---
kind: "section"
citation: "9 C.F.R. § 113.6"
title: "9"
number: "113.6"
heading: "Animal and Plant Health Inspection Service testing."
url: "https://uscodex.org/cfr/9/113.6"
---

# §113.6. Animal and Plant Health Inspection Service testing.


A biological product shall with reasonable certainty yield the results intended when used as recommended or suggested in its labeling or proposed labeling prior to the expiration date.

- (a) The Administrator is authorized to cause a biological product, manufactured in the United States or imported into the United States, to be examined and tested for purity, safety, potency, or efficacy; in which case, the licensee or permittee shall withhold such product from the market until a determination has been made.
- (b) The final results of each test conducted by the licensee and Animal and Plant Health Inspection Service shall be considered in evaluating a biological product. A serial or subserial which has been found unsatisfactory by a required test prescribed in a filed Outline of Production or Standard Requirement is not in compliance with the regulations and shall not be released for market.

## Notes

### Amendments

[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 45420, Oct. 2, 1975; 40 FR 53378, Nov. 18, 1975; 41 FR 6751, Feb. 13, 1976; 56 FR 66784, Dec. 26, 1991]

### 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

[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 45420, Oct. 2, 1975; 40 FR 53378, Nov. 18, 1975; 41 FR 6751, Feb. 13, 1976; 56 FR 66784, Dec. 26, 1991]