Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 9 - Animals and Animal Products |
Chapter I - Animal and Plant Health Inspection Service, Department of Agriculture |
SubChapter E - Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors |
Part 113 - Standard Requirements |
Ingredient Requirements |
§ 113.50 - Ingredients of biological products.
Latest version.
-
§ 113.50 Ingredients of biological products.
All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be sufficiently nontoxic so that the amount present in the recommended dose of the product shall not be toxic to the recipient; and in the combinations used shall not denature the specific substances in the product below the minimum acceptable potency within the dating period when stored at the recommended temperature.
[38 FR 29889, Oct. 30, 1973]