21 CFR Part 209 — Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement

PART 209—REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371; 42 U.S.C. 241. Source: 73 FR 404, Jan. 3, 2008, unless otherwise noted. Subpart A—General Provisions § 209.1 Scope and purpose. (a) This part sets forth requirements for human prescription drug products approved under section 505 of the Federal Food, Drug, and Cosmetic Act and dispensed by authorized dispensers and pharmacies to consumers. This part requires distribution of a side effects statement and applies to new and refill prescriptions. This part is not intended to apply to authorized dispensers dispensing or administering prescription drug products to inpatients in a hospital or health care facility under an order of a licensed practitioner, or as part of supervised home health care. (b) The purpose of providing the side effects statement is to enable consumers to report side effects of prescription drug products to FDA. § 209.2 Definitions. For the purposes of this part, the following definitions apply: Act Authorized dispenser Consumer medication information Medication Guide Pharmacy Side effects statement Subpart B—Requirements § 209.10 Content and format of the side effects statement. (a) Content. (b) Format. § 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.

Related documents

• 5 CFR Part 595 — Physicians' Comparability Allowances#504058
• 18 CFR Part 401 — Rules of Practice and Procedure#506439
• 27 CFR Part 16 — Alcoholic Beverage Health Warning Statement#507627
• 17 CFR Part 166 — Customer Protection Rules#506290
• 21 CFR Part 352 — Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]#506837