[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: 21CFR209.1]

[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 A_General Provisions
 
Sec.  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.