[Code of Federal Regulations] [Title 9, Volume 1] [Revised as of January 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 9CFR114.1] [Page 722-723] 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. 114.1 Applicability. Sec. 114.1 Applicability. 114.2 Products not prepared under license. 114.3 Separation of establishments. 114.4 Identification of biological products. 114.5 Micro-organisms used as seed. 114.6 Mixing biological products. 114.7 Personnel at licensed establishments. 114.8 Outline of Production required. 114.9 Outline of Production guidelines. 114.10 Antibiotics as preservatives. 114.11 Storage and handling. 114.12 Expiration date required. 114.13 Expiration date determination. 114.14 Extension of expiration date for a serial or subserial. 114.15 Disposal of unsatisfactory products and byproducts. 114.16 Producing subsidiaries. 114.17 Rebottling of biological products. 114.18 Reprocessing of biological products. Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. Source: 39 FR 16869, May 10, 1974, unless otherwise noted. Unless exempted by regulation or otherwise authorized by the Administrator, all biological products prepared, sold, bartered or exchanged, shipped or delivered for shipment in or from the [[Page 723]] United States, the District of Columbia, any Territory of the United States, or any place under the jurisdiction of the United States shall be prepared in accordance with the regulations in this part. The licensee or permittee shall adopt and enforce all necessary measures and shall comply with all directions the Administrator prescribes for carrying out such regulations. [52 FR 11026, Apr. 7, 1987, as amended at 56 FR 66784, Dec. 26, 1991]