{"data":{"id":"us/21-cfr-209.2","jurisdiction":"us","citation":"21 CFR 209.2","heading":"Definitions.","body":"For the purposes of this part, the following definitions apply:\nAct means the Federal Food, Drug, and Cosmetic Act (sections 201-907 (21 U.S.C. 301-397)).\nAuthorized 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.\nConsumer medication information means written information voluntarily provided to consumers by dispensing pharmacists as part of patient medication counseling activities.\nMedication Guide means FDA-approved patient labeling conforming to the specifications set forth in part 208 of this chapter and other applicable regulations.\nPharmacy 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.\nSide 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.”","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER C—DRUGS: GENERAL","PART 209—REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT","Subpart A—General Provisions"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"02c576dfd7ce2f53a85a126eae13a578c99f9532a9c209c87ba7fc7947cc06bf","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-209.1","next":"us/21-cfr-209.10"},"notice":"GroundRules: Original legal text. Not legal advice."}