9 CFR 101.6 - Cell cultures.

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There is 1 rule appearing in the Federal Register for 9 CFR 101. View below or at eCFR (GPOAccess)
§ 101.6 Cell cultures.
When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures, the following terms shall mean:
(a) Batches of primary cells. A pool of original cells derived from normal tissue up to and including the 10th subculture.
(b) Cell line. A pool of cells which are 11 or more subcultures from the tissue of origin.
(c) Subculture. Each flask to flask transfer or passage regardless of the number of cell replications.
(d) Master Cell Stock (MCS). The supply of cells of a specific passage level from which cells for production of biologics originate.
[38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 49 FR 22624, May 31, 1984]

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 101 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