Sampling of biological products.

CFR · 2024-01-01 · US · Title 9

Each licensee and permittee shall furnish representative samples of each serial or subserial of a biological product manufactured in the United States or imported into the United States as prescribed in this section. Additional samples may be purchased in the open market by a Animal and Plant Health Inspection Service representative. (a) Either an employee of the Department of Agriculture, of the licensee, or of the permittee, as designated by the Administrator shall select prerelease (1) Selection shall be made as follows: (i) Nonviable liquid biological products—either bulk or final container samples of completed product shall be selected for purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi. (ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the end of the filling operation. Bulk containers of completed product may be sampled when authorized by the Administrator. (iii) Desiccated biological products; samples shall be in final containers and shall be randomly selected if desiccated in the final container. Biological products desiccated in bulk shall be sampled at the end of the filling operation. (iv) Representative samples of each serial or subserial in each shipment of imported biological products shall be selected. (2) Comparable samples shall be used by Animal and Plant Health Inspection Service, the licensee, and the permittee for si

official document · source cfr-2024 · id 9:§ 113.3