---
kind: "section"
citation: "9 C.F.R. § 113.206"
title: "9"
number: "113.206"
heading: "Wart Vaccine, Killed Virus."
url: "https://uscodex.org/cfr/9/113.206"
---

# §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)](/cfr/9/113.200.md?p=c-1) and [(3)](/cfr/9/113.200.md?p=c-3).
- (b) **Safety.** Bulk or final container samples of completed product shall meet the requirements for safety as prescribed in §§ [113.33(b)](/cfr/9/113.33.md?p=b) and [113.38](/cfr/9/113.38.md).
- (c) **Formaldehyde content.** Bulk or final container samples of completed product shall meet the requirements for formaldehyde content as prescribed in [§ 113.200(f)](/cfr/9/113.200.md?p=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)](/cfr/9/112.7.md?p=h).

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

### Source

Source: 34 FR 18004, Nov. 7, 1969, unless otherwise noted.

### Amendments

[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]