Regulation Text
(a) FDA will grant the request for addition of a new animal drug to the index if none of the reasons described in § 516.149 for denying such a request applies.
(b) When a request for addition of a new animal drug to the index is granted, FDA will notify the requestor in accordance with § 516.153 .
Authority
21 U.S.C. 360ccc-1,360ccc-2,371.