[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR102.5]

[Page 584-585]
 
                  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. 102.5  U.S. Veterinary Biological Product License.

    (a) Authorization to produce each biological product shall be 
specified on a U.S. Veterinary Biological Product License, issued by the 
Administrator, and supplementary to the U.S. Veterinary Biologics 
Establishment License named therein.
    (b) The following shall appear on the U.S. Veterinary Biological 
Product License:
    (1) The U.S. Veterinary Biologics Establishment License Number for 
the establishment from which the product is released for marketing.
    (2) The true name of the product.
    (3) The product code number for the product.

[[Page 585]]

    (4) The date of issuance.
    (5) Any restrictions designated by the Administrator under paragraph 
(e) of this section.
    (6) When necessary to comply with Sec. 102.6 of this part, a 
termination date and a brief description of requirements to be met for 
reissuance.
    (c) The following provisions shall apply to all licensed biological 
products:
    (1) Licensed biological products shall be prepared as required by 
the regulations and in accordance with a filed Outline of Production as 
prescribed in Sec. Sec. 114.8 and 114.9 of this subchapter. No change 
shall be made in the preparation of a biological product without prior 
approval of the Administrator.
    (2) In addition to restrictions imposed by the Administrator 
pursuant to paragraph (e) of this section, biological products may be 
subject to restrictions which are imposed by any State or other 
jurisdiction pertaining to the distribution and use of such products, 
based on local disease conditions.
    (3) When requested by the Administrator, a licensee shall submit a 
list of licensed biological products prepared in the licensed 
establishment.
    (d) Where the Administrator determines that the protection of 
domestic animals or the public health, interest, or safety, or both, 
necessitates restrictions on the use of a product, the product shall be 
subject to such additional restrictions as are prescribed on the 
license. Such restrictions may include, but are not limited to, limits 
on distribution of the product or provisions that the biological product 
is restricted to use by veterinarians, or under the supervision of 
veterinarians, or both.
    (e) Any person may request that the distribution and use of a 
veterinary biological product be restricted if the restriction pertains 
to the protection of domestic animals or the public health, interest, or 
safety, or both. All requests must be sent, in writing, to the Director, 
Center for Veterinary Biologics, Licensing and Policy Development, 510 
South 17th Street, Suite 104, Ames, IA 50010-8197. Requests must specify 
the restriction(s) being requested and must explain why the restrictions 
are needed. Copies of any supporting documents, such as scientific 
literature, published or unpublished articles, or data from tests, 
should be attached to the request. When a decision is reached regarding 
the request, the person submitting the request will be sent written 
notification of such decision.

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

[39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 
50 FR 50764, Dec. 12, 1985; 52 FR 11026, Apr. 7, 1987; 56 FR 66783, Dec. 
26, 1991; 57 FR 38760, Aug. 27, 1992; 59 FR 67616, Dec. 30, 1994; 62 FR 
13294, Mar. 20, 1997; 64 FR 43044, Aug. 9, 1999]