Drug And Feed Additives

(1) Prior to approval of a registration application and/or approval of a label for commercial feed which contains additives (including drugs, other special purpose additives, or nonnutritive additives) the distributor may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions on the label. (2) Satisfactory evidence of safety and efficacy of a commercial feed may be: (a) When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in the Code of Federal Regulations, Title 21, or which are “prior sanctioned” or “generally recognized as safe” for such use, or (b) When the commercial feed is itself a drug as defined in Section 3 (g) of the Act and is generally recognized as safe and effective for the label use or is marketed subject to an application approved by the Food and Drug Administration under Title 21 U.S.C. 360(b).