In Force Checked October 24, 2026
In force.
What It Covers
The content and handling of new drug applications and abbreviated applications, and — for a manufacturer — the rules for changing an approved product and reporting after approval.
Who It Applies To
Holders of NDAs and ANDAs, and the manufacturers who make products under them.
Key Requirements
- Changes to an approved application reported by category: prior approval supplement, changes-being-effected supplements, or annual report, by potential effect on the product (§314.70).
- Field alert reports within three working days for certain quality problems with distributed batches (§314.81(b)(1)).
- Annual reports and postmarketing safety reporting (§314.80, §314.81).
What an Auditor Asks to See
- Change control records showing the regulatory category decided for each change.
- Field alert evaluations for distribution problems, contamination, or failing batches.
Where Systems Fall Short
- Changes implemented before the filing category was decided.
- Field alert decisions made outside the quality system and never recorded.
How QES Helps
Change control that asks the regulatory question before the change is made, not after.
Related Standards
Sources. eCFR — 21 CFR Part 314 (opens in a new tab). Status checked October 24, 2026. This page summarizes 21 CFR Part 314; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.