[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR114.14]

[Page 732]
 
                  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. 114.14  Extension of expiration date for a serial or subserial.

    (a) Unless otherwise provided for in a filed Outline of Production 
for the product, the expiration date shall not be extended:
    (1) If all fractions of the product are not evaluated for potency by 
tests designated in the filed Outline of Production for such product in 
accordance with Sec. 113.4(b) of this subchapter.
    (2) For any serial or portion of any serial which has left licensed 
premises: Provided, That product which has been shipped from one 
licensed premises to another licensed premises shall be exempt from this 
requirement.
    (3) For a serial or portion of a serial if the expiration date has 
been extended previously, unless otherwise authorized in accordance with 
Sec. 114.1.
    (b) An extension of the expiration date may be granted by Animal and 
Plant Health Inspection Service if a request from the licensee is 
substantiated by valid test data which demonstrate the potency of the 
product meets or exceeds the requirements for release. The new 
expiration date shall be calculated from the date the latest 
satisfactory potency test was initiated. The extension of the expiration 
date shall not exceed the maximum dating allowed in the filed Outline of 
Production.
    (1) Serials are approved for redating under the condition that 
Animal and Plant Health Inspection Service may require the firm to 
retest the redated serial for potency during the extended dating period 
and if found unsatisfactory require it be removed from the market by the 
licensee.
    (2) [Reserved]

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