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2009 California Food and Agricultural Code - Section 9241-9245 :: Article 5. Biologic Registration
FOOD AND AGRICULTURAL CODESECTION 9241-9245
9241. No person shall offer for sale or use any biologic unless it is registered by the director pursuant to this article, except, however, no such registration shall be required of any biologic manufactured pursuant to the terms of a valid license issued by the United States Department of Agriculture unless the director finds that, due to local conditions, it is necessary that the biologic be registered in order to assure that it have value for the purpose intended and it is safe to use in this state. 9242. The director shall register any biologic that meets all of the following requirements: (a) It is produced under acceptable procedures, which include tests to insure its purity and safety. (b) The production and use of such type of biologic has not been specifically forbidden or disapproved by the director, the United States Department of Agriculture, or the United States Public Health Service. (c) It has been demonstrated to the director that such a biologic is safe and noninjurious to human or animal health. (d) It has been demonstrated to the director that such a biologic is of value for the purpose intended. (e) It is labeled for proper handling and use, and is not misrepresented. (f) It is produced in an establishment that meets the requirements of subdivision (a) or (c) of Section 9211. 9243. The director shall register a biologic, if it is produced in an establishment exempt from licensing pursuant to subdivision (b) of Section 9211 and meets the requirements of subdivisions (a), (b), and (c) of Section 9242. 9244. An application for registration of a biologic shall include both of the following: (a) A protocol of methods of production in detail which is followed in the production of the product. (b) A sample of the label to be placed on the biologic. 9245. The director may impose such conditions on the production or use of biologics as he deems necessary to accomplish the purposes of this chapter.
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