Regulatory Outline in the

The regulatory authority for approving veterinary drugs in the United States resides with the Food and Drug Administration (FDA) Center for Veterinary Medi- 

To assist the animal health industry, the FDA has developed a set of general guidelines that may be used as an acceptable basis for determining drug safety 

From the results of the toxicological studies, a NOEL for the most sensitive species could be determined. This NOEL was used in the calculation of the tolerance according to the equation 

The food factors suggested by the FDA for various edible products of different animal species are given in Table 11.2 In cattle, the food factor for muscle is 1.0 but it is 0.5 for liver. Because of the halving of the food factor for liver, the tolerance in this tissue is twice the value of the tolerance in muscle. The food factor for swine liver is 0.33, indicating that swine liver si consumed less than beef liver. Poultry kidney is not given a factor because its consumption is insignificant in the human diet and it is usually removed with the viscera. 

If the drug is not a carcinogen, a NOEF will be determined from the noncarcinogenic toxicity endpoints. The NOEL is then used in calculation of the safe 

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