---
kind: "section"
citation: "21 C.F.R. § 358.301"
title: "21"
number: "358.301"
heading: "Scope."
url: "https://uscodex.org/cfr/21/358.301"
---

# §358.301. Scope.

- (a) An over-the-counter ingrown toenail relief drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in [§ 330.1](/cfr/21/330.1.md) of this chapter.
- (b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter 1 of title 21 unless otherwise noted.

## Notes

### Source

Source: 68 FR 24348, May 7, 2003, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 55 FR 33255, Aug. 14, 1990, unless otherwise noted.