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  1. Surveillance: Post Drug-Approval Activities

Field Alert Reports

The purpose of field alert reports (FARs) is to quickly identify quality defects in distributed drug products that may present a potential safety threat. Within 3 days of receiving information concerning significant quality problems with distributed drug product, applicants of approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) must submit a FAR to FDA to comply with 21 CFR 314.81(b)(1). FDA has also issued a guidance concerning FARS titled Field Alert Report Submission: Questions and Answers.

What must be reported?

Information concerning one or more of the following:

  • Incidents that cause the drug product or its labeling to be mistaken for or applied to another article;
  • Bacterial contamination;
  • Any significant chemical, physical, or other change or deterioration in the distributed drug product;
  • Any failure of one or more distributed batches of the drug product to meet the specifications established in its application.

How do I submit a FAR?

Submit Form FDA 3331a to the FDA district office that is responsible for the facility involved; contact information is provided in the form. Links to the form, form instructions, questions and answers, and related resources (e.g., applicable regulations) are found below. You can use Form FDA 3331a to submit FARs for CDER or CBER regulated drug products that are approved under an NDA or ANDA.

Form and Instructions

Frequently Asked Questions

Related Resources

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