21 CFR § 209.11 - Dispensing and distributing the side effects statement.

---
identifier: "/us/cfr/t21/s209.11"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 209.11 - Dispensing and distributing the side effects statement."
title_number: 21
title_name: "Food and Drugs"
section_number: "209.11"
section_name: "Dispensing and distributing 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"
---


# 209.11 Dispensing and distributing the side effects statement.

(a) Each authorized dispenser or pharmacy must distribute the side effects statement with each prescription drug product approved under section 505 of the act and dispensed. The side effects statement must be distributed with new and refill prescriptions.

(b) An authorized dispenser or pharmacy must choose one or more of the following options to distribute the side effects statement:

(1) Distribute the side effects statement on a sticker attached to the unit package, vial, or container of the drug product;

(2) Distribute the side effects statement on a preprinted pharmacy prescription vial cap;

(3) Distribute the side effects statement on a separate sheet of paper;

(4) Distribute the side effects statement in consumer medication information; or

(5) Distribute the appropriate FDA-approved Medication Guide that contains the side effects statement.