[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: 21CFR610.11a]

[Page 62]
 
                        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. 610.11a  Inactivated influenza vaccine, general safety test.

    For inactivated influenza vaccine, the general safety test shall be 
conducted in the manner indicated in Sec. 610.11 of this chapter except 
that, with reference to guinea pigs, the test shall be satisfied if the 
product provides satisfactory results using either the subcutaneous or 
intraperitoneal injection of 5.0 milliliters of inactivated influenza 
vaccine into each guinea pig. The requirements for general safety for 
inactivated influenza vaccine shall not be considered to be satisfied 
unless each lot of influenza vaccine is assayed for endotoxin in 
comparison to a reference preparation provided by the Food and Drug 
Administration, and such lot is found to contain no more endotoxin than 
the reference preparation.

[39 FR 40016, Nov. 13, 1974]

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