9 CFR 114.3 - Separation of establishments.

§ 114.3 Separation of establishments.

(a) Each licensed establishment shall be separate and distinct from any other establishment in which a biological product is prepared.

(b) No biological products authorized to be prepared in a licensed establishment shall be prepared in whole or in part by another licensed establishment except as provided in paragraphs (c) and (d) of this section.

(c) When a partially prepared biological product cannot be completed at a licensed establishment due to failure of essential equipment, the Administrator may authorize the use of similar equipment at another licensed establishment: Provided, That, such authorization shall be limited to the duration of the emergency and to the phase of production affected by the equipment failure.

(d) Partially prepared products or serials of completed products for further manufacture may be moved from one licensed establishment to another licensed establishment, imported under the provisions of § 104.5, or moved from a licensed establishment for purpose of being exported under conditions prescribed in an Outline of Production filed with Animal and Plant Health Inspection Service. Licensed products or products imported for distribution and sale may be prepared and recommended for final use, for further manufacturing purposes, or both. All serials shall be subject to the requirements for testing and release specified in § 113.5 or § 113.10 and to the requirements for identification specified in § 114.4.

[ 39 FR 16869, May 10, 1974, as amended at 40 FR 46093, Oct. 6, 1975; 49 FR 45846, Nov. 21, 1984; 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 114 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
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