[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: 9CFR103.1]

[Page 574]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 103--EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING--Table of Contents
 
Sec. 103.1  Preparation of experimental biological products.

    Except as otherwise provided in this section, experimental 
biological products which are neither composed of nor prepared with 
organisms or antigens used in biologicals already licensed, shall not be 
prepared in the production facilities of a licensed establishment. Upon 
application therefor, the Administrator may authorize the preparation of 
experimental products on the premises of a licensed establishment if he 
determines that such preparation will not result in contamination of the 
licensed products. Each request for permission to prepare an 
experimental biological product on licensed premises shall indicate the 
nature of the unlicensed product, designate facilities to be used, and 
specify precautions which will be taken to prevent contamination of 
licensed products. Such requests shall be submitted to the 
Administrator. Research facilities that are entirely separate and apart 
from facilities used for the preparation of licensed biological products 
will not be considered a part of the licensed premises for purposes of 
this section.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 
56 FR 66783, Dec. 26, 1991]