General requirements for antibody products.

CFR · 2024-01-01 · US · Title 9

Unless otherwise prescribed in a Standard Requirement or in a filed Outline of Production, all antibody products shall meet the applicable requirements of this section. (a) (b) (1) (2) (3) (4) (c) (1) No animal shall be used while showing clinical signs of disease. The presence of minor localized injuries or lesions (contusions, lacerations, burns, etc.) without body temperature elevation and without significant pain and distress shall not be construed as clinical evidence of disease. (2) Before first use and on a regular basis, all animals used in the manufacture of antibody products shall be individually subjected to applicable tests for infectious diseases. Records of all test results shall be maintained. An animal which tests positive for an infectious disease shall not be used in the manufacture of antibody products. Retests shall be conducted as deemed necessary by the Administrator. (i) Before first use, horses shall be tested as follows for: (A) Equine infectious anemia (EIA) at a laboratory approved by APHIS. (B) Piroplasmosis, dourine, and glanders at the National Veterinary Services Laboratories. (C) Brucellosis at a laboratory approved by APHIS. Horses with standard agglutination titers of 1:50 or less can be used for production. Horses with standard agglutination titers equal to or greater than 1:100 may be tested by the Rivanol or card tests. Reactors to these supplemental tests shall not be used for production. Nonreactors to the supplemental tests shall be ret

official document · source cfr-2024 · id 9:§ 113.450