Regulations last checked for updates: May 02, 2024

Title 9 - Animals and Animal Products last revised: Apr 22, 2024
§ 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]
authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4
source: 34 FR 18004, Nov. 7, 1969, unless otherwise noted.
cite as: 9 CFR 113.50