[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: 9CFR105.1]

[Page 578-579]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 105--SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES OR PERMITS--Table of Contents
 
Sec. 105.1  Suspension or revocation.

    (a) An establishment license, product license, or permit issued 
under the Virus-Serum-Toxin Act may be formally suspended or revoked 
after opportunity for hearing has been accorded the licensee or 
permittee as provided in part 123 of this subchapter if the Secretary is 
satisfied that the license or permit is being used to facilitate or 
effect the preparation, sale, barter, exchange, shipment, or importation 
contrary to said Act of any worthless, contaminated, dangerous, or 
harmful biological product. Such use may be found to exist if:
    (1) The construction of the establishment in which the biological 
product is prepared is defective, or the establishment is not conducted 
as required by the regulations in parts 101 through 118 of this 
subchapter;
    (2) The methods of preparation of the product are faulty, or the 
product contains impurities or lacks potency;
    (3) The product is so labeled or advertised as to mislead or deceive 
the purchaser in any particular;

[[Page 579]]

    (4) The licensee, permittee, or the foreign manufacturer has failed 
to maintain and make available for inspection records in connection with 
the development and preparation of product, has failed to provide 
complete and accurate information when requested, or has failed to 
provide complete and accurate information in the Outline of Production 
or in reports and records;
    (5) The licensee or permittee has violated or failed to comply with 
any provision of the Virus-Serum-Toxin Act or the regulations in this 
subchapter;
    (6) The license or permit is otherwise used to facilitate or effect 
the preparation, sale, barter, exchange, shipment, or importation, 
contrary to the Virus-Serum-Toxin Act, of any worthless, contaminated, 
dangerous, or harmful biological product.
    (b) In case of willfulness or where the public health, interest, or 
safety so required the Secretary may, without hearing, informally 
suspend such establishment license, product license, or permit upon the 
grounds set forth in paragraph (a) of this section pending determination 
of formal proceedings under part 123 of this subchapter for suspension 
or revocation of the license or permit.

[38 FR 23512, Aug. 31, 1973, as amended at 41 FR 44359, Oct. 8, 1976; 61 
FR 52874, Oct. 9, 1996; 64 FR 43044, Aug. 9, 1999]