[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: 9CFR114.18]

[Page 787]
 
                  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. 114.18  Reprocessing of biological products.

    The Administrator may authorize a licensee to reprocess a serial of 
completed product subject to the conditions prescribed in this section.
    (a) Reprocessing shall not include any method or procedure which 
would be deleterious to the product.
    (b) All appropriate tests for purity, safety, potency, and efficacy 
for the product shall be conducted on the reprocessed product. A serial 
found unsatisfactory by a required test shall not be released.
    (c) The reprocessed serial shall be identified by a new serial 
number and the records for the serial shall accurately reflect the 
action taken.
    (d) Test samples of the reprocessed serial and test reports for all 
tests conducted shall be submitted to Animal and Plant Health Inspection 
Service. The licensee shall not release the serial until notified by 
Animal and Plant Health Inspection Service that the serial is eligible 
for release.

[50 FR 24904, June 15, 1985, as amended at 56 FR 66784, Dec. 26, 1991]