9 CFR § 113.206 - Wart Vaccine, Killed Virus.

---
identifier: "/us/cfr/t9/s113.206"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "9 CFR § 113.206 - Wart Vaccine, Killed Virus."
title_number: 9
title_name: "Animals and Animal Products"
section_number: "113.206"
section_name: "Wart Vaccine, Killed Virus."
chapter_name: "ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE"
subchapter_number: "E"
subchapter_name: "VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS"
part_number: "113"
part_name: "STANDARD REQUIREMENTS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4."
regulatory_source: "34 FR 18004, Nov. 7, 1969, unless otherwise noted."
cfr_part: "113"
---


# 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(h).

[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; 81 FR 59436, Aug. 30, 2016]