Yes, FDA requires that animal-derived ingredients be controlled in a manner to assure that contamination does not occur, beginning with initial collection and handling of the animal-derived material through its processing and subsequent use in a finished pharmaceutical. See, for example, the Federal Food, Drug, and Cosmetic Act sections 501(a)(2)(A) and 501(a)(2)(B).
FDA has special concerns regarding the vulnerability of animal-derived ingredients to contamination by pathogenic agents (i.e., agents that can cause disease or illness in humans or other animals). As background, ingredients are also called “components,” and there are two categories of components used in finished pharmaceutical production: inactive ingredient (often called excipients) and active ingredient (often called Active Pharmaceutical Ingredient). For the purpose of this guidance, an animal-derived ingredient is a substance of animal origin used to manufacture a drug product. They are primarily derived by-products of food production and include extractions certain animal material, and include milked animal fluids (e.g., venoms) and may even be human-derived. Products of animal cell cultures, including monoclonal antibodies and therapeutic proteins, are not considered animal-derived APIs for the purpose of this guidance. For additional information concerning biotechnology, products refer to Guidance for Industry, Q5A Viral Safety Evaluation of Biotechnology Products Derived Cell Lines of Human or Animal Origin.
