[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR200.15]

[Page 6]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 200--GENERAL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 200.15  Definition of term ``insulin.''

    For purposes of sections 801 and 802 of the act and this title, the 
term insulin means the active principle of the pancreas that affects the 
metabolism of carbohydrates in the animal body and which is of value in 
the treatment of diabetes mellitus. The term includes synthetic and 
biotechnologically derived products that are the same as, or similar to, 
naturally occurring insulins in structure, use, and intended effect and 
are of value in the treatment of diabetes mellitus.

[63 FR 26698, May 13, 1998]

Subpart B [Reserved]