[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.6]

[Page 557]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 113--STANDARD REQUIREMENTS--Table of Contents
 
Sec. 113.6  Animal and Plant Health Inspection Service testing.

    A biological product shall with reasonable certainty yield the 
results intended when used as recommended or suggested in its labeling 
or proposed labeling prior to the expiration date.
    (a) The Administrator is authorized to cause a biological product, 
manufactured in the United States or imported into the United States, to 
be examined and tested for purity, safety, potency, or efficacy; in 
which case, the licensee or permittee shall withhold such product from 
the market until a determination has been made.
    (b) The final results of each test conducted by the licensee and 
Animal and Plant Health Inspection Service shall be considered in 
evaluating a biological product. A serial or subserial which has been 
found unsatisfactory by a required test prescribed in a filed Outline of 
Production or Standard Requirement is not in compliance with the 
regulations and shall not be released for market.

[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 45420, Oct. 2, 1975; 40 
FR 53378, Nov. 18, 1975; 41 FR 6751, Feb. 13, 1976; 56 FR 66784, Dec. 
26, 1991]