Yes, FDA requires that animal-derived ingredients be controlled in a manner to ensure 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 (FD&C Act) section 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 (API)).

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 from byproducts of food production and include extractions from certain animal material and 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 ICH guidance for industry Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

Ingredient manufacturers are responsible for the quality and safety of the material they produce for use in finished pharmaceuticals. Ingredients are drugs and drugs are required to conform with current good manufacturing practice (FD&C Act, section 501(a)(2)(B)). Finished pharmaceutical manufacturers are also responsible for their selection, qualification, and use of ingredients in finished pharmaceuticals (e.g., the CGMP regulations at 21 CFR part 211, subpart E). Ingredient and finished pharmaceutical manufacturers should fully understand the potential for pathogenic agent contamination beginning with the livestock processing establishment (LPE) and continuing through subsequent handling and processing, and establish stringent controls to prevent contamination. It is also essential that appropriate tests or examinations are developed and applied to detect contamination as part of any meaningful control program.