---
kind: "section"
citation: "21 C.F.R. § 209.11"
title: "21"
number: "209.11"
heading: "Dispensing and distributing the side effects statement."
url: "https://uscodex.org/cfr/21/209.11"
---

# §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](/cfr/21/505.md) 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.**

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371; 42 U.S.C. 241.

### Source

Source: 73 FR 404, Jan. 3, 2008, unless otherwise noted.