21 CFR § 314.540 - Postmarketing safety reporting.

---
identifier: "/us/cfr/t21/s314.540"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 314.540 - Postmarketing safety reporting."
title_number: 21
title_name: "Food and Drugs"
section_number: "314.540"
section_name: "Postmarketing safety reporting."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "314"
part_name: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1."
regulatory_source: "50 FR 7493, Feb. 22, 1985, unless otherwise noted."
cfr_part: "314"
---


# 314.540 Postmarketing safety reporting.

Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved drug products, as provided in §§ 314.80 and 314.81.