9 CFR 113.7 - Multiple fractions.

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There are 2 Updates appearing in the Federal Register for 9 CFR 113. View below or at eCFR (GPOAccess)
§ 113.7 Multiple fractions.
(a) When a biological product contains more than one immunogenic fraction, the completed product shall be evaluated by tests applicable to each fraction.
(b) When similar potency tests are required for more than one fraction of a combination biological product, different animals must be used to evaluate each fraction except when written Standard Requirements or outlines of production make provisions and set forth conditions for use of the same animals for testing different fractions.
(c) When the same safety test is required for more than one fraction, requirements are fulfilled by satisfactory results from one test of the completed product.
(d) When an inactivated fraction(s) is used as a diluent for a live virus fraction(s), the inactivated fraction(s) may be tested separately and the live virus fraction(s) may be tested separately: Provided, That, the viricidal test requirements prescribed in § 113.100 are complied with.
(e) Virus titrations for a multivirus product shall be conducted by methods which will quantitate each virus.
[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 46093, Oct. 6, 1975; 56 FR 66785, Dec. 26, 1991]

Title 9 published on 2014-01-01

The following are only the Rules published in the Federal Register after the published date of Title 9.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-18; vol. 79 # 181 - Thursday, September 18, 2014
    1. 79 FR 55968 - Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Final rule.
      Effective Date: October 20, 2014.
      9 CFR Parts 101 and 113

Title 9 published on 2014-01-01

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

  • 2014-09-18; vol. 79 # 181 - Thursday, September 18, 2014
    1. 79 FR 55968 - Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Final rule.
      Effective Date: October 20, 2014.
      9 CFR Parts 101 and 113