[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.7]

[Page 652]
 
                  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. 113.7  Multiple fractions.

    (a) When a biological product contains more than one immunogenic 
fraction, the completed product shall be evaluated by tests applicable 
to each fraction.
    (b) When similar potency tests are required for more than one 
fraction of a combination biological product, different animals must be 
used to evaluate each fraction except when written Standard Requirements 
or outlines of production make provisions and set forth conditions for 
use of the same animals for testing different fractions.
    (c) When the same safety test is required for more than one 
fraction, requirements are fulfilled by satisfactory results from one 
test of the completed product.
    (d) When an inactivated fraction(s) is used as a diluent for a live 
virus fraction(s), the inactivated fraction(s) may be tested separately 
and the live virus fraction(s) may be tested separately: Provided, That, 
the viricidal test requirements prescribed in Sec. 113.100 are complied 
with.
    (e) Virus titrations for a multivirus product shall be conducted by 
methods which will quantitate each virus.

[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 46093, Oct. 6, 1975; 56 
FR 66785, Dec. 26, 1991]