---
kind: "section"
citation: "21 C.F.R. § 314.170"
title: "21"
number: "314.170"
heading: "Adulteration and misbranding of an approved drug."
url: "https://uscodex.org/cfr/21/314.170"
---

# §314.170. Adulteration and misbranding of an approved drug.


All drugs, including those the Food and Drug Administration approves under [section 505](/cfr/21/505.md) of the act and this part, are subject to the adulteration and misbranding provisions in sections [501](/cfr/21/501.md), [502](/cfr/21/502.md), and [503](/cfr/21/503.md) of the act. FDA is authorized to regulate approved new drugs by regulations issued through informal rulemaking under sections [501](/cfr/21/501.md), [502](/cfr/21/502.md), and [503](/cfr/21/503.md) of the act.


## Notes

### Amendments

[50 FR 7493, Feb. 22, 1985. Redesignated at 57 FR 17983, Apr. 28, 1992, and amended at 64 FR 402, Jan. 5, 1999]

### Source

Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted. Redesignated at 57 FR 17983, Apr. 28, 1992.

### 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.

### Amendments

[50 FR 7493, Feb. 22, 1985. Redesignated at 57 FR 17983, Apr. 28, 1992, and amended at 64 FR 402, Jan. 5, 1999]