---
kind: "section"
citation: "21 C.F.R. § 338.1"
title: "21"
number: "338.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/338.1"
---

# §338.1. Scope.

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

## Notes

### Authority

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

### Source

Source: 54 FR 6826, Feb. 14, 1989, unless otherwise noted.