Products for treatment of failure of passive transfer.

CFR · 2024-01-01 · US · Title 9

A product for the treatment of failure of passive transfer (FPT) shall contain a specified minimum quantity of IgG per dose and shall be recommended for use only in neonates of the same species as that of antibody origin. A product for oral administration shall not be recommended for use in animals more than 24 hours of age, while one for parenteral administration shall only be recommended for use in neonatal animals. Each serial shall meet the applicable general requirements provided in § 113.450 and be tested for potency as provided in this section. Any serial found unsatisfactory by a prescribed test shall not be released. (a) (1) At least 20 newborn, colostrum-deprived animals of the species for which the product is recommended shall be randomly selected. (2) Blood samples shall be taken from each animal. (3) Each animal shall be administered one dose of reference by the recommended route and shall be observed for 24 hours. (i) Any adverse reactions shall be recorded. (ii) The dosage of reference administered to each animal shall be in accordance with label directions. Label directions may indicate a single dosage regardless of weight, in which case the animals in the study shall be at or near the maximum weight for neonates of the species. (4) After 24 hours, blood samples shall be taken from each animal. (5) Pretreatment and post treatment serum IgG concentrations shall be concurrently determined for each animal using a radial immunodiffusion (RID) method acceptable to

official document · source cfr-2024 · id 9:§ 113.499