Shipment of experimental biological products.

CFR · 2024-01-01 · US · Title 9

Except as provided in this section, no person shall ship or deliver for shipment in or from the United States, the District of Columbia, or any Territory of the United States any unlicensed biological product for experimental use in animals. For the benefit of license applicants and to permit and encourage research, a person may be authorized by the Administrator to ship unlicensed biological products for the purpose of evaluating such experimental products by treating limited numbers of animals, (a) One copy of a permit or letter of permission from the proper State or foreign animal health authorities of each State or foreign country involved. (b) Two copies of a tentative list of the names of the proposed recipients and quantity of experimental product that is to be shipped to each individual. In the event of subsequent changes, additional information shall be furnished when such facts are known; (c) Two copies of a description of the product, recommendations for use, and results of preliminary research work; (d) A copy of the labels or label sketches which show the name or identification of the product and bear the statement “Notice! For experimental use only-Not For Sale” or equivalent. Such statement shall appear on final container labels, except that it may appear on the carton in the case of very small final container labels and labeling for diagnostic test kits. The U.S. Veterinary License legend shall not appear on such labels; and (e) Two copies of a proposed genera

official document · source cfr-2024 · id 9:§ 103.3