[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: 9CFR102.6]

[Page 573]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 102--LICENSES FOR BIOLOGICAL PRODUCTS--Table of Contents
 
Sec. 102.6  Conditional licenses.

    In order to meet an emergency condition, limited market, local 
situation, or other special circumstance, including production solely 
for intrastate use under a State-operated program, the Administrator 
may, in response to an application submitted as specified in 
Sec. 102.3(b) of this part, issue a conditional U.S. Veterinary 
Biological Product License to an establishment under an expedited 
procedure which assures purity and safety, and a reasonable expectation 
of efficacy. Preparation of products under a conditional license shall 
be in compliance with all applicable regulations and standards and may 
be restricted as follows:
    (a) The preparation may be limited to a predetermined time period 
which shall be established at the time of issuance and specified on the 
license. Prior to termination of the license, the licensee may request 
reissuance. Such requests shall be substantiated with data and 
information obtained since the license was issued. After considering all 
data and information available, the Administrator shall either reissue 
the U.S. Veterinary Biological Product License or allow it to terminate.
    (b) Distribution may be limited to the extent necessary to assure 
that the product will meet the basic criteria for issuance of the 
conditional license.
    (c) Labeling for the product may be required to contain information 
on the conditional status of the license.

[52 FR 11026, Apr. 7, 1987, as amended at 60 FR 48021; Sept. 18, 1995]

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