[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.10]

[Page 64]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                      Subpart B--General Provisions
 
Sec. 610.10  Potency.

    Tests for potency shall consist of either in vitro or in vivo tests, 
or both, which have been specifically designed for each product so as to 
indicate its potency in a manner adequate to satisfy the interpretation 
of potency given by the definition in Sec. 600.3(s) of this chapter.