21 CFR § 209.10 - Content and format of the side effects statement.

---
identifier: "/us/cfr/t21/s209.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 209.10 - Content and format of the side effects statement."
title_number: 21
title_name: "Food and Drugs"
section_number: "209.10"
section_name: "Content and format of the side effects statement."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "209"
part_name: "REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT"
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, 331, 351, 352, 353, 355, 360, 371; 42 U.S.C. 241."
regulatory_source: "73 FR 404, Jan. 3, 2008, unless otherwise noted."
cfr_part: "209"
---


# 209.10 Content and format of the side effects statement.

(a) *Content.* The side effects statement provided with each prescription drug product approved under section 505 of the act must read: “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.”

(b) *Format.* The side effects statement must be in a single, clear, easy-to-read type style. The letter height or type size used for the side effects statement in accordance with paragraphs (b)(1) and (b)(2) of § 209.11 must be no smaller than 6 points (1 point = 0.0138 inch). The letter height or type size for the side effects statement under paragraphs (b)(3), (b)(4), and (b)(5) of § 209.11 must be no smaller than 10 points.