[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR299.5]

[Page 180]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 299--DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 299.5  Drugs; compendial name.

    (a) The name by which a drug is designated shall be clearly 
distinguishing and differentiating from any name recognized in an 
official compendium unless such drug complies in identity with the 
identity prescribed in an official compendium under such recognized 
name.
    (b) The term drug defined in an official compendium means a drug 
having the identity prescribed for a drug in an official compendium.
    (c) A statement that a drug defined in an official compendium 
differs in strength, quality, or purity from the standard of strength, 
quality, or purity set forth for such drug in an official compendium 
shall show all the respects in which such drug so differs, and the 
extent of each such difference.