9 CFR 113.50 : Animals And Animal Products (§ 1.1 To Parts 593-599) — (§ 1.1 To Parts 168-199) — Animal And Plant Health Inspection Service, Department Of Agriculture (§ 1.1 To Parts 168-199) — Viruses, Serums, Toxins, And Analogous Products; Organisms And Vectors (§ 101.1 To § 124.43) — Standard Requirements (§ 113.1 To § 113.499) — Ingredient Requirements (§ 113.50 To § 113.55) — 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.