[Code of Federal Regulations] [Title 9, Volume 1] [Revised as of January 1, 2007] From the U.S. Government Printing Office via GPO Access [CITE: 9CFR114.3] [Page 779] TITLE 9--ANIMALS AND ANIMAL PRODUCTS CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE PART 114_PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS --Table of Contents Sec. 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 Sec. 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 Sec. 113.5 or Sec. 113.10 and to the requirements for identification specified in Sec. 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]