[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: 9CFR102.4]

[Page 529-530]
 
                  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. 102.4  U.S. Veterinary Biologics Establishment License.

    (a) Before a U.S. Veterinary Biologics Establishment License will be 
issued by the Administrator for any establishment, an inspection shall 
be made to determine whether the condition, equipment, facilities, and 
the like, of the establishment, and the methods used to prepare 
biological products are in conformity with the requirements in the 
regulations.
    (b) A license shall not be issued unless:

[[Page 530]]

    (1) In the opinion of the Administrator, the condition of the 
establishment, including its facilities, and the methods of preparation 
of biological products are such as reasonably to assure that the 
products shall accomplish the purpose for which they are intended; and
    (2) The Administrator is satisfied on the basis of information 
before him that:
    (i) The establishment shall be operated in compliance with the Act 
and applicable regulations and be under the supervision of person(s) 
competent in the preparation of biological products; and
    (ii) The applicant, or the person having the responsibility for 
producing biological products in the establishment, or both, is 
qualified by education and experience, and has demonstrated fitness to 
produce such products in compliance with the Act and regulations issued 
pursuant thereto; Provided, That, previous violations of the Act, or 
such regulations or both shall be relevant to the Administrator's 
determination of fitness.
    (3) Written assurance is filed with Animal and Plant Health 
Inspection Service that the biological products which are licensed to be 
prepared therein shall not be so advertised as to mislead or deceive the 
purchasers and that the packages or containers in which the same are to 
be marketed shall not bear any statement, design, or device which is 
false or misleading in any particular.
    (c) U.S. Veterinary Biologics Establishment Licenses shall be 
numbered.
    (d) Two or more licenses may bear the same number when they are 
issued for establishments under the same ownership or control, provided 
a serial letter is added to one or more to identify each license and the 
product produced thereunder.
    (e) When a U.S. Veterinary Biologics Establishment License is issued 
for an establishment, it shall not apply to more than one person at the 
same location, except that subsidiaries of the licensee, when named in 
the license, may operate thereunder at the establishment named. The 
licensee with its subsidiaries will be held responsible for all 
operations conducted in the licensed establishment.
    (f) When a licensee no longer holds at least one unexpired, 
unsuspended, or unrevoked product license authorizing the preparation of 
a biological product, or is in the process of obtaining a product 
license, the establishment license shall no longer be valid and shall be 
returned to the Administrator. In the case where an establishment 
license expires or is suspended or revoked, any product license 
authorizing preparation of a product at such establishment shall be 
invalid indefinitely or for as long as the suspension is in effect.
    (g) Any license issued under this part to establishments in which 
biological products are prepared shall be issued on condition that the 
licensee permit the inspection of such establishments, products, product 
preparation, and all relevant records as provided in part 115 of this 
subchapter. Failure to permit inspection may result in the license being 
suspended or revoked.
    (h) The provisions of paragraph (b) of this section shall also be 
applicable to, and be considered by, the Administrator in connection 
with each application for an additional product license.

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

[39 FR 37762, Oct. 24, 1974; 39 FR 38364, Nov. 1, 1974, as amended at 41 
FR 44359, Oct. 8, 1976; 48 FR 57472, Dec. 30, 1983; 52 FR 11026, Apr. 7, 
1987; 52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991; 60 FR 
48021, Sept. 18, 1995; 61 FR 52873, Oct. 9, 1996; 62 FR 13294, Mar. 20, 
1997]