[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR114.13]

[Page 731]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 114_PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS--Table of Contents
 
Sec.  114.13  Expiration date determination.

    Unless otherwise provided for in a Standard Requirement of filed 
Outline of Production, the expiration date for each product shall be 
computed from the date of the initiation of the potency test. Prior to 
licensure, stability of each fraction shall be determined by methods 
acceptable to Animal and Plant Health Inspection Service. Expiration 
dates based on this stability data shall be confirmed as follows:
    (a) Products consisting of viable organisms. Each serial shall be 
tested for potency at release and at the approximate expiration date 
until a statistically valid stability record has been established.
    (b) Nonviable biological products. Each serial presented in support 
of licensure shall be tested for potency at release and at or after the 
dating requested.
    (c) Subsequent changes in the dating period for a product may be 
granted, based on statistically valid data submitted to support a 
revision of the Outline of Production.

[50 FR 24903, June 14, 1985, as amended at 56 FR 66784, Dec. 26, 1991]