[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.50]

[Page 19]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201--LABELING--Table of Contents
 
 Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin
 
Sec. 201.50  Statement of identity.


    (a) The label of prescription and insulin-containing drugs in 
package form shall bear as one of its principal features a statement of 
the identity of the drug.
    (b) Such statement of identity shall be in terms of the established 
name of the drug. In the case of a prescription drug that is a mixture 
and that has no established name, the requirement for statement of 
identity shall be deemed to be satisfied by a listing of the 
quantitative ingredient information as prescribed by Sec. 201.10.
    (c) The statement of identity of a prescription drug shall also 
comply with the placement, size and prominence requirements of 
Sec. 201.10.

[40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998]