Current through 2024-51, December 18, 2024
Section 001-311-8 - Drug and Feed AdditivesA. Prior to approval of a registration application and/or approval of a label for commercial feed which contain additives (including drugs, other special purpose additives, or non-nutritive 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 furnished on the label.B. Satisfactory evidence of safety and efficacy of a commercial feed maybe: 1. 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, or2. When the commercial feed is itself a drug as defined in Section 712(7) of the Act and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the Food and Drug Administration under Title 21 U.S.C. 360(b).01-001 C.M.R. ch. 311, § 8