---
kind: "section"
citation: "9 C.F.R. § 113.54"
title: "9"
number: "113.54"
heading: "Sterile diluent."
url: "https://uscodex.org/cfr/9/113.54"
---

# §113.54. Sterile diluent.


Sterile Diluent shall be supplied in a final container by the licensee when such diluent is required for rehydration or dilution of the vaccine.

- (a) Sterile Diluent may be distilled or deionized water or it may be a special liquid solution formulated in accordance with an acceptable outline on file with Animal and Plant Health Inspection Service.
- (b) Each quantity prepared at one time in a single container and bottled into final containers shall be designated as a serial. Each serial shall be given a number which shall be used in records, test reports, and on the final container label.
- (c) Final container samples from each serial shall be tested for bacteria and fungi in accordance with the test provided in [§ 113.26](/cfr/9/113.26.md). Any serial found to be unsatisfactory shall not be released.

## Notes

### Amendments

[39 FR 27428, July 29, 1974, as amended at 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

[39 FR 27428, July 29, 1974, as amended at 56 FR 66784, Dec. 26, 1991]