---
kind: "section"
citation: "21 C.F.R. § 369.3"
title: "21"
number: "369.3"
heading: "Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C)."
url: "https://uscodex.org/cfr/21/369.3"
---

# §369.3. Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C).


Drugs exempted from prescription-dispensing requirements under [section 503(b)(1)(C)](/cfr/21/503.md?p=b-1-C) of the act are subject to the labeling requirements prescribed in [§ 310.201(a)](/cfr/21/310.201.md?p=a) of this chapter. Although, for convenience, warning and caution statements for a number of the drugs named in [§ 310.201](/cfr/21/310.201.md) of this chapter (cross-referenced in the text of this part) are included in [subpart B](/cfr/21/subpartB.md) of this part, the inclusion of such drugs in §§ [369.20](/cfr/21/369.20.md) or [369.21](/cfr/21/369.21.md) in no way affects the requirements for compliance with [§ 310.201(a)](/cfr/21/310.201.md?p=a) of this chapter, or the provisions of an effective application pursuant to [section 505(b)](/cfr/21/505.md?p=b) of the act.


## Notes

### Amendments

[85 FR 72907, Nov. 16, 2020]

### Authority

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

### Source

Source: 39 FR 11745, Mar. 29, 1974, unless otherwise noted.

### Amendments

[85 FR 72907, Nov. 16, 2020]