TITLE 9 - ANIMALS AND ANIMAL PRODUCTS

CHAPTER I - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE

SUBCHAPTER E - VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS

PART 113 - STANDARD REQUIREMENTS

113.206 - Wart Vaccine, Killed Virus.

Wart Vaccine, Killed Virus, shall be prepared from virus-bearing epidermal tumors (warts) obtained from a bovine. Each serial shall meet the requirements prescribed in this section and any serial found unsatisfactory by a prescribed test shall not be released.

  (a) Purity. Final container samples of completed product shall meet the requirements for purity as prescribed in 113.200 (c)(1) and (3).

  (b) Safety. Bulk or final container samples of completed product shall meet the requirements for safety as prescribed in 113.33(b) and 113.38.

  (c) Formaldehyde content. Bulk or final container samples of completed product shall meet the requirements for formaldehyde content as prescribed in 113.200(f).

  (d) Potency and efficacy. The efficacy of wart vaccine has been demonstrated to the satisfaction of Veterinary Services as being a valuable biological product. The inherent nature of the product precludes the possible development of serial to serial potency tests and none is required: Provided, That, (1) The vaccine shall be a tissue extract representing at least 10 percent weight to volume suspension of wart tissue; and (2) The vaccine shall be limited to use in the prevention of warts in cattle. Labeling recommendations shall be in accordance with 112.7(i).

[40 FR 14084, Mar. 28, 1975, as amended at 40 FR 23989, June 4, 1975; 40 FR 30803, July 23, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991]