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# FDA Guide on ANDA Refusals Related to Impurity Limits
- URL: https://www.fdaweb.com/fda-guide-on-anda-refusals-related-to-impurity-limits/
- Published: 2016-08-24T12:00:00.000Z
- Updated: 2026-09-14T21:26:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136591

FDA has posted a [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM414598.pdf?ref=fdaweb.com) on “ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits” — that is intended to help applicants preparing to submit ANDAs and prior approval supplements for approval of a new strength of a drug product. The guidance highlights deficiencies about impurities that may cause the agency to refuse to receive the submission. According to the agency, typical deficiencies leading to an refuse-to-receive decision include: (**1**) failing to provide justification for proposed limits in drug substances and drug products for specified identified impurities that are above qualification thresholds; (**2**) failing to provide justification for proposed limits for specified unidentified impurities that are above identification thresholds; and (**3**) proposing limits for unspecified impurities(e.g., any unknown impurity) that are above identification thresholds.