[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: 21CFR209.2]

[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.  209.2  Definitions.

    For the purposes of this part, the following definitions apply:
    Act means the Federal Food, Drug, and Cosmetic Act (sections 201-907 
(21 U.S.C. 301-397)).
    Authorized 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.
    Consumer medication information means written information 
voluntarily provided to consumers by dispensing pharmacists as part of 
patient medication counseling activities.
    Medication Guide means FDA-approved patient labeling conforming to 
the specifications set forth in part 208 of this chapter and other 
applicable regulations.
    Pharmacy 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.
    Side 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.''