81(b)(1), a FAR must be submitted within 3 working days of receiving information about:

• Product contamination

• Sterility failure

• Labeling errors

• Mislabeling or incorrect packaging

• Product mix-ups (wrong strength or product)

• Any significant chemical, physical, or biological changes

• Failure to meet established specifications

These issues are especially critical when they are discovered post-distribution.

Timeline for Submission

• Initial notification must be submitted within 3 working days of first receiving the information.

• This can be followed by a detailed follow-up report with investigation findings, corrective actions, and any updates.

How to Submit a FAR

FARs are typically submitted via:

• Electronic Submissions Gateway (ESG)

• CDER Direct (for drug products regulated by CDER)

• Submissions are made using FDA Form 3331 or through Electronic Common Technical Document (eCTD) format.

Purpose and Importance of FAR

• Allows FDA to evaluate the potential public health impact of product defects.

• Facilitates prompt regulatory action if a recall or alert is needed.

• Encourages drug manufacturers to maintain robust quality systems.

• Supports transparency and compliance with post-marketing surveillance obligations.

Examples of Situations Requiring FAR

• A sterile injectable found to have microbial contamination.

• A tablet bottle labeled as 10 mg actually contains 20 mg tablets.

• A stability study reveals unexpected degradation of the API in a distributed batch.

Best Practices for Compliance

• Establish a FAR SOP (Standard Operating Procedure).

• Train QA/RA teams on early detection and reporting.

• Maintain a system for continuous monitoring of distributed products.

• Conduct timely investigations and submit updates to the FDA.