[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: 9CFR114.17]

[Page 691]
 
                  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. 114.17  Rebottling of biological products.

    The Administrator may authorize the rebottling of a completed 
product in liquid form subject to the conditions prescribed in this 
section.
    (a) All or part of a serial which has not left the licensed 
establishment may be aseptically returned to the mixing tank, thoroughly 
mixed, and rebottled in new final containers.
    (b) The rebottled product shall be adequately identified by serial 
number or subserial number, as the case may be.
    (c) Required purity tests for final container samples of the product 
shall be conducted on new samples selected from the rebottled product 
(serial or subserials). Rebottled product found to be unsatisfactory by 
such tests shall not be released.
    (d) New test samples from each serial or subserial and copies of 
test reports of all tests conducted on the rebottled product shall be 
submitted to Animal and Plant Health Inspection Service.
    (e) The licensee shall not release the rebottled product unless 
notified by Animal and Plant Health Inspection Service that such product 
is eligible for release. Production records shall show the results of 
all tests conducted and shall accurately reflect the actions taken.

[39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991