[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: 21CFR208.1]

[Page 132]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 208_MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  208.1  Scope and purpose.


    (a) This part sets forth requirements for patient labeling for human 
prescription drug products, including biological products, that the Food 
and Drug Administration (FDA) determines pose a serious and significant 
public health concern requiring distribution of FDA-approved patient 
information. It applies primarily to human prescription drug products 
used on an outpatient basis without direct supervision by a health 
professional. This part shall apply to new prescriptions and refill 
prescriptions.
    (b) The purpose of patient labeling for human prescription drug 
products required under this part is to provide information when the FDA 
determines in writing that it is necessary to patients' safe and 
effective use of drug products.
    (c) Patient labeling will be required if the FDA determines that one 
or more of the following circumstances exists:
    (1) The drug product is one for which patient labeling could help 
prevent serious adverse effects.
    (2) The drug product is one that has serious risk(s) (relative to 
benefits) of which patients should be made aware because information 
concerning the risk(s) could affect patients' decision to use, or to 
continue to use, the product.
    (3) The drug product is important to health and patient adherence to 
directions for use is crucial to the drug's effectiveness.