[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.14]

[Page 68]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                      Subpart B--General Provisions
 
Sec. 610.14  Identity.

    The contents of a final container of each filling of each lot shall 
be tested for identity after all labeling operations shall have been 
completed. The identity test shall be specific for each product in a 
manner that will adequately identify it as the product designated on 
final container and package labels and circulars, and distinguish it 
from any other product being processed in the same laboratory. Identity 
may be established either through the physical or chemical 
characteristics of the product, inspection by macroscopic or microscopic 
methods, specific cultural tests, or in vitro or in vivo immunological 
tests.