21 CFR § 209.2 - Definitions.

---
identifier: "/us/cfr/t21/s209.2"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 209.2 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "209.2"
section_name: "Definitions."
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"
---


# 209.2 Definitions.

For the purposes of this part, the following definitions apply:

*Act* means the Federal Food, Drug, and Cosmetic Act (sections 201-907 (21 U.S.C. 301-397)).

*Authorized dispenser* means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice.

*Consumer medication information* means written information voluntarily provided to consumers by dispensing pharmacists as part of patient medication counseling activities.

*Medication Guide* means FDA-approved patient labeling conforming to the specifications set forth in part 208 of this chapter and other applicable regulations.

*Pharmacy* includes, but is not limited to, a retail, mail order, Internet, hospital, university, or clinic pharmacy, or a public health agency, regularly and lawfully engaged in dispensing prescription drugs.

*Side effects statement* means the following verbatim statement: “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.”