[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
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]
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