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

---
identifier: "/us/cfr/t21/s369.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 369.3 - Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C)."
title_number: 21
title_name: "Food and Drugs"
section_number: "369.3"
section_name: "Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C)."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "369"
part_name: "INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "39 FR 11745, Mar. 29, 1974, unless otherwise noted."
cfr_part: "369"
---


# 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) of the act are subject to the labeling requirements prescribed in § 310.201(a) of this chapter. Although, for convenience, warning and caution statements for a number of the drugs named in § 310.201 of this chapter (cross-referenced in the text of this part) are included in subpart B of this part, the inclusion of such drugs in §§ 369.20 or 369.21 in no way affects the requirements for compliance with § 310.201(a) of this chapter, or the provisions of an effective application pursuant to section 505(b) of the act.

[85 FR 72907, Nov. 16, 2020]