---
kind: "section"
citation: "21 C.F.R. § 314.540"
title: "21"
number: "314.540"
heading: "Postmarketing safety reporting."
url: "https://uscodex.org/cfr/21/314.540"
---

# §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](/cfr/21/314.80.md) and [314.81](/cfr/21/314.81.md).


## Notes

### Source

Source: 57 FR 58958, Dec. 11, 1992, unless otherwise noted.

### Authority

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.

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.