[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.14]

[Page 74-75]
 
                        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. 610.14  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

[[Page 75]]

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.