[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR209.11]

[Page 136]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 209_REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT--Table of Contents
 
                         Subpart B_Requirements
 
Sec.  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.

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