recommended or suggested in the proposed labeling. In addition, methods , facilities and controls used for the manufacturing , processing and packaging of the drug must be shown to be adequate to preserve its identity , strength , quality and purity. for food-animal products safety include safety of drug residues in animal-derived food. Tolerances for residues in animal drugs in food may be found in 21. Safety would also includes an assessment of the effects of the proposed animal drug on the environment and human health.