9 CFR 113.54 - Sterile diluent.

§ 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. Any serial found to be unsatisfactory shall not be released.

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

Title 9 published on 14-Sep-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 113 after this date.

  • 2016-08-30; vol. 81 # 168 - Tuesday, August 30, 2016
    1. 81 FR 59427 - Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Final rule.
      Effective October 31, 2016.
      9 CFR Parts 101, 103, 112, 113, and 114