9 CFR 113.105 - Leptospira Hardjo Bacterin.

§ 113.105 Leptospira Hardjo Bacterin.

Leptospira Hardjo Bacterin shall be produced from a culture of Leptospira hardjo which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira hardjo fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a)Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b)Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c)Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the test written into the filed Outline of Production.

[ 40 FR 17003, Apr. 16, 1975, as amended at 40 FR 20067, May 8, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, 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